Dimia, film-coated tablets. Birth control pills "Dimia": reviews from doctors, instructions and analogues How long does it take for Dimia pills to start working

Dimia ® is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol. In terms of its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by pronounced antiandrogenic and moderate antimineralocorticoid effects. The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation, increased viscosity of cervical secretions and changes in the endometrium. The Pearl index, an indicator reflecting the pregnancy rate in 100 women of reproductive age during a year of contraceptive use, is less than 1.

Pharmacokinetics

Drospirenone

Suction

When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax of drospirenone in serum is about 38 ng/ml and is achieved approximately 1-2 hours after a single dose.

Bioavailability - 76-85%. Concomitant use with food does not affect the bioavailability of drospirenone.

Distribution

After oral administration, plasma concentrations of drospirenone decreased with a final half-life of 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 total serum concentrations of drospirenone exist as free steroids. The ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to serum proteins. The average apparent Vd of drospirenone is 3.7±1.2 l/kg.

During the treatment cycle, C ss max of drospirenone in blood plasma is about 70 ng/ml, it is achieved after 8 days of treatment. Serum concentrations of drospirenone increase approximately 3-fold due to the ratio of final half-life and dosing interval.

Metabolism

Drospirenone is actively metabolized after oral administration. The main metabolites in the blood plasma are the acidic forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both formed without the participation of the P450 system. Drospirenone is slightly metabolized by CYP3A4 and is capable of inhibiting this enzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro.

Removal

Renal clearance of drospirenone metabolites in blood 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 intestines with an excretion ratio of about 1.2:1.4. T1/2 of metabolites by the kidneys and through the intestines is about 40 hours.

Ethinyl estradiol

Suction

When taken orally, ethinyl estradiol is absorbed quickly and completely. Cmax in blood serum is about 33 pkg/ml and is achieved within 1-2 hours after a single oral dose. Absolute bioavailability as a result of first pass conjugation and first pass metabolism is approximately 60%. Concomitant food intake decreased the bioavailability of ethinyl estradiol in approximately 25% of the patients studied; others had no changes.

Distribution

Serum concentrations of ethinyl estradiol decreased biphasically, in the final distribution phase T1/2 is approximately 24 hours. Ethinyl estradiol binds well, but nonspecifically, to serum albumin (approximately 98.5%) and induces an increase in serum concentrations of SHBG. Apparent V d - about 5 l/kg.

C ss is achieved in the second half of the treatment cycle, and the serum concentration of ethinyl estradiol increases by 2-2.3 times.

Metabolism

Ethinyl estradiol is a substrate of presystemic conjugation in the mucous membrane of the small intestine and in the liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, resulting in a wide range of hydroxylated and methylated metabolites, which are present both in free form and as conjugates with glucuronic acid. Renal clearance of ethinyl estradiol metabolites is approximately 5 ml/min/kg.

Removal

Unchanged ethinyl estradiol is practically not excreted from the body. Metabolites of ethinyl estradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T1/2 of metabolites is about 24 hours.

Pharmacokinetics in special clinical situations

If kidney function is impaired

Css of drospirenone in blood plasma in women with mild renal failure (creatinine clearance 50-80 ml/min) was comparable to the corresponding values ​​in women with normal renal function (creatinine clearance > 80 ml/min). In women with moderate renal failure (creatinine clearance 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. Taking drospirenone did not have a clinically significant effect on serum potassium levels. Pharmacokinetics in severe renal failure have not been studied.

In case of liver dysfunction

Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment have not been studied.

Release form

White or off-white, film-coated tablets, round, biconvex, embossed with "G73" on one side of the tablet; on a cross section, the core is white or almost white (24 pieces in a blister).

Excipients: lactose monohydrate - 48.53 mg, corn starch - 16.6 mg, pregelatinized corn starch - 9.6 mg, copolymer of macrogol and polyvinyl alcohol - 1.45 mg, magnesium stearate - 0.8 mg.

Film shell composition: opadry II white 85G18490 - 2 mg (polyvinyl alcohol - 0.88 mg, titanium dioxide - 0.403 mg, macrogol 3350 - 0.247 mg, talc - 0.4 mg, soy lecithin - 0.07 mg).

Placebo tablets

Green film-coated tablets, round, biconvex; on a cross section, the core is white or almost white (4 pieces in a blister).

Excipients: microcrystalline cellulose - 42.39 mg, lactose - 37.26 mg, pregelatinized corn starch - 9 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0.45 mg.

Film shell composition: opadry II green 85F21389 - 3 mg (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 oxide dye black - 0.003 mg, sunset yellow dye - 0.003 mg).

28 pcs. - blisters (1) - cardboard packs.
28 pcs. - blisters (3) - cardboard packs.

Dosage

The tablets should be taken daily, at approximately the same time, with a small amount of water, in the order indicated on the blister pack. The tablets are taken continuously for 28 days, 1 tablet/day. Taking tablets from the next package begins after taking the last tablet from the previous package. Withdrawal bleeding usually begins 2-3 days after starting placebo tablets (last row) and does not necessarily end by the start of the next pack.

How to start taking Dimia ®

If hormonal contraceptives have not been used in the last month, Dimia ® should be taken on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is possible to start taking it on days 2-5 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 (combined oral contraceptives in the form of tablets, vaginal ring or transdermal patch)

You should start taking Dimia ® 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 drugs containing 21 tablets per package. 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 is planned to be inserted or the patch is replaced.

Switching from contraceptives containing only progestogens (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 IUD on the day of their removal, from injectable forms of drugs - on the day when the next injection was due), but in all cases it is necessary to use additionally a barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

Taking Dimia ® can be started as prescribed by a doctor 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 21-28 days after childbirth (provided she is not breastfeeding) or abortion in the second trimester of pregnancy. If use is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting to take Dimia ® . With the resumption of sexual activity (before starting to take Dimia ®), pregnancy should be excluded.

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 only apply to missed tablets containing active ingredients.

If the delay in taking the pill is less than 12 hours, contraceptive protection is not reduced. A 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 axis, 7 days of continuous pill use are required.

In accordance with this, women can be given the following recommendations:

A woman should take the missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the pills at the usual time. Additionally, a barrier method such as a condom should be used for the next 7 days. If sexual intercourse occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills you miss and the closer this skip is to the 7-day break in taking the drug, the higher the risk of pregnancy.

A woman should take the missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the pills at the usual time. If during the 7 days preceding the first missed pill, a woman took her pills as prescribed, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier - for example, a condom) is required for 7 days.

The reliability of the method inevitably decreases as the placebo pill phase approaches. However, adjusting your pill regimen can still help prevent pregnancy. When following one of the two regimens described below, and if in the previous 7 days before skipping the pill the woman complied with the drug regimen, there will be no need to use additional contraceptive measures. If this is not the case, she should follow the first of two regimens and use additional precautions for the next 7 days.

1. A woman should take the last missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the tablets at the usual time until the active tablets are gone. 4 placebo tablets from the last row should not be taken; you should immediately start taking tablets from the next blister pack. Most likely, there will be no withdrawal bleeding until the end of the second package, but spotting or withdrawal bleeding may occur on the days of taking the drug from the second package.

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

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

Use of the drug for gastrointestinal disorders

In case of severe gastrointestinal disorders (for example, vomiting or diarrhea), 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, you must take a new (replacement) tablet as quickly 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 as directed when missing tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from a different pack.

Delay of menstrual-like withdrawal bleeding

To delay bleeding, a woman should skip taking placebo tablets from the started pack and start taking drospirenone + ethinyl estradiol tablets from a new pack. The delay can be extended until the active tablets in the second package run out. During the delay, a woman may experience acyclic heavy or spotting bleeding from the vagina. Regular use 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 heavy or spotting bleeding from the vagina when taking the next package (the same as when the cycle is lengthened).

Overdose

There have been no cases of overdose of Dimia ® yet. Based on general experience with combined oral contraceptives, potential symptoms of overdose may include: nausea, vomiting, mild vaginal bleeding.

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

Interaction

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.

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

Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is not clear.

Women during short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (while taking other drugs simultaneously and for another 7 days after its end), in addition to COCs, barrier methods of contraception.

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

If a woman is constantly taking drugs that induce microsomal liver enzymes, 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 affect the metabolism of drospirenone.

Effect of Dimia ® on other drugs

Oral contraceptives may affect the metabolism of some other active ingredients. Accordingly, the concentrations of these substances in blood plasma or tissues may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Based on in vitro inhibition studies and in vivo interaction studies in female volunteers taking omeprazole, simvastatin and midazolam as substrates, the effect of drospirenone 3 mg on the metabolism of other active substances is unlikely.

Other interactions

In patients without renal failure, simultaneous use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on serum potassium levels. However, the simultaneous use of Dimia ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, the concentration of serum potassium should be monitored.

Laboratory tests

Taking contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, concentrations of plasma proteins (transporters), such as corticosteroid binding proteins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and blood coagulation parameters and fibrinolysis. In general, changes remain within the normal range. Drospirenone causes an increase in renin activity in the blood plasma and, due to its slight antimineralocorticoid activity, reduces the concentration of aldosterone in the plasma.

Side effects

The following adverse events have been reported while taking Dimia ®:

The following serious adverse events have been reported in women using combined oral contraceptives (COCs):

• venous thromboembolic diseases;
• arterial thromboembolic diseases;
• liver tumors;
• the occurrence or exacerbation of conditions for which the connection with taking COCs has not been proven: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes during previous pregnancy, rheumatic chorea, hemolytic-uremic syndrome, cholestatic jaundice;
• chloasma;
• acute or chronic liver diseases may necessitate discontinuation of COCs until liver function tests return to normal;
• In women with hereditary angioedema, exogenous estrogens may induce or worsen symptoms of angioedema.

Indications

• oral contraception.

Contraindications

Dimia ®, like other combined oral contraceptives, is contraindicated in any of the following conditions:

• thrombosis (arterial and venous) and thromboembolism currently or in history (including thrombosis, deep vein thrombophlebitis; pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders);
• conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history;
• multiple or severe 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, major surgery with prolonged immobilization, smoking over the age of 35 years, obesity with a BMI >30 kg/m2;
• hereditary or acquired predisposition to venous or arterial thrombosis, for example, 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);
• pancreatitis with severe hypertriglyceridemia currently or in history;
• severe chronic or acute renal failure;
• liver tumor (benign or malignant) currently or in history;
• hormone-dependent malignant neoplasms of the genital organs or breast, currently or in history;
• bleeding from the vagina of unknown origin;
• history of migraine with focal neurological symptoms;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption, lapp lactase deficiency (lactase deficiency in some peoples of the North);
• pregnancy and suspicion of it;
• lactation period;
• hypersensitivity to the drug or any of the components of the drug.

Carefully

• risk factors for the development of thrombosis and thromboembolism: smoking under the age of 35 years, 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 any of the immediate relatives);
• diseases in which peripheral circulatory disorders may occur: diabetes mellitus without vascular complications, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of the superficial veins;
• hereditary angioedema;
• hypertriglyceridemia;
• severe liver disease (until normalization of liver function tests);
• diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including jaundice and/or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, history of herpes during pregnancy, minor chorea (disease Sydenham), chloasma);
• postpartum period.

Features of application

Use during pregnancy and breastfeeding

Dimia ® is contraindicated during pregnancy.

If pregnancy occurs while using the drug Dimia ®, its use should be stopped immediately. Extensive 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 if taken unintentionally during pregnancy.

According to preclinical studies, it is impossible to exclude undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components.

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 during COC use. These amounts may affect the child. The use of Dimia ® during breastfeeding is contraindicated.

Use for liver dysfunction

Contraindicated:

• existing severe liver disease (or history) provided that liver function is not currently normalized;
• liver tumor (benign or malignant) currently or in history.

Use for renal impairment

Contraindicated:

• severe chronic or acute renal failure

Use in children

The use of the drug before menarche is not indicated.

special instructions

If you have any of the conditions/risk factors listed 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 occur, the woman should contact her doctor. The doctor must decide whether to stop taking the COC.

Circulatory disorders

Taking any combined oral contraceptive increases the risk of venous thromboembolism (VTE). The increase in the risk of VTE is most pronounced in the first year of a woman's use of a combined oral contraceptive.

Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogens (<0.05 мг этинилэстрадиола) в составе комбинированного перорального контрацептива, составляет примерно 20 случаев на 100 000 женщин-лет (для левоноргестрелсодержащих КПК "второго поколения") или 40 случаев на 100 000 женщин-лет (для дезогестрел/гестоденсодержащих КПК "третьего поколения"). У женщин, не пользующихся КПК, случается 5-10 ВТЭ и 60 беременностей на 100 000 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 venous thromboembolism using the combination of ethinyl estradiol and drospirenone 0.03 mg + 3 mg was the same as the incidence of VTE in women using levonorgestrel-containing oral contraceptives and other PDAs. The degree of risk of venous thromboembolism when taking Dimia ® has not currently been established.

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

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

Symptoms of venous or arterial thrombotic/thromboembolic events or acute cerebrovascular accidents:

• unusual unilateral pain and/or swelling of the lower extremities;
• sudden severe pain in the chest, regardless of whether it radiates to the left arm or not;
• sudden shortness of breath;
• sudden onset of cough;
• any unusual severe, long-lasting 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 that suddenly affects one side or part of the body;
• movement disorders;
• symptom complex "acute" abdomen.

Before starting to take COCs, a woman should consult a specialist.

The risk of venous thromboembolic disorders when taking COCs increases with:

• increasing age;
• hereditary predisposition (venous thromboembolism has ever occurred in siblings or parents at a relatively early age);
• prolonged immobilization, extensive surgery, any surgery on the lower extremities or major trauma. In such situations, it is recommended to stop taking the drug (in the case of planned surgery, at least four weeks in advance) and not to resume until two weeks have passed after complete restoration of mobility. If the drug is not stopped promptly, 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 years of age are strongly advised to quit smoking if they want to take COCs);
• dyslipoproteinemia;
• arterial hypertension;
• migraine without focal neurological symptoms;
• obesity (BMI more than 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 starting to take COCs;
• damage to the heart valves;
• atrial fibrillation.

Having 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 (indirect anticoagulants - coumarin derivatives).

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

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

An increase in the frequency or severity of migraine while taking COCs may be an indication for immediate discontinuation of combined oral contraceptives.

The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of combined oral contraceptives, but there remains controversy regarding the extent to which these findings are attributable to confounding factors such as testing for cervical cancer or use of barrier methods of contraception.

A meta-analysis of 54 epidemiological studies found a small increase in the relative risk (RR = 1.24) of breast cancer in women who were currently taking COCs. The risk gradually decreases over 10 years after stopping COC use. Because Breast cancer rarely develops in women under 40 years of age, and an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of breast cancer. These studies did not find sufficient evidence of causality. The increased risk may result from earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both factors. Diagnosed breast cancer in women who had ever taken COCs was clinically less severe, which was due to 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 the event of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Other states

The progestogen component of the drug Dimia ® is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in potassium levels is not expected. However, in a clinical study in some patients with mild to moderate kidney disease who were taking potassium-sparing medications, serum potassium levels increased slightly while taking drospirenone. Therefore, it is recommended to monitor serum potassium levels during the first cycle of treatment in patients with renal failure whose pre-treatment serum potassium concentrations were at the upper limit of normal and, especially, while taking potassium-sparing drugs.

Women with hypertriglyceridemia or a hereditary predisposition to it may have an increased risk of pancreatitis when taking COCs.

Although slight increases in blood pressure were observed in many women taking COCs, clinically significant increases were rare. Only in these rare cases is it justified to immediately stop taking the COC. 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, taking COCs should be discontinued. After normalization of blood pressure with the help of antihypertensive drugs, COC use can be resumed.

The following diseases appeared or worsened both during pregnancy and when taking COCs, but the evidence of their relationship with taking COCs is inconclusive: jaundice and/or itching associated with cholestasis, gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; rheumatic chorea (Sydenham's chorea); herpes during pregnancy; otosclerosis with hearing loss.

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

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

Although COCs may influence peripheral insulin resistance and glucose tolerance, changing the treatment regimen in patients with diabetes mellitus while taking COCs with low hormone content (containing< 0.05 мг этинилэстрадиола) не показано. Однако следует внимательно наблюдать женщин с сахарным диабетом, особенно на ранних стадиях приема КПК.

While taking COCs, an increase in endogenous depression, epilepsy, Crohn's disease and ulcerative colitis was observed.

Chloasma may occur from time to time, especially in women who have a history of chloasma during 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 of lactose monohydrate, placebo tablets contain 37.26 mg of anhydrous lactose per tablet. Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should not take this drug.

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

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

Medical examinations

Before starting or re-using Dimia ®, obtain a complete medical history (including family history) and exclude pregnancy. It is necessary to measure blood pressure and conduct a medical examination, guided by contraindications and precautions. A woman should be reminded to carefully read the instructions for use and adhere to the recommendations contained therein. 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.

Women should be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the COC may be reduced, for example, if you skip a dose of drospirenone + ethinyl estradiol tablets, have gastrointestinal disorders while taking drospirenone + ethinyl estradiol tablets, or take other medications at the same time.

Insufficient cycle control

As with other COCs, a woman 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 adaptation period.

If acyclic bleeding recurs or begins after several regular cycles, the possibility of developing disorders of a non-hormonal nature should be taken into account 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 administration were violated before the first missed menstrual-like withdrawal bleeding, or if two bleedings were missed, pregnancy should be excluded before continuing to take the COC.

Impact on the ability to drive vehicles and operate machinery

Photo of the drug

Latin name: Dimia

ATX code: G03AA12

Active substance: Ethinylestradiol + Drospirenone

Manufacturer: Gedeon Richter (Hungary)

Description is valid on: 25.10.17

Prices in online pharmacies:

The most effective method of contraception, which is popular in Western Europe and Russia, is the use of hormonal pills, including estrogen and gestagen.

Currently, many different drugs have been developed with minimal side effects, one of which is Dimia. Reviews of this new drug indicate that it is well tolerated and side effects occur in only a small number of women.

Components of the drug

The drug contains two types of tablets: 24 tablets containing 0.02 ethinyl estradiol and 3 mg drospirenone, and 4 tablets, which are pacifiers. This is done for the convenience of women. The first 24 tablets are taken one at a time every day at a certain time of day. Women most often set reminders on their mobile phones. It is the hormones included in its composition that provide the contraceptive effect.

After this, a break from taking the pills is required for menstruation to occur. 4 placebo tablets allow you to continue taking Dimia. In order not to get confused with taking contraceptives and take pills daily, these are the pacifiers that are used. This ensures continued use of the contraceptive.

How the drug works

Ethinyl estradiol in the drug supports the proliferation or growth of the endometrium, thereby providing so-called cycle control - the absence of intermenstrual bleeding when taking the drug "Dimia". Reviews from doctors indicate that in the absence of a sufficient amount of estradiol in the ovaries while taking any oral contraceptive, synthetic ethinyl estradiol replaces its production.

Drospirenone is a synthetic progestogen, a derivative of spironolactone, which has a number of effects that determine the contraceptive effect of the drug. This:

• secretory degeneration of the endometrium, which is caused by estrogens;
• interacting with progesterone receptors, it prevents the release of gonadotropins by the pituitary gland, which leads to the suppression of ovulation;
• blocks the receptors of other steroid hormones: androgens, glucocorticoids and mineralocorticoids, which reduces the risk of various side effects that are characteristic of various hormonal contraceptives.

Side effects from using Dimia

Due to the low content of hormones in the drug, when used correctly, no significant side effects are observed. You can find out by reading reviews. "Dimia" - birth control pills that cause minor unpleasant symptoms:

• headache, dizziness;
• flatulence, nausea, vomiting;
• dyskinesia;
• constant mastodynia - tension of the mammary glands;
• increased blood pressure numbers;
• thrombophlebitis;
• disorders in the blood coagulation system;
• convulsions;
• nervousness, irritability, depression;
• decreased libido;
• significant weight gain;
• bleeding between periods;
• breakthrough bleeding;
• absence of menstruation after taking the drug.

Each side effect depends on individual intolerance and compliance or non-compliance with recommendations at the time when Dimia birth control pills are used. Feedback from women suggests that when taking these tablets, general well-being is normalized, skin condition improves - seborrhea and acne disappear, swelling decreases, and symptoms of premenstrual tension are eliminated. A blood test reveals a decrease in testosterone and normal indicators of the protein and lipid composition of the blood. It was noted that while taking these pills for 3 months, women lost an average of 0.8 kg.

Contraindications to taking oral contraceptives

There are absolute and relative contraindications to taking the drug "Dimia". Instructions for use (reviews from doctors also warn about this) prohibit the use of the drug when:

• thrombosis of deep and superficial veins;
• complex surgical intervention, after which long-term rehabilitation is provided;
• congenital thrombophilias with increased levels of blood clotting;
• IHD, stroke;
• arterial hypertension, when the numbers are above 160 systolic and 100 diastolic pressure;
• complicated diseases of the heart valve apparatus;
• a combination of two or more risk factors: age 35 years or more, smoking more than 10 cigarettes per day, diabetes mellitus, hypertension;
• liver diseases;
• migraine with and without focal neurological symptoms;
• diabetes mellitus for more than 20 years;
• breast cancer;
• pregnancy and breastfeeding.

It is also not recommended to take the drug if a woman has suffered a pulmonary embolism. There are relative contraindications in which the drug can be prescribed, but it should be done with caution after a preliminary examination of the woman. In each specific case, you should start taking the drug after talking with your doctor.

How often should you visit a doctor?

A woman should be under the supervision of her gynecologist when taking Dimia tablets. Reviews from patients testify to this. It is advisable to visit a gynecologist once every six months. This requires an examination with the taking of cytological smears, colposcopy, palpation of the mammary glands, blood pressure control, and, if necessary, a special examination: ultrasound, biochemical blood test, etc.

Correct use of tablets

Only an obstetrician-gynecologist, taking into account indications and contraindications, sets the rules for taking Dimia tablets. Feedback from women that the drug can be used and prescribed independently without harm to health cannot be considered true. This may lead to unwanted complications.

The initial dose of oral contraceptive should be prescribed from the first day of the cycle. If pills are started on day 5 or later, additional use of other methods of contraception is required.

After an abortion at any stage and after a septic interruption, treatment begins immediately on the same day. After childbirth, taking the drug is not indicated. If there is no lactation, then you can start from 21 days.

There are a number of recommendations for patients who take Dimia birth control pills. Reviews indicate that if you follow these tips, the negative effect of the drug on the body will decrease. Doctors advise:

• stop smoking;
• do not skip taking pills;
• take the pills at the same time, preferably before bedtime;
• have the “Rules of Forgotten Pills” on hand;
• if intermenstrual bleeding occurs during the first three months of use, you should consult a doctor to find out the cause;
• in case of amenorrhea, pregnancy must be excluded;
• if the drug is stopped, pregnancy may occur in the first month;
• simultaneous use of Dimia and antibiotics or anticonvulsants reduces the contraceptive effect;
• if vomiting or diarrhea occurs, it is necessary to supplement the intake with another tablet;
• the appearance of severe headache, heart pain, acute visual impairment, shortness of breath, jaundice, increased blood pressure above normal levels indicates that it is urgent to stop taking the drug and consult a doctor.

Analogues of the drug "Dimia"

The drug is produced by the Hungarian company Gedeon Richter. "Jess", "Midiana", "Yarina" are 100% analogues of the contraceptive "Dimia". The instructions and reviews indicate that the composition of these drugs does not differ from the Hungarian drug, the contraceptive effect and side effects are the same, but the price of Dimia is much lower, which is most convenient for women who must take a contraceptive for a year.

Treatment of gynecological diseases

It should be noted that the drug “Dimia” is also used to treat some diseases. Reviews from gynecologists indicate its positive effect in the treatment of such diseases: endometriosis, fibroids, polycystic ovary syndrome, iron deficiency anemia in reproductive age, premenstrual syndrome and menstrual dysfunction.

Dimia tablets are also used to prevent endometrial hyperplastic processes. Reviews from doctors who prefer this particular drug are positive. After examining patients while taking the drug, they note that in women the thickness of the endometrium is significantly reduced, which reduces the risk of developing cancer of the uterus and mammary glands.

One cannot help but mention the positive effect of Dimia tablets on the reproductive function. Reviews from both doctors and patients indicate that after using this drug for three to four months (after stopping use), withdrawal syndrome occurs and pregnancy occurs.

Combined oral contraceptives, when taken correctly, are the most reliable method of contraception. In addition, such drugs contain female sex hormones in a strictly adjusted, small dosage. And this allows you to solve many women’s health problems, improve the condition of your skin, hair and nails.

Dimia is a modern, multiphase contraceptive that has received a lot of positive reviews. What features does the drug have, what is the regimen for taking the tablets, and who should refrain from using OCs?

Compound

The contraceptive drug has the form of round, white and green tablets with a “G73” marker, available in a blister pack of 28 pieces. Dispensed with a doctor's prescription.

White tablets contain the following components:

1. Active. This is microfollin, a progestogen, a derivative of spironolactone.
2. Auxiliary. This category includes lactolin, corn dextrin, polyethylene glycol copolymer, stearic acid, a polymer of a hypothetical vinyl alcohol with a structural formula of a repeating compound unit.

Green pills are a placebo. Contain:

1. Milk sugar.
2. Dietary fiber from purified cotton pulp.
3. Stearic acid.
4. Corn dextrin.
5. The adsorbent is pyrogenic silicon dioxide.

Self-medication, in particular, incorrect medication use, can cause side effects or reduce the contraceptive function of the drug.

Pharmacology

Dimia is, first of all, an effective contraceptive. It can be prescribed by a doctor to both nulliparous and artificially terminated pregnancies in the first and second trimesters. It is also recommended for women who have given birth and are not breastfeeding.

In addition to its direct purpose (protection against unwanted pregnancy), the medicine can be prescribed to girls of reproductive age for the treatment of acne, seborrhea, and severe dysmenorrhea. In addition, taking COCs reduces the likelihood of developing:

• Genital cancer.
• Inflammatory diseases of the pelvic organs.
• Osteoporosis.

The tablets are prescribed to women who have had or are predisposed to an ectopic pregnancy. Also suffering from infertility (increase the likelihood of fertilization after stopping the use of COCs).

It should be borne in mind that every woman’s body has its own characteristics. Therefore, before using a contraceptive, you should strictly undergo all the necessary tests to determine the tolerability of the components of the medication. It would be a good idea to collect a complete medical history and consult with your treating gynecologist.

Side effects

Taking Dimia birth control pills can have unpleasant consequences if the dosage of the drug is incorrectly selected, or if the patient regularly violates the medication regimen. The most common side effects of using COCs are: dizziness, nausea, sleep disturbance, loss of consciousness, increased blood pressure, depressed state, bleeding from the nasal cavity. More severe ones include:

• Skin diseases and allergic responses of the body to the active or auxiliary components of the drug (itching, rashes, burning sensation).
• Inflammation of the gallbladder, vaginal mucosa, local proliferation of tissues of the cervical canal and mammary gland.
• Sexual dysfunction and decreased desire for sexual intercourse.
• Stopping menstruation.
• Pathology of the mammary gland cavity with liquid contents, chest pain.
• Vaginal pain, vaginal dryness, thrush.
• Bloating or abdominal pain.
• Headaches, muscle pain (spasmodic), pain in the lumbosacral region, limbs.
• Motor function disorder.

There have been no cases of drug intoxication from taking Dimia. But potential syndromes of using the drug in excess of the norm (based on other COCs) may be: nausea, vomiting, slight vaginal blood excretion.

Contraindications

Like most OCs, Dimia contraceptives should not be used during pregnancy or breastfeeding. This is due to the fact that increased concentrations of hormones can negatively affect the natural development of the fetus. Also, the active substances in the product can not only reduce its amount, but also change its composition.

Contraindications to the use of contraceptives include the presence of:

• Intolerance to one or more components of the drug.
• Acute inflammation of the pancreas.
• Malignant tumors of generative organs, mammary glands, liver.
• Disorders of one or more liver functions.
• High blood pressure, blockages of arterial vessels, veins.
• Quantitative and qualitative disturbances in the composition of blood lipoproteins.
• Diseases associated with insufficient amount or activity of the C1 inhibitor, impaired blood circulation in the peripheral arteries.
• Migraine with pronounced focal neurological symptoms.
• Diseases associated with impaired absorption of glucose and lactose.
• Supraventricular tachyarrhythmia with chaotic electrical activity of the atria.

You should definitely consult your doctor to prescribe the most effective dosage of Dimia birth control pills if you have work-related illnesses:

• Liver.
• Cardiac muscle.
• Blood flow and other acute or chronic conditions.

In addition, women in the postnatal period should take special care and caution when using Dimia. Also, with caution, the drug is prescribed to those who have had diseases caused by pregnancy or the use of hormone-containing drugs (herpes, jaundice, porphyrin disease, etc.).

Women suffering from obesity, tobacco intoxication, and heart pathologies have an increased risk of side effects.

Admission rules

Dimia's intake is designed for 28 days, during which a woman should take one tablet (alternating active and placebo) every day. Approximately necessary at the same time, drinking plenty of clean, still water. After the package is finished, you need to start taking a new one immediately, without taking breaks. The use of medications from one blister should not be interrupted for more than one week (7 days).

1. If a woman has not taken oral contraceptives before or took a break from taking it for 30–31 days, then the start of taking the drug should occur on the first day of menstruation. It is also permissible on days 2–5 of the cycle, but during sexual intercourse you should additionally protect yourself with barrier contraceptives.
2. When switching to Dimia from other OCs, you should start taking it the next day after taking a placebo tablet (medicines for 28 days) or tablets with the active substance (for contraceptives for 21 days).
3. If you refuse implants, injections, hormonal minimal pills or intrauterine contraceptives in favor of COCs, it is recommended to start using oral contraceptives on the day you stop injections or withdraw contraceptive forms.
4. Taking the drug with a delay of no more than 12 hours will not affect the quality of the contraceptive protection of the drug. If more than 12 hours have passed after the estimated time of administration without taking the medication, then the pill should be taken as soon as the woman remembers, even if this leads to taking several pills together. Next, taking the contraceptive should follow the usual pattern.

The adaptation period (for primary and secondary use) but after a significant break in contraceptive use averages up to three months.

If, after this period, the use of contraceptives is accompanied by unpleasant sensations, then you should consult a women's doctor to adjust the dosage regimen or a new prescription.

Interaction with other medications

By reacting with other medications, the effectiveness of Dimia can be either reduced or increased. Thus, a decrease in the main function of the contraceptive is observed with the simultaneous use of antibiotics (especially ampicillin, tetracycline).

OCs can enhance the process of metabolism of active substances:

• Antiviral and sedative drugs.
• Medicines prescribed for the treatment of diseases of the respiratory and urinary tract, liver and gastrointestinal tract of an infectious nature.
• The effect of oral contraceptives can be supported and increased by taking metronidazole and vitamin C.

At the same time, the rapid metabolism of active substances in OCs is prevented by:

• Pomegranate juice.
• III generation lipid-lowering drugs from the group of statins.

In addition, COCs can also affect the level of drug concentrations in the blood. So, the drug is capable of:

1. Reduce the plasma concentration of some medications from the group: aldehydes (Paracetamol), fourth generation fluoroquinolones (Trovafloxacin), salicylic acid.
2. Increase the degree of influence of caffeine, some antidepressants (imipramine), and immunosuppressants (for example, cyclosporine) on the body.

Dimia is an excellent contraceptive drug, but even it must be taken with the permission of a gynecologist.

flovit.ru

Dimia

Compound

Dimia is a drug that consists of two types of tablets. One white-coated contraceptive pill contains ethinyl estradiol (0.02 mg) and drospirenone (3 mg).

In addition, as auxiliary compounds the drug contains substances such as: corn starch (16.6 mg), including pregelatinized (9.6 mg), magnesium stearate (0.8 mg) and alcohol copolymer polyvinyl (1.45 mg.).

The drug shell contains a complex of Opadry II 85G18490 compounds, which, in turn, includes substances such as talc, polyvinyl alcohol, titanium dioxide, as well as soy lecithin and macrogol.

The second tablet (the so-called placebo), coated with a green coating, contains 37.26 mg. lactose, 42.39 mg. MCC, 0.9 mg. magnesium stearate, 0.45 mg. colloidal silicon dioxide, as well as 9 mg. pregelatized corn starch.

The film coating of the placebo tablet contains a complex of compounds called Opadry II 85F21389, the chemical composition of which includes macrogol, polyvinyl alcohol, talc, yellow quinoline dye, indigo carmine, and also the Sunset dye.

Release form

Dimia tablets containing the active substances drospirenone and ethinyl estradione have a round, biconvex shape. On one side of the tablet medicinal product the marking “G73” is applied by embossing.

Placebo tablets, which are the same round and biconvex in shape, have a green shell. One package of the drug contains 28 tablets, which can be packaged in 1 or 3 blisters.

pharmachologic effect

Dimia is a combination drug that is a monophasic contraceptive.

Pharmacodynamics and pharmacokinetics

This drug contains ethinyl estradiol, as well as drospirenone (a substance close to progesterone of natural origin). The active substances included in this contraceptive do not have antiglucocorticoid, estrogenic, glucocorticoid abilities, as well as a pronounced moderate antimineralocorticoid and antiandrogenic effect.

The contraceptive Dimia achieves its effectiveness due to several factors, for example, by inhibiting ovulation, changing the endometrium and increasing the viscosity of the secretion located in the cervix.

When taken orally, drospirenone is almost completely and fairly quickly absorbed from the stomach. The maximum concentration of the substance in the blood (Cmax) is achieved a maximum of two hours after taking the contraceptive. After the stage of distribution and metabolism, drospirenone is excreted from the body by the kidneys, a small part of the drug is excreted through the intestines.

The active substance ethinyl estradiol, which is part of the contraceptive, as well as drospirenone, is quickly absorbed and reaches its maximum concentration in the blood after two hours. The compound is excreted from the body by the intestines and kidneys.

Indications for use

Dimia is used as a contraceptive.

Contraindications

This contraceptive is contraindicated in conditions such as:

• hypersensitivity to any of the active components of the drug;
• venous or arterial thrombosis;
• thrombophlebitis;
• thromboembolism;
• heart attack;
• cerebrovascular disorders;
• angina pectoris;
• some diseases of the cardiovascular system, such as damage to the heart valve or atrial fibrillation;
• stroke;
• cerebrovascular diseases;
• hypertension;
• smoking, provided that the woman has reached the age of 35 years or more;
• pregnancy, including suspicions of it;
• pancreatitis;
• lactation period;
• renal failure;
• tumors, including benign ones;
• migraine;
• causeless vaginal bleeding;
• lactase deficiency;
• Lapp deficiency.

Dimia contraceptives should be used with caution in case of obesity, angioedema, otorosclerosis, porphyria, minor chorea, thromboembolism, cholelithiasis, as well as in diseases that are accompanied by circulatory disorders, for example, diabetes mellitus, lupus, Crohn's disease, phlebitis, colitis and others.

Side effects of Dimia

Side effects of Dimia can be expressed in the following ailments from the genitourinary, nervous, digestive and cardiovascular systems:

• vaginal bleeding of spotting or breakthrough acyclic nature;
• candidiasis;
• engorgement of the mammary glands;
• rare, but mammary gland hypertrophy may develop, and the composition of vaginal secretion may also change;
• increase or decrease in libido;
• headache;
• migraine;
• mood changes;
• extremely rarely, but arterial as well as venous thrombosis may occur;
• nausea;
• hyperkalemia;
• insomnia;
• diarrhea;
• vomit.

In addition, while taking the drug, allergic reactions may occur and be expressed in itching, rashes on the skin, urticaria and erythema. It is worth remembering that when using a contraceptive, including the drug Dimia, body weight may increase, as well as intolerance to contact lenses, and chloasma (hyperpigmentation) may develop.

Dimia tablets, instructions for use (Method and dosage)

You can read about how to take the drug correctly in the instructions for Dimia. These contraceptives should be taken every day without skipping. Doctors recommend doing this at the same time, always in the order that is usually indicated on the blister. Dimia contraceptives, as well as other similar drugs, must be used continuously for 28 days.

A new package of Dimia birth control pills should be opened only after finishing the previous one. From about the third day from the start of taking the last row of tablets in the blister (placebo period), light bleeding may begin. If the contraceptive package is not finished by the end of the month, then the pills are started again on the first day of menstruation.

During sexual intercourse during the first seven days of using the drug, it is necessary to use additional methods of contraception (barrier). When switching to using Dimia after other complex contraceptives, for example, transdermal patches, tablets, vaginal rings, etc., you should start taking this drug immediately the next day after using the previous method of contraception.

When switching to Dimia after using a contraceptive that contains exclusively progesterone (injections, implants, mini-pills) or after intrauterine contraceptives (spiral), you can take this drug on any convenient day. However, before starting to use the pills, barrier methods of contraception should be used.

If prescribed by a doctor, a woman can start taking these pills on the day after termination of pregnancy (abortion, vacuum). After giving birth, it is recommended to wait 28 days and only then resume taking the drug. It is important to note that a missed dose of placebo tablets (from the 4th row of the blister) is a minor factor.

However, this rule does not apply to tablets containing the active ingredients ethinyl estradiol and drospirenone. If 12 hours have not passed since the last pill was taken, the level of contraceptive protection does not decrease. The missed tablet should be taken as soon as possible, and the next one at the usual time.

You should not take a break from taking pills for more than 7 days, since this is the amount of time needed to suppress the hypothalamic-pituitary ovarian system. To use contraceptives correctly, you should adhere to the following recommendations:

• If you miss taking a pill during the first week of using the drug, a woman should resume using the contraceptive as soon as possible, and also, in order to avoid the risk of becoming pregnant, be sure to resort to additional methods of barrier contraception over the next seven days;
• if you miss taking the drug from 8 to 14 days of its use, you should also resume using Dimia as soon as possible, and then return to the usual schedule, and there is no need for additional contraception if the woman did not forget to take birth control pills in the previous seven days;
• The effectiveness and reliability of this method of contraception is significantly reduced if the drug is missed during the period from 15 to 24 days of its use, since at this time the woman needs to switch to placebo pills.

To avoid unwanted pregnancy, if the last of the described situations of missing a drug dose occurs, the woman should take a pill to replace the missed one as quickly as possible. Next, you should stick to your usual schedule of taking the drug until the active tablets run out. As a result of mixing the 28-day contraceptive dosing schedule, there will be placebo pills in the blister that do not need to be taken.

Most likely, with this option, normal bleeding will not be “withdrawal” until the end of the next package of contraceptives, however, spotting may appear. If a dose of the drug is missed between 15 and 24 days of starting its use, the woman may not return to her usual schedule of contraceptive use and take 4 days (including missed days) of placebo tablets, and then start a new package.

If withdrawal bleeding does not occur with this option, then the possibility of pregnancy should be considered. In the presence of a gastrointestinal disorder, the effectiveness of the drug is reduced, since the active compounds will not be completely absorbed by the stomach. If a woman vomits 4 hours after taking a contraceptive pill, she should immediately take a second one, i.e. replacement pill.

If you do not have your period while taking Dimia, this may indicate pregnancy. It is worth noting that a woman can correct “withdrawal” bleeding, for example, delay it on her own by changing the schedule for taking the drug.

To do this, you can skip the placebo tablets and immediately start taking tablets containing the active compound from the new package. It is noteworthy that when withdrawal bleeding is delayed or delayed, acyclic spotting or profuse bleeding may appear.

Overdose

At the moment, there is no information about cases of overdose of Dimia. However, based on the experience of using complex contraceptives like this drug, in case of an overdose, symptoms such as nausea, vaginal bleeding, and vomiting may occur. If these symptoms occur, you should stop using the drug and consult a doctor for advice.

Interaction

To avoid weakening the effectiveness of contraceptives, you should not use Dimia in conjunction with drugs that affect liver enzymes, for example, Topiramate, Griseofulvin, Primidon, Phenytoin, Oxcarbazepine, Rifampicin, felbamate, barbiturates and others, as well as drugs containing St. John's wort in their chemical composition .

The hepatic metabolism of the drug can be negatively affected by HIV protease and non-nucleoside inhibitors, as well as their combinations. A decrease in the circulation of estrogen, and therefore the effectiveness of Dimia, occurs with the simultaneous use of Tetracyclines and Ampicillin.

For 28 and 7 days (respectively) after taking medications that affect the induction of liver enzymes, as well as antibiotics, you should stop using this drug. Contraceptives may affect the effect of some medications, so you should carefully read the instructions before using Dimia.

Terms of sale

Sold only by prescription.

Storage conditions

Contraceptives are stored out of the reach of children, at a temperature not exceeding 25 C.

Best before date

special instructions

Chronic use of contraceptives may increase the risk of thromboembolism. Moreover, this risk is highest in the first year of using a contraceptive. If the following symptoms occur while taking Dimia, you should immediately stop using the drug:

• swelling of the lower extremities and severe pain;
• dyspnea;
• sudden loss of vision;
• cough;
• causeless severe headache;
• diplopia;
• vertigo;
• aphasia;
• speech disorder;
• acute stomach;
• collapse;
• numbness;
• weakness;
• movement disorders.

During the use of Dimia, the risk of dangerous thromboembolic disorders occurs significantly when:

• hereditary disposition;
• after the age of 30;
• obesity;
• immobilization and after emergency surgery;
• smoking;
• hypertension;
• atrial fibrillation;
• migraine;
• dyslipoproteinemia;
• heart valve diseases.

When using contraceptives, you should definitely take into account the risk of thromboembolism, especially after childbirth, as well as the development of other adverse effects in diabetes mellitus, Crohn's disease, colitis, anemia, and so on. Women should not start taking the drug without a doctor’s recommendation, as well as a preliminary medical examination.

It is important to exclude pregnancy. While using a contraceptive, withdrawal bleeding may occur, so the normality of such discharge can be assessed after three months (adaptation period) from the moment you start using birth control pills.

Dimia's analogs

Perhaps the most common structural analogues of Dimia can be considered the following drugs, similar in chemical composition and mechanism of action:

• Jess;
• Midiana;
• Dailla;
• Yarina;
• Simicia.

Dimia or Jess?

Quite often, women cannot make a choice between these two contraceptive pills, which are similar in action. The main difference between Dimia and Jess can be considered that the first drug is a cheaper analogue of the second.

During pregnancy and lactation

The drug should not be used during pregnancy. If conception occurs while taking Dimia, you should immediately stop taking contraceptives. It is worth noting that this contraceptive has a negative effect on the amount of milk and its composition. Therefore, the drug should be discontinued during breastfeeding.

Reviews about Dimia

We can say that in general the reviews about Dimia are positive, the drug copes with its task and protects against unwanted pregnancy when used correctly and regularly. However, some women speak negatively about this contraceptive because they have experienced side effects of the drug, such as itchy skin, weight gain, and the appearance of varicose veins.

It is especially worth noting that in many reviews of Dimia birth control pills, women talk about the positive cosmetic effect that the drug has on the skin. Reviews from doctors about this contraceptive are good, although doctors also draw the attention of women to contraindications and side effects of the drug, and also urge them to undergo a medical examination before starting to take the contraceptive.

Dimia price, where to buy

Although the price of Dimia will vary depending on the region, the drug can be classified as a low-cost and at the same time effective contraceptive. The average price of Dimia birth control pills does not exceed 500 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in KazakhstanKazakhstan

WER.RU

ZdravZone

• Dimia No. 28 tabletsGedeon Richter
• Dimia No. 28x3 tabletsGedeon Richter

Pharmacy IFC

• DimiaGedeon Richter, Hungary

BIOSPHERE

• Dimia 3 mg/0.02 mg No. 28 tablet p.p.o. Gedeon Richter (Hungary)

NOTE! Information about medications on the site is for reference and general information, collected from publicly available sources and cannot serve as a basis for making a decision on the use of medications in the course of treatment. Before using the drug Dimia, be sure to consult with your doctor.

medside.ru

Contraceptive pills "Dimia": reviews from doctors, instructions and analogues:: SYL.ru

The most effective method of contraception, which is popular in Western Europe and Russia, is the use of hormonal pills, including estrogen and gestagen.
Currently, many different drugs have been developed with minimal side effects, one of which is Dimia. Reviews of this new drug indicate that it is well tolerated and side effects occur in only a small number of women.

Components of the drug

The drug contains two types of tablets: 24 tablets containing 0.02 ethinyl estradiol and 3 mg drospirenone, and 4 tablets, which are pacifiers. This is done for the convenience of women. The first 24 tablets are taken one at a time every day at a certain time of day. Women most often set reminders on their mobile phones. It is the hormones included in its composition that provide the contraceptive effect.

After this, a break from taking the pills is required for menstruation to occur. 4 placebo tablets allow you to continue taking Dimia. In order not to get confused with taking contraceptives and take pills daily, these are the pacifiers that are used. This ensures continued use of the contraceptive.

How the drug works

Ethinyl estradiol in the drug supports the proliferation or growth of the endometrium, thereby providing so-called cycle control - the absence of intermenstrual bleeding when taking the drug "Dimia". Reviews from doctors indicate that in the absence of a sufficient amount of estradiol in the ovaries while taking any oral contraceptive, synthetic ethinyl estradiol replaces its production.

Drospirenone is a synthetic progestogen, a derivative of spironolactone, which has a number of effects that determine the contraceptive effect of the drug. This:

• secretory degeneration of the endometrium, which is caused by estrogens;
• interacting with progesterone receptors, it prevents the release of gonadotropins by the pituitary gland, which leads to the suppression of ovulation;
• blocks the receptors of other steroid hormones: androgens, glucocorticoids and mineralocorticoids, which reduces the risk of various side effects that are characteristic of various hormonal contraceptives.

Side effects from using Dimia

Due to the low content of hormones in the drug, when used correctly, no significant side effects are observed. You can find out by reading reviews. "Dimia" - birth control pills that cause minor unpleasant symptoms:

• headache, dizziness;
• flatulence, nausea, vomiting;
• dyskinesia;
• constant mastodynia - tension of the mammary glands;
• increased blood pressure numbers;
• thrombophlebitis;
• disorders in the blood coagulation system;
• convulsions;
• nervousness, irritability, depression;
• decreased libido;
• significant weight gain;
• bleeding between periods;
• breakthrough bleeding;
• absence of menstruation after taking the drug.

Each side effect depends on individual intolerance and compliance or non-compliance with recommendations at the time when Dimia birth control pills are used. Feedback from women suggests that when taking these tablets, general well-being is normalized, skin condition improves - seborrhea and acne disappear, swelling decreases, and symptoms of premenstrual tension are eliminated. A blood test reveals a decrease in testosterone and normal indicators of the protein and lipid composition of the blood. It was noted that while taking these pills for 3 months, women lost an average of 0.8 kg.

Contraindications to taking oral contraceptives

There are absolute and relative contraindications to taking the drug "Dimia". Instructions for use (reviews from doctors also warn about this) prohibit the use of the drug when:

• thrombosis of deep and superficial veins;
• complex surgical intervention, after which long-term rehabilitation is provided;
• congenital thrombophilias with increased levels of blood clotting;
• IHD, stroke;
• arterial hypertension, when the numbers are above 160 systolic and 100 diastolic pressure;
• complicated diseases of the heart valve apparatus;
• a combination of two or more risk factors: age 35 years or more, smoking more than 10 cigarettes per day, diabetes mellitus, hypertension;
• liver diseases;
• migraine with and without focal neurological symptoms;
• diabetes mellitus for more than 20 years;
• breast cancer;
• pregnancy and breastfeeding.

It is also not recommended to take the drug if a woman has suffered a pulmonary embolism. There are relative contraindications in which the drug can be prescribed, but it should be done with caution after a preliminary examination of the woman. In each specific case, you should start taking the drug after talking with your doctor.

How often should you visit a doctor?

A woman should be under the supervision of her gynecologist when taking Dimia tablets. Reviews from patients testify to this. It is advisable to visit a gynecologist once every six months. This requires an examination with the taking of cytological smears, colposcopy, palpation of the mammary glands, blood pressure control, and, if necessary, a special examination: ultrasound, biochemical blood test, etc.

Correct use of tablets

Only an obstetrician-gynecologist, taking into account indications and contraindications, sets the rules for taking Dimia tablets. Feedback from women that the drug can be used and prescribed independently without harm to health cannot be considered true. This may lead to unwanted complications.

The initial dose of oral contraceptive should be prescribed from the first day of the cycle. If pills are started on day 5 or later, additional use of other methods of contraception is required.

After an abortion at any stage and after a septic interruption, treatment begins immediately on the same day. After childbirth, taking the drug is not indicated. If there is no lactation, then you can start from 21 days.

There are a number of recommendations for patients who take Dimia birth control pills. Reviews indicate that if you follow these tips, the negative effect of the drug on the body will decrease. Doctors advise:

• stop smoking;
• do not skip taking pills;
• take the pills at the same time, preferably before bedtime;
• have the “Rules of Forgotten Pills” on hand;
• if intermenstrual bleeding occurs during the first three months of use, you should consult a doctor to find out the cause;
• in case of amenorrhea, pregnancy must be excluded;
• if the drug is stopped, pregnancy may occur in the first month;
• simultaneous use of Dimia and antibiotics or anticonvulsants reduces the contraceptive effect;
• if vomiting or diarrhea occurs, it is necessary to supplement the intake with another tablet;
• the appearance of severe headache, heart pain, acute visual impairment, shortness of breath, jaundice, increased blood pressure above normal levels indicates that it is urgent to stop taking the drug and consult a doctor.

Analogues of the drug "Dimia"

The drug is produced by the Hungarian company Gedeon Richter. "Jess", "Midiana", "Yarina" are 100% analogues of the contraceptive "Dimia". The instructions and reviews indicate that the composition of these drugs does not differ from the Hungarian drug, the contraceptive effect and side effects are the same, but the price of Dimia is much lower, which is most convenient for women who must take a contraceptive for a year.

Treatment of gynecological diseases

It should be noted that the drug “Dimia” is also used to treat some diseases. Reviews from gynecologists indicate its positive effect in the treatment of such diseases: endometriosis, fibroids, polycystic ovary syndrome, iron deficiency anemia in reproductive age, premenstrual syndrome and menstrual dysfunction.

Dimia tablets are also used to prevent endometrial hyperplastic processes. Reviews from doctors who prefer this particular drug are positive. After examining patients while taking the drug, they note that in women the thickness of the endometrium is significantly reduced, which reduces the risk of developing cancer of the uterus and mammary glands.

One cannot help but mention the positive effect of Dimia tablets on the reproductive function. Reviews from both doctors and patients indicate that after using this drug for three to four months (after stopping use), withdrawal syndrome occurs and pregnancy occurs.

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Dimia tablets - instructions for use, reviews, indications

Dimia is a monophasic oral contraceptive.

Composition and release form of Dimia

Release Dimia film-coated tablets.

1 tablet of Dimia contains the following active ingredients: 20 mcg ethinyl estradiol and 3 mg drospirenone. The preparation also contains the following additional substances: magnesium stearate, pregelatinized corn starch, lactose monohydrate, copolymer of polyvinyl alcohol and macrogol.

The drug is produced in blisters of 28 tablets.

Pharmacological action of Dimia

The drug Dimia contains ethinyl estradiol and drospirenone. Drospirenone in its pharmacological action can be compared with natural progesterone. It does not have antiglucocorticoid, glucocorticoid and estrogenic activity and has a pronounced antiandrogenic and moderate antimineralocorticoid effect.

The contraceptive effect of Dimia is based on its ability to inhibit the onset of ovulation, change the endometrium and increase the viscosity of the secretory fluid of the cervix.

According to reviews, Dimia is a very effective contraceptive.

Indications for use of Dimia

The instructions for Dimia indicate that the tablets are indicated for women of childbearing age for oral contraception.

Method of use of Dimia and dosage regimen

Dimia tablets must be taken every day at approximately the same time. The tablets are taken in the order indicated on the blister pack and washed down with a small amount of water. Duration of administration is 28 days, 1 tablet per day. Taking Dimia tablets from the next package should be started the next day after taking the last tablet from the previous package. As a rule, bleeding begins 2-3 days after starting to take placebo tablets (last row) and does not necessarily end before starting to take tablets from the next pack.

Contraindications

According to the instructions, Dimia, like other combined contraceptive drugs, is contraindicated in the following cases:

• any conditions preceding thrombosis (including angina pectoris, transient ischemic attacks);
• venous and arterial thrombosis and thromboembolism (including stroke, myocardial infarction, deep vein thrombophlebitis, cerebrovascular disorders, pulmonary embolism);
• hereditary or acquired tendency to the occurrence of arterial or venous thrombosis;
• various risk factors contributing to the development of arterial or venous thrombosis (arterial hypertension, cerebrovascular diseases, damage to the heart valves, smoking after the age of 35, obesity, etc.);
• acute or severe chronic renal failure;
• pancreatitis with severe hypertriglyceridemia;
• bleeding from the vagina of unknown nature;
• liver tumor of a benign or malignant nature;
• the presence of any severe liver disease;
• breastfeeding period (negatively affects the quantity and composition of milk);
• hormone-dependent malignant tumors of the breast or genital organs;
• hypersensitivity to one or more components of the drug;
• pregnancy or suspicion of it;
• lactose intolerance, lactase deficiency;
• migraine with focal neurological symptoms.

According to reviews, Dimia should be prescribed with great caution in the following cases:

Side effects

According to reviews, Dimia can cause the following unwanted side effects:

• Lymphatic system and hematopoietic system: thrombocytopenia, anemia.
• Metabolism: anorexia, weight loss or gain, increased appetite, hyponatremia, hyperkalemia.
• Infections: candidiasis.
• Immune system: development of various allergic reactions.
• Nervous system: dizziness, headache, paresthesia, tremor, vertigo, depression, insomnia, anorgasmia, drowsiness, decreased libido.
• Cardiovascular system: varicose veins, migraine, nosebleeds, tachycardia, fainting, increased blood pressure.
• Digestive system: diarrhea, vomiting, nausea, abdominal pain.
• Musculoskeletal system: pain in the limbs and back, muscle cramps.
• From the skin and subcutaneous tissue: itching, rash, eczema, dry skin, skin stretch marks, contact dermatitis.
• Biliary tract and liver: cholecystitis, gallbladder pain.
• Reproductive system: breast pain, absence of bleeding, enlarged mammary glands, pelvic pain, vaginitis, vaginal discharge, heavy or scanty bleeding, dry vaginal mucosa, cervical polyps, cyst or breast hyperplasia.

Overdose

To date, there have been no reviews of Dimia regarding overdose. According to general experience with oral contraceptives, Dimia tablets may cause overdose symptoms such as nausea, vomiting, and minor vaginal bleeding.

Use of Dimia tablets during pregnancy and lactation

According to the instructions, Dimia is contraindicated during pregnancy and breastfeeding.

If pregnancy occurs while taking Dimia tablets, then further use should be stopped immediately. According to epidemiological studies, taking Dimia, according to the instructions, does not have any negative effects on the development of the fetus, however, undesirable effects that have a negative impact on the course of pregnancy cannot be excluded.

According to reviews, Dimia negatively affects lactation, reduces the amount of breast milk and changes its composition, which has a negative effect on the child. Therefore, it is advisable to stop breastfeeding while taking the drug.

How to take food gelatin for joints

Tradename

Description

For drospirenone + ethinyl estradiol tablets:
white or almost white, round, biconvex film-coated tablets, about 6 mm in diameter; On one side of the tablet there is an engraving “G73”.
For placebo tablets:
Green, round, biconvex film-coated tablets, diameter 6 mm.

Pharmacotherapeutic group

Combined contraceptive (estrogen + gestagen)

ATX code:

Release form, composition and packaging

Active ingredient	1 film-coated tablet
Drospirenone	3 mg
Ethinyl estradiol	0.02 mg
Excipients
Core: lactose monohydrate, corn starch, pregelatinized corn starch, macrogol and polyvinyl alcohol copolymer, magnesium stearate; Film shell: Opadry II white 85G18490 (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soy lecithin).
Excipients (placebo tablet)
Core: microcrystalline cellulose, anhydrous lactose, pregelatinized corn starch, magnesium stearate, colloidal silicon dioxide, anhydrous. Film casing: Opadry II 85F21389 green (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, indigo carmine aluminum varnish (E132), quinoline yellow aluminum varnish (E104), iron dioxide black (E172), sunset yellow FCF aluminum varnish (E110)).
Release form: 24 tablets of the drug and 4 tablets of placebo in a blister pack made of PVC/PE/PVDC film and aluminum foil. 1 or 3 blister packs in a cardboard case, enclosed together with instructions for medical use in a cardboard box.

Structural formula, gross formula and chemical name

Pharmacological properties

A combined oral contraceptive (COC) containing ethinyl estradiol and the progestin drospirenone. At a therapeutic dose, drospirenone also has antiandrogenic and weak antimineralocorticoid effects. Does not have estrogenic, glucocorticoid and antiglucocorticoid activity. Thus, drospirenone has a pharmacological profile close to the natural hormone progesterone.
Clinical studies have shown that the antimineralocorticoid properties of Dimia® lead to a weak antimineralocorticoid effect.
It has antiandrogenic activity, which leads to a reduction in the formation of acne and a decrease in the production of sebaceous glands, and does not affect the increase in the formation of sex hormone-binding globulin caused by ethinyl estradiol (inactivation of endogenous androgens).
: 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 inhibition of ovulation and changes in the endometrium.

Pharmacokinetics

Drospirenone

Suction
When taken orally, drospirenone is rapidly and almost completely absorbed. The maximum serum concentration of drospirenone, equal to 37 ng/ml, is achieved 1-2 hours after a single oral dose. Bioavailability ranges from 76 to 85%. Food intake does not affect the bioavailability of drospirenone.

Distribution
Following oral administration, serum levels of drospirenone decrease with a terminal half-life of 31 hours. Drospirenone is observed to bind to serum albumin, but the drug does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG). Only 3-5% of total serum concentrations of active substance are present as free steroid. The ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to serum proteins. The average apparent V d of Drospirenone is 3.7 ± 1.2 l/kg.
During one treatment cycle, the maximum serum Cmax of drospirenone (approximately 70 ng/ml) is achieved after 8 days of treatment. Serum concentrations of drospirenone increase by approximately 3 orders of magnitude due to the final half-life ratio and dosing interval.

Metabolism
Drospirenone is actively metabolized after oral administration. The main metabolites in the blood plasma are the acid form of drospirenone, formed by opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both formed without the participation of the P450 (CYP) system. Drospirenone is slightly metabolized by CYP3A4 and is capable of inhibiting this isoenzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro.

Removal
The rate of metabolic clearance of drospirenone in serum is 1.5±0.2 ml/min/kg. Drospirenone is excreted only in trace amounts unchanged. Drospirenone metabolites are excreted in feces and urine in a ratio of approximately 1.2:1.4. T1/2 for excretion of metabolites in urine and feces is approximately 40 hours.

Ethinyl estradiol

Suction
Ethinyl estradiol, after oral administration, is rapidly and completely absorbed. Cmax in blood serum after a single dose of 33 pg/ml is achieved after 1-2 hours. After presystemic conjugation and presystemic metabolism in the small intestine and liver, absolute bioavailability is 60%. Concomitant food intake reduced the bioavailability of ethinyl estradiol in approximately 25% of people studied, whereas no similar changes were observed in other people.

Distribution
Serum ethinyl estradiol levels decrease in two phases, with a final pharmacokinetic phase characterized by T1/2 of approximately 24 hours. Ethinyl estradiol binds to albumin to approximately 98.5% and induces an increase in serum SHBG and DSG concentrations. The apparent V d is approximately 5 l/kg.
The C ss state is achieved during the second half of the treatment cycle, with serum ethinyl estradiol levels increasing by a factor of approximately 2.0-2.3.

Metabolism
Ethinyl estradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, resulting in the formation of a variety of hydroxylated and methylated metabolites, presented both as free metabolites and as conjugates with glucuronic and sulfuric acids. Ethinyl estradiol is completely metabolized. The rate of metabolic clearance of ethinyl estradiol is 5 ml/min/kg.

Removal
Ethinyl estradiol is practically not excreted unchanged. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6. Half life of metabolites is approximately 1 day. Elimination T1/2 is 20 hours.

Pharmacokinetics in special groups of patients

Patients with impaired renal function. C ss of drospirenone in serum in women with mild renal failure: (creatinine clearance 50-80 ml/min) was comparable to that in women with normal renal function (creatinine clearance>80 ml/min). Serum drospirenone levels were on average 37% higher in women with moderate renal impairment (CrCl = 30-50 ml/min) compared to women with normal renal function. Drospirenone therapy was well tolerated by women with both mild and moderate renal impairment.
Treatment with drospirenone did not have a clinically significant effect on serum potassium levels.

Patients with impaired liver function.
In a single-dose study, total clearance in volunteers with moderate hepatic impairment was approximately 50% reduced compared with that in subjects with normal hepatic function.
The observed decrease in drospirenone clearance in volunteers with moderate hepatic impairment does not lead to any significant differences in serum potassium concentration. Even with diabetes and concomitant treatment with spironolactone (two factors that can precipitate hyperkalemia in the patient), there was no increase in serum potassium concentrations above the ULN. It can be concluded that the combination of drospirenone/ethinyl estradiol is well tolerated in patients with moderate hepatic impairment (Child-Pugh class B).

Ethnic groups. There were no clinically relevant differences in the pharmacokinetics of drospirenone or ethinyl estradiol between Japanese and Caucasian women.

Indications for use

• Oral contraception.

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

Directions for use and doses

The tablets must be taken every day at approximately the same time, if necessary, with a small amount of liquid, in the order indicated on the package. It is necessary to take 1 tablet/day for 28 days in a row. Each subsequent package should begin after taking the last tablet from the previous package. Withdrawal bleeding usually begins on day 23 after taking placebo tablets (last row) and may not end by the time the next pack is started.

If you have not previously used hormonal contraceptives (in the last month)
Taking Dimia® begins on the first day of a woman’s natural menstrual cycle (i.e., on the first day of menstrual bleeding).

If you are replacing another PDA, vaginal ring, or transdermal patch
It is preferable for a woman to start taking Dimia ® the next day after the usual hormone-free interval in the previous combined contraceptive regimen. When replacing a vaginal ring or transdermal patch, it is advisable to start taking Dimia ® on the day the previous product was removed; in such cases, taking Dimia ® should begin no later than the day of the planned replacement procedure.

In case of replacement of a method using only gestagens (mini-pills, injection forms, implants) or an intrauterine system (IUD) with the release of gestagens

A woman can switch from the mini-pill on any day (from an implant or IUD on the day of its removal, from an injectable form - from the day when the next injection was due). However, in all these cases it is advisable to use additionally during the first 7 days of taking the tablets.

After termination of pregnancy in the first trimester

The woman can start taking it immediately. If this condition is met, there is no need for additional contraceptive measures.

After childbirth or termination of pregnancy in the second trimester

It is advisable for a woman to start taking Dimia ® on days 21-28 after childbirth or termination of pregnancy in the second trimester. If taken later, it is necessary to use additionally during the first 7 days of taking the tablets. If you have sexual intercourse, pregnancy should be excluded before starting to take the drug or you must wait until your first menstruation.

Taking missed pills

Omission of 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 is less than 12 hours, contraceptive protection is not reduced. A 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 pills is more than 12 hours, contraceptive protection may be reduced. Correcting missed pills 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 use are necessary.

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

Week 1
You should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. The next tablet is taken at the usual time. Additionally, a barrier method of contraception must be used for the next 7 days. If sexual intercourse took place within 7 days before missing a pill, the possibility of pregnancy must be taken into account. The more pills you miss and the closer this skip 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 this 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 over the previous 7 days, there is no need to use additional contraception. However, if she has missed more than 1 tablet, additional precautions must be taken in the next 7 days.

Week 3
The likelihood of a decrease in the contraceptive effect is significant due to the approaching phase of placebo pills. However, by adjusting the schedule for taking pills, you can prevent a decrease in contraceptive protection. If you follow any of the following two tips, you will not need additional methods of contraception if you have taken all your pills correctly in the previous 7 days before missing a 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. You should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. The next tablets are taken at the usual time until the active tablets are gone. You should not take 4 placebo tablets from the last row; you should immediately start taking tablets from the next pack. Most likely, there will be no withdrawal bleeding until the end of the second pack, but spotting or breakthrough uterine bleeding may occur on the days of taking the pills.
2. The woman may be advised to stop taking active tablets from the started pack. Instead, she should take the placebo pills from the last row for 4 days, including the days she missed pills, and then start taking the pills from the next pack.
   If you miss taking pills and there is no withdrawal bleeding in the placebo pill phase, pregnancy must be ruled out.

Gastrointestinal disorders
In case of severe gastrointestinal reactions (such as vomiting or diarrhea), absorption may be incomplete and additional contraceptive measures must be used.
If vomiting occurs within 3-4 hours after taking the active tablet, you should take a new replacement tablet as soon as possible. If possible, the next tablet should be taken within 12 hours after the usual dosing time. If more than 12 hours are missed, if possible, you must follow the rules for taking the drug specified in the section “Taking missed tablets.” If the patient does not want to change the normal regimen of taking the drug, she should take an additional tablet (or several tablets) from a different package.

How to delay withdrawal bleeding
To delay the onset of menstruation, you must skip taking placebo tablets from the started package and start taking active Dimia ® tablets from a new package without interruption. A delay is possible until the end of the tablets in the second package.
During the lengthening of the cycle, spotting bloody discharge from the vagina or uterine breakthrough bleeding may occur. Regular use of Dimia ® ends after the placebo phase.
To move the start of your period to another day of the week on your regular schedule, shorten the upcoming placebo pill phase by as many days as necessary. The shorter the interval, the higher the risk that there will be no “withdrawal” bleeding, and while taking the second package, spotting and breakthrough bleeding will be observed (as well as in the case of a delay in the onset of menstruation).

Side effect

Contraindications

• pregnancy;
• breastfeeding period;
• the presence of venous thrombosis currently or in history (for example, deep vein thrombosis, pulmonary embolism);
• current or history of arterial thrombosis (eg, myocardial infarction) or previous conditions (eg, angina and transient ischemic attack);
• cerebrovascular diseases currently or in history; 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), antithrombin 3 deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
• pancreatitis with severe hypertriglyceridemia, incl. in the anamnesis;
• severe liver disease (before normalization of liver tests) currently or in history; severe chronic renal failure or acute renal failure;
• liver tumors (benign or malignant), currently or in history;
• hormone-dependent malignant diseases of the reproductive system (genital organs, mammary glands) or suspicion of them;
• vaginal bleeding of unknown origin;
• migraine with local neurological symptoms in history;
• galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
• hypersensitivity to the active substance or any of the excipients.

Pregnancy and lactation

If pregnancy occurs while taking Dimia ® , the drug must be discontinued immediately. Epidemiological studies have shown neither an increase in the risk of childbirth for children in women who took COCs before pregnancy, nor a teratogenic effect when COCs were inadvertently taken during pregnancy. No such studies have been conducted with the drug.
COCs may affect lactation because they can reduce the quantity and change the composition of breast milk. Therefore, the use of PDAs cannot be recommended until a breastfeeding woman has completely stopped breastfeeding. Small amounts of contraceptive hormones or their metabolites may be excreted in milk during the use of COCs. These amounts may affect the child.

special instructions

If any of the conditions/risk factors listed below currently exist, the potential risks and expected benefits of using COCs 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, intensify, or appear for the first time, a woman should consult her doctor, who may decide whether to discontinue the COC.

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 COCs (< 50 мкг этинилэстрадиола) составляет примерно от 20 случаев на 100 000 женщин в год (для левоноргестрел-содержащих КПК 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.
Use of any combined oral contraceptives is associated with an increased risk of venous thromboembolism comparable to that without use. The additional risk is greatest during the first year of combined oral contraceptive use. 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 attack).
In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as the 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 the limb;
• sudden severe chest pain, with or without radiation to the left arm; sudden shortness of breath;
• sudden attack 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 a seizure;
• weakness or extreme 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, the woman needs to consult a specialist before prescribing a COC;
• after prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is recommended to stop taking the drug (in the case of planned surgery, at least four weeks before it) and not to resume taking it for two weeks after the end of immobilization. Additionally, it is possible to prescribe antithrombotic therapy if the pills were not stopped within the recommended time frame;
• obesity (body mass index more than 30 mg/m2);
• There is no consensus on the possible role of varicose veins and superficial vein thrombophlebitis in the onset or progression of venous thrombosis.

The risk of arterial thrombotic complications of thrombosis of cerebrovascular disease in women taking COCs increases:

• with age;
• in smokers (women over 35 years of age are strictly not recommended to smoke if they want to use COCs);
• with dyslipoproteinemia;
• for hypertension;
• for migraines;
• for diseases of the heart valves;
• with atrial fibrillation.

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

Other diseases

Other diseases that are associated with severe vascular pathology include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell disease.
An increase in the frequency and severity of migraines during the use of COCs (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.
An increased risk of cervical cancer with long-term use of combined oral contraceptives has been reported in some epidemiological studies. Its connection with the use of COCs has not been proven. Controversy remains over the extent to which these findings are attributable to sexual behavior and other factors such as human papillomavirus (HPV).

Mammary cancer

A meta-analysis of 54 epidemiological studies demonstrated that there was a slightly increased relative rate (RR=1.24) of breast cancer diagnosed in women who were using combined oral contraceptives at the time of the study. Its connection with the use of COCs has not been proven. The observed increased risk may be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives. Breast cancer in women who had ever used combined oral contraceptives was clinically less severe than in women who had never used such drugs. In rare cases, the development of benign liver tumors has been observed during the use of COCs, and in extremely rare cases, the development of malignant liver tumors. In some cases, these tumors lead to life-threatening intra-abdominal bleeding. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur when making a differential diagnosis in a woman taking COCs, the likelihood of developing a liver tumor should be taken into account.

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 did not significantly increase serum potassium levels when taking drospirenone. It is therefore recommended to check serum potassium levels during the first cycle of treatment in patients with renal failure whose pre-treatment serum potassium levels were at the upper limit of normal and who are additionally using potassium-sparing drugs.
In women with hypertriglyceridemia or a family history of this disease, an increased risk of developing pancreatitis while taking COCs cannot be excluded. Although slight increases in blood pressure have been reported in many women taking combined oral contraceptives, clinically significant increases have rarely been observed. Only in rare cases is the immediate abolition of the CCP justified. If, while taking a COC with existing arterial hypertension, persistently or significantly elevated blood pressure does not adequately respond to antihypertensive treatment, you should stop taking the COC.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: jaundice and/or pruritus associated with cholestasis, gallstone formation, porphyria, systemic red lupus, hemolytic uremic syndrome, Sydenham chorea, gestational herpes, hearing loss associated with otosclerosis. In women prone to angioedema, exogenous estrogens may induce 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 and/or itching associated with cholestasis, which developed for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COC use. Although COCs may have an effect on 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 КПК.
Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs, however, the connection with taking the drugs has not been proven.
Worsening of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis has been reported with COC use.
In rare cases, chloasma may develop, especially in women with skin pigmentation during pregnancy. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs. The drug contains 48.53 mg of lactose per tablet and 37.26 mg of anhydrous lactose per inactive tablet. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should keep this in mind.
Women who are allergic to soy lecithin may experience mild allergic reactions.

Medical examinations/consultations

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

PDAs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced if pills are missed, gastrointestinal disorders, or concomitant medications are taken.

Reduced cycle control

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

If irregular bleeding recurs or develops after previous regular cycles, non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignancy or pregnancy. These may include curettage.

In some women, withdrawal bleeding may not develop during a break from taking the pills. If COCs are taken as directed, it is unlikely that the woman will be pregnant. However, if COCs have not been taken regularly before or if there are no two withdrawal bleedings in a row, pregnancy should be ruled out before continuing to take COCs.

Impact on the ability to drive vehicles and operate machinery

There have been no studies examining the effect of the drug on the ability to drive a car or operate machinery with an increased risk of injury.

Overdose

Symptoms: nausea, vomiting, slight vaginal bleeding in young girls.
Treatment: symptomatic.

Interaction with other drugs

Some drugs, due to the induction of microsomal enzymes, can increase the clearance of sex hormones (hydantoin, phenytoin, barbiturates, primidone, carbamazepine and rifampicin; the same effect is also possible with oxycarbazepine, topiramate, felbamate, ritonavir, griseofulvin and herbal remedy based on St. John's wort (Hypericum perforatum)). Maximal induction of liver microsomal enzymes usually does not occur for 2–3 weeks, but may then persist for at least 4 weeks after drug therapy is stopped. The 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.
Co-administration with certain antibiotics, such as penicillins and tetracyclines, reduces the enterohepatic recirculation of estrogens, which may lead to a decrease in ethinyl estradiol concentrations.
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 continuous treatment with drugs containing active substances that affect liver enzymes must additionally use a non-hormonal method of contraception for 28 days after their discontinuation.
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 taking concomitant medications lasts longer than the expiration date of the active tablets in the package, the placebo tablets should be discarded and immediately begin taking the active tablets from the next package.
The main metabolism of drospirenone in human plasma occurs without the involvement of the CYP system. Inhibitors of this enzyme system therefore do not affect the metabolism of drospirenone.
Oral contraceptives may affect the metabolism of certain other active compounds. In addition, their concentrations in plasma and tissues may change, either increasing (for example, cyclosporine) or decreasing (for example, lamotrigine).
In female volunteers taking omeprazole, simvastatin and midazolam as tracer substrates, the effect of drospirenone 3 mg on the metabolism of other active substances is unlikely.
In patients with renal failure, simultaneous administration of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on serum potassium levels. However, the simultaneous 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.
Co-administration of drugs should be discussed to identify possible drug interactions.
Taking hormones for contraception may affect the results of certain laboratory tests, including biochemical indicators 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 limits.
Due to its slight antimineralocorticoid activity, drospirenone increases the activity of plasma renin and aldosterone.

Storage conditions and expiration dates

The drug should be stored in its original packaging, out of the reach of children, protected from light at a temperature of 15° to 25°C. Shelf life – 2 years.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Analogs

The decision to change the drug is made by the attending physician; do not take it yourself.

Manufacturer

JSC "Gedeon Richter" 1103, Budapest, st. Demrei, 19-21, Hungary.