Index of drugs

Treatment of moderate to severe acne (with and without seborrhoea) associated with androgens and / or hirsutism sensitivity in women of childbearing age. It should only be used to treat acne when local and systemic antibiotic therapy has failed. As the preparation is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives.

1 tabl powl. contains 2 mg cyproterone acetate and 0.035 mg ethinyl estradiol. The product contains lactose and sucrose.

Combined preparation containing ethinyl estradiol - estrogen and cyproterone acetate - gestagen with antiandrogenic properties. Ciproterone acetate competitively blocks the binding of androgens to receptors in target organs and indirectly inhibits the production of androgens in the ovaries and adrenal glands. The clinical effect of this action is the elimination of the effects of excessive androgen activity - disappearance of acne symptoms (after about 4 cycles), normalization of seborrhoea, disappearance of facial hair and reduction of hair loss in male pattern baldness (achieved after 6-10 cycles). In addition to the antiandrogenic effect, cyproterone acetate also has a progestagenic effect. It should be used in combination with ethinylestradiol, as cyproterone acetate alone may lead to cycle disorders. Ethinyl estradiol is a synthetic estradiol derivative used in all hormone disorders in which female sex hormone therapy is indicated. Following oral administration, cyproterone acetate is completely absorbed over a wide dose range. The maximum concentration of cyproterone acetate in plasma occurs 1.6 h after administration of the preparation. Then its concentration decreases in two phases in which T_0,5 is 0.8 and 2.3 days. Cyproterone acetate is metabolised by various metabolic pathways. The major metabolite in the plasma is the 15β-hydroxy derivative. Ciproterone acetate has an affinity for adipose tissue and accumulates in it, and then gradually releases. After metabolism in the liver, it is excreted completely: 1/3 in the urine and 2/3 in the faeces, mainly in the form of metabolites. Cyproterone acetate almost completely binds to plasma albumin (approximately 3.5-4% of the total dose remains unbound). Because protein binding is unspecific, changes in sterol hormone-binding globulin levels do not affect the pharmacokinetics of cyproterone acetate. The drug is accumulated during the treatment cycle. The stationary state is reached after about 16 days. During long-term use, cyproterone acetate is 2-fold accumulated during treatment cycles. Ethinyl estradiol is rapidly and completely absorbed from the gastrointestinal tract and is metabolized very slowly. After the dose of the drug, the maximum plasma concentration of ethinyl estradiol occurs after 1.7 hours. Plasma ethinyl estradiol concentration decreases in two phases in which T_0,5 is 1-2 h and 20 h respectively. Ethinyl estradiol binds strongly but nonspecifically to plasma albumin. Approx. 2% remains in free form. Ethinylestradiol induces hepatic synthesis of steroid hormone binding globulin and corticosteroid hormone globulins during continuous use.

Hypersensitivity to the active substances or to any of the excipients. Simultaneous use with another contraceptive. Current or past venous thrombosis (deep vein thrombosis, pulmonary embolism). Current or past arterial thrombosis (eg myocardial infarction) or prodromal symptoms (e.g. angina pectoris and transient ischemic attack). Current or previous stroke. The presence of a serious risk factor or many risk factors for venous or arterial thrombosis such as: diabetes with vascular complications, severe hypertension, severe dyslipoproteinaemia. Hereditary or acquired predisposition to venous or arterial thrombosis, eg resistance to active C protein (APC), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). Migraine with focal neurological symptoms in an interview.Diagnosed or suspected breast or reproductive cancer or other hormone-dependent cancer, present or in the past. Bleeding from the genital tract with an unexplained cause. Past or present severe hepatic insufficiency, until liver parameters return to normal. Liver cancer now or in history (benign or malignant). Current or previous pancreatitis with increased triglycerides. Pregnancy or suspected pregnancy. Breast-feeding. The preparation is not used in men.

The preparation has a similar composition to the combined oral contraceptives. The time taken to relieve symptoms is at least 3 months - the need to continue treatment should be periodically evaluated by the attending physician. Take special care with the preparation if you have diabetes, obesity, high blood pressure, heart valve or arrhythmia, phlebitis, varicose veins, migraine attacks, epilepsy, thrombosis, heart attack or stroke in close relatives, liver or gallbladder disease, systemic lupus erythematosus (SLE), skin discoloration (yellow-brown pigment changes, so-called chloasma), increased cholesterol or triglyceride levels in the blood, Crohn's disease or ulcerative colitis. If any of these symptoms occur, or if the symptoms of hirsutism occur or worsen, the patient should contact a doctor. If any of the following conditions or risk factors are present, consideration should be given to the benefits and risks of the preparation to each woman and to be discussed with the woman before she decides to start the treatment. If any of the above-mentioned conditions or risk factors deteriorate, worsen or occur for the first time, the woman should report to the treating physician who will decide if it is necessary to stop using the product. The use of the preparation is associated with an increased risk of venous thromboembolism (VTE). The increased risk of VTE is highest in the first year of application in women who begin their use for the first time and when the oral contraceptive is restarted or changed after discontinuation of tablets lasting for at least one month. Venous thromboembolism can be fatal in 1-2%. Epidemiological studies have shown that the risk of VTE is 1.5 to 2 times higher in women using the product than in women using the combined oral levonorgestrel containing levonorgestrel and may be comparable with the risk of using oral contraceptives containing dezogestrel, gestodene or drospirenone. In the group of patients using the preparation may be patients who are inherently at increased risk of cardiovascular diseases such as those associated with polycystic ovary syndrome. Epidemiological studies have also shown a relationship between the use of hormonal contraceptives and an increased risk of arterial thromboembolic events (myocardial infarction, transient ischemic attack). In women using contraceptives, the presence of thrombosis in other blood vessels, such as hepatic, mesenteric, renal, cerebral or retinal arteries, has been reported very rarely. The factors that increase the risk of venous thromboembolic events are: age; smoking (the risk increases in addition to increasing the number of cigarettes smoked and with age, especially in women over 35 years of age, who are strongly advised to quit smoking if they intend to use the preparation); positive family history (ie occurrence of venous thromboembolism in siblings or parents at a relatively young age) - if genetic predisposition is suspected, before a decision on the use of a contraceptive is made, the woman should be referred to a specialist for consultation; long-term immobilization, extensive surgery, any operation in the lower limbs or a serious injury - in these situations it is recommended to discontinue the use of the preparation (at least 4 weeks before the planned surgery) and not resume taking the product before 2 weeks.since the return to mobility, anticoagulation should be considered if the use of the preparation has not been discontinued in good time; obesity (index above 30 kg / m)²). The factors that increase the risk of arterial thromboembolism or stroke are: age; smoking (the risk increases in addition to increasing the number of cigarettes smoked and with age, especially in women over 35 years of age, who are strongly advised to quit smoking if they intend to use the preparation); dyslipoproteinaemia; obesity (index above 30 kg / m)²); hypertension; migraine; heart valve defects; atrial fibrillation; positive family history (occurrence of arterial thrombotic disorders in siblings or parents at a relatively young age) - if genetic predisposition is suspected before making a decision about the use of a contraceptive, the woman should be referred to a specialist for consultation. Other medical conditions that are associated with cardiovascular adverse events include: diabetes, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel diseases (eg Crohn's disease or ulcerative colitis) and sickle cell anemia. The increased risk of thromboembolism during puerperium should be considered. Increasing the frequency or severity of migraine during the use of the preparation (which may indicate the occurrence of a cerebrovascular event) may be a reason to discontinue its use immediately. Lack of unanimity regarding the role of varicose veins and superficial thrombophlebitis in VTE. Women who use the product should be especially emphasized to contact their doctor if symptoms of thrombosis occur. If you suspect or confirm thrombosis, stop taking the medicine. The appropriate method of contraception should be started due to the teratogenic effect of anticoagulants (coumarin derivatives). Epidemiological studies have reported an increased risk of cervical cancer during long-term use of oral contraceptives. However, this risk may not be directly related to the use of these formulations, but may be due to specific sexual behaviors or other factors, such as, for example, papilloma virus (HPV) infection. Epidemiological studies have shown a slight increase in the relative risk of breast cancer in women using hormonal contraception. This risk gradually disappears within 10 years after discontinuation of hormonal contraceptives. In the event of severe abdominal pain, enlargement of the liver or symptoms of abdominal bleeding, the presence of a liver tumor should be considered in the differentiation. The effectiveness of the preparation may be reduced if the tablet is omitted, gastro-intestinal disorders or when other medicines are used concurrently. In case of irregular bleeding, proper assessment of the cause of their occurrence is possible only after the adaptive period of the organism, lasting about 3 cycles. If irregular bleeding occurs or persists after previous regular cycles, non-hormonal reasons should be considered and appropriate diagnostic tests (with curettage of the uterine cavity if necessary) should be considered to diagnose the cancer or detect pregnancy. Some women may not have withdrawal bleeding during a break in taking tablets. The product contains sucrose - should not be used in patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or malabsorption of glucose-galactose. 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.

The preparation is contraindicated in pregnancy if you are suspected of being pregnant or breastfeeding. If pregnancy is found during the use of the preparation, it should be immediately discontinued.

The use of the preparation is associated with an increased risk of thromboembolism (frequency of occurrence - rare).Severe side effects: venous thromboembolism; arterial thromboembolic disorders; hormone-dependent tumors; liver disease; systemic lupus erythematosus (SLE); chorea. Lighter side effects, occurring mainly during the first few months of taking the preparation: eye pain when using contact lenses; nausea and stomach discomfort; change in body weight; headaches; changes of libido, depression; spotting or bleeding in the middle of the cycle; rash, itching, mycosis, skin changes, hair loss; pain in the chest.

Oral: 1 tablet powl. daily, at the same time of the day, for 21 days. Then 7 days break before the Next package starts. The time taken to relieve symptoms is at least 3 months. The need to continue treatment should be periodically evaluated by the attending physician. - According to the security announcement from July 2013.Taking the preparation for the first time. For the first time, the preparation begins on the first day of menstruation - this ensures protection against unwanted pregnancy already in the first cycle of treatment. When taking the first tablet on day 5 of the cycle, you must use an additional method of contraception throughout the first cycle or refrain from sexual intercourse. This cycle may be prolific (the possibility of ovulation due to insufficient, too late - from day 5 - control of the secretion of sex hormones). After 21 days there is a 7 day break in the use of the preparation before the start of the next pack. During the break period menstrual bleeding should occur. Regardless of whether it ended, after 7 days it is necessary to take the first tablet from the next pack.If you have previously taken another combined contraceptive. Taking the product should be started the next day after the 7-day break resulting from the use of the previous preparation or the day after the last inactive tablet (without hormones) from the current package (please instruct the patient to ask your doctor or pharmacist if in doubt).If you have used mini-pills (single-dose pills). You can stop taking minipigs on any day and take the preparation instead of them at the same time. The patient should use other contraception at the same time if she has sexual intercourse during the first 7 days of taking the product.If you previously used contraception in the form of an intrathecal, implant or intrauterine release. Start taking the product on the day the next injection was to be made or on the day the implant or insert was removed. If during the first 7 days of taking the preparation the patient has sexual intercourse, she should also use other methods of contraception.Taking the product after a childbirth or a natural or artificial abortion. The preparation should be started 21 to 28 days after delivery. Patients who have had an intercourse before starting treatment should not be given until the first natural menstruation, to ensure that the patient is not pregnant. The first 7 days of taking the preparation should use additional methods of contraception. Do not use during breast-feeding.Proceeding in case of skipping tablets. If the omitted tablet is taken within 12 hours, the effectiveness of the drug is preserved. Take the tablet as soon as possible and take your next tablet at the usual time. If more than 12 hours have passed, the effectiveness of the medicine may be reduced. It is therefore recommended to use additional methods of contraception for 7 consecutive days (the time of taking 7 consecutive tablets). If the patient forgot to take the tablets and during the first interruption in their reception did not expect the expected bleeding, the possibility of pregnancy should be taken into account.Skipping the tablet in the first week. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and taking the next tablet at the same time. Additional methods of contraception should be used for the next 7 days. If the patient had sexual intercourse during the week preceding the missed tablet, there is a risk of becoming pregnant.Skipping the tablet in the 2nd week Take the missed tablet as soon as possible, even if it means taking two tablets at the same time, and taking the next tablet at the same time. The contraceptive effectiveness of the preparation is preserved and there is no need to use additional contraceptives.Skipping the tablet in the third week You can choose one of the following options: 1. The patient should take the missed tablet as soon as possible and the next one at the usual time, even if it means taking two tablets at the same time. Taking the tablets from the next pack should be started immediately after completing the current one, i.e. without a 7-day break in the use of the preparation. Bleeding will occur after completing the second pack, but staining or minor bleeding may occur on tablet days. 2. The patient may also no longer take the tablets from the current packaging, take a 7-day or shorter break (you must also count the day the tablet was left out), and then continue to take the tablets from the next pack. If the patient forgot to take the tablets and during the first interruption in their reception did not expect the expected bleeding, the possibility of pregnancy should be taken into account.Proceedings in case of vomiting or acute diarrhea. If the patient has vomiting or acute diarrhea, the active substances may not be completely absorbed. If vomiting or acute diarrhea occurred within 3-4 hours after taking the tablet, follow the above recommendations for the case of skipping tablets.Proceeding in the case of the intention to delay the period of menstrual bleeding. You can delay the onset of bleeding if after the completion of the current pack, you start taking the tablets from the Next, without a 7-day break. You can take the tablets even while the package is empty. Small bleeding or spotting may occur when using the tablets from the next pack. The next package should be started after a 7-day break.Proceeding in case of the intention to change the day of the menstrual bleeding. In order to postpone the date of the bleeding to a different day of the week than that resulting from the pattern of taking the drug, shorten the next break in taking tablets for as many days as you intend to postpone the date of bleeding. The shorter the break in taking the tablets, the greater the risk that you will not have withdrawal bleeding. Slight bleeding or spotting may occur when using the next pack.The occurrence of unexpected bleeding. During the first few months of use, irregular bleeding from the genital tract (spotting or menstrual bleeding) may occur. Nevertheless, you should continue taking the tablets. Irregular bleeding from the genital tract usually disappears after 3 cycles of drug use. If the bleeding persists, becomes abundant or recurrent, the patient should report it to the doctor.No bleeding. If the patient took all the tablets at the right time, had no acute diarrhea or vomiting or used other medicines, the likelihood of getting pregnant is small. Should continue taking the preparation. The lack of bleeding during the next two months may be a sign of pregnancy. The patient should immediately see a doctor. Do not start the next pack until you are sure that you are not pregnant.