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Decyclen is a low-dose monophasic oral hormonal contraceptive. The contraceptive effect is based on the interaction of various factors, the most important of which is the inhibition of ovulation and changes in the viscosity of the cervical mucus, as a result of which it becomes impermeable to sperm, penetration of sperm through the cervical canal is difficult. If used correctly, the Pearl Index (a measure reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip pills or misuse, the Pearl Index may increase.
In addition to the contraceptive effect, it has other associated positive properties. In women taking combined oral contraceptives, the cycle becomes more regular, soreness, intensity and duration of menstrual bleeding decrease, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduction in the risk of endometrial and ovarian cancer.
The gestagein component dienogest, which is part of the preparation, is an active gestagen, is a derivative of nortestosterone with antiandrogenic activity and has a positive effect on the lilide profile, increasing the concentration of high density lipoproteins (HDL).
- oral contraception;
- treatment of mild and moderate acne and seborrhea.
1 tab. ethinyl estradiol 0.03 mg dienogest 2 mg
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Dosage and Administration
Orally, daily, preferably at the same time, in the order indicated on the package, with a small amount of water. Take 1 tablet per day continuously for 21 days. Taking pills from each of the next package begins after a 7-day break, during which there is a "withdrawal" bleeding (menstrual-like bleeding). It usually starts 2-3 days from taking the last pill and may continue until the beginning of taking the pill for a new package. In the absence of taking any hormonal contraceptives in the previous month, taking the drug begins on the first day of the menstrual cycle (on the first day of the menstrual bleeding). It is allowed to start taking on the 2-5 day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package. When switching from the previous intake of other combined oral contraceptives, it is preferable to start taking the drug the next day after taking the last active pill from the previous package, but not later than the next day after the usual 7-day break in reception (for drugs containing 21 pills) or after taking the last one. inactive pills (for drugs containing 28 pills per pack). When switching from the vaginal ring of a transdermal patch, it is preferable to start taking the drug Diecyclen on the day the ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is glued. When switching from contraceptives containing only gestagens (“mini-pili”, injection 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 injection form - from the day when the next injection should have been given. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills. After an abortion in the first trimester of pregnancy, you can start taking immediately. Subject to this condition, there is no need for additional contraceptive protection. After childbirth or abortion in the second trimester of pregnancy, it is recommended to start taking the drug Diecyclen on days 21-28 after giving birth or abortion. If the reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had a sexual life, pregnancy should be excluded before the start of medication, or it is necessary to wait for the first menstruation. Recommendations in case of an irregular intake of the drug Detytsiklen: In case of a miss in the intake of the drug, if the delay in taking the pill was less than 12 hours, the contraceptive protection does not decrease. It is necessary to take a pill as soon as possible, the next pill is taken at the usual time. If the delay in taking the pill is more than 12 hours, contraceptive protection can be reduced. In the first 2 weeks of taking the drug, if the interval since taking the last pill is more than 36 hours: you need to take the last missed pill as soon as possible (even if it means taking 2 pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception (condom) should be used within the next 7 days. If there was sexual intercourse within 1 week before the pill was missed, the likelihood of pregnancy should be considered. The more pills are missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy. At 3 weeks of taking the drug, if the interval since taking the last pill is more than 36 hours: you need to take the last missed pill as soon as possible (even if it means taking 2 pills at the same time).The next pill is taken at the usual time. Additionally, a barrier method of contraception (condom) should be used within the next 7 days. In addition, taking the pill from a new pack should be started as soon as the current pack is finished. nonstop. Most likely, the "withdrawal" bleeding will not be until the end of taking the pills from the second package, but there may be a "spotting" discharge or a uterine bleeding "breakthrough" on the days of taking the pills. If a woman misses taking a pill and then during a break in taking the drug she has no "withdrawal" bleeding, it is necessary to exclude pregnancy. In case of gastrointestinal disorders: If a woman has vomiting or diarrhea within 3 to 4 hours after taking Dieticlen, the absorption may be incomplete. In this case, you need to focus on the recommendations regarding the omission of the pill. If a woman does not want to change the normal mode of taking the drug, she should take an extra pill from a spare pack, if necessary. Changing the day of the onset of menstrual bleeding: To postpone the onset of menstrual bleeding, you must continue taking the pills from the new package immediately after all the pills from the previous one are taken, without interruption. pills from the new packaging can be taken until the packaging is over. On the background of taking the drug from the second package, a woman may experience "spotting" discharge or uterine bleeding "breakthrough." Resume taking the drug from the new pack should be after the usual 7-day break. In order to postpone the day of the onset of menstrual bleeding to another day of the week, it is necessary to shorten the closest interruption in taking Diecyclen pills for as many days as necessary to postpone the day of the onset of menstrual bleeding. The shorter the interval, the higher the risk of no bleeding "cancellation" and the appearance of further "spotting" discharge and bleeding "breakthrough" while taking pills from the second package (as well as in case of delaying the onset of menstrual-like bleeding).
- hypersensitivity to any of the components of the drug Detytsiklen; - thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, thromboembolism of the pulmonary artery, myocardial infarction, stroke, cerebrovascular disorders); - conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history; - Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, vascular diseases of the brain or coronary arteries; uncontrolled arterial hypertension, volume surgical intervention with prolonged immobilization, smoking over the age of 35, obesity with a body mass index of> 30 kg / m2; - diabetes mellitus with diabetic angiopathy; - identified susceptibility 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 the restoration and normalization of laboratory parameters of liver function); - benign or malignant liver tumors, incl. in the anamnesis; - severe forms of arterial hypertension with blood pressure> 160/100 mm Hg; - identified hormone-dependent malignant diseases of the genital or mammary glands, or suspicion of them, incl. in the anamnesis; - Bleeding from the vagina of unknown origin; - migraine with focal neurological symptoms at present or in history; - pancreatitis, accompanied by severe hypertriglyceridemia now or in history; - severe and / or acute renal failure; - pregnancy or suspicion of it; - lactation period; - hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome or hypersensitivity to peanuts or soy (due to the presence of lactose and soy lecithin in the composition of the drug Diethiklen).Precautions: Risk factors for thrombosis and thromboembolism: obesity, smoking, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valvular heart disease, prolonged immobilization, serious surgery, extensive trauma, marrow, hemorrhage, ancestral jugular artery, marrow, marrow, cardiovascular, cardiac marrow, prolonged immobilization, marrow cerebral circulation at a young age in one of the closest relatives). Other diseases in which violations of the peripheral circulation can be noted: diabetes mellitus without diabetic angiopathy, phlebitis of superficial veins, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia. Diseases that first occurred or worsened during pregnancy or against the background of previous sex hormones, for example, jaundice and / or itching against cholestasis, gallbladder disease, porphyria, Sydenhem's chorea, herpes during pregnancy with a history of hearing impairment (associated with otosclerosis ). Endogenous depression, epilepsy; hereditary angioedema; hypertriglyceridemia; liver disease; postpartum period.
Irregular intake can lead to acyclic bleeding and reduce the contraceptive effectiveness of the drug. Before starting or resuming the use of the drug, it is recommended to conduct a thorough general medical and gynecological examination (including examination of the mammary glands and cytological examination of a scraping from the cervix), to exclude pregnancy. In addition, violations of the blood coagulation system should be excluded. When using the drug, it is necessary at least 1 time in 6 months to conduct preventive control examinations. The drug Diecyclen does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Cardiovascular diseases: Venous thromboembolism (VTE) may occur in the form of deep vein thrombosis and / or pulmonary embolism when using hormonal contraceptives. The approximate frequency of VTE in women taking oral contraceptives with a low dose of estrogen (less than 50 μg of ethinyl estradiol) is up to 4 per 10 thousand women per year compared to 0.5-3 per 10 thousand women not using oral contraceptives. However, the frequency of VTE, developing when taking combined oral contraceptives, is less than the frequency of VTE associated with pregnancy (6 per 10 thousand pregnant women per year). In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as liver, mesenteric, renal arteries and veins or veins and retinal arteries, are described. The relationship of these cases with the reception of combined oral contraceptives has not been proven. A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include unilateral pain in the lower limb and / or edema; sudden severe chest pain; with or without radiation in the left hand; sudden shortness of breath; sudden bouts of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraine; sudden partial or complete loss of vision; diplopia; inarticulate speech or aphasia; dizziness; collapse with or without partial seizure; weakness or a very significant loss of sensation, suddenly appearing on one side or in one part of the body; movement disorders; "sharp" belly. The risk of thrombosis (venous and / or arterial) and thromboembolism increases: with age, in smokers (with an increase in the number of cigarettes smoked or an increase in age, the risk further increases, especially in women older than 35 years old), with a family history or arterial thromboembolism ever in close relatives or parents at a relatively young age), obesity, dyslipoproteinemia, arterial hypertension, valvular heart disease, prolonged immobilization, extensive surgical intervention, any operation on the lower limbs or extensive trauma, atrial fibrillation.In case of prolonged immobilization, in case of serious surgery, any surgery on the legs or an extensive injury, it is advisable to stop using the drug (in the case of the planned operation, at least 4 weeks before it) and not to resume taking it within 2 weeks after the end of immobilization. The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. Consideration should be given to an increased risk of thromboembolism in the postpartum period. Disorders of microcirculation can also occur 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 human papillomavirus infection. There are reports of some increase in the risk of cervical cancer with prolonged use of combined oral contraceptives. However, the relationship with the reception of combined oral contraceptives is not proven. The possibility of the relationship of these data with screening for diseases of the cervix uterus and with the characteristics of sexual behavior (more rare use of barrier methods of contraception) is discussed. A meta-analysis of 54 epidemiological studies has shown that there is a slightly increased relative risk of developing breast cancer diagnosed in women who are currently taking oral oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rarely observed in women under 40 years old, an increase in the number of breast cancer diagnoses in women who are currently taking or taking a recent oral contraceptive pill is insignificant 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 result of careful observation and earlier diagnosis of breast cancer in women using combined oral contraceptives. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them. In rare cases, on the background of the use of combined oral contraceptives, benign development was observed, and in extremely rare cases, malignant liver tumors, which in some cases resulted in life-threatening intra-abdominal bleeding. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, this should be considered when conducting a differential diagnosis. Other conditions: Women with hypertriglyceridemia or a family history may have an increased risk of developing pancreatitis when taking combined oral contraceptives. Although a small increase in blood pressure (BP) has been reported in many women taking combined oral contraceptives, clinically significant increases have been rare. The relationship between taking combined oral contraceptives and increasing blood pressure has not been established. However, if persistent, clinically significant arterial hypertension develops at the time of taking them, it is advisable to cancel combined oral contraceptives and treatment of hypertension. Reception of the combined oral contraceptives can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.Influence on a menstrual cycle: Irregular (acyclic) bleedings ("spotting" bleeding or "breakthrough" bleedings), especially during the first months of use, may be observed against the use of combined oral contraceptives. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles. If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignant tumors or pregnancy. Some women may not develop “withdrawal” bleeding during a break in the pill. If combined oral contraceptives were taken as directed, then pregnancy is unlikely. However, if combined oral contraceptives were not taken regularly, or if there are no two withdrawal bleedings, then pregnancy should be avoided. Impact on laboratory test results: The use of oral combined contraceptive drugs may affect the results of some laboratory tests, including biochemical blood tests (indicators of liver, thyroid, kidney and adrenal function, concentration of transport proteins in plasma (such as SHBG), carbohydrate metabolism fractions of lipids / lipoproteins), as well as indicators of coagulation and fibrinolysis. However, changes in these indicators remain within the normal range. Impact on the ability to drive vehicles and mechanisms: There is no data on the negative effect of the Dietiklen drug on the ability to drive vehicles and engage in potentially hazardous activities requiring increased concentration and psychomotor speed.
Possible symptoms of an overdose of the Dietziklen drug: nausea, vomiting, irregular bleeding, no menstrual bleeding. If necessary, symptomatic therapy is carried out.
- Brand name: Diecyclen
- Active ingredient: Ethinyl Estradiol, Dienogest
- Dosage form: Film Coated pills
- Manufacturer: Laboratories Leon Pharma S.A.
- Country of Origin: Spain