Last update of the description by the manufacturer 07/13/2015

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Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

Compound

Film-coated tablets [set]
Drospirenone + ethinyl estradiol tablets	1 tab.
active substances:
drospirenone	3 mg
ethinylestradiol	0.02 mg
Excipients: lactose monohydrate - 48.53 mg; corn starch - 16.6 mg; pregelatinized corn starch - 9.6 mg; macrogol and polyvinyl alcohol copolymer - 1.45 mg; magnesium stearate - 0.8 mg
film sheath: Opadry II white 85G18490 (polyvinyl alcohol - 0.88 mg, titanium dioxide - 0.403 mg, macrogol 3350 - 0.247 mg, talc - 0.4 mg, soy lecithin - 0.07 mg) - 2 mg
placebo pills	1 tab.
MCC - 42.39 mg; lactose - 37.26 mg; pregelatinized corn starch - 9 mg; magnesium stearate - 0.9 mg; colloidal silicon dioxide - 0.45 mg
film sheath: Opadry II green 85F21389 (polyvinyl alcohol - 1.2 mg, titanium dioxide - 0.7086 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, indigo carmine - 0.0177 mg, quinoline yellow dye - 0.0177 mg, iron dye black oxide - 0.003 mg, dye "Sunset" yellow - 0.003 mg) - 3 mg

Description of the dosage form

Drospirenone + ethinylestradiol tablets: round, biconvex, film-coated, white or off-white, marked "G73" on one side of the tablet, applied by embossing.

Core:

Placebo tablets: round, biconvex, film-coated green.

Core: white or almost white.

pharmachologic effect

pharmachologic effect- contraceptive.

Pharmacodynamics

Dimia® is a combined monophasic oral contraceptive (COC) containing drospirenone and ethinyl estradiol. According to its pharmacological profile, drospirenone is close to natural progesterone - it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid effect. The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. Pearl index - an indicator that reflects the frequency of pregnancy in 100 women of reproductive age during the year of using a contraceptive - less than 1.

Pharmacokinetics

Drospirenone

Suction. When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. C max drospirenone in serum - about 38 ng / ml, is achieved approximately 1-2 hours after a single dose. Bioavailability - 76-85%. Simultaneous administration with food does not affect the bioavailability of drospirenone.

Distribution. After oral administration, the concentration of drospirenone in the blood plasma decreases with a final T 1/2 - 31 hours. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The average apparent V d of drospirenone is (3.7 ± 1.2) l / kg.

Metabolism. Drospirenone is extensively metabolized after oral administration. The main metabolites in blood plasma - acidic forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate - are formed without the participation of the P450 system. Drospirenone is metabolized to a small extent by cytochrome P450 3A4 and is able to inhibit this enzyme, as well as cytochromes P450 1A1, P450 2C9 and P450 2C19 in vitro.

Withdrawal. Renal clearance of drospirenone metabolites in serum is (1.5±0.2) ml/min/kg. Drospirenone is excreted only in trace amounts unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines with an excretion ratio of about 1.2:1.4. T1 / 2 metabolites by the kidneys and through the intestines is about 40 hours.

C ss . During the treatment cycle, the maximum C ss of drospirenone in plasma is about 70 ng / ml, which is achieved after 8 days of treatment. Serum concentrations of drospirenone increase approximately 3-fold due to the ratio of the final T 1/2 and dosing interval.

Ethinylestradiol

Suction. When taken orally, ethinylestradiol is absorbed rapidly and completely. C max in blood serum is about 33 pg / ml, achieved within 1-2 hours after a single oral administration. Absolute bioavailability as a result of first-pass conjugation and first-pass metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinylestradiol in approximately 25% of the examined patients; there were no other changes.

Distribution. Serum concentrations of ethinylestradiol decrease biphasically, in the final distribution phase T 1/2 is approximately 24 hours. Ethinylestradiol binds well, but non-specifically, to serum albumin (approximately 98.5%) and induces an increase in SHBG serum concentrations. V d - about 5 l / kg.

Metabolism. Ethinylestradiol is a substrate for presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing a wide range of hydroxylated and methylated metabolites, which are present both in free form and as conjugates with glucuronic acid. The renal clearance of ethinylestradiol metabolites is approximately 5 ml/min/kg.

Withdrawal. Unchanged ethinylestradiol is practically not excreted from the body. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T 1/2 metabolites is about 24 hours.

C ss . It occurs in the second half of the treatment cycle, and the serum concentration of ethinylestradiol increases by 2-2.3 times.

Special patient groups

In violation of kidney function. C ss drospirenone in plasma in women with mild renal insufficiency (Cl creatinine - 50-80 ml / min) was comparable with the corresponding indicators in women with normal kidney function (Cl creatinine -> 80 ml / min). In women with moderate renal insufficiency (Cl creatinine from 30 ml / min to 50 ml / min), the plasma concentration of drospirenone was on average 37% higher than in women with normal renal function. Drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on the content of potassium in the blood serum. Pharmacokinetics in severe renal insufficiency has not been studied.

In violation of liver function. Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.

Indications for Dimia ®

Oral contraception.

Contraindications

Dimia ® , like other COCs, is contraindicated in any of the following conditions:

hypersensitivity to the drug or any of the components of the drug;

thrombosis (arterial and venous) and thromboembolism at present or in history (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders). Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris), currently or in history;

multiple or pronounced risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, extensive surgery with prolonged immobilization, smoking over the age of 35, obesity with a body mass index> 30;

hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antibodies against phospholipids (presence of antibodies to phospholipids - antibodies to cardiolipin, lupus anticoagulant);

pregnancy and suspicion of it;

lactation period;

pancreatitis with severe hypertriglyceridemia at present or in history;

existing (or history of) severe liver disease, provided that liver function is not currently normal;

severe chronic or acute renal failure;

a liver tumor (benign or malignant) at present or in history;

hormone-dependent malignant neoplasms of the genital organs or the mammary gland at present or in history;

bleeding from the vagina of unknown origin;

migraine with a history of focal neurological symptoms;

lactase deficiency, lactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency.

Carefully: risk factors for the development of thrombosis and thromboembolism - smoking under the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin); diseases in which peripheral circulation disorders can occur (diabetes mellitus without vascular complications, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins); hereditary angioedema; hypertriglyceridemia; severe liver disease (until normalization of liver function tests); diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy in history, minor chorea (Sydenham's disease); chloasma; postpartum period.

Use during pregnancy and lactation

Dimia ® is contraindicated during pregnancy. If pregnancy occurs during the use of the drug Dimia ® , it should be stopped immediately. Extended epidemiological studies have found neither an increased risk of birth defects in children born to women who took COCs before pregnancy, nor a teratogenic effect of COCs when taken unintentionally during pregnancy. According to preclinical studies, undesirable effects that affect the course of pregnancy and fetal development cannot be ruled out due to the hormonal action of the active ingredients. The drug Dimia ® can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk while taking COCs. These amounts may affect the child. The use of the drug Dimia ® during breastfeeding is contraindicated.

Side effects

The following adverse events have been reported while taking Dimia ® (see table).

Organ system class	Frequent (≥1/100 to<1/10)	Less frequent (≥1/1000 to<1/100)	Rare (≥1/10000 up to<1/1000)
Infections and infestations	—	—	Candidiasis, incl. oral cavity
From the blood and lymphatic system	—	—	Anemia, thrombocytopenia
From the side of the immune system	—	—	Allergic reaction
From the side of metabolism and nutrition	—	Weight gain	Increased appetite, anorexia, hyperkalemia, hyponatremia, weight loss
From the side of the psyche	Emotional lability	Depression, decreased libido, nervousness, drowsiness	Anorgasmia, insomnia
From the side of the nervous system	Headache	Dizziness, paresthesia	Vertigo, tremor
From the organ of vision	—	—	Conjunctivitis, dryness of the mucous membrane of the eye, visual disturbances
From the side of the heart	—	—	Tachycardia
From the side of the vessels		Migraine, varicose veins, increased blood pressure	Phlebitis, vascular lesions, epistaxis, syncope
From the gastrointestinal tract	Nausea, abdominal pain	Vomiting, diarrhea
From the side of the liver and biliary tract	—	—	Gallbladder pain, cholecystitis
From the skin and subcutaneous tissue	—	Rash (including acne), itching	Chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, skin lesions, skin stretch marks, contact dermatitis, photodermatitis, skin nodules
From the musculoskeletal and connective tissue	—	Back pain, limb pain, muscle cramps
From the reproductive system and mammary gland	Chest pain, no withdrawal bleeding	Vaginal candidiasis, pelvic pain, breast enlargement, breast fibrocystic disease, vaginal discharge, flushing, vaginitis, acyclic spotting, painful menstrual bleeding, heavy withdrawal bleeding, scanty menstrual bleeding, dryness of the vaginal mucosa, changes in the cytological picture in a smear Papanicolaou	Painful intercourse, vulvovaginitis, postcoital bleeding, breast cyst, breast hyperplasia, breast cancer, cervical polyps, endometrial atrophy, ovarian cyst, uterine enlargement
General disorders and disorders at the injection site		Asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema)	Feeling uncomfortable

Women using COCs have experienced the following serious adverse events:

Venous thromboembolic diseases;

Arterial thromboembolic diseases;

Tumors of the liver;

The occurrence or exacerbation of conditions for which the connection with the use of COCs has not been proven: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, SLE, herpes during a previous pregnancy, rheumatic chorea, hemolytic uremic syndrome, cholestatic jaundice;

Chloasma;

Acute or chronic liver disease may necessitate discontinuation of COCs until liver function tests return to normal;

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate the symptoms of angioedema.

Interaction

Note: Before taking concomitant medications, you should read the instructions for use of the drug to identify potential interactions.

The influence of other drugs on the drug Dimia ® . Interactions between oral contraceptives and other drugs may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature.

The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and St. John's wort preparations ( Hypericum perforatum) is based on the ability of these active substances to induce microsomal liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.

Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is unclear. Women with short-term treatment (up to one week) with any of the above groups of drugs or monopreparations should temporarily use (during the period of simultaneous administration of other drugs and for another 7 days after its completion), in addition to COCs, barrier methods of contraception.

Women receiving rifampicin therapy, in addition to taking COCs, should use a barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medications last longer than the expiration date of the active tablets in the package, the inactive tablets should be discontinued and the drospirenone + ethinyl estradiol tablets should be started immediately from the next package.

If a woman is constantly taking microsomal liver enzyme inducers, she should use other reliable non-hormonal methods of contraception.

The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system. Cytochrome P450 inhibitors are therefore unlikely to interfere with the metabolism of drospirenone.

Effect of Dimia ® on other drugs . Oral contraceptives may affect the metabolism of some other active substances. Accordingly, plasma or tissue concentrations of these substances can either increase (eg, cyclosporine) or decrease (eg, lamotrigine). Based on inhibition studies in vitro and interactions in vivo in female volunteers taking omeprazole, simvastatin and midazolam as a substrate, the effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.

Other interactions. In patients without renal insufficiency, the simultaneous use of drospirenone and ACE inhibitors or NSAIDs does not significantly affect the content of potassium in the blood serum. But still, the simultaneous use of the drug Dimia ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, it is necessary to control the concentration of serum potassium.

Laboratory tests. The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (transporter) concentrations, such as corticosteroid-binding proteins and lipid / lipoprotein fractions, parameters of carbohydrate metabolism and parameters of blood clotting and fibrinolysis . In general, the changes remain within the range of normal values. Drospirenone is the cause of an increase in plasma renin activity and, due to a small antimineralocorticoid activity, reduces the concentration of aldosterone in plasma.

Dosage and administration

inside, daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 table. per day. Taking pills from the next pack begins after taking the last pill from the previous pack. Withdrawal bleeding usually begins 2-3 days after the start of placebo tablets (last row) and does not necessarily end by the start of the next pack.

How to take Dimia ®

Hormonal contraceptives have not been used in the last month. Dimia ® is started on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). The start of the reception is possible on the 2-5th day of the menstrual cycle, in this case, additional use of a barrier method of contraception is necessary during the first 7 days of taking the tablets from the first package.

Switching from other combined contraceptives (COC tablets, vaginal ring or transdermal patch). Dimia ® should be started the next day after taking the last inactive tablet (for preparations containing 28 tablets) or the next day after taking the last active tablet from the previous package (possibly the next day after the end of the usual 7-day break) - for preparations containing 21 tab. packaged. If a woman uses a vaginal ring or transdermal patch, it is preferable to start taking Dimia® on the day of their removal or, at the latest, on the day when a new ring or patch is planned to be inserted.

Switching from progestogen-only contraceptives (mini-pills, injections, implants) or from an intrauterine system (IUD) that releases progestogens. A woman can switch from taking a mini-pill to taking Dimia ® on any day (from an implant or from an IUD on the day they are removed, from injectable forms of drugs on the day the next injection was due), but in all cases it is necessary use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy. Taking the drug Dimia ® can be started on the doctor's prescription on the day of termination of pregnancy. In this case, the woman does not need to take additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy. A woman is recommended to start taking the drug on the 21-28th day after childbirth (provided that she is not breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting Dimia ®. With the resumption of sexual activity (before the start of taking the drug Dimia ®), pregnancy should be excluded.

Taking missed pills

Skipping placebo tablets from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The indications below apply only to missed tablets containing the active ingredients.

If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible (as soon as she remembers) and the next pill at the usual time.

If the delay exceeds 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:

1. Taking pills should never be interrupted for more than 7 days.

2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

Accordingly, women can be given the following recommendations:

Days 1-7. A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. Then she should take her tablets at the usual time. In addition, for the next 7 days, a barrier method, such as a condom, should be used. If sexual intercourse has occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer this pass is to the 7-day break in taking the drug, the higher the risk of pregnancy.

Days 8-14. The woman should take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take her tablets at the usual time. If during the 7 days preceding the first missed pill, the woman took the pills as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier, such as a condom) is needed for 7 days.

Days 15-24. The reliability of the method inevitably declines as the placebo pill phase approaches. However, correcting the pill regimen can still help prevent pregnancy. If one of the two schemes described below is followed, and if the woman has observed the drug regimen in the previous 7 days before skipping the pill, there will be no need to use additional contraceptive measures. If this is not the case, she must complete the first of the two regimens and use additional precautions for the next 7 days.

1. A woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take the tablets at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next blister pack. Most likely, there will be no withdrawal bleeding until the end of the second pack, but there may be spotting or withdrawal bleeding on the days of taking the drug from the second pack.

2. A woman can also stop taking active tablets from the started package. Instead, she should take the placebo pills from the last row for 4 days, including the days she skipped pills, and then start taking the pills from the next pack.

If a woman missed pills and subsequently did not experience withdrawal bleeding during the placebo pill phase, the possibility of pregnancy should be considered.

The use of the drug in gastrointestinal upset

In case of severe gastrointestinal disorders (eg vomiting or diarrhea), the absorption of the drug will be incomplete and additional contraceptive measures will be required. If vomiting occurs within 3-4 hours after taking the active tablet, a new (replacement) tablet should be taken as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time. If more than 12 hours have passed, it is recommended to proceed according to the instructions for skipping tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from another pack.

Delay menstrual-like withdrawal bleeding

To delay bleeding, the woman should skip taking the placebo tablets from the started package and start taking the drospirenone + ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second pack run out. During the delay, a woman may experience acyclic profuse or spotting bleeding from the vagina. Regular intake of Dimia ® is resumed after the placebo phase. To shift bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When the cycle is shortened, it is more likely that the woman will not have menstrual-like withdrawal bleeding, but will have acyclic copious or spotting vaginal discharge on the next pack (same as with lengthening the cycle).

Overdose

Cases of overdose of Dimia ® have not yet been described.

Based on general experience with COC use, potential overdose symptoms may include: nausea, vomiting, slight bleeding from the vagina.

Treatment: there are no antidotes. Further treatment should be symptomatic.

special instructions

If there are any of the conditions/risk factors mentioned below, the benefits of taking COCs should be assessed individually for each woman and discussed with her before starting use. If an adverse event worsens or if any of these conditions or risk factors appear, the woman should contact her doctor. The doctor must decide whether to stop taking COCs.

Circulatory disorders

Taking any COC increases the risk of venous thromboembolism (VTE). The increase in the risk of VTE is most pronounced in the first year of COC use by a woman.

Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (<0,05 мг этинилэстрадиола) в составе КОК , составляет примерно 20 случаев на 100000 женщин-лет (для левоноргестрелсодержащих КОК второго поколения) или 40 случаев на 100000 женщин-лет (для дезогестрел/гестоденсодержащих КОК третьего поколения). У женщин, не пользующихся КОК , случается 5-10 ВТЭ и 60 беременностей на 100000 женщин-лет. ВТЭ фатальна в 1-2 % случаев.

Data from a large, prospective, 3-arm study showed that the incidence of VTE in women with or without other risk factors for VTE who used the combination of ethinyl estradiol and drospirenone 0.03+3 mg was the same as the incidence of VTE in women who used levonorgestrel-containing oral contraceptives and other COCs . The degree of risk of VTE while taking the drug Dimia ® is not currently established.

Epidemiological studies have also revealed an association between COC use and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).

Very rarely, thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidneys, brain or retina, has occurred in women taking oral contraceptives. There is no consensus regarding the relationship of these phenomena with the use of hormonal contraceptives.

Symptoms of venous or arterial thrombotic / thromboembolic events or acute disorders of cerebral circulation:

Unusual unilateral pain and / or swelling of the lower extremities;

Sudden severe chest pain, whether it radiates to the left arm or not;

sudden shortness of breath;

Sudden onset of cough;

any unusual severe prolonged headache;

Sudden partial or complete loss of vision;

Diplopia;

Impaired speech or aphasia;

Vertigo;

Collapse with or without partial epileptic seizures;

Weakness or very noticeable numbness, suddenly affecting one side or one part of the body;

Movement disorders;

Sharp belly.

A woman should consult with a specialist before taking COCs. The risk of venous thromboembolic disorders when taking COCs increases:

With increasing age;

Hereditary predisposition (VTE has ever happened to siblings or parents at a relatively early age);

Prolonged immobilization, advanced surgery, any surgical intervention on the lower extremities or major trauma. In such situations, it is recommended to stop taking the drug (in the case of a planned surgical intervention, at least 4 weeks in advance) and not resume until two weeks after the full restoration of mobility. If the drug has not been discontinued in advance, anticoagulant treatment should be considered;

Lack of consensus on the possible role of varicose veins and superficial thrombophlebitis in the appearance or exacerbation of venous thrombosis.

The risk of arterial thromboembolic complications or acute cerebrovascular accident when taking COCs increases:

With increasing age;

Smoking (women over 35 are strongly advised to stop smoking if they want to take COCs);

Dyslipoproteinemia;

arterial hypertension;

Migraines without focal neurological symptoms;

Obesity (body mass index over 30 kg/m2);

Hereditary predisposition (arterial thromboembolism ever in siblings or parents at a relatively early age). If a hereditary predisposition is possible, a woman should consult a specialist before taking COCs;

Damage to the heart valves;

Atrial fibrillation.

The presence of one major risk factor for venous disease or multiple risk factors for arterial disease may also be a contraindication. Anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their physician if symptoms of thrombosis are suspected. If thrombosis is suspected or confirmed, COC use should be discontinued. It is necessary to start adequate alternative contraception due to the teratogenicity of anticoagulant therapy with indirect anticoagulants - coumarin derivatives.

An increased risk of thromboembolism in the postpartum period should be taken into account.

Other medical conditions associated with adverse vascular events include diabetes mellitus, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency or severity of migraine while taking COCs may be an indication for their immediate abolition.

Tumors

The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of developing cervical cancer with long-term use of COCs, but conflicting opinions remain as to the extent to which these findings relate to concomitant factors, such as testing for cervical cancer or the use of barrier methods of contraception.

A meta-analysis of 54 epidemiological studies found a small increase in relative risk ( relative risk—RR\u003d 1.24) development of breast cancer in women who are currently taking COCs. The risk gradually decreases over 10 years after stopping COC use. Since breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of developing breast cancer. These studies did not find sufficient evidence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both. Diagnosed breast cancer in women who have ever taken COCs was clinically less severe, due to the early diagnosis of the disease.

Rarely, benign liver tumors and even more rarely, malignant liver tumors have occurred in women taking COCs. In some cases, these tumors were life-threatening (due to intra-abdominal bleeding). This should be taken into account when making a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Other

The progestogen component of Dimia® is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in potassium is not expected. However, in a clinical study in some patients with mild or moderate kidney disease who were taking potassium-sparing drugs, serum potassium levels increased slightly while taking drospirenone. Therefore, it is recommended to monitor serum potassium during the first cycle of treatment in patients with renal insufficiency, in whom the serum potassium concentration was at the VGN level before treatment, and especially when taking potassium-sparing drugs at the same time. In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis may be increased when taking COCs. Although a slight increase in blood pressure was noted in many women taking COCs, a clinically significant increase was rare. Only in these rare cases is immediate discontinuation of COCs warranted. If, when taking COCs in patients with concomitant arterial hypertension, blood pressure constantly increases or significantly elevated blood pressure cannot be corrected with antihypertensive drugs, COCs should be discontinued. After normalization of blood pressure with antihypertensive drugs, COC use can be resumed.

The following diseases appeared or worsened both during pregnancy and when taking COCs: jaundice and / or itching associated with cholestasis, gallstones; porphyria; SLE; hemolytic-uremic syndrome; rheumatic chorea (Sydenham's chorea); herpes during pregnancy; otosclerosis with hearing loss. However, the evidence for their association with COC use is inconclusive.

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of edema.

Acute or chronic liver disease may be an indication to stop taking COCs until liver function tests return to normal. Recurrence of cholestatic jaundice and/or cholestasis-related pruritus, which developed during a previous pregnancy or with earlier use of sex hormones, is an indication for discontinuation of COC use.

Although COCs may affect peripheral insulin resistance and glucose tolerance, changing the treatment regimen in patients with diabetes mellitus while taking COCs with low levels of hormones (containing<0,05 мг этинилэстрадиола) не показано. Однако следует внимательно наблюдать женщин с сахарным диабетом, особенно на ранних стадиях приема КОК .

Exacerbation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis was observed during COC use.

Chloasma may occur from time to time, especially in women who have a history of chloasma of pregnancy. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet light while taking COCs.

Drospirenone + ethinyl estradiol coated tablets contain 48.53 mg lactose monohydrate, placebo tablets contain 37.26 mg anhydrous lactose per tablet. Patients with rare hereditary diseases (such as galactose intolerance, lactase deficiency or malabsorption of glucose-galactose) who are on a lactose-free diet should not take this drug.

Women who are allergic to soy lecithin may experience allergic reactions.

The efficacy and safety of Dimia ® as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years, the efficacy and safety of the drug are similar to those in women after 18 years. The use of the drug before the establishment of menarche is not indicated.

Medical examinations

Before you start taking or re-using Dimia ®, you should collect a complete medical history (including family history) and exclude pregnancy. It is necessary to measure blood pressure, conduct a medical examination, guided by contraindications and precautions. A woman needs to be reminded of the need to carefully read the instructions for use and adhere to the recommendations indicated in it. The frequency and content of the survey should be based on existing practice guidelines. The frequency of medical examinations is individual for each woman, but should be carried out at least once every 6 months.

A woman needs to be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may decrease, for example, if you skip taking drospirenone + ethinylestradiol tablets, gastrointestinal disorders during the period of taking drospirenone + ethinylestradiol tablets, or while taking other drugs.

Insufficient cycle control

As with other COCs, women may experience acyclic bleeding (spotting or withdrawal bleeding), especially in the first months of use. Therefore, any irregular bleeding should be assessed after a three-month adjustment period.

If acyclic bleeding recurs or begins after several regular cycles, the possibility of developing non-hormonal disorders should be considered and measures should be taken to exclude pregnancy or cancer, including therapeutic and diagnostic curettage of the uterine cavity. Some women do not experience withdrawal bleeding during the placebo phase. If the COC was taken in accordance with the instructions for use, then it is unlikely that the woman is pregnant. However, if the rules of admission were violated before the first missed menstrual-like withdrawal bleeding or two bleedings were missed, pregnancy should be excluded before continuing to take COCs.

Dosage form

Film-coated tablets, 3mg/0.02mg

Compound

One tablet contains

active substances: crystalline drospirenone 100% 3 mg and micronized ethinyl estradiol 100% 0.02 mg,

Excipients: lactose monohydrate, corn starch, pregelatinized starch, macrogol and polyvinyl alcohol copolymer, magnesium stearate,

film coating composition: Opadry II white 85G18490: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, lecithin (soy),

placebo composition: microcrystalline cellulose, type 12, anhydrous lactose, pregelatinized starch, magnesium stearate, colloidal anhydrous silica,

composition of the film coating (placebo): Opadry II green 85F21389: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine (E 132), quinoline yellow (E 104), iron oxide black (E 172), sunset yellow (E 110).

Description

Tablets, round, biconvex, film-coated, white or off-white, debossed on one side with "G73"

Tablets, film-coated green, round, with a biconvex surface (placebo).

Pharmacotherapeutic group

Hormonal oral contraceptives. Progestogens and estrogens (fixed combinations).

ATX code G03AA12

Pharmacological properties

Pharmacodynamics

Pearl Index: 0.31 (upper 95% confidence interval: 0.85).

The contraceptive effect of the drug is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the endometrium.

DIMIA® 24+4 is a combined oral contraceptive (COC) with a combination of ethinyl estradiol and the progestin drospirenone. At a therapeutic dose, drospirenone also has antiandrogenic and weak antimineralocorticoid effects. It does not have estrogenic, glucocorticoid and antiglucocorticoid activity. Thus, drospirenone has a pharmacological profile similar to the natural hormone progesterone.

In clinical studies, it was found that the antimineralocorticoid properties of the drug DIMIA® lead to a weak antimineralocorticoid effect.

It has antiandrogenic activity, which leads to a decrease in the formation of acne and a decrease in the production of sebaceous glands, does not affect the increase in the formation of globulin that binds sex hormones (inactivation of endogenous androgens) caused by ethinylestradiol.

Indications for use

oral contraception

The drug has a positive effect on the symptoms associated with fluid retention in the body, as well as on acne and seborrhea, due to its antimineralocorticoid and antiandrogenic action.

Dosage and administration

Tablets should be taken every day at about the same time, if necessary, with a small amount of liquid, in the sequence indicated on the package. It is necessary to take one tablet a day for 28 days in a row. Each next pack should begin after taking the last tablet from the previous pack. Withdrawal bleeding usually starts 2-3 days after taking the placebo pills (last row) and may not be over by the time the next pack is started.

If you have not used hormonal contraceptives before (in the last month)

DIMIA® is started on the first day of a woman's natural menstrual cycle (that is, on the first day of her menstrual bleeding).

If you change another COC, vaginal ring or transdermal patch

It is preferable for a woman to start taking DIMIA® the day after the usual hormone-free interval in the regimen of the previous combined contraceptive. When replacing the vaginal ring or transdermal patch, it is advisable to start taking DIMIA® on the day of their removal of the previous agent; in such cases, DIMIA® should be started no later than the day of the scheduled replacement procedure.

When replacing a progestin-only method (mini-pills, injectables, implants) or an intrauterine system (IUS) with progestin release

A woman can switch from the minipill any day (from the implant or IUS on the day it was removed, from the injectable from the day the next injection was due). However, in all these cases, it is desirable to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester

A woman can start taking immediately. Under this condition, there is no need for additional contraceptive measures.

After childbirth or termination of pregnancy in the second trimester

It is desirable for a woman to start taking the drug DIMIA® on the 21-28th day after childbirth or termination of pregnancy in the second trimester. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. If there is sexual intercourse before taking the drug, pregnancy should be excluded or it is necessary to wait for the first menstruation.

Taking missed pills

Skipping a placebo tablet from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The instructions below apply only to missed active tablets:

If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next pill at the usual time.

If the delay in taking the tablets was more than 12 hours, contraceptive protection may be reduced. Correction of missed tablets should be guided by the following two simple rules:

1. Taking pills should not be stopped for more than 7 days;

2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

Accordingly, in daily practice, the following advice can be given:

Week 1

You should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. In addition, a barrier method of contraception must be used for the next 7 days. If sexual intercourse took place within 7 days before missing the tablet, the possibility of pregnancy must be considered. The more pills missed and the closer this pass is to the 7-day break in taking the drug, the higher the risk of pregnancy.

Week 2

You should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. If a woman has taken the pills correctly during the previous 7 days, there is no need to use additional contraceptives. However, if she missed more than 1 tablet, extra precautions should be taken for the next 7 days.

Week 3

The likelihood of a decrease in the contraceptive effect is significant due to the approach of the placebo pill phase. However, by adjusting the pill schedule, a decrease in contraceptive protection can be prevented.

If you follow any of the following two tips, no additional methods of contraception will be needed if the woman has taken all the pills correctly in the previous 7 days before missing the pill. If this is not the case, she should follow the first of the two methods and also use additional precautions for the next 7 days.

1. Take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets are taken at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next package. Most likely, there will be no "withdrawal" bleeding until the end of the second pack, but there may be spotting spotting or breakthrough uterine bleeding on the days of taking the pills.

2. A woman can be advised to stop taking active tablets from the started package. Instead, she should take the placebo pills from the last row for 4 days, including the days she skipped the pills, and then start taking the pills from the next pack.

In the event of missed pills and no "withdrawal" bleeding in the placebo pill phase, pregnancy should be ruled out.

Tips for gastrointestinal disorders

In case of severe gastrointestinal reactions (such as vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be used.

In case of vomiting within 3-4 hours after taking the active tablet, a new replacement tablet should be taken as soon as possible. The next tablet, if possible, should be taken within 12 hours after the usual time of taking. If more than 12 hours are missed, if possible, it is necessary to follow the rules for taking the drug indicated in the section "Taking Missed Pills". If the patient does not want to change the normal mode of taking the drug, she must take an additional tablet (or several tablets) from another package.

How to Delay "Withdrawal" Bleeding

To delay the day of the onset of menstruation, it is necessary to skip taking the placebo tablets from the started package and start taking active DIMIA® 24+4 tablets from the new package without interrupting the intake. A delay is possible until the end of the tablets in the second package.

During the lengthening of the cycle, there may be spotting from the vagina or uterine breakthrough bleeding. Regular intake of DIMIA® 24+4 ends after the placebo phase.

To move the day of the start of menstruation to another day of the week of the usual schedule, shorten the upcoming phase of placebo tablets by as many days as necessary. The shorter the interval, the higher the risk that there will be no "withdrawal" bleeding, and spotting spotting and breakthrough bleeding will be noted during the reception of the second package (as in the case of a delay in the onset of menstruation).

Side effects

Often (> 1/100 do<1/10 )

Headache

Emotional lability, depression

Nausea

Menstrual disorders (metrorrhagia, amenorrhea), intermenstrual bleeding

Chest pain

Infrequently ( > 1/1 000 do <1/100)

Dizziness, migraine

Nervousness, drowsiness, decreased mood, paresthesia

Hypertension

Phlebeurysm

Soreness and tension of the mammary glands, fibrocystic changes in the mammary gland

Nausea, vomiting, gastritis, abdominal pain, dyspepsia, flatulence, diarrhea

Acne, pruritus, dry skin

Back pain, limb pain, muscle cramps

Decreased libido

Vaginal discharge, vaginal candidiasis, vaginal dryness, vaginitis

Menstrual irregularities (dysmenorrhea, hypomenorrhea, menorrhagia)

Asthenia, increased sweating, fluid retention in the body

Weight gain

Rarely ( > 1/10 000 do <1/1 000)

Weight loss

Increased appetite, anorexia

Hives

Anemia, thrombocytopenia

Hyperkalemia, hyponatremia

Anorgasmia, insomnia

Vertigo, tremor

Nosebleeds, fainting

Thromboembolism, venous thrombosis/thromboembolism, arterial thrombosis/thromboembolism

Conjunctivitis, dry eyes, poor contact lens tolerance

Tachycardia, arterial hypertension

Tumors of the liver

Crohn's disease, ulcerative colitis

Epilepsy

Endometriosis, uterine fibroids

porfiria

Systemic lupus erythematosus

Herpes pregnant

Chorea

Hemolytic uremic syndrome

cholestatic jaundice

Chloasma, dry skin, acne or contact dermatitis

Angioedema

Eczema, hypertrichosis, photodermatitis, erythema nodosum, erythema multiforme

Breast cyst, breast hyperplasia

Painful intercourse, postcoital bleeding, withdrawal bleeding, cervical polyps, endometrial atrophy, ovarian cyst, uterine enlargement

Increased libido

Contraindications

Pregnancy and lactation

Current or history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism)

Current or history of arterial thrombosis (eg, myocardial infarction) or prior conditions (eg, angina pectoris and transient ischemic attack)

Current or past cerebrovascular disease

Presence of severe or multiple risk factors for arterial thrombosis

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to APC (activated protein C, activated protein C), antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant)

Pancreatitis with severe hypertriglyceridemia, including history

Current or history of severe liver disease (before normalization of liver tests)

Severe chronic renal failure or acute renal failure

Liver tumors (benign or malignant), current or history

Hormone-dependent malignant diseases of the reproductive system (genital organs, mammary glands) or suspicion of them

Unexplained vaginal bleeding

Migraine with a history of local neurological symptoms

Hypersensitivity to the active substance or any of the excipients

- galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome

Drug Interactions

Metabolism in the liver

Some drugs, due to the induction of microsomal enzymes, are able to increase the clearance of sex hormones (hydantoin, phenytoin, barbiturates, primidone, carbamazepine and rifampicin; the same effect of oxycarbazepine, topiramate, felbamate, ritonavir, griseofulvin and herbal remedy based on St. John's wort (Hypericum perforatum) is also possible. induction of microsomal liver enzymes usually does not appear within 2-3 weeks, but may then persist for at least 4 weeks after discontinuation of drug therapy.

Possible effects of HIV protease inhibitors (eg ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and their combinations on hepatic metabolism have been reported.

enterohepatic recirculation

Co-administration with certain antibiotics, such as penicillins and tetracyclines, reduces the enterohepatic recirculation of estrogen, which can lead to a decrease in the concentration of ethinyl estradiol.

Women receiving any of the above classes of drugs or individual active substances should use a barrier method of contraception in addition to DIMIA®, or switch to any other method of contraception. Women receiving permanent treatment with drugs containing active substances that affect liver enzymes must additionally use a non-hormonal method of contraception within 28 days after their withdrawal.

Women receiving rifampicin therapy should use a barrier method of contraception in addition to taking COCs and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medication lasts longer than the expiration date of the active tablets in the package, the placebo tablets should be discarded and the active tablets from the next package should be started immediately.

The basic metabolism of drospirenone in human plasma is generated without the involvement of the cytochrome P450 system. Inhibitors of this enzyme system, therefore, do not affect the metabolism of drospirenone.

Effect of DIMIA® on other medicinal products

Oral contraceptives may interfere with the metabolism of certain other active compounds. In addition, their concentrations in plasma and tissues can change - both increase (for example, cyclosporine) and decrease (for example, lamotrigine).

In female volunteers taking omeprazole, simvastatin and midazolam as indicator substrates, the effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.

Other interactions

In patients with renal insufficiency, the simultaneous administration of drospirenone and ACE inhibitors or NSAIDs (non-steroidal anti-inflammatory drugs) does not significantly affect the level of potassium in the blood serum. However, the concomitant use of DIMIA® and aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, it is necessary to study the level of potassium in the serum during the first cycle of taking the drug.

Note: Co-administration of drugs should be discussed to identify possible drug interactions.

Laboratory research

Hormone use for contraception may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, as well as levels of plasma transport proteins such as corticosteroid-binding globulin and lipid / lipoprotein fractions, indicators of carbohydrate metabolism, coagulation and fibrinolysis. Changes usually occur within laboratory norms.

Due to its small antimineralocorticoid activity, drospirenone increases the activity of renin and plasma aldosterone.

special instructions

Precautionary measures

If any of the conditions/risk factors listed below are currently present, then the potential risk and expected benefit of COC use should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, worsen, or appear for the first time, the woman should consult her doctor, who can decide whether to discontinue COCs.

Circulatory system disorders

Epidemiological studies have shown that the incidence of VTE (venous thromboembolism) in women without risk factors for VTE taking low-dose estrogen combined oral contraceptives (<50 мкг этинилэстрадиола) составляет примерно от 20 случаев на 100 000 женщин в год (для левоноргестрел-содержащих КОК «второго поколения» или до 40 случаев на 100 000 женщин в год (для дезогестрел/гестоден-содержащих КОК «третьего поколения»). Это сравнимо с цифрами от 5 до 10 случаев на 100 000 женщин, не использующих контрацептивы, и 60 случаев на 100 000 беременностей.

The use of any combined oral contraceptive is associated with an increased risk of venous thromboembolism comparable to that without use. The additional risk is highest during the first year of using a combined oral contraceptive. Venous thromboembolism is fatal in 1-2% of cases.

Epidemiological studies have also associated COC use with an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic attacks).

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, for example, hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described.

Symptoms of venous or arterial thrombosis/thromboembolism or cerebrovascular disease may include:

Unusual unilateral pain and/or swelling of a limb

sudden severe chest pain, with or without radiating to the left arm

sudden shortness of breath

sudden onset of coughing

any unusual, severe, prolonged headache

Sudden partial or complete loss of vision

diplopia

slurred speech or aphasia

· dizziness

Loss of consciousness with or without seizure

Weakness or severe loss of sensation that suddenly appears on one side or in one part of the body

movement disorders

symptom of "acute abdomen".

The risk of complications associated with venous thromboembolism when taking COCs increases:

· with age

in the presence of a family history (venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); if a hereditary predisposition is suspected, a woman needs to consult a specialist before prescribing COCs

after prolonged immobilization, major surgery, any operation on the legs or extensive trauma. In these situations, it is recommended to stop taking the drug (in the case of a planned operation, at least four weeks before it) and not resume taking it within two weeks after the end of immobilization. Additionally, it is possible to prescribe antithrombotic therapy if the pills were not stopped at the recommended time

obesity (body mass index over 30 mg/m²)

There is no consensus on the possible role of varicose veins and thrombophlebitis of superficial veins in the onset or progression of venous thrombosis.

The risk of arterial thromboembolic complications of thrombosis or cerebrovascular disease in women taking COCs is increased:

· with age

in smokers (women over 35 are strictly advised not to smoke if they want to use COCs)

with dyslipoproteinemia

with hypertension

with migraine

in diseases of the heart valves

in atrial fibrillation.

The presence of one of the major risk factors or multiple risk factors for arterial or venous disease, respectively, may be a contraindication. Women using COCs should immediately consult a doctor if symptoms of a possible thrombosis occur. In cases of suspected thrombosis or confirmed thrombosis, COC use should be discontinued. It is necessary to choose an adequate method of contraception due to the teratogenicity of anticoagulant therapy (coumarins).

An increased risk of thromboembolism in the postpartum period should be taken into account.

Other diseases that are associated with severe vascular disease include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of COCs (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

An increased risk of developing cervical cancer with long-term use of combined oral contraceptives has been reported in some epidemiological studies. Its connection with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these results relate to sexual behavior and other factors such as human papillomavirus (HPV).

A meta-analysis of 54 epidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were using combined oral contraceptives at the time of the study. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives. Breast cancer in women who have ever used combined oral contraceptives were clinically less pronounced than in women who have never used such drugs.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign liver tumors was observed, and in extremely rare cases, the development of malignant liver tumors. In some cases, these tumors lead to life-threatening intra-abdominal bleeding. In the case of severe pain in the abdomen, an enlarged liver, or signs of intra-abdominal bleeding, when conducting a differential diagnosis in a woman taking COCs, the likelihood of developing a liver tumor should be considered.

Other states

The progestin component in DIMIA® is an aldosterone antagonist with potassium-sparing properties. In most cases, potassium levels are not expected to increase. But in a clinical study in some patients with mild to moderate renal impairment, concomitant use of potassium-sparing drugs slightly increased serum potassium levels when taking drospirenone. Therefore, it is recommended to check the serum potassium level during the first cycle of treatment in patients with renal insufficiency, whose serum potassium level was at the upper limit of normal before treatment, and who are additionally using potassium-sparing drugs.

In women with hypertriglyceridemia, or a family history of this disease, an increased risk of pancreatitis cannot be excluded while taking combined oral contraceptives.

Although a slight increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically significant increases have been rare. Only in rare cases is immediate withdrawal of COCs justified. If, while taking COCs with existing arterial hypertension, persistently or significantly elevated blood pressure does not adequately respond to antihypertensive treatment, it is worth stopping taking COCs.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with the use of combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes pregnancy, hearing loss associated with otosclerosis. In women with a tendency to angioedema, exogenous estrogens may induce or exacerbate the symptoms of angioedema.

Acute or chronic liver dysfunction may require the withdrawal of COCs until liver function tests return to normal. Recurrent cholestatic jaundice and / or itching associated with cholestasis, which developed for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COCs.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using combined oral contraceptives (containing
< 0.05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться, особенно на ранней стадии приема КОК.

Cases of Crohn's disease and ulcerative colitis have also been described with the use of combined oral contraceptives, however, the relationship with the use of drugs has not been proven.

Worsening of endogenous depression, epilepsy, Crohn's disease, and ulcerative colitis has been reported with COCs.

In rare cases, chloasma may develop, especially in women with skin pigmentation during pregnancy. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

This medicinal product contains 48.53 mg of lactose per tablet, inactive tablets contain 37.26 mg of anhydrous lactose per tablet. Patients with rare hereditary galactose intolerance, lactase deficiency or malabsorption of glucose-galactose who are on a lactose-free diet should be aware of this. Women who are allergic to soy lecithin may experience mild allergic reactions.

Medical examinations/consultations

Before starting the use or resuming the use of the drug DIMIA®, a woman is recommended to undergo a thorough general medical examination (including anamnesis), to exclude pregnancy. Blood pressure should be measured and a physical examination performed. The doctor should be guided by contraindications to taking COCs and warnings. The woman should be instructed to read the summary carefully and follow the advice given. The frequency and nature of examinations should be based on certain practical guidelines and adapted to the characteristics of each woman.

Women should be warned that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced by missing pills, gastrointestinal disorders, or concomitant medication.

Reduced cycle control

While taking all combined oral contraceptives, irregular bleeding (spotting spotting or withdrawal bleeding) may occur, especially during the first months of use. Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. They may include scraping.

In some women, withdrawal bleeding may not develop during the pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if combined oral contraceptives have been taken irregularly before, or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take combined oral contraceptives.

Pregnancy and lactation

If pregnancy occurs while taking DIMIA®, the drug should be discontinued immediately. Conducted epidemiological studies have not revealed any increased risk during childbirth for children in women who took COCs before pregnancy, nor a teratogenic effect when COCs were inadvertently taken during pregnancy. Such studies with the drug have not been conducted.

COCs can affect lactation because they can reduce the amount and composition of breast milk. Thus, the use of COCs cannot be recommended until a lactating woman completely stops breastfeeding. Small amounts of contraceptive hormones or their metabolites may be excreted in milk during COC use. These quantities may have an effect on the child.

Features of the influence of the drug on the ability to drive a vehicle and potentially dangerous mechanisms

Storage conditions

Store in original packaging, protected from light, at a temperature between 15°C and 25°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiry date!

Content

Combined oral contraceptives are one of the most popular and sought-after types of protection against unwanted pregnancy. The use of such tablets is prescribed exclusively by a gynecologist, while the patient is monitored. Dimia becomes a good option for contraceptives - the instructions for using the drug will tell you in detail about the nuances of its effects, contraindications and other features of the reception.

Producer Dimia

The hormonal drug is produced by the world famous company Gedeon Richter. This company has been working in the field of pharmaceuticals since 1901, in the same year it was founded. The company is based in Hungary, in the city of Budapest. The company is engaged in the manufacture of not only hormonal contraception, but also other drugs. Particular attention is paid to the following areas of medicine:

• women Health;
• neurology;
• cardiovascular problems;
• over-the-counter drugs.

Contraceptive pills "Dimia" are of high quality, however, they must be taken according to the indications and instructions for use. Gedeon Richter is the choice of people who trust time-tested professional pharmaceuticals.

Pharmacotherapeutic group and properties

The drug belongs to the group of combined contraceptives aimed at protecting against unwanted pregnancy. This pharmacotherapeutic group includes drugs based on two active ingredients - gestagen and estrogen. Pharmacodynamic and pharmacokinetic properties of the drug are as follows:

1. Antimineralocorticoid action - prevents weight gain and prevents fluid retention in the body.
2. Antiandrogenic action - suppression of the effects of androgens on the body.
3. Ovulation suppression.
4. Changes in the properties of the secret of the cervix.
5. Improving the regularity of the menstrual cycle.

The drug "Dimia" is rapidly absorbed, regardless of the meal. Excretion of the substance occurs with the help of the kidneys and intestines after 40 hours. When used correctly according to the instructions, the tablets help to alleviate the painful condition of a woman before menstruation.

Composition of Dimia

Effective COCs "Dimia" are produced in tablet form. There are 28 tablets in a pack, 24 of which contain active substances, and the remaining 4 green tablets are auxiliary. You can often find the name "Dimia" 24 + 4, which indicates the number of active and inactive tablets.

Important! The inactive pills in contraceptive preparations are designed to regulate the menstrual cycle.

In the instructions for use, you can find the following information about the composition:

• drospirenone - an active substance that has an antiandrogenic effect;
• ethinylestradiol - a synthetic analogue of estradiol, contributes to the thickening of the endometrium;
• lactose monohydrate - used to fill the tablet;
• corn starch - fastens the components of the drug;
• macrogol and polyvinyl alcohol copolymer - help the tablet dissolve in water;
• magnesium stearate - gives the tablets shape.

Each tablet contains 3 mg of drospirenone and 0.02 mg of ethinyl estradiol. Inactive tablets consist of cellulose, starch, magnesium stearate and silicon dioxide.

Indications for use

Only a gynecologist prescribes the use of tablets, regardless of the reason for which Dimia was prescribed. You can start drinking tablets on your own only after fully reading the instructions for use.

The main indication for taking a contraceptive will be the ability to protect yourself from unwanted pregnancy. The drug is used as oral contraception - it must be taken orally with water. Often, doctors prescribe a remedy for medicinal purposes - to correct the hormonal background, eliminate pain before menstruation. You can learn more about the indications from the video

Contraindications to Dimia

Most hormonal contraceptives have contraindications. All prohibitions are indicated in the instructions, if the patient has negative symptoms or develops these conditions after taking, the tablets are canceled.

Contraindications to contraceptives "Dimia":

• venous thromboembolism;
• arterial thromboembolism;
• severe liver disease;
• acute or chronic renal failure;
• bleeding from the vagina for unknown reasons;
• the presence of malignant tumors of the liver;
• the presence of hormone-dependent tumors;
• pregnancy.

These conditions must be present in the anamnesis, then the use of "Dimia" is prohibited.

Attention! If side effects are observed at the start of the reception, then the gynecologist cancels contraception.

How to take Dimia

Start taking the remedy according to the instructions for use, drinking water. The drug must be drunk every day at the same time, following the arrows on the blister. The drug is designed for a menstrual cycle of 28 days, so it contains exactly 28 tablets.

How to take Dimia for the first time

If no oral contraceptives were used in the past month, then the medicine is taken from the first pill from the first day of the menstrual cycle. A woman chooses a convenient time for her, at which it is better to take the drug. Now this will need to be done daily.

It is necessary to constantly monitor the intake according to the instructions and do not skip active pills, otherwise you will have to take additional contraceptives. Hormonal pills "Dimia" begin to act from the first dose, so you can forget about condoms and other methods of protection against unwanted pregnancy.

How to drink Dimia green tablets

The green colored tablets do not contain the active substances drospirenone and ethinyl estradiol. On the blister, they are arranged in the direction of the arrows, starting with the 25th tablet and ending with the 28th tablet. After the 24th day of the cycle, the reliability of active tablets decreases, so the manufacturer uses a placebo.

Comment! Placebo tablets are needed in order not to miss a daily dose of the drug.

Skipping 1 green tablet "Dimia" does not entail anything. If, nevertheless, one inactive tablet was missed, it is recommended not to use it, but simply throw it away. Such a move will help not to get confused when taking the drug further. Often, menstruation occurs after taking a placebo.

What to do if you missed a tablet Dimia

There are several rules that will help a woman act competently if the Dimia tablet was missed. The missed pill should be drunk immediately, as soon as the woman remembered it, however, do not forget that the maximum dosage of the drug according to the instructions is no more than two units per day.

Depending on the day of the pass, the following recommendations will apply:

1. 1-7 days: the tablet is taken as soon as it is remembered. Further, the drug is drunk according to the established scheme. In addition, it is necessary to use a barrier method of contraception for the next 7 days.
2. 8-14 days: the tablet is taken immediately, even if it is necessary to drink 2 units at the same time. If a week before the pass, the medicine was taken according to the scheme, then it is not worth additional protection.
3. 15-24 days: the tablet is taken immediately, even if it is necessary to take 2 tablets. If the intake regimen was observed 7 days before the pass, additional contraception is not required. If before that there were the same gaps, then it is recommended not to take inactive tablets from the last row, but to start a new pack.

Advice! By following the instructions for using Dimia tablets, following the recommended scheme for skipping, you can prevent unwanted pregnancy.

How much can you drink Dimia without a break

In numerous sources, you can find information that taking hormonal contraceptives is harmful to a woman's health with prolonged use. The instruction to the drug says the opposite: they can be taken for a long period of time.

You can take the drug without interruption, like other combined hormonal drugs for a long time. Some women take the medicine for 5 years and feel great: the menstrual cycle is getting better, the pain goes away, there is no need to think about additional contraception. The drug is not suitable for other women, side effects occur, the doctor cancels the remedy.

When you can not use protection with Dimia

The hormonal drug "Dimia" was created so that sexual partners are not protected during sex. But pills will be effective only in such cases:

• in full compliance with the instructions for use;
• in the absence of contraindications;
• in the absence of passes.

If a girl starts to skip taking the drug, there is a high chance of pregnancy: then the use of additional barrier-type contraceptives cannot be avoided. If the patient strictly adheres to the regimen, you can forget about condoms.

Pregnancy after Dimia

Conception after taking occurs during the period of drug withdrawal. As a rule, the lack of protection makes itself felt: unprotected intercourse threatens with an early pregnancy. However, doctors do not recommend rushing with fertilization, because the body is in a stage of hormonal stress after the abolition of oral contraception.

According to the reviews of the girls, pregnancy after cancellation occurred on the 2nd month, although doctors recommend waiting at least 3-4 months. This is necessary in order for the female body to rest and recover after taking hormones. By allowing the body to adjust to the previous hormonal background, a woman contributes to the natural preparation for conception.

Side effects of Dimia

The manufacturer in the instructions indicates that side effects may occur during use. The probability of their manifestation is small, but still a small percentage exists:

1. Gastrointestinal: weight gain, anorexia, nausea, diarrhea, increased appetite.
2. allergic reactions from the immune system.
3. Nervous system: changeable mood, headaches, dizziness, nervousness, insomnia, rarely - lack of orgasm.
4. Vessels: migraine, varicose veins, rarely - fainting.
5. Reproductive system: chest pain, lack of menstruation after withdrawal, pelvic pain, painful menstruation.

According to statistics, some women had venous and arterial thromboembolic diseases.

Is it possible to get fat from Dimia

It is necessary to purchase, use hormonal contraceptives only as prescribed by a doctor and according to the instructions for use. This helps to avoid unwanted side effects such as weight gain. According to statistics, hormonal tablets "Dimia" in rare cases can cause weight gain.

Women note a slight increase in appetite, which contributes to weight gain by 2-3 kg. However, this side effect is not observed in every girl. Some patients do not notice that weight gain occurred for a different reason, however, they associate this phenomenon with taking the drug. According to the reviews, the weight gained in the first month after taking it was later successfully eliminated.

Chest pain from Dimia

Another most common side effect is breast pain. This phenomenon occurs for the following reasons:

• breast augmentation;
• approaching menstruation;
• the presence of diseases of the mammary glands.

If all the tests carried out showed that the listed conditions are absent and the chest hurts precisely from birth control pills, the doctor should cancel and prescribe another drug to the patient. Breast pain may be associated with hormonal changes and adaptation, then they disappear next month and the woman continues treatment.

Special instructions and precautions

It is necessary to take contraception only according to the instructions, which also indicate special cases when caution should be exercised:

• smoking women under 35;
• tendency to obesity;
• arterial hypertension;
• migraine;
• heart defects;
• predisposition to thrombosis.

All of these conditions can lead to the appearance of thromboembolism, which significantly worsens the patient's condition when taking the medicine. In addition, with caution, it is necessary to take the remedy for those women who have developed various diseases after taking other COCs.

Drug Interactions

Many girls are interested in the issue of interaction with other drugs. The manufacturer in the instructions for use indicates the following information:

1. Primidone, barbiturates and phenytoin have a weakening effect of contraception. This also includes preparations containing St. John's wort.
2. Substances that increase or decrease the concentration of estrogens are inhibitors of proteases of HIV or hepatitis C virus.
3. Preparations containing itraconazole, clarithromycin, erythromycin, grapefruit juice can increase the concentration of estrogens in the blood plasma.

Important! While taking drugs that reduce the effect, you should consult your doctor for the possible additional prescription of other contraceptives.

Dimia and alcohol

The compatibility of Dimia and alcohol should not be in doubt, because both substances are absorbed and processed separately. However, with simultaneous use, there is a strong load on the liver, where processing takes place. Take "Dimia" and alcohol is not worth it for the following reasons:

• there may be an increase in side effects;
• the effectiveness of the drug may decrease.

If it is impossible to give up alcohol in certain situations, then it is recommended to take alcohol 3 hours after the pill.

Dimia and smoking

As mentioned above, smoking is not desirable for women under 35 years of age while taking contraceptives. This combination not only harms the general health of a woman, but increases the risk of thrombosis. Women who have a history of problems with blood vessels need to be extremely careful, because smoking makes it difficult for blood to move through the veins. All listed risks can be read in the instructions for use.

Terms and conditions of storage

Tablets "Dimia", photos of which can be seen in this material, are dispensed in pharmacies by prescription. Storage recommendations would be:

• storage is carried out no more than 2 years;
• it is necessary to store the drug in a dark place;
• it is not allowed to store the contraceptive in a place accessible to children.

After the expiration date of the storage period, the medicine can not be used, which is indicated in the instructions for use. Expiration dates can be seen on the pack of the drug, as well as on the blister with tablets.

Price Dimia in pharmacies

The cost of Dimia will vary according to the points of sale: you can buy the drug in city pharmacies and online. Hormonal pills are sold in small and large packs, designed for several months of admission:

1. 28 pieces in a pack - from 640 to 720 rubles.
2. 84 pieces in a pack - from 1600 to 1800 rubles.

It is recommended to purchase a large pack if the woman has passed the adaptation period without side effects. A doctor for medicinal purposes can prescribe the drug for six months, so a large pack is just designed for half of this period.

Dimia's analogs

Substitutes for the drug should be based on a similar active substance - ethinyl estradiol. These drugs include:

• "Yarina";
• "Belaru";
• "Silhouette";
• Lindinet 20.

Dimia or Belara: which is better

As part of the drug "Belara" are ethinylestradiol and chlormadinone. If the first component is a synthetic analogue of the female hormone, then chlormadinone in the preparation is responsible for the antiandrogenic effect. Contraindications to the drug are the same as those of "Dimia" - they are indicated in the instructions for use.

Gynecologists can transfer a patient from Dimia to Belara if individual side effects occur. "Belara" has the same cost as "Dimia".

Dimia or Silhouette: which is better

As part of the drug "Silhouette" is a combination of substances ethinylestradiol and dienogest - a progestogen, close in origin to progesterone. "Silhouette" is prescribed not only for oral contraception, but also for the treatment of acne associated with hormones.

"Silhouette" will be an analogue of "Dimia", only cheaper in cost. It can be purchased from 600 rubles for a pack of 21 pieces. Here there is a slightly different way of taking: when all the pills are taken, a seven-day break is made, after which they begin to take the next pack. According to the instructions for use, menstruation comes during this break.

Dimia or Lindinet 20: which is better

"Lindinet 20" in addition to ethinyl estradiol, contains gestodene - a progestogen. There are no auxiliary inactive tablets, each tablet contains an active ingredient: more details can be found in the instructions for use. Lindinet 20, like Dimia, is prescribed for oral contraception.

"Lindinet 20" has a lower cost than "Dimia", so gynecologists often prescribe it to women who first decide on oral contraception. Over time, the doctor may recommend switching to Dimia.

Dimia or Yarina: which is better

COC "Yarina" are one of the most common drugs used not only for contraception, but for medicinal purposes. "Yarina" is prescribed for:

• normalization of the menstrual cycle;
• treatment of endometriosis;
• cyst treatment;
• elimination of pain in the first days of menstruation.

Yarina also contains drospirenone and ethinyl estradiol. The drugs are equally well tolerated by patients, so they are prescribed as interchangeable with each other.

Conclusion

The hormonal drug "Dimia", the instructions for use of which will tell you how to take pills correctly, is prescribed for young girls and women for contraception. Compliance with all the rules and schemes of admission guarantee the absence of unwanted pregnancy.

Catad_pgroup Combined oral contraceptives

The most physiological contraceptive that preserves the quality of sexual life. For the treatment of heavy and / or prolonged menstrual bleeding without organic pathology.
INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS

Dimia - official instructions for use

Registration number:

LP-001179

Trade name of the drug:

Dimia® (Dimia®)

International non-proprietary name:

drospirenone + ethinylestradiol (drospirenone + ethinylestradiol)

Dosage form:

film-coated tablets [set]

Compound:

for 1 tablet:
Drospirenone + ethinyl estradiol tablets
active substance: drospirenone 3.000 mg, ethinylestradiol 0.020 mg;
Excipients: lactose monohydrate, corn starch, pregelatinized corn starch, macrogol and polyvinyl alcohol copolymer, magnesium stearate.
Film casing (Opadray II white*): polyvinyl alcohol, titanium dioxide, macrogol-3350, talc, soy lecithin.
*code 85G18490
placebo pills
microcrystalline cellulose, lactose, pregelatinized corn starch, magnesium stearate, colloidal silicon dioxide.
Film casing (Opadry II green**): polyvinyl alcohol, titanium dioxide, macrogol-3350, talc, indigo carmine, quinoline yellow dye, iron oxide black dye; dye sunny sunset yellow.
** code 85F21389

Description:

For drospirenone + ethinyl estradiol tablets:
Round, biconvex, white or off-white film-coated tablets, marked "G73" on one side of the tablet, embossed. In cross section, the nucleus is white or almost white.
For placebo pills:
Round, biconvex, green film-coated tablets. In cross section, the nucleus is white or almost white.

Pharmacotherapeutic group:

combined contraceptive (estrogen + gestagen)

ATX code:

G03AA12

Pharmacological properties

Pharmacodynamics
Dimia® is a combined hormonal contraceptive with antimineralocorticoid and antiandrogenic effects. The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, the most important of which include the suppression of ovulation and changes in the properties of the secretion of the cervix, as a result of which it becomes less permeable to spermatozoa.
When used correctly, the Pearl Index (the number of pregnancies per 100 women per year) is less than 1. If pills are missed or used incorrectly, the Pearl Index may increase.
In women taking COCs, the menstrual cycle becomes more regular, painful periods are less common, bleeding intensity decreases, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of COCs reduces the risk of developing endometrial cancer and ovarian cancer.
Drospirenone contained in Dimia® has an antimineralocorticoid effect. Prevents weight gain and the appearance of edema associated with fluid retention caused by estrogens, which ensures good tolerability of the drug. Drospirenone has a positive effect on premenstrual syndrome (PMS). The combination of drospirenone/ethinyl estradiol has been shown to be clinically effective in relieving symptoms of severe PMS, such as severe psychoemotional disturbances, breast engorgement, headache, muscle and joint pain, weight gain, and other symptoms associated with the menstrual cycle. Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne (blackheads), oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the body.
Drospirenone does not have androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. All this, combined with antimineralocorticoid and antiandrogenic effects, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone.
In combination with ethinylestradiol, drospirenone shows a favorable effect on the lipid profile, characterized by an increase in high density lipoproteins.

Pharmacokinetics
Drospirenone
Suction
When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum plasma concentration after a single oral administration is reached after about 1-2 hours and is about 38 ng / ml. Bioavailability 76-85%. Simultaneous administration with food does not affect the bioavailability of drospirenone.
Distribution
After oral administration, a two-phase decrease in the concentration of drospirenone in blood plasma is observed, with half-lives of 1.6 ± 0.7 hours and 27.0 ± 7.5 hours, respectively. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG ), or with corticosteroid-binding globulin. Only 3-5% of the total plasma concentration of drospirenone is present as free steroids. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to plasma proteins. The mean apparent volume of distribution of drospirenone is 3.7±1.2 l/kg.
Metabolism
Drospirenone is extensively metabolized after oral administration. Most metabolites in plasma are represented by acidic forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by the cytochrome P450 isoenzyme CYP3A4.
breeding
The rate of metabolic clearance of drospirenone in plasma is 1.5±0.2 ml/min/kg. In unchanged form, drospirenone is excreted only in trace amounts. Drospirenone metabolites are excreted through the intestines and by the kidneys in a ratio of approximately 1.2:1.4. The half-life of metabolites by the kidneys and through the intestines is about 40 hours.
Equilibrium concentration
During cyclic administration, the maximum equilibrium concentration of drospirenone in blood plasma is reached between the 7th and 14th day of taking the drug and is approximately 70 ng / ml. Plasma concentrations of drospirenone increase by about 2-3 times (due to cumulation), due to the ratio of the terminal half-life and dosing interval. A further increase in the concentration of drospirenone in the blood plasma is observed between 1 and 6 cycles of administration, after which no increase in concentration is observed.
Special populations of patients
Patients with renal insufficiency
Steady-state plasma concentrations of drospirenone in women with mild renal insufficiency (creatinine clearance (CC) 50–80 ml/min) were comparable to those in women with normal renal function (CC>80 ml/min). In women with moderate renal insufficiency (CC 30-50 ml / min), the plasma concentration of drospirenone was on average 37% higher than in women with normal renal function. Treatment with drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on the concentration of potassium in the blood plasma. The pharmacokinetics of drospirenone in severe renal insufficiency has not been studied.
Patients with liver failure
Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.
Ethinylestradiol
Suction
When taken orally, ethinylestradiol is rapidly and completely absorbed. The maximum plasma concentration after a single oral administration is reached after 1-2 hours and is about 88-100 pg / ml. Absolute bioavailability as a result of first pass conjugation and first pass metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinylestradiol in approximately 25% of the examined patients, while no such changes were observed in other patients.
Distribution
The concentration of ethinylestradiol in the blood plasma decreases biphasically, the terminal phase is characterized by an elimination half-life of approximately 24 hours.
Ethinylestradiol is significantly, but non-specifically, bound to serum albumin (approximately 98.5%) and induces an increase in plasma concentrations of SHBG. The apparent volume of distribution is about 5 l/kg.
Metabolism
Ethinylestradiol undergoes significant primary metabolism in the intestine and liver. Ethinylestradiol and its oxidized metabolites are primarily conjugated to glucuronides or sulfate. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg.
breeding
Ethinylestradiol is practically not excreted unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. The half-life of metabolites is about 24 hours.
Equilibrium concentration
The state of equilibrium concentration is reached during the second half of the cycle of taking the drug, and the concentration of ethinylestradiol in the blood plasma increases by about 1.5-2.3 times.
Preclinical safety data
Preclinical data from standard studies of repeated dose toxicity, as well as genotoxicity, carcinogenic potential and reproductive toxicity, do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.

Indications for use

• Contraception.
• Contraception and treatment of moderate acne (acne vulgaris).
• Contraception and treatment of severe premenstrual syndrome (PMS).

Contraindications

Dimia® is contraindicated in the presence of any of the conditions, diseases/risk factors listed below. If any of these conditions, diseases / risk factors develop for the first time while taking the drug, the drug should be immediately canceled:

• thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders;
• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris), currently or in history;
• identified acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant);
• the presence of a high risk of venous or arterial thrombosis (see section "Special Instructions");
• migraine with focal neurological symptoms at present or in history;
• diabetes mellitus with vascular complications;
• liver failure and severe liver disease (before normalization of liver function tests);
• liver tumors (benign or malignant) at present or in history;
• severe renal failure, acute renal failure;
• adrenal insufficiency;
• identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them;
• bleeding from the vagina of unknown origin;
• pregnancy or suspicion of it;
• breastfeeding period;
• hypersensitivity to any of the components of the drug Dimia®;
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the preparation contains lactose monohydrate);
• hypersensitivity to peanuts or soy.

Carefully

If any of the conditions, diseases / risk factors listed below are currently present, then the potential risk and the expected benefit of COC use should be carefully weighed in each individual case:

• risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident under the age of 50 in any of the next of kin; overweight (body mass index (BMI) less than 30 kg / m 2); dyslipoproteinemia; controlled arterial hypertension; migraine; uncomplicated heart valve disease; violation of the heart rhythm;
• other diseases in which peripheral circulatory disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of superficial veins;
• hereditary angioedema;
• hypertriglyceridemia;
• liver disease;
• diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham's chorea);
• postpartum period.

Use during pregnancy and during breastfeeding

Pregnancy
Dimia® is contraindicated during pregnancy. If the patient is planning a pregnancy, she may stop taking Dimia® at any time. If pregnancy is detected during the use of Dimia®, it should be discontinued immediately. However, extensive epidemiological studies have not found any increased risk of developmental defects in children born to women who received sex hormones (including COCs) before pregnancy, or teratogenic effects when sex hormones were taken through negligence in early pregnancy.
Existing data on the results of taking Dimia® during pregnancy are limited, which does not allow drawing any conclusions about the effect of the drug on the course of pregnancy, the health of the newborn and the fetus. There are currently no significant epidemiological data on Dimia®.
breastfeeding period
The use of the drug Dimia® during breastfeeding is contraindicated. Taking COCs can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. A small amount of sex hormones and / or their metabolites can pass into breast milk and affect the body of the newborn.

Dosage and administration

Method of application: for oral administration.
How to take Dimia®
The tablets should be taken daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 tablet per day. Taking tablets from each subsequent package should be started the next day after taking the last tablet from the previous package. Withdrawal bleeding usually begins 2-3 days after the start of the green placebo tablets (last row) and may not end before the start of the next pack of tablets. Pills from a new pack should always be started on the same day of the week, and "withdrawal" bleeding will occur on about the same days each month.
How to start taking Dimia®

• In the absence of taking any hormonal contraceptive drugs in the previous month
  Dimia® should be started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding), in which case additional contraceptive measures are not required. It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
• When switching from other combined contraceptive products (COC, vaginal ring or transdermal patch)
  It is preferable to start taking Dimia the day after taking the last inactive tablet (for preparations containing 28 tablets per package) or the day after taking the last active tablet from the previous package, but in no case later than the day after the usual 7- day break (for preparations containing 21 tablets). Dimia® should be started on the day the vaginal ring or patch is removed, but no later than the day a new ring or patch is to be inserted.
• When switching from contraceptive preparations containing only gestagens ("mini-pill", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive
  A woman can switch from a mini-drink to Dimia® any day (without a break); from an implant or intrauterine contraceptive with a progestogen - on the day of its removal, from an injectable contraceptive - on the day when the next injection should be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
• After an abortion in the first trimester of pregnancy
  A woman can start taking the drug immediately after a spontaneous or medical abortion in the first trimester of pregnancy. If this condition is met, the woman does not need additional contraceptive measures.
• After an abortion in the second trimester of pregnancy or childbirth
  The drug can be started on the 21-28th day after a spontaneous or medical abortion or after childbirth, in the absence of breastfeeding. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if sexual intercourse has already taken place, pregnancy should be excluded before taking Dimia®, or it is necessary to wait for the first menstruation.

Stopping Dimia®
You can stop taking the drug at any time. If a woman is not planning a pregnancy or pregnancy is contraindicated because she is taking medications that are potentially harmful to the fetus, other methods of contraception should be discussed with her doctor.
If a woman is planning a pregnancy, it is recommended to stop taking the drug and wait for natural menstrual bleeding, and only then try to get pregnant. This will help to more accurately calculate the gestational age and time of birth.
Taking missed pills
Missing a placebo tablet from the last (4th) row of the blister can be ignored.
However, they should be discarded to avoid inadvertently prolonging the placebo phase. The following recommendations apply only to missing active tablets. If the delay in taking the drug was less than 24 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next pill at the usual time.
If the delay in taking the tablets was more than 24 hours, contraceptive protection may be reduced. The more pills missed, and the closer the missed pills are to the inactive green placebo pill phase, the higher the chance of pregnancy.
In this case, you can be guided by the following two basic rules:

1. The drug should never be interrupted for more than 7 days;
2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

Accordingly, the woman can be given the following recommendations:

• When skipping tablets in the period from 1 to 7 days of admission:
  The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.
• When skipping tablets in the period from 8 to 14 days of admission:
  The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. If during the 7 days preceding the first missed pill, the woman took the pills correctly, there is no need for additional contraceptive measures. Otherwise, as well as if you miss two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
• When skipping tablets in the period from 15 to 24 days of admission:
  The risk of reduced reliability is inevitable due to the approaching period of inactive green placebo pills. You must strictly adhere to one of the two following options. In this case, if during the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods. Otherwise, the woman must use the first of the following regimens and additionally use a barrier method of contraception (eg, a condom) for 7 days.

1. The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. The next pills are taken at the usual time until the active pills in the pack are finished, the 4 green placebo pills from the last row should be discarded and the pills from the next pack should be started immediately.
   "Withdrawal" bleeding is unlikely until the pills in the second pack run out, but "spotting" discharge and/or "breakthrough" bleeding may occur while taking the pills.
2. The woman may also stop taking active tablets from the current pack. She should then take the green placebo pills from the last row for 4 days, including the days she skipped pills, and then start taking the pills from the new pack.
   If a woman misses taking the active pills and does not experience withdrawal bleeding while taking the inactive green placebo pills, pregnancy should be ruled out.

Recommendations for gastrointestinal disorders
In case of severe gastrointestinal disturbances, absorption may be incomplete, so additional contraceptive measures should be taken. If within 3-4 hours after taking the active tablet there was vomiting or diarrhea, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the start of her period to another day of the week, an additional active tablet should be taken.
How to change/delay the timing of withdrawal bleeding
To delay the onset of withdrawal bleeding, the woman should continue taking the tablets from the next pack of Dimia®, skipping the inactive green pills from the current pack. Thus, the cycle can be extended as desired for any period until the active tablets from the second package run out, that is, about 3 weeks later than usual.
If you plan to start the next cycle earlier, at any time you need to stop taking the active tablets from the second package, discard the remaining active tablets and start taking the inactive green tablets (within a maximum of 4 days), and then start taking the tablets from the new package. In this case, approximately 2-3 days after taking the last active tablet from the previous package, "withdrawal" bleeding should begin. While taking the drug from the second package, a woman may experience "spotting" discharge and / or "breakthrough" uterine bleeding. Regular intake of Dimia® is then resumed after the end of the period of taking the inactive green tablets.
To reschedule the onset of "withdrawal" bleeding to another day of the week, the woman should shorten her next inactive green pill period by the desired number of days. The shorter the interval, the higher the risk that she will not have "withdrawal" bleeding and will have "spotting" discharge and/or "breakthrough" bleeding in the future while taking the pills from the second pack.
Use in special categories of patients
Children and teenagers
The drug Dimia® is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.
Elderly patients
Dimia® is not indicated after menopause.
Patients with impaired liver function
Dimia® is contraindicated in women with severe liver disease until liver function tests return to normal (see also sections "Contraindications" and "Pharmacological properties").
Patients with impaired renal function
The drug Dimia® is contraindicated in women with severe renal insufficiency or with acute renal failure (see also sections "Contraindications" and "Pharmacological properties").

Side effect

The following adverse drug reactions (ADRs) have been reported during the use of the drospirenone/ethinylestradiol combination.
Adverse drug reactions are presented by system organ class according to the MedDRA classification and with the frequency of occurrence: often (> 1/100 and<1/10), нечасто (>1/1000 and<1/100) и редко (>1/10 000 and<1/1000). В пределах каждой группы, выделенной в зависимости от частоты возникновения, НЛР представлены в порядке уменьшения их тяжести. Для дополнительных нежелательных реакций, выявленных только в процессе пострегистрационных наблюдений, и для которых оценку частоты возникновения провести не представлялось возможным, указано «частота неизвестна».

* The frequency of irregular bleeding decreases as the duration of taking Dimia® increases.

Additional Information
Listed below are adverse reactions with a very rare frequency of occurrence or with delayed symptoms, which are believed to be associated with taking drugs from the COC group (see also sections "Contraindications" and "Special Instructions").
Tumors

• The frequency of diagnosing breast cancer in women taking COCs is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking COCs is insignificant in relation to the overall risk of this disease.
• Tumors of the liver (benign and malignant).

Other states

• women with hypertriglyceridemia have an increased risk of pancreatitis while taking COCs;
• increase in blood pressure;
• conditions that develop or worsen while taking COCs, but their relationship has not been proven: jaundice and / or itching associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis;
• in women with hereditary angioedema, estrogens may cause or exacerbate its symptoms;
• liver dysfunction;
• changes in glucose tolerance or effects on insulin resistance;
• Crohn's disease, ulcerative colitis;
• chloasma;
• hypersensitivity (including symptoms such as rash, urticaria).

Interaction
The interaction of COCs with other drugs (enzyme inducers) can lead to "breakthrough" bleeding and / or a decrease in contraceptive efficacy (see section "Interaction with other drugs").
If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Serious violations in case of overdose have not been reported. In preclinical studies, there were also no serious adverse effects resulting from overdose.
Symptoms that may occur in overdose: nausea, vomiting, spotting vaginal discharge or metrorrhagia.
Treatment. There is no specific antidote, symptomatic treatment should be carried out.

Interaction with other drugs

Effects of other medicinal products on Dimia®
Interaction with drugs that induce microsomal enzymes is possible, as a result of which the clearance of sex hormones may increase, which, in turn, may lead to “breakthrough” uterine bleeding and / or a decrease in the contraceptive effect. Women who receive treatment with these drugs in addition to Dimia® are recommended to use a barrier method of contraception or choose another non-hormonal method of contraception (if long-term use of inducer drugs is necessary).
The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their withdrawal. If the use of microsomal liver enzyme inducers continues after the end of the active tablets in the Dimia® package, you should start taking the Dimia® tablets from the new package without taking the green placebo tablets from the old package.

• Substances that increase the clearance of Dimia®(weakening efficacy by enzyme induction): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, as well as preparations containing St. John's wort.
• Substances with different effects on the clearance of Dimia®
  When co-administered with Dimia, many inhibitors of HIV or hepatitis C proteases and non-nucleoside reverse transcriptase inhibitors can either increase or decrease plasma concentrations of estrogens or progestogens. In some cases, this effect may be clinically significant.
• Substances that reduce the clearance of COCs (enzyme inhibitors)
  Strong and moderate inhibitors of CYP3A4, such as azole antimycotics (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase plasma concentrations of estrogen or progestogen, or both. It was shown that etoricoxib at doses of 60 and 120 mg / day, when taken together with COCs containing 0.035 mg of ethinylestradiol, increases the concentration of ethinylestradiol in blood plasma by 1.4 and 1.6 times, respectively.

Effect of Dimia® on other medicinal products
COCs can interfere with the metabolism of other drugs, resulting in an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.
In vitro, drospirenone is able to weakly or moderately inhibit cytochrome P450 isoenzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.
Based on in vivo interaction studies in female volunteers treated with omeprazole, simvastatin or midazolam as marker substrates, it can be concluded that a clinically significant effect of drospirenone 3 mg on drug metabolism mediated by enzymes of the cytochrome P450 system is unlikely.
In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2 isoenzymes, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2 isoenzymes. In clinical studies, the administration of a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or only a slight increase in plasma concentrations of substrates of the CYP3A4 isoenzyme (for example, midazolam), while the concentrations of substrates of the CYP1A2 isoenzyme in the blood plasma may increase slightly. (eg, theophylline) or moderately (eg, melatonin and tizanidine).
Other forms of interaction
In patients with preserved renal function, the combined use of drospirenone and angiotensin-converting enzyme inhibitors or non-steroidal anti-inflammatory drugs does not significantly affect the concentration of potassium in the blood plasma. However, the concomitant use of Dimia® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be monitored during the first cycle of taking the drug (see section "Special Instructions").

special instructions

If any of the conditions, diseases/risk factors listed below are currently present, then the potential risk and expected benefit of COC use in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the drug. In case of worsening, worsening or first manifestation of any of these conditions, diseases or risk factors, a woman should consult her doctor, who can decide on the need to discontinue the drug.
Diseases of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of COCs and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders). These diseases are rare.
The risk of developing venous thromboembolism (VTE) is highest in the first year of using these drugs. An increased risk is present after the initial use of COCs or the resumption of use of the same or different COCs (after a break between doses of 4 weeks or more). Data from a prospective study involving 3 groups of patients show that this increased risk is present mainly during the first 3 months of the drug. The overall risk of VTE in patients taking low-dose COCs (<0,05 мг этинилэстрадиола) в 2-3 раза выше, чем у небеременных пациенток, которые не принимают КОК, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах. ВТЭ может угрожать жизни или привести к летальному исходу (в 1-2% случаев).
VTE manifesting as deep vein thrombosis or pulmonary embolism can occur with any COC.
Very rarely, when using COCs, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. There is no consensus regarding the relationship between the occurrence of these diseases and the use of COCs.
Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower extremity or along a vein in the lower extremity, pain or discomfort in the lower extremity only when standing or walking, localized temperature increase in the affected lower extremity, redness or discoloration of the skin on the lower limb.
Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden cough, including hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more or less severe conditions/diseases (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction.
Symptoms of a stroke are as follows: sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with or without an epileptic seizure.
Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, an "acute" abdomen.
Symptoms of myocardial infarction include: pain, discomfort, feeling of pressure, heaviness, squeezing or fullness in the chest, in the arm or behind the breastbone; discomfort with irradiation to the back, cheekbone, larynx, arm, stomach; cold sweats, nausea, vomiting or dizziness, severe weakness, feeling anxious or short of breath; fast or irregular heartbeat.
Arterial thromboembolism can be life threatening or fatal. In women with a combination of several risk factors or a high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, taking Dimia® is contraindicated (see section "Contraindications").
The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:

• with age;
• in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);

in the presence of:

• obesity (BMI over 30 kg/m2);
• family history (for example, venous or arterial thromboembolism ever in close relatives or parents under the age of 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;
• prolonged immobilization, major surgery, any lower limb surgery, or major trauma. In these cases, the use of Dimia® should be discontinued. In the case of a planned operation, the drug should be stopped at least 4 weeks before it and not resumed for two weeks after the full restoration of motor activity. Temporary immobilization (eg, air travel longer than 4 hours) may also be a risk factor for venous thromboembolism, especially if other risk factors are present;
• dyslipoproteinemia;
• arterial hypertension;
• migraine;
• heart valve disease;
• atrial fibrillation.

The use of any combined hormonal contraceptive increases the risk of VTE. The use of drugs containing levonorgestrel, norgestimate or norethisterone is associated with the lowest risk of VTE. The use of other drugs, such as Dimia®, can lead to a two-fold increase in risk. The decision to use another drug other than the one with the lowest risk of developing VTE should be made only after discussing with the woman to make sure that she understands that the use of Dimia® is accompanied by the likelihood of developing VTE, understands how her risk factors affect the likelihood of developing VTE, and also understands that in every first year of using the drug, the risk of developing VTE for her is greatest.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.
An increased risk of thromboembolism in the postpartum period should be taken into account. Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of COCs (which may precede cerebrovascular disorders) is the basis for the immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).
When evaluating the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose COCs (<0,05 мг этинилэстрадиола).
Tumors
The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs, but the relationship with the use of COCs has not been proven. Controversy remains as to the extent to which these findings are related to screening for cervical pathology or sexual behavior (lower use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who are currently taking COCs or have recently taken them is insignificant in relation to the overall risk of this disease. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using COCs, their biological effects, or a combination of both factors. In women who used COCs, earlier stages of breast cancer are detected than in women who have never used them.
In rare cases, against the background of the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. These conditions should be taken into account when conducting a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.
Tumors can be life threatening or fatal.
Other states
Clinical studies have shown no effect of drospirenone on the concentration of potassium in the blood plasma in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with an initial potassium concentration at the upper limit of normal, while taking drugs that lead to potassium retention in the body. In women with an increased risk of developing hyperkalemia, it is recommended to determine the concentration of potassium in the blood plasma during the first cycle of taking Dimia®.
In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking COCs.
Although a slight increase in blood pressure has been described in many women taking COCs, clinically significant increases have been rare. However, if a persistent clinically significant increase in blood pressure develops while taking COCs, these drugs should be discontinued and treatment of arterial hypertension should be initiated. Taking COCs can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and when taking COCs, but their relationship with COC use has not been proven: jaundice and / or itching associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. There are also described cases of worsening of the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis against the background of the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COCs.
Although COCs may affect insulin resistance and glucose tolerance, there is no need to change the dose of hypoglycemic drugs in diabetic patients using low-dose COCs (<0,05 мг этинил-эстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема КОК.
Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking COCs should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Laboratory tests
Taking COCs may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein concentrations, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values. Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid action.
Medical examinations
Before starting or resuming the use of Dimia®, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough medical (including measurement of blood pressure, heart rate, BMI) and gynecological examination (including examination of the mammary glands and cytological examination of scrapings from the cervix), exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations is determined individually. Usually control examinations should be carried out at least 1 time in 6 months.
Women should be warned that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of COCs can be reduced in the following cases: when active tablets are missed, with vomiting and diarrhea, or as a result of drug interactions.
Insufficient control of the menstrual cycle
While taking COCs, irregular bleeding (“spotting” spotting and / or “breakthrough” bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough diagnostic examination should be performed to exclude malignant neoplasms or pregnancy.
Some women may not experience "withdrawal" bleeding while taking the green inactive placebo pills. If the drug was taken as directed, it is unlikely that the woman is pregnant. However, if the drug has been taken irregularly before, or if there are no consecutive withdrawal bleedings, pregnancy should be excluded until the drug is continued.
Lactose
Dimia®, film-coated tablets, contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency and malabsorption of glucose and galactose should not take this medicine.
Soya
Dimia® film-coated tablets contain soy lecithin. Patients with peanut and soy allergy should not take this drug.

Influence on the ability to drive vehicles and mechanisms

Not found.

Release form

Film-coated tablets [set], 3 mg + 0.02 mg.
24 tablets each of drospirenone + ethinyl estradiol and 4 tablets of placebo in a PVC/PE/PVDC-aluminum foil blister pack.
1 or 3 blisters in a cardboard box along with instructions for use. A cardboard flat case for storing the blister is enclosed in a cardboard pack.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C.
Keep out of the reach of children!

Shelf life

2 years.
Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Manufacturer

OJSC "Gedeon Richter"
1103 Budapest, st. Dömröi, 19-21, Hungary

Consumer claims should be sent to:
Moscow Representative Office of JSC "Gedeon Richter"
119049 Moscow, 4th Dobryninsky lane, building 8,

Content

The use of hormonal pills is considered the most effective method of contraception. Today, various pharmaceutical companies produce a huge number of products that help women avoid unwanted pregnancies. One of the most popular is Dimia. Many experts advise it to their patients due to the good tolerance of the main components and the rare occurrence of side effects.

Pharmacological action

The combination drug Dimia is a monophasic oral agent. This medicine contains ethinyl estradiol and drospirenone (an analogue of natural progesterone). The active substances that make up the drug do not have estrogenic, antiglucocorticoid, glucocorticoid abilities. The drug achieves its effectiveness by changing the endometrium, inhibiting ovulation and increasing the viscosity of the secretion of the cervix, which prevents the penetration of spermatozoa into its cavity.

After taking the drug inside, the active substances are completely absorbed into the bloodstream from the small intestine. They are distributed evenly throughout all tissues of the body. The maximum concentration of the drug is reached two hours after ingestion. The decay products of ethinylestradiol and drospirenone are excreted from the body mainly in the urine.

Release form and composition

The drug Dimia (dimia) is produced in the form of round, biconvex white film-coated tablets with a special marking G73 on one side. Also, the composition of the medicine additionally includes green placebo tablets that do not contain active active ingredients. One package of the drug includes 28 tablets, packaged in one or three blisters. The composition of the product is presented in the table:

How to take Dimia

Dimia hormonal tablets should be taken daily, at the same time, with water, in the order indicated on the blister pack. The medicine should be taken continuously for 28 days, one piece per day. Taking tablets from the next package should be started after the remedy from the previous box is over. Only a doctor can tell you how to take Dimia correctly, without health consequences. As a rule, the beginning of the use of the tool is different:

• When switching from other OCs (oral contraceptives), it is necessary to start drinking Dimia the next day after taking the last tablet of another drug (28 pieces) or a week after using the drug containing 21 capsules. When using a transdermal patch or vaginal ring, take dimia only after they have been removed.
• Before starting taking the pills, if a woman has not used other OCs for a month, it is necessary to start drinking dimia from the first day of the menstrual cycle. You can take the remedy from the 3rd day of the onset of menstruation, but you should use condoms for a week.
• After removal of the intrauterine device, the use of tablets begins on the day of the procedure.
• If a woman took non-combined progesterone-based drugs, then the contraceptive can be started on any day.
• When a pregnancy is terminated in the first trimester, a woman, as prescribed by a doctor, can drink pills on the same day.
• After an abortion or childbirth, experts advise starting taking pills on the 28th day.

If a woman missed taking another pill, the following recommendations should be followed in relation to the resumption of their use:

• skipping a placebo tablet can be ignored and then you need to continue taking the next day according to the scheme indicated in the instructions;
• if less than 12 hours have passed since the missed dose, the patient should take the pill as soon as possible;
• if more than 12 hours have passed since the last use of the drug, then the woman should take the pill as soon as she remembers it, even if it coincides with the next one (you can take 2 pills at once).

Indications and contraindications for taking pills

Dimia contraceptives are indicated for women of reproductive age to prevent unwanted pregnancy. In addition, the use of the drug is possible in the treatment of such diseases:

• fibroids;
• endometriosis;
• dysfunction of the menstrual cycle;
• iron deficiency anemia;
• polycystic ovary syndrome;
• premenstrual syndrome.

The use of tablets is contraindicated in the following situations:

• thrombophlebitis, thromboembolism (movement of blood clots through arterial vessels) or thrombosis (the appearance of blood clots in the lumen of venous or arterial vessels);
• malignant hormone-dependent neoplasms of the mammary glands or organs of the reproductive system;
• hereditary or acquired predisposition to thrombosis (lack of protein, hyperhomocysteinemia);
• individual intolerance to the main or auxiliary components of the drug;
• pancreatitis (inflammation of the pancreas);
• pathological processes that preceded the appearance of severe thrombosis (transient ischemic attack, myocardial infarction, angina pectoris);
• transferred surgical intervention with further immobilization of the body;
• acute or chronic severe insufficiency of kidney activity;
• the presence in the female body of processes that can lead to cardiovascular diseases (damage to the heart valves, disruption of the rhythm of contractions, pathology of the coronary vessels);
• smoking over the age of 35;
• lactation period;
• hypertension;
• liver disease;
• acquired or congenital lactase deficiency;
• the presence of pathological bleeding from the vagina;
• confirmed pregnancy.

Care should be taken to take the drug in the postpartum period and with concomitant pathologies leading to impaired peripheral circulation:

• Crohn's disease;
• diabetes mellitus;
• sickle cell anemia;
• systemic lupus erythematosus;
• hereditary angioedema,
• phlebitis of superficial veins;
• hypertriglyceridemia (increased levels of triglycerides in the blood).

Side effects

Before starting to use a medicinal contraceptive, a woman should consult a doctor, because. there is a risk of thromboembolic complications. In addition, the use of the drug can lead to the development of such side effects:

• emotional instability;
• nausea, vomiting;
• dizziness;
• migraine;
• stomach ache;
• inflammation of the gallbladder (cholecystitis);
• headache;
• depression;
• drowsiness;
• tremor (trembling) of the hands;
• muscle cramps;
• increased blood pressure;
• tachycardia (increased heart rate);
• thrombocytopenia (decrease in the number of platelets);
• phlebitis (inflammation of the veins);
• anemia (anemia);
• development of vaginal candidiasis;
• weight gain;
• back pain;
• dyspareunia (painful intercourse);
• breast enlargement;
• acne (acne);
• dryness of the vaginal mucosa;
• alopecia (hair loss);
• allergic reactions.

With the development of side effects or complications (coughing up blood, double vision, sudden or partial loss of vision), you should immediately seek medical help. The risk of negative symptoms and vascular thrombosis increases with arterial hypertension, alcohol abuse, increased body weight, and age over 40 years. The use of the drug does not exclude the possibility of infection with infectious diseases, sexually transmitted.

Interaction of Dimia with other drugs

The effectiveness of the contraceptive can be weakened by the joint use of the drug with barbiturates (a group of drugs derived from barbituric acid) and drugs that affect liver enzymes: Griseofulvin, Oxcarbazepine, Topiramate, Phenytoin, Primidone, Felbamate, Rifampicin. In addition, the instructions indicate that drugs that contain St. John's wort in their chemical composition, when used simultaneously with dimia, induce (stimulate) microsomal liver enzymes, which also negatively affects the female body.

A decrease in the circulation of estrogen and at the same time the effectiveness of a contraceptive occurs while using Ampicillin and Tetracycline with antibiotics. HIV protease inhibitors and their combinations have a negative effect on the hepatic metabolism of the drug. Women with short-term treatment with any of the above means should temporarily use barrier methods of contraception (condom).

Analogues

The manufacturer of the drug Dimia is the Hungarian company Gedeon Richter. Absolute structural analogues of the agent, similar in the mechanism of action and chemical composition, are:

• Midian;
• Angelique;
• Yarina;
• Jess;
• Vidor;
• Dailla;
• Belara;
• Simicia;
• Yarina plus;
• Annabella;
• Delsia;
• Modell trend.

Price for Dimia tablets

You can buy dimia at any pharmacy, but you will need to get a prescription from your doctor. You can not start taking pills on your own or on the recommendation of friends, before you start using it, you should definitely visit a specialist. The cost of the drug depends on the region of distribution and the number of tablets in the package, the average price for 28 pieces is 700 rubles. The approximate cost of a contraceptive in Moscow is presented in the table.