Index of drugs

Oral contraception.

1 tabl contains 0.02 mg ethinylestradiol and 0.075 mg gestodene or 0.03 mg ethinyl estradiol and 0.075 mg gestodene.

Monophasic, oral contraceptive. The basic mechanism of the contraceptive effect of the preparation is inhibition of ovulation and induction of changes in the cervical mucosa and endometrium. Ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract, reaching a maximum blood concentration after 1-2 h, total bioavailability is about 40%. It binds to albumin and increases the binding capacity of SHBG. It is excreted in the form of metabolites in 40% with urine and 60% with faeces. T_0,5 ethinyl estradiol in the elimination phase is 25 h. Gestodene is rapidly and completely absorbed after oral administration, the maximum concentration of the drug in the blood is reached after 1-2 h, the bioavailability is complete. It is almost completely bound by SHBG. It is excreted in the form of metabolites in 50% with urine and 33% with faeces. T_0,5 Gestodene in the elimination phase is 18 h.

Hypersensitivity to the components of the preparation. Venous thrombo-embolism present or present (eg, phlebitis, pulmonary embolism) with or without a triggering factor. Arterial thrombo-embolic disorders present or present (eg myocardial infarction, stroke). Predisposition to vein thrombosis or arterial thrombosis: antithrombin-III deficiency, protein C deficiency, protein S deficiency, resistance to activated C protein (APC), presence of antiphospholipid antibodies, hyperhomocysteinemia. Risk factors for venous thrombosis or arterial thrombosis. Vascular diseases of the vascular origin. Cardiovascular diseases: uncontrolled hypertension, angina pectoris, heart valve disease, blood coagulation disorders. Diabetes complicated by vascular changes. Current or in an interview, pancreatitis associated with severe hypertriglyceridaemia. Presence or suspicion of tumors dependent on sex hormones (eg genital organs, breasts). Severe liver problems present or present (until liver function returns to normal). Liver cancer (benign or malignant) as currently or in an interview. Porphyria. Collagen diseases. Pituitary tumors. Bleeding from the genital tract of unknown etiology. Migraine in an interview with focal neurological symptoms.

When using oral contraceptives, the risk of thromboembolic vein or artery disease increases. The highest risk occurs in the first year of use and in the presence of risk factors such as age, positive family history of thromboembolic vein or artery in siblings or at an early age in parents, long-term immobilisation, surgery, superficial phlebitis and varicose veins, period puerperium, obesity (body mass index over 30 kg / m²), smoking (especially affects women over 35 years of age), diabetes, dyslipidemia, hypertension, migraines, arterial disease or heart valves. Caution should be taken in the case of: hypertriglyceridemia, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel diseases, sickle cell disease, jaundice and / or pruritus, cholelithiasis, porphyria, chorea, herpes of pregnant women, epilepsy, otosclerosis, asthma, depression. Long-term use of the preparation increases the risk of developing cervical cancer. Oral contraceptives slightly increase the relative risk of breast cancer. In women with elevated triglycerides, the preparation may increase the risk of pancreatitis. There was a slight increase in blood pressure and effect on peripheral insulin resistance and Glucose tolerance. In women with congenital angioneurotic edema, exogenous oestrogens may cause or worsen symptoms of angioedema. Due to the possibility of chloasma, especially in women who have developed chloasma, patients with a tendency to develop it should avoid exposure to UV radiation during use.Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency, malabsorption of glucose-galactose.

Do not use during pregnancy and breast-feeding

Very common: headache, migraine, bleeding and spotting from the genital tract. Common: vaginitis, including candidiasis; fluid retention, peripheral edema, mood changes including depression, change of libido, nausea, vomiting, abdominal pain, acne, nervousness, dizziness, pain or tenderness of the breast, discharge from the breast, painful menstruation, change in menstrual bleeding, change of vaginal discharge , increase or decrease body weight. Uncommon: increased or decreased appetite, abdominal muscle contraction, flatulence, rash, chloasma that may persist, hirsutism, alopecia, hypertension, change in blood lipids (including hypertriglyceridaemia). Rare: anaphylactic reactions (including very rarely urticaria, angioneurotic edema and disorders of the respiratory and cardiovascular system), glucose intolerance, contact lens irritation, cholestatic jaundice, erythema nodosum. Very rare: severity of Lupus Erythematosus, exacerbation of porphyria, exacerbation of chorea, optic neuritis, retinal vascular thrombosis, pancreatitis, hepatic adenoma, hepatocellular carcinoma, cholelithiasis, cholestasis, erythema multiforme, haemolytic-uremic syndrome.

Oral: 1 tablet once a day at the same time for 21 consecutive days. During the Next 7 days, no tablets are taken and during this time, usually on the 2nd or 3rd day, withdrawal bleeding should occur. Taking the tablets from the next pack should begin on the 8th day, even if the withdrawal bleed is still ongoing.Beginning of the preparation. If during the last month the patient did not use any hormonal contraceptive method - the first tablet should be taken on the first day of the cycle (on the first day of menstrual bleeding), tablets may also be started between day 2 and 5 of the cycle, but in this case an additional mechanical method of contraception for the first 7 days of taking tablets in the first cycle. If you have previously taken another composite oral contraceptive, take the next day after taking the last active tablet of the previous preparation, but no later than the day after the end of the break or when taking the placebo tablets of the previous preparation. If the patient previously used a contraceptive containing only progestogen (mini-tablet, injection, implant) - taking the preparation instead of the minitabletki should be started the day after the end of the previous method; in the case of an implant - on the day of implant removal; in the case of injections - on the day on which the next injection was to be performed - in all these cases an additional mechanical contraceptive method should be used for the first 7 days of taking the tablets. In the event of a miscarriage in the first trimester of pregnancy, the preparation can be immediately started; no other methods of contraception are necessary. In the event of delivery or miscarriage in the second trimester of pregnancy, the preparation may be started 21-28 days after delivery or after a miscarriage; if the patient starts using the product later, additional mechanical contraceptive methods should be used for the first 7 days. Patients who have had an intercourse before taking the preparation should exclude pregnancy or wait for the first menstrual bleeding.Proceeding if you miss a tablet. If less than 12 hours have passed since the tablet was missed, the contraceptive effectiveness is maintained; omit the tablet should be taken as soon as possible, and the next - at the usual time. If more than 12 hours have elapsed since the tablet was missed, the effectiveness may be reduced, then proceed as follows. If you miss a tablet in the first week, take it as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time. For the next 7 days, use mechanical contraceptive methods. If sexual intercourse was maintained during the week preceding the omission of the tablet, there is a possibility of pregnancy.The more tablets are missed and the closer the 7-day break in the use of the preparation, the greater the risk of getting pregnant. If you miss a tablet in the second week, take it as soon as possible, even if it means taking two tablets at the same time, take your next tablet at the usual time. If the preparation was taken correctly within 7 days before skipping the tablet, no additional contraceptive methods are required. If, however, more than one tablet has been omitted, barrier methods of contraception should be used for 7 days. If you miss the tablet in the third week, there are two options for the procedure. If the preparation was used correctly for 7 days before skipping the tablet, one of the following recommendations may be chosen without the need for any additional contraceptive methods, otherwise recommendation 1 should be used and the contraceptive barrier method should be used for 7 days. 1. - Skip the tablet as soon as possible, even if it means taking two tablets at the same time, take the next tablets at the usual time, and take the tablets from the next packet immediately after completing the current one, not taking a 7-day break (withdrawal bleeding occurs after completion of the second pack, spotting or bleeding may occur while taking the tablets). 2. - You can stop taking the tablets from the current packaging, take a 7-day break (including the days you missed the tablet) and start taking the tablets from the next pack.In case of vomiting or acute diarrheawithin 4 hours after taking the tablet, you should proceed as if you missed the tablet.