This combination tablet is indicated for the treatment of women with severe acne that does not respond to oral antibiotics or other available therapies. It is also used in cases associated with signs of androgen excess, such as seborrhea and mild hirsutism.

Each blister pack contains 21 tablets. Each tablet contains: Cyproterone acetate 2 mg and Ethinylestradiol 0.035 mg. The treatment cycle consists of 21 days of active tablets followed by a 7-day pill-free interval (3 weeks on treatment, 1 week off).

Cyproterone acetate is a steroid compound with strong anti-androgenic, progestogenic, and anti-gonadotropic properties. It works by blocking androgen receptors and reducing androgen production through feedback inhibition of the hypothalamic-pituitary-ovarian axis.

Ethinylestradiol increases sex hormone-binding globulin (SHBG), thereby reducing free circulating androgens in plasma. Cyproterone does not reduce SHBG levels.

When used alone in women, cyproterone may cause menstrual irregularities, which are minimized when combined with ethinylestradiol. When taken cyclically, this combination also inhibits ovulation and prevents conception. Both components are rapidly absorbed after oral administration. Due to the long half-life of cyproterone, plasma levels increase approximately fourfold after 6–12 days of continuous use. Long-term use (up to 36 months) shows minimal effects on lipid metabolism, with slight increases in cholesterol and triglycerides, a decrease in LDL, and a rise in HDL levels.

This tablet should not be prescribed solely for its contraceptive properties. If patient compliance is uncertain and contraception is necessary, then a supplementary nonhormonal contraceptive method should be considered.

First Treatment Course:The patient is instructed to take 1 tablet daily for 21 consecutive days beginning on day 1 of her menstrual cycle. (For the first cycle only, the first day of menstrual flow is considered Day 1). The tablets are then discontinued for 7 days (1 week). Withdrawal bleeding should usually occur during the period that the patient is off the tablets. The first cycle will be somewhat shorter than usual, whereas all following cycles will last 4 weeks. The patient should be instructed to take the first tablet from the blister pack from the section marked with the corresponding day (e.g., “Mon” for Monday) and swallow it with liquid. The tablet should be taken at the same time each day.

Subsequent Courses :The patient begins her next and all subsequent 21-day courses (21 days on, 7 days off) on the same day of the week that she began her first course. She starts the next pack 7 days after discontinuation, regardless of whether withdrawal bleeding is still in progress.

Treatment Duration:Treatment may need to be continued for several months, as improvement may not be seen for at least 3 months.

The need to continue treatment should be evaluated periodically by the physician. The drug should be discontinued 3 to 4 cycles after symptoms have completely resolved.

Pregnancy should be ruled out before continuing treatment in patients who miss a menstrual period. If pregnancy is suspected, medication should be discontinued.

Missed Dose :If the patient forgets to take a tablet, it may be taken within 12 hours. If more than 12 hours have passed, the missed tablet should be discarded and the remaining tablets should be continued at the usual time to avoid premature withdrawal bleeding. A supplementary nonhormonal contraceptive method must be used until the pack is finished to prevent pregnancy, which would require immediate discontinuation of treatment.

Concomitant use of the following medicines may reduce the effectiveness of this tablet and increase the risk of breakthrough bleeding: ampicillin, analgesics, antihistamines, antimigraine drugs, chloramphenicol, griseofulvin, isoniazid, neomycin, nitrofurantoin, penicillin V, phenylbutazone, sulfonamides, and tetracyclines. Use with anticoagulants may reduce the anticoagulant effect.

The effect of the following drugs may be altered when used together: antihypertensives, benzodiazepines (oxidatively metabolized types), beta-blockers, caffeine, corticosteroids, hypoglycemic agents, phenothiazines, theophylline, tricyclic antidepressants, and vitamins.

Enzyme-inducing drugs such as carbamazepine, phenobarbital, phenytoin, pyrimidine derivatives, and rifampicin may decrease the efficacy of this tablet by increasing estrogen metabolism.

Diabetic patients may require adjustment of antidiabetic medications when using estrogen/progestogen combinations. Co-administration of vitamin C (ascorbic acid) may increase plasma levels of ethinylestradiol.

Pregnancy should be ruled out before starting treatment. Due to antiandrogenic effects, feminization of male fetuses has been observed in animal studies and may potentially occur in humans.

• Thrombophlebitis, thromboembolic disorders, or history of such conditions.
• Cerebrovascular disorders.
• Myocardial infarction or coronary artery disease.
• Active liver disease, hepatic adenoma, or carcinoma.
• History of cholestatic jaundice.
• Breast cancer (known or suspected).
• Estrogen-dependent tumors (known or suspected).
• Undiagnosed abnormal vaginal bleeding.
• Ocular vascular disease causing vision loss or field defects.
• Pregnancy (suspected or confirmed).
• Previous or existing liver tumors.
• Severe diabetes with vascular complications.
• History of otosclerosis worsened during pregnancy.

Common side effects include bleeding, dizziness, depression, weight gain, headache, edema, breast pain, lactation, blood clots, and gallstones.

Fetal abnormalities have been reported when estrogen/progestogen combinations are taken in early pregnancy. Pregnancy must be ruled out before starting therapy. Use during breastfeeding is generally not recommended, as hormones are excreted in breast milk and may reduce both the quantity and quality of milk. Long-term effects on the infant are unknown. This medicine may also cause fluid retention and should be used cautiously in conditions such as epilepsy.

Women with risk factors for coronary artery disease—such as cigarette smoking, hypertension, hypercholesterolemia, obesity, diabetes, and increasing age—may face an increased risk when using estrogen or progestogen combinations. After 35 years of age, these medications should be used only in exceptional cases after careful evaluation of the risk–benefit ratio by both physician and patient. Smoking significantly increases the risk of serious cardiovascular and thrombotic complications associated with this class of drugs. The risk becomes higher with increasing age and heavy smoking (15 or more cigarettes per day), particularly in women over 35 years. Patients using these medicines should strictly avoid smoking. Estrogen/progestogen combinations may increase plasma lipoprotein levels and should be used cautiously in patients with pre-existing hyperlipoproteinemia. Regular monitoring of lipid profiles is recommended. The combination of obesity, hypertension, and diabetes is especially dangerous, and alternative non-hormonal therapy should be considered when possible.

Treatment should be discontinued immediately at the first sign of thromboembolic or cardiovascular disorders, including thrombophlebitis, pulmonary embolism, cerebrovascular events, myocardial ischemia, mesenteric thrombosis, or retinal thrombosis. These products should be avoided in conditions associated with venous stasis or thrombosis risk, such as prolonged immobilization after trauma or long-term bed rest. Non-hormonal treatment options should be considered in such situations, including perioperative periods when surgery is planned. Medication must also be stopped if any of the following occur:

• visual disturbances (partial or complete loss of vision),
• papilledema, ocular vascular lesions,
• severe or unexplained headache,
• worsening migraine, jaundice,
• hepatitis,
• or generalized itching.

Patients with well-controlled essential hypertension may receive this drug only under close supervision. If a significant rise in blood pressure occurs, treatment must be discontinued immediately.

The onset of new migraine, worsening of existing migraine, or persistent/recurrent severe headache requires stopping the medication and proper evaluation.

Diabetic patients and those with a family history of diabetes should be closely monitored for changes in carbohydrate metabolism. High-risk patients may receive therapy only under strict medical supervision. Young patients with recent-onset, well-controlled diabetes without vascular complications should also be carefully observed for any ocular or vascular changes.

No cases of overdose have been reported with this tablet. There is no specific antidote. Management should be symptomatic and supportive based on the known pharmacological effects of the ingredients.

Oral contraceptive preparations, oral hormonal preparations for acne

Store below 30°C in a dry place. Protect from light. Keep out of reach of children.