Diecyclene, 2 mg+0.03 mg 63 pcs

Diecyclene is a low-dose monophasic oral hormonal contraceptive. Contraceptive effect is based on the interaction of various factors, the most important of which is inhibition of ovulation and a change in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm, the penetration of sperm through the cervical canal is difficult.

When used correctly, the Perl index (a measure of the number of pregnancies per 100 women using the contraceptive in a year) is less than 1. If the pills are missed or used incorrectly, the Perl index may increase.

In addition to its contraceptive effect, it has other concomitant positive properties. In women taking combined oral contraceptives, the cycle becomes more regular, the pain, intensity and duration of menstrual bleeding are reduced, and as a result the risk of iron deficiency anemia is reduced. There is also data on decrease of risk of endometrial and ovarian cancer.

Dienogest ingredient of the preparation is an active gestagen and a derivative of normestosterone with anti-androgenic activity and positively influences the lipid profile, increasing concentration of high density lipoproteins (HDL).

Indications

– oral contraception;

Treatment of mild to moderate acne and seborrhea.

Active ingredient

Composition

Tablets, film-coated

The composition

1 tablet ethinyl estradiol 0.03 mg

Dienogest 2 mg

How to take, the dosage

Enally, daily, preferably at the same time, in the order indicated on the package, with a small amount of water. Take 1 tablet a day continuously for 21 days. Taking pills from each subsequent package begins after a 7-day break, during which there is bleeding “cancellation” (menstrual-like bleeding). It usually begins on the 2nd or 3rd day after taking the last pill and may last until the beginning of taking the pill from the new package.

In the absence of taking any hormonal contraceptives in the previous month, taking the drug starts on the first day of the menstrual cycle (the first day of menstrual bleeding). It is allowed to start taking it on days 2-5 of the menstrual cycle, but in this case it is recommended to use an additional barrier method of contraception during the first 7 days of taking the pills from the first package. If you are switching from a previous use of other combined oral contraceptives, it is preferable to start taking the product the day after taking the last active pill from the previous package, but no later than the day after the usual 7-day break in intake (for products containing 21 pills) or after taking the last inactive pill (for products containing 28 pills in a package).

When switching from a vaginal ring to a transdermal patch, it is preferable to start Diecyclene on the day the ring or patch is removed, but no later than the day the new ring or patch is to be inserted. When switching from contraceptives containing only gestagens (“mini-pili”, injectable forms, implant) the drug is taken: from “mini-pili” – on any day (without a break), from the implant – on the day of its removal, from the injectable form – from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy, it is possible to start taking immediately. No additional contraceptive protection is necessary if this condition is met. After childbirth or an abortion in the second trimester of pregnancy, it is recommended to start Diecyclene 21-28 days after childbirth or abortion If started later, additional barrier method of contraception should be used during the first 7 days of taking the pills. However, if a woman has already been sexually active, pregnancy must be ruled out or the first menstrual period must be awaited before taking the pills.

Recommendations in case of irregular use of Diecyclene: If you miss taking the drug, if the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. It is necessary to take the pill as soon as possible, the next pill is taken at the usual time. If the delay in taking the pill was more than 12 hours, contraceptive protection may be reduced. In the first 2 weeks of taking the drug, if the interval since the last pill was taken more than 36 hours: it is necessary to take the last missed pill as soon as possible (even if it means taking 2 pills at once). The next tablet is taken at the usual time.

In addition, a barrier method of contraception (condom) must be used for the next 7 days. If there was sexual intercourse within 1 week before skipping the pill, it is necessary to consider the possibility of pregnancy. The more pills you miss, and the closer it is to the 7-day break in your medication, the greater the risk of pregnancy. At 3 weeks of taking the drug, if the interval since the last pill is more than 36 hours: you should take the last missed pill as soon as possible (even if it means taking 2 pills at the same time).

The next tablet is taken at the usual time. Additionally, a barrier method of contraception (condom) must be used for the next 7 days. In addition, the pill from the new pack should be started as soon as the current pack is finished, i.e. without interruption. It is most likely that you will not have “cancellation” bleeding until the end of the second package of pills, but you may have “masculine” discharge or “breakthrough” uterine bleeding on the days you take the pills. If a woman misses taking the pill and then has no bleeding “cancellation” during a break in the medication, pregnancy must be ruled out.

In gastrointestinal disorders: If the woman had vomiting or diarrhea within 3 to 4 hours after taking the drug Diecyclene absorption may be incomplete. In this case, it is necessary to be guided by the recommendations regarding skipping taking the pill.

If a woman does not want to change her normal regimen of taking the drug, she should take an additional tablet from the spare package if necessary. Changing the day menstrual bleeding begins: To delay the onset of menstrual bleeding, the pills in the new pack should be continued as soon as all pills in the previous pack are taken, without interruption.

The pills in the new pack can be taken until the pack is finished. While taking the drug from the second package, a woman may experience “smeary” discharge or uterine bleeding “breakthroughs”. You should resume taking the drug from the new pack after the usual 7-day break.

In order to reschedule the start day of menstrual bleeding to another day of the week, the nearest break in taking Diecyclene pills should be reduced by as many days as necessary to reschedule the start day of menstrual bleeding.

The shorter the interval, the greater the risk of no “cancellation” bleeding and the subsequent occurrence of “smeary” discharge and “breakthrough” bleeding while taking pills from the second pack (just as in the case of delaying the start of menstrual-like bleeding).

Interaction

Some drugs can increase the rate of metabolic clearance of sex hormones and lead to significant bleeding or to a decrease in the contraceptive effect of the drug. Such effects are characteristic of drugs that induce microsomal liver enzymes: hydantoin, barbiturates, primidone, carbamazepine and rifampicin. Rifabutin, efavirenz, nevirapine, oxcarbazenine, topiramate, felbamate, ritonavir, nelvinafir, fiseofulvin, and medications containing St. John’s wort (Hypericum perforatum) are also suspected. Some antibiotics that reduce intestinal hepatic circulation of estrogen (such as ampicillin or tetracycline) reduce the effectiveness of combined oral contraceptives.

Women taking short courses (maximum 1 week) of the above medications should use additional contraceptive measures (e.g., barrier method) during concomitant use of the drugs and in the following 7 days.

In case of concomitant use of oral contraceptives with rifampicin, additional contraceptive measures (e.g., barrier method) should be used during the simultaneous use of the drugs and in the next 4 weeks after discontinuation of treatment. If the package of oral contraceptives ends before the end of the course of other drugs, the pills from the next package of the drug should be started without a break.

The dose of contraceptives should be increased during a long-term course of treatment with drugs that induce microsomal liver enzymes. If side effects develop (e.g., irregular menstruation) or if the drug is ineffective, other non-hormonal contraceptives should be used additionally.

Peroral contraceptives may affect the metabolism of some other drugs. Accordingly, this may lead to an increase (cyclosporine) or a decrease (lamotrigine) in their plasma or tissue concentrations. Dienogest is a substrate of cytochrome P450 (CYP3A4). Known CYP3A4 inhibitors such as antifungals (e.g., ketoconazole), cimetidine, verapamil, macrolides (e.g., erythromycin), diltiazem, antidepressants and grapefruit juice can increase the plasma concentration of dienogest.

Special Instructions

Ingregular use may lead to acyclic bleeding and reduce the contraceptive effectiveness of the drug. Before starting or resuming use of the drug it is recommended to perform a thorough general medical and gynecological examination (including examination of the breast and cytological examination of cervical scrape), to exclude pregnancy. In addition, disorders of the blood-clotting system should be excluded.

When using the drug it is necessary at least once every 6 months to conduct preventive control examinations. The drug Dietsiklen does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Diseases of the cardiovascular system: Possible occurrence of venous thromboembolism (VTE) in the form of deep vein thrombosis and/or pulmonary embolism when using hormonal contraceptives. The estimated incidence of VTE in women taking low-dose estrogen oral contraceptives (less than 50 mcg ethinyl estradiol) is up to 4 per 10,000 women per year, compared with 0.5-3 per 10,000 women not using oral contraceptives. However, the incidence of VTE developing while taking combined oral contraceptives is lower than the incidence of pregnancy-related VTE (6 per 10,000 pregnant women per year).

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, or vein and retinal arteries, have been described. The association of these cases with the use of combined oral contraceptives has not been proven. A woman should stop taking the drug and consult a physician if she develops symptoms of venous or arterial thrombosis, which may include unilateral lower extremity pain and/or swelling; sudden severe chest pain; with or without irradiation into the left arm; sudden shortness of breath; sudden bouts of cough; any unusual, severe, prolonged headache increased frequency and severity of migraine; sudden partial or total loss of vision; diplopia; slurred speech or aphasia; dizziness; collapse with or without partial seizure; weakness or very significant loss of sensation, suddenly on one side or in one body part; motor disturbances; “acute” abdomen.

The risk of thrombosis (venous and/or arterial) and thromboembolism increases: with age, in smokers (with increasing number of cigarettes smoked or increasing age the risk further increases, especially in women over 35 years), with a family history (i.e. venous or arterial thromboembolism ever in a close relative or parent at a relatively young age), obesity dyslipoproteinemia, arterial hypertension, heart valve disease, prolonged immobilization, extensive surgery, any lower extremity surgery or extensive trauma, atrial fibrillation.

In case of prolonged immobilization, major surgery, any leg surgery or extensive trauma, it is advisable to discontinue the drug (in case of planned surgery, at least 4 weeks before it) and not to resume administration for 2 weeks after the end of immobilization. The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. An increased risk of thromboembolism in the postpartum period should be considered.

Microcirculatory disorders may also be seen in diabetes mellitus, SLE, hemolytic-uremic syndrome, Crohn’s disease, ulcerative colitis and sickle cell anemia. Tumors: The most significant risk factor for cervical cancer is persistent papillomavirus infection. There have been reports of some increased risk of cervical cancer with long-term use of combined oral contraceptives.

However, the association with taking combined oral contraceptives has not been proven. The possibility of a correlation of these data with cervical disease screening and with patterns of sexual behavior (less frequent use of barrier methods of contraception) is discussed. A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk 1.24).

The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under age 40, the increase in breast cancer diagnoses in women currently or recently taking combined oral contraceptives is small relative to the overall risk of the disease. The relationship between the development of breast cancer and taking combined oral contraceptives has not been proven.

The observed increase in risk may also be a consequence of close monitoring and earlier diagnosis of breast cancer in women who use combined oral contraceptives. Women who have ever used combined oral contraceptives are detected earlier stages of breast cancer than women who have never used them. In rare cases, during the use of combined oral contraceptives development of benign, and in very rare cases – malignant tumors of the liver have been observed, which in some cases led to life-threatening intra-abdominal bleeding. If severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding occur, this should be considered in the differential diagnosis.

Other conditions: Women with hypertriglyceridemia or a family history of it may have an increased risk of pancreatitis when taking combined oral contraceptives. Although small increases in blood pressure (BP) have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if persistent, clinically significant arterial hypertension develops while taking the combined oral contraceptives, cancellation of the combined oral contraceptives and treatment of arterial hypertension is warranted.

The combined oral contraceptives may be continued if normal BP values are achieved with hypotensive therapy. Effect on the menstrual cycle: During the use of combined oral contraceptives, irregular (acyclic) bleeding (“spotting” or “breakthrough” bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be evaluated only after an adjustment period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough evaluation should be performed to rule out malignancy or pregnancy. Some women may not develop “withdrawal” bleeding during a break in the pill. If the combined oral contraceptive has been taken as directed, pregnancy is unlikely However, if the combined oral contraceptive has been taken irregularly before, or if there are no two consecutive “cancellation” bleeds, pregnancy should be ruled out before continuing the medication.

The effect on laboratory test values: The use of oral combination contraceptives may affect the results of some laboratory tests, including blood chemistry (liver, thyroid, kidney, and adrenal function parameters, plasma transport protein concentrations (such as hGH), carbohydrate metabolism, lipid/lipoprotein fractions), and coagulation and fibrinolysis parameters.

However, changes in these parameters remain within normal values. Effect on the ability to drive vehicles and mechanisms: There are no data on the negative effect of the drug Diecyclen on the ability to drive vehicles and engage in potentially dangerous activities that require high concentration and quick psychomotor reactions.

Contraindications

– hypersensitivity to any of the ingredients of the drug Diecyclene;

– thrombosis (venous and arterial) and thromboembolism (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders) at present or in the past;

– Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris), current or history;

– Multiple or significant risk factors for venous or arterial thrombosis, including complicated heart valve lesions, atrial fibrillation, cerebral vascular disease, or coronary artery disease uncontrolled arterial hypertension, massive surgery with prolonged immobilization, smoking over 35 years of age, obesity with Body Mass Index > 30 kg/m2;

Diabetes with diabetic angiopathy;

– – diagnosed predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids, lupus antigen;

– severe liver disease (until recovery and normalization of laboratory indicators of liver function);

– benign or malignant liver tumors, including a history.

– severe forms of arterial hypertension with BP >160/100 mmHg;

– identified or suspected hormone-dependent malignant diseases of the genitals or mammary glands, including history; – bleeding from the vagina of unclear genesis;

– migraine with focal neurological symptoms at present or in the history;

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– pancreatitis accompanied by significant hypertriglyceridemia currently or in the history;

– severe and/or acute renal failure;

– pregnancy or suspected pregnancy;

– lactation period;

– hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome or hypersensitivity to peanuts or soybeans (due to the presence of lactose and soy lecithin in the drug Dietsiklen).

With caution: Risk factors for thrombosis and thromboembolism: Obesity, smoking, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, heart valve defects, prolonged immobilization, major surgery, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or stroke at a young age in any immediate family member).

Other diseases in which peripheral circulatory disorders may be noted: diabetes without diabetic angiopathy, surface vein phlebitis, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia.

Diseases that first appeared or worsened during pregnancy or on previous use of sex hormones, such as jaundice and/or pruritus with cholestasis, gallbladder disease, porphyria, Sydenham’s chorea, herpes in pregnancy history, impaired hearing (associated with otosclerosis). Endogenous depression, epilepsy; hereditary angioedema; hypertriglyceridemia; liver disease; postpartum period.

Overdose

Possible symptoms of overdose of the drug Diecyclen: nausea, vomiting, irregular bloody discharge, absence of menstrual bleeding.

If necessary, symptomatic therapy is carried out.

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