Index of drugs

Contraception in women. The product is intended for use in women of childbearing age. Safety of use and efficacy were defined in the group of women aged 18-45.

1 transdermal patch (patch) contains 6 mg norelgestromin and 600 μg ethinyl estradiol (1 system releases 203 μg norelgestromin and 33.9 μg ethinylestradiol over 24 h).

The preparation works by inhibiting the secretion of gonadotropins as a consequence of estrogen and progestagen effects of ethinyl estradiol and norelgestromin. The primary mechanism of action is inhibition of ovulation, but contraceptive effect may also be affected by changes in cervical mucus and changes in the endometrium. After attaching the transdermal patch, norelgestromin and ethinyl estradiol concentrations in the blood reach a plateau after about 48 hours. Norelgestromin and its metabolite - norgestrel are very much bound (> 97%) bound to serum proteins. Norelgestromin is associated with albumin, is not associated with sex hormone binding globulins (SHBG), while norgestrel is mainly associated with SHBG, which limits its biological activity. Ethinylestradiol is extensively bound to serum albumin. Norelgestromin and ethinyl estradiol are metabolized in the liver. After removal of the patch, the mean half-lives of norelgestromin and ethinylestradiol are respectively 28 h and 17 h. Metabolites of norelgestromin and ethinylestradiol are excreted in urine and faeces.

Hypersensitivity to active ingredients or any of the excipients of the preparation. Venous thrombosis present or present in history, with or without pulmonary embolism. Arterial thrombosis present or present (eg cerebral infarction, myocardial infarction, retinal artery thrombosis) or symptoms that predict thrombosis (eg angina pectoris, transient ischemic attack). The presence of serious or numerous risk factors for arterial thrombosis. Severe hypertension (stable values ​​of systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg). Diabetes with vascular changes. Hereditary dyslipoproteinaemia. Hereditary predisposition to the development of venous or arterial thrombosis, such as: resistance to active protein C, deficiency of antithrombin III, protein C deficiency, protein S deficiency, hyperhomocysteinemia, occurrence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). Migraine with focal aura. Diagnosed breast cancer or suspected breast cancer. Endometrial cancer or another cancer that is known to be estrogen-dependent or is thought to be estrogen-dependent. Hepatic dysfunction depending on acute or chronic hepatocellular disease. Adenoma or liver cancer. Unrecognized abnormal genital tract bleeding.

Do not use during pregnancy. Particularly with caution (after considering the risk / benefit ratio), patients with risk factors for venous or arterial thromboembolic disorders, such as progressive age, puerperium, smoking, positive family history of thrombosis, obesity (BMI> 30 kg / m²), dyslipoproteinaemia, hypertension, valvular heart disease, atrial fibrillation, prolonged immobilisation, surgery, lower limb surgery or severe trauma (it is recommended to discontinue the preparation at least 4 weeks before the planned treatment and reapply only after 2 weeks from returning to full mobility). There is no unambiguous opinion on the role of varicose veins and thrombophlebitis of superficial veins in the development of venous thromboembolism. You should also be cautious if you have other diseases that lead to circulatory disorders such as diabetes, systemic lupus erythematosus, haemolytic-uremic syndrome, and chronic inflammatory bowel diseases. Due to the risk of pancreatitis, caution should be used in patients with hypertriglyceridemia or a positive family history of hypertriglyceridemia.Use with caution in patients with impaired renal function. Caution in patients with: jaundice and / or pruritus associated with cholestasis, cholelithiasis, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, Syden's chorea, herpes of pregnant women, hearing loss associated with otosclerosis, epilepsy, depression, Crohn's disease, ulcerative colitis, as the above-mentioned diseases may be more severe when using hormonal contraceptives. Patients with diabetes should be closely monitored due to the risk of drug effects on peripheral insulin resistance and Glucose tolerance. Women with a tendency to chloasma should avoid exposure to sunlight or UV radiation when using the product. During the use of the preparation, herbal preparations containing St John's wort (Hypericum perforatum). In women about the month of ≥90 kg contraceptive effectiveness may be reduced. Discontinuation of the preparation should be considered if thrombosis is suspected or diagnosed, the frequency or severity of migraine pain, acute or chronic hepatic dysfunction (until hepatic parameters return to normal), and recurrent cholestatic jaundice. In the event of a clinically significant hypertension during the use of the preparation, treatment with the preparation may be continued only if the correct blood pressure values ​​can be maintained with the antihypertensive medication. In case of severe pain in the epigastric region, enlargement of the liver or symptoms of bleeding into the abdominal cavity, the differentiation should take into account the possibility of liver cancer.

The preparation is contraindicated for use in pregnancy. It is not recommended to use the product until the woman has completely stopped breastfeeding.

Very common: headache, nausea, breast tenderness. Common: vaginal mycosis, vaginal candidiasis, fungal infections of the vulva and vagina, depression, mood disorders, mood swings, dizziness, migraine, bloating, gastric pain, lower abdominal pain, epigastric pain, vomiting, diarrhea, acne, pruritus, skin irritation, cramps muscles, breast discomfort, breast enlargement, breast pain, menstrual disorders, menstrual bleeding, uterine hemorrhage, uterine contraction, vaginal discharge, reaction at the site of administration (erythema, irritation, pruritus, rash), fatigue, malaise, weight gain body. Uncommon: fluid retention, hypercholesterolemia, lability of affective disorders, anxiety, insomnia, decreased libido, contact dermatitis, erythema, breast disorder, mammary gland hyperplasia, breast swelling, breast fibrocystic cyst, galactorrhoea, premenstrual syndrome, vaginal bleeding, dryness of the vulva and vagina, reaction at the site of administration (dermatitis, skin discoloration, hypersensitivity, pain, papules, vesicles), generalized edema, increased blood pressure, increased triglycerides in the blood. Rare: crying, increased libido, crying, pulmonary embolism, cholecystitis, chloasma, vaginal discharge, menstrual disorders, irregular menstruation, injection site urticaria, edema, increased cholesterol in the blood. Very rare: aggression, frequent menstruation, swelling at the injection site. In addition, the following adverse reactions were observed after marketing: application site pustules, pustular rash, breast cancer, stage IV breast cancer, cervical cancer, fibromyalgia, hepatic adenoma, liver cancer, myoma, hypersensitivity reactions, hyperglycemia, resistance to insulin, anger, emotional disorders, frustration, basal artery thrombosis, cerebral infarction, occlusion of the carotid artery, cerebral embolism, cerebral artery occlusion, cerebral embolism, cerebral infarction, cerebral infarction, cerebral thrombosis, cerebral vein thrombosis, cerebrovascular incident , taste disorders, embolism, intracranial hemorrhage, hemorrhagic stroke, intracranial venous sinus thrombosis, ischemic stroke, ischemic stroke, sinus infarction, migraine with aura, subarachnoid haemorrhage, upper sinuses thrombosis, thromboembolic stroke, thrombotic stroke, transient attack niedokr vaginal sinus thrombosis, intolerance of contact lenses, acute myocardial infarction,myocardial infarction, arterial thrombosis, arterial limb thrombosis, axillary vein thrombosis, Buddha-Chiari syndrome, coronary artery thrombosis, deep vein thrombosis, embolism, hepatic vein thrombosis, arterial hypertension, hypertensive crisis, iliac arterial thrombosis, intracardiac thrombosis, venous thrombosis , mesenteric thrombosis, pelvic vein thrombosis, peripheral embolism, portal vein thrombosis, kidney embolism, renal vein thrombosis, retinal artery occlusion, retinal vascular thrombosis, retinal vein obstruction, splenic vein thrombosis, superficial thrombophlebitis, thrombophlebitis, thrombosis, main vein thrombosis, venous thrombosis, limb venous thrombosis, pulmonary artery thrombosis, pulmonary thrombosis, colitis, cholelithiasis, bile retention, liver damage, cholestatic jaundice, alopecia, angioedema, allergy skin burning, eczema, erythema multiforme, erythema nodosum, skin rash with peeling, hypersensitivity reaction to light, generalized pruritus, rash, erythematous rash, pruritic rash, seborrheic dermatitis, skin reaction, urticaria, amenorrhea, breast tumor, cervical dysplasia uterine period, abnormal menstruation, abnormal irregular menstruation, scanty menstruation, inhibition of lactation, reaction at the site of administration (abscess, disturbances of feeling, atrophy, bleeding, bruising, exudation, discomfort, dryness, eczema, erosion, epidermis closure, skin exfoliation, induration, infection, inflammation, tumor, lump, unpleasant odor, paraesthesia, photosensitivity reaction, scab, scar, swelling, ulcer, feeling hot), face edema, irritability, local swelling, peripheral edema, edema, cholesterol concentration outside norms, blood glucose outside the normal range, reduction in concentration blood Glucose, LDL reduction, complications with contact lenses.

Outwardly. Each transdermal patch (patch) should be removed and immediately replaced with a new one on the same day of the week ("Patch Change Day") - on the 8th day and on the 15th day of the menstrual cycle. In the fourth week of the cycle (starting from the 22nd day of the cycle), the patch is not sticked. On the first day after the end of this week, another patch should be applied, even if the bleeding has not occurred or if the bleeding has not yet ended. In no case may the interval between the cycles of application of the patches exceed 7 days.Beginning of the preparation. If during the last month the patient did not use any hormonal contraceptive method, the preparation should be started on the first day of the cycle (ie on the first day of menstrual bleeding). One patch should be applied and worn for 7 days. The day on which the patch was first put on ("Day 1 - Start Day") marks "Patch Change Days". If the first cycle of application starts after the first day of the menstrual cycle, an additional non-hormonal method of contraception should be used simultaneously for the first 7 days of application. If the patient previously took another composite oral contraceptive, the patch should be started on the 1st day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (containing hormone) pill of the oral contraceptive, it is necessary to exclude pregnancy before using the patch. When the patch starts after the first day of withdrawal bleed, non-hormonal contraception should be used concomitantly during the first 7 days. If more than 7 days have elapsed since the last active oral contraceptive tablet was taken, ovulation may occur. If a sexual intercourse occurred during a prolonged period of more than 7 days in the use of an oral contraceptive pill, the possibility of pregnancy should be considered. If the patient previously used only progestagen containing contraceptive (mini-tablet, implant or injection), the use of the patch instead of the minipig can be started on any day of the cycle; in the case of an implant - on the day of implant removal; in the case of injections - the day on which the Next injection was to be performed - in all these cases an additional barrier method of contraception should be used for the first 7 days of applying the patch.After a miscarriage: if the miscarriage occurred before the 20th week of pregnancy, the use of the preparation can be started immediately - there is no need to use another contraceptive method at the same time; if the miscarriage occurred in the 20th week of pregnancy or later, the use of the preparation can start on the 21st day after the miscarriage or on the first day of the first spontaneous menstrual bleeding, whichever comes first. After childbirth: women who decide that they will not breastfeed should start using the product no earlier than 4 weeks after giving birth; in the event that the woman starts using the product later, use the additional barrier method of contraception for the first 7 days; if, however, the sexual intercourse has occurred before starting the use of the product, pregnancy should be ruled out or the menstrual bleed should be allowed to wait.Procedure if the patch is completely or partially detached. If the patch is partially removed for less than a day (up to 24 hours) - immediately reattach it in the same place or use a new one, no additional method of contraception is needed; the next patch should be applied as usual on the "Patch Change Day". If the patch is removed for more than one day (24 h or longer) or if the woman has not noticed when the patch has peeled off - the contraceptive effectiveness of the preparation may be reduced, the current application cycle should be discontinued and a new application cycle started immediately a new patch, thus determining the new "Day 1" and the new "Patch Change Day"; it is necessary to use non-hormonal contraception at the same time during the first 7 days of the new cycle.Procedure in case of being late with the patch change. The initial part of the patch application cycle ("Tydzień Pierwszy" / "Day 1"): the first patch in the new application cycle should be applied immediately after remembering, thus setting a new "Day 1." and "Patch Change Day". For the first 7 days of the new cycle, a non-hormonal method of contraception should be used. If sexual intercourse has occurred during a prolonged> 7 days break in the use of the patch, the possibility of fertilization should be considered.The middle part of the patch cycle ("Tydzień Drugi" / "Dzień 8. or" Tydzień Trzeci "/" Dzień 15. "): delay by 1 or 2 days (up to 48 hours) - a new patch should be applied immediately. The next one should be applied on the ordinary "Patch Change Day". If during the 7 days preceding the first day of late application of the patch, it was properly worn, no additional method of contraception is necessary. Delay by> 2 days (48 h or longer) - discontinue the current contraceptive cycle and immediately start a new 4-week cycle by applying a new patch, thereby setting a new "Day 1" and "Patch Change Day." For the first 7 days The new cycle should also use a non-hormonal method of contraception.The final part of the cycle ("Week Four" / "Day 22."): if the patch has not been removed at the beginning of the "Fourth Week" of the cycle ("Day 22."), it should be removed as soon as possible.The next cycle should begin on the usual "Patch Change Day", which is the day after day 28. It is not necessary using an additional method of contraception.Adaptation of the "Plastra Change Day" . In order to move menstrual bleeding one cycle, the next patch should be applied at the beginning of the "Fourth Week" (on "Day 22."). Then there will be no interruption in the use of the preparation, intermenstrual bleeding or spotting may occur. After the next 6 weeks of wearing a patch, a 7-day break should be taken. After this time, the regular use of the preparation resumes. To move the "Patch Day", complete the current cycle by removing the third patch on the right day. During the week when you do not use a patch, you can choose a new "Patch Change Day" by pasting the first patch of the next cycle on the selected date. The shorter the interval, the greater the risk that no withdrawal bleeding will occur, and in the next cycle of application of the patches, intermenstrual bleeding and spotting may occur.
The patch should be applied to clean, dry, hairless, intact healthy skin of the buttocks, abdomen, outer arm or upper torso in a place where tight clothing will not rub the patch.The patch must not be placed on the breast. Each subsequent patch should be glued elsewhere on the skin. In areas of the skin on which the patch is adhered or will stick to you in the near future, you can not apply cosmetics or topical medications. It is recommended to check daily whether the patch adheres properly. Do not use additional adhesive substances or bandages to keep the patch. Only one patch can be applied at a time.