Europe — EMA
Midane (Cyproterone Acetate, Ethinylestradiol)
GNH USA supplies Midane (Cyproterone acetate/Ethinylestradiol), a combined estrogen‑progestogen oral contraceptive for contraception and androgen‑dependent
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What is Cyproterone Acetate, Ethinylestradiol?
Cyproterone acetate and ethinylestradiol, the active ingredients in Midane, are a combined estrogen‑progestogen oral contraceptive presented as an unspecified strength/oral tablet for oral use. It provides hormonal contraception and anti‑androgen therapy for women of reproductive age, and is indicated for prevention of pregnancy and for treatment of androgen‑dependent conditions such as acne and hirsutism.
GNH USA supplies Midane as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Cyproterone Acetate, Ethinylestradiol used for?
Midane, a combined estrogen‑progestogen oral contraceptive, is used in hormonal regulation pathways for several clinical indications. - Contraception: Prevents pregnancy by inhibiting ovulation. - Acne: Reduces androgen‑driven facial and trunk acne in women. - Hirsutism: Decreases excessive facial and body hair growth associated with androgen excess.
What are the side effects of Cyproterone Acetate, Ethinylestradiol?
Midane may cause a range of adverse reactions, varying from mild to serious.
Common Side Effects: - Nausea: mild stomach upset often occurring early in treatment. - Headache: transient tension‑type or migraine‑like headaches. - Breast tenderness: mild swelling or discomfort of the breasts. - Weight change: slight increase or fluctuation in body weight.
Serious or Rare Side Effects: - Venous thromboembolism: blood clot formation in deep veins or lungs. - Hepatic dysfunction: abnormal liver enzymes or jaundice. - Hypertensive crisis: sudden severe increase in blood pressure, especially with certain medications.
What precautions apply to Cyproterone Acetate, Ethinylestradiol?
Before prescribing Midane, clinicians should consider several precautionary measures to ensure patient safety. - Contraindication: pregnancy – product is classified as Category X and must not be used. - Cardiovascular risk: avoid in women with a history of thromboembolic disorders, myocardial infarction or stroke. - Liver disease: use with caution in patients with active hepatic disease or impaired function. - Smoking: contraindicated in women over 35 who smoke heavily. - Drug interactions: review concomitant medications that may increase clot risk or affect hormone metabolism. - Store at ambient temperature: keep below 25 °C, retain in original packaging and protect from moisture.
What does Cyproterone Acetate, Ethinylestradiol interact with?
Midane can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Combined hormonal contraceptives with other estrogen‑containing products: increased risk of thrombosis. - Anticoagulants (e.g., warfarin): may reduce anticoagulant effect, requiring monitoring. - CYP3A4 inducers (e.g., rifampicin, carbamazepine): may lower plasma levels of both components, reducing effectiveness.
Moderate Interactions (Monitor Closely): - Antiepileptics (e.g., phenytoin): may modestly decrease hormone levels. - Antiretrovirals (e.g., protease inhibitors): can increase hormone concentrations, raising side‑effect risk. - St. John’s wort: may reduce contraceptive efficacy.



