Index of drugs

Contraception. Treatment of mild to moderate acne symptoms in women who also want to use contraception.

1 tabl powl. contains 0.03 mg ethinylestradiol and 2 mg dienogest. The preparation contains lactose.

Combined oral contraceptive (COC). The contraceptive effect is achieved thanks to the interaction of several different factors, the most important of which is inhibition of ovulation and changes in cervical mucus. Dienogest after oral administration is rapidly and almost completely absorbed. The maximum plasma concentration is reached 2.5 h after a single dose. The bioavailability in combination with ethinyl estradiol is approx. 96%. Approx. 10% of the total serum concentration is in the form of an unrelated steroid, and 90% bind non-specifically to the albumin. Dienogest does not bind to the sex hormone transport protein (SHBG) or the corticosteroid binding protein (CBG). The increase in SHBG levels induced by ethinyl estradiol does not affect the binding of dienogest to serum proteins. Dienogest is mainly metabolised by hydroxylation and conjugation with the formation of inactive endocrine metabolites. T_0,5 dienogest is about 8.5-10.8 h. Only a small amount is excreted unchanged in the urine. Metabolites are excreted in urine and bile in a 3: 1 ratio. T_0,5 metabolite excretion is 14.4 h. Ethinylestradiol is rapidly and completely absorbed after oral administration. The maximum serum concentration is reached within 1.5-4 h. During absorption and the first pass effect of the liver, ethinylestradiol is extensively metabolised, resulting in an average bioavailability of approx. 44%. It is extensively but non-specifically bound to serum albumin (approximately 98%) and results in an increase in serum SHBG protein concentration. Ethinylestradiol undergoes pre-systemic coupling in the mucous membrane of the small intestine and in the liver. It is metabolized mainly by aromatic hydroxylation, however, also large amounts of various hydroxyl and methyl metabolites are formed, in free or conjugated form with glucuronic and sulfuric acid. The concentration of ethinyl estradiol decreases in the 2 phases characterized by T_0,5 approximately 1 h and 10-20 h. Ethinylestradiol is not excreted unchanged and its metabolites are excreted in urine and bile at a ratio of 4: 6. T_0,5 metabolite excretion is about 1 day.

Hypersensitivity to the active substances or to any of the ingredients. Current or previous history of venous or arterial thrombosis or embolism (eg deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular accident. Current prodromal (prodromal) symptoms of thrombosis or their occurrence in the past (eg transient ischemic episode, angina pectoris). Migraine with focal neurological symptoms in an interview. Diabetes with damage to blood vessels. Serious or numerous risk factors for venous or arterial thrombosis may also constitute a contraindication to the use of the preparation. Pancreatitis present or in the past if associated with hypertriglyceridemia. Severe liver disease, currently or in history, until normalization of liver function indicators. Liver tumors, present or in history (benign or malignant). Presence or suspicion of malignant tumors that may be affected by sex hormones (reproductive organs of the reproductive organ or breast). Bleeding from the vagina of an unrecognized cause. Pregnancy or suspected pregnancy.

The use of oral combined oral contraceptives (COCs) is associated with an increased risk of arterial and venous thrombosis and thromboembolism such as myocardial infarction, cerebral ischemic attack, deep vein thrombosis and pulmonary embolism. The risk of venous thrombosis is highest in the first years of COC use. In women using these preparations, thrombosis in other blood vessels has been reported very rarely, e.g.hepatic, mesenteric, renal, cerebral or retinal veins and arteries (lack of unambiguous opinion whether these incidents are associated with the use of COC). Factors that increase the risk of venous or arterial thrombosis and / or thromboembolic events or cerebral vascular episodes are: age; smoking (more cigarettes and older age increase the risk, especially for women over 35); positive family history (ie, venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age) - if hereditary predisposition is suspected, a woman should be referred to a specialist before deciding to use COC; obesity - BMI over 30 kg / m² pc .; dyslipoproteinaemia; hypertension; migraine; valvular heart disease; atrial fibrillation; long-term immobilization, extensive surgery, any surgical procedures on the lower limbs, severe injuries - in these cases, it is appropriate to discontinue the use of COC (at least 4 weeks before the planned surgery) and start re-use at least after 2 weeks from time return to full mobility. There is no unambiguous opinion on the possible role of varicose veins and superficial thrombophlebitis in the formation of venous thromboembolism. There is an increased risk of thromboembolism during the puerperium period. Other illnesses associated with cardiovascular side effects include diabetes mellitus, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. An increase in the incidence or severity of migraine headaches during COC use (which may be a prodromal sign of a cerebrovascular event) may be the reason for their immediate discontinuation. Biochemical factors that may indicate an inherited or acquired predisposition for the development of venous or arterial thrombosis include: resistance to activated C protein (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency and the presence of anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). When considering the benefit / risk ratio, it should be taken into account that appropriate treatment of these conditions may reduce the risk of thrombosis and the risk of pregnancy is greater than that resulting from low-dose COCs (<0.05 mg ethinyl estradiol). Some epidemiological studies have shown that the risk of developing cervical cancer may be increased as a result of long-term COC use. The most important risk factor for the development of cervical cancer is chronic infection with human papillomavirus (HPV). However, there are still discrepancies regarding the impact of additional factors, e.g. cervical screening and sexual behavior, including the use of barrier methods of contraception. In women using COC there is a slightly increased relative risk of breast cancer, which gradually decreases within 10 years after discontinuation of these preparations. If a patient using oral composite oral contraceptives develops severe pain in the epigastrium, enlargement of the liver or symptoms of intraabdominal bleeding, the possibility of a liver tumor in differential diagnosis should be considered. In women with hypertriglyceridaemia currently or in a family history, there may be an increased risk of pancreatitis when using COC. If clinical hypertension develops during treatment with COC, caution and discontinuation of therapy and treatment of hypertension are recommended. Resumption of use is possible after obtaining the correct blood pressure values ​​as a result of antihypertensive treatment. In the case of acute and chronic hepatic impairment, it may be necessary to discontinue use until the liver parameters return to normal. Discontinuation of COC therapy is also required for recurrent cholestasis jaundice that occurred for the first time during pregnancy or during prior use of sex hormones. COCs can affect peripheral insulin resistance and Glucose tolerance, there is no evidence that antidiabetic therapy should be changed in patients with diabetes using low-dose hormonal combined oral contraceptives (<0.05 mg ethinyl estradiol) - patients with diabetes should be closely monitored. Women with a predisposition to chloasma should avoid tanning and exposure to ultraviolet rays when using COC. The efficacy of COC can be reduced if e.g. the tablet is omitted, in the case of gastrointestinal disorders or when other medicines are used concomitantly.When using COC mainly during the first months of use, irregular bleeding may occur - the search for the causes of irregular bleeding should begin after the adaptation period of approximately 3 cycles. If irregular bleeding persists or occurs after a period of regular cycles, it is necessary to exclude non-hormonal causes and conduct appropriate diagnostic procedures to exclude cancer or pregnancy. It may also require curettage of the uterine cavity. Some women may not have bleeding during stopping tablets. The product contains lactose - should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Do not use the product during pregnancy. If the patient becomes pregnant while taking the preparation, she must stop using it. Epidemiological studies, however, did not show an increased risk of birth defects in newborns whose mothers were taking combined oral contraceptives in the pre-pregnancy period or a teratogenic effect in cases where these preparations were unintentionally taken during early pregnancy. Oral combined contraceptives may affect lactation, reducing the amount and composition of milk. Therefore, they should not be used during breastfeeding until the child is removed from the breast. Small amounts of contraceptive steroids and / or their metabolites may pass into the milk of nursing mothers, although there is no evidence of their harmful effects on the health of the child.

Common: depressed mood, changed mood, headache, nausea, abdominal pain, breast pain, feeling of tightness in the breast, weight gain. Uncommon: fluid retention, decreased libido, migraine, vomiting, diarrhea, rash, urticaria, breast enlargement. Rarely: hypersensitivity, increased libido, contact lens intolerance, erythema nodosum, erythema multiforme, discharge, discharge from the breast, weight loss. In women with congenital angioneurotic edema, exogenous oestrogens may cause or worsen symptoms of angioedema. The use of COC is associated with an increased risk of arterial and venous thrombosis and thromboembolism. Other illnesses associated with cardiovascular side effects include diabetes mellitus, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. The risk of developing cervical cancer may be increased as a result of prolonged COC use. In women using COC there is a slightly increased relative risk of breast cancer. In addition, mild liver tumors were rarely diagnosed, and in very rare cases were malignant tumors of the liver. A slight increase in blood pressure has been reported; rarely - a clinically significant increase in pressure. The following conditions have been reported or worsening both during pregnancy and during the use of COC (the relationship between these conditions and the use of COC has not been fully established): jaundice and / or pruritus associated with cholestasis, formation of biliary deposits, porphyria, lupus systemic lupus erythematosus, haemolytic-uremic syndrome, Sydenham chorea, herpes of pregnant women, hearing loss associated with otosclerosis. Chloasma may occur occasionally, especially in women who have experienced pregnancy chloasma in the past.

Orally. The tablets should be used according to the prescribed schedule, at approximately the same time each day. The tablets are taken with liquid, depending on the need. For the Next 21 days, 1 tabl is accepted. per day. The use of tablets from a new pack begins after a 7-day tablet-free interval during which withdrawal bleeding occurs, occurring approximately 2-3 days after the last tablet has been taken and which may not be completed before taking the tablets from the next pack. To obtain the best results of acne treatment, the preparation should be used for at least 6 months. A more pronounced improvement in the symptoms of acne is usually observed only after the 3rd cycle.It is appropriate to take the preparation on a long-term basis in accordance with the rules applicable to contraception guidelines.Beginning of the preparation. No hormonal contraception last month: the use of tablets should begin on the first day of the natural menstrual cycle (ie on the first day of menstrual bleeding). It is also possible to start using the second to fifth day of the cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of the first cycle.Transition from another combined contraceptive, vaginal ring or transdermal contraceptive patchThe use of the preparation is best started immediately the day after the last tablet (the last tablet containing active substances) of the previous oral contraceptive, but no later than the day after the usual discontinuation or use period of the previous oral combined oral contraceptive pill. If a vaginal ring or transdermal patch is used, the preparation should be started preferably on the day of removal and at the latest on the day when it should be re-inserted.Transition from a contraceptive method containing only progestogen (mini-pill, injection, implant) or intrauterine progestin releasing system (IUS): the transition from a mini-pill is possible at any time (from the implant or IUS - on the day of removal, from injection - on the day on which it should be done another injection), but in all these cases it is advisable to additionally use the barrier method of contraception for the first 7 days of using the tablets.Use after a miscarriage in the first trimester of pregnancy: the preparation can be started immediately, no additional contraceptive precautions are required.Use after delivery or after miscarriage in the second trimester of pregnancy: it is recommended to start taking the preparation between the 21st and 28th day after giving birth or a second pregnancy in the second trimester. In case of later onset, it is recommended to additionally use a barrier method of contraception for the first 7 days of using the tablets. However, if there is sexual intercourse, it is necessary to exclude pregnancy or wait for the first menstrual bleeding before starting oral contraceptive.Proceeding if you miss a tablet. If the tablet has been delayed by less than 12 hours, contraceptive protection is preserved. The tablet must be taken immediately after realizing the mistake, and the next tablet should be taken at the usual time. If the tablet has been delayed by more than 12 hours, contraceptive protection may be reduced. In this case, the procedure is based on the following basic principles: 1. taking tablets must never be interrupted for more than 7 days; 2. To achieve the proper inhibition of the hypothalamic-pituitary-ovary axis, a 7-day period of uninterrupted use of tablets is necessary.If you miss a tablet in the first week: take the last missed tablet immediately after realizing the mistake, even if it means taking 2 tablets at the same time. The next tablets should be taken at the usual time. In addition, barrier methods of contraception, eg a condom, should be used for the next 7 days. If you have had sexual intercourse during the previous 7 days, you should consider the possibility of getting pregnant. The more tablets are missed and the closer to the usual break in the use of tablets, the greater the risk of getting pregnant.If you miss a tablet in the 2nd week: take the last missed tablet immediately after realizing the mistake, even if it means taking 2 tablets at the same time. The next tablets should be taken at the usual time. If the preparation was taken regularly for 7 days before skipping the first tablet, it is not necessary to use additional methods of contraception. If this condition is not met or if more than one tablet has been missed, use additional contraception for 7 days.If you miss a tablet in the third week: due to the impending break in the use of tablets, there is a high risk of reducing the reliability of contraception. However, by adjusting the dosage regimen, you can still prevent a reduction in contraceptive protection.If one of the two following procedures is used, no other methods of contraception are necessary, provided that all tablets have been used correctly for 7 days prior to skipping the tablet. If this condition is not met, use one of the following two options and additionally use other methods of contraception for 7 days. 1. Take the last missed tablet immediately after realizing the mistake, even if it means taking 2 tablets at the same time. The next tablets should be taken according to the usual schedule. Taking the tablets from the next pack should be started immediately after taking all the tablets from the previous packet, ie without taking a break between the packagings. Bleeding associated with discontinuation will probably occur only after completing the tablets from the second pack, but when taking them it is also possible for spotting or intermenstrual bleeding to occur. 2. It may also be recommended to discontinue the use of tablets from the current packaging. In this way, a 7-day break in the use of tablets will occur, including the days when the tablets have been omitted, and then the tablets from the next packet will be taken. If the woman forgets to take the tablets and during the first normal interruption of use, there is no withdrawal bleeding, pregnancy should be considered.Proceedings in the case of gastrointestinal disorders. In the case of severe gastrointestinal disturbances, complete absorption may not occur and additional contraception may be necessary. If vomiting occurs within 3-4 hours after taking the tablet, the appropriate procedure for omitting the tablet should be used. If a woman does not want to change the usual pattern of use of tablets, she should take the additional tablet (s) from the next pack.Procedure to delay or change the date of bleeding. To delay the occurrence of bleeding, continue taking the tablets from the next pack without interruption in use. In this way, it is possible to continue to take, as necessary, until the tablets from the second package are finished. During this time, intermenstrual bleeding or spotting may occur. After a 7-day break in use, regular intake of the preparation should be continued. To move menses to a different day of the week than the current dosing schedule, shorten the tablet interval for the desired number of days. The shorter the break, the greater the risk of intermenstrual bleeding and spotting during the period of taking the tablets from the second pack (just as in the case of delayed bleeding).