Ginette 35 is a combined oral contraceptive and antiandrogenic medication primarily indicated for the treatment of signs of androgenization, such as severe acne and hirsutism, in women of reproductive age. It is also prescribed for the management of polycystic ovary syndrome (PCOS)-related symptoms, offering a dual mechanism of action through ethinylestradiol and cyproterone acetate. This product card provides a detailed, evidence-based overview of Ginette 35 for healthcare professionals, covering its pharmacological profile, clinical applications, and essential safety information.

Features

• Contains 2 mg cyproterone acetate and 0.035 mg ethinylestradiol per tablet
• 21-day active tablet regimen followed by a 7-day hormone-free interval
• Antiandrogenic and estrogenic activity
• White, round, sugar-coated tablets
• Packaged in blisters of 21 tablets
• Requires prescription and medical supervision

Benefits

• Effectively reduces sebum production and improves moderate to severe acne that is resistant to topical treatments
• Regulates menstrual cycles in women with PCOS, reducing the frequency of anovulatory cycles
• Diminishes androgen-dependent symptoms such as hirsutism and alopecia
• Provides reliable contraception when taken correctly
• Helps restore hormonal balance in hyperandrogenic conditions
• May improve quality of life by addressing cosmetic and metabolic concerns associated with androgen excess

Common use

Ginette 35 is commonly prescribed for women presenting with moderate to severe acne vulgaris, particularly when it is of hormonal origin and has proven resistant to conventional acne therapies. It is also indicated for the treatment of seborrhea and mild hirsutism. In clinical practice, it is frequently used off-label to manage the symptomatic manifestations of polycystic ovary syndrome, including menstrual irregularities, acne, and hirsutism, though specific regional approvals may vary. It is not intended for use as a primary contraceptive in women without androgen-related conditions.

Dosage and direction

The standard dosage is one tablet daily for 21 consecutive days, followed by a 7-tablet-free interval. Tablets should be taken at approximately the same time each day, with water, and can be taken with or without food. Treatment typically begins on day 1 of the menstrual cycle (first day of bleeding). If starting later than day 5, additional contraceptive precautions are recommended for the first 7 days of the first cycle. For optimal results and cycle control, it is advised to take Ginette 35 for at least 3–6 months, though treatment duration should be individualized based on therapeutic response and tolerability.

Precautions

Prior to initiation, a thorough medical history should be taken, with attention to contraindications and risk factors for venous thromboembolism (VTE). Blood pressure should be measured, and a clinical examination performed if indicated. Liver function tests are recommended in women with a history of liver disease. Use with caution in patients with diabetes, hypertension, hyperlipidemia, or a history of depression. Smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years of age. Periodic reevaluation is advised, particularly if risk factors develop during treatment.

Contraindications

Ginette 35 is contraindicated in the presence of any of the following conditions: current or history of venous or arterial thrombosis/thromboembolism; known or suspected hormone-dependent malignancies; severe hepatic disease; unexplained vaginal bleeding; known hypersensitivity to any component; pancreatitis with severe hypertriglyceridemia; and pregnancy or breastfeeding. It is also contraindicated in women with migraine with aura, major surgery with prolonged immobilization, or diabetes with vascular complications.

Possible side effects

Common side effects may include headache, nausea, breast tenderness, mood changes, and weight changes. Less frequently, irregular bleeding, decreased libido, and chloasma may occur. Serious but rare adverse effects include venous thromboembolism, arterial thromboembolism, hypertension, hepatic tumors, gallbladder disease, and hypersensitivity reactions. Any sudden severe headache, chest pain, visual disturbances, or jaundice should prompt immediate medical evaluation.

Drug interaction

Ginette 35 may interact with drugs that induce liver enzymes, such as rifampicin, phenytoin, barbiturates, and St. John’s wort, potentially reducing its efficacy. Broad-spectrum antibiotics may also decrease ethinylestradiol levels. Concurrent use with other antiandrogens or hormonal therapies is not recommended. Caution is advised with drugs that increase serum potassium, such as ACE inhibitors or potassium-sparing diuretics, due to cyproterone’s anti-mineralocorticoid activity.

Missed dose

If a tablet is missed and less than 12 hours have passed, take the missed tablet as soon as possible and continue the schedule. If more than 12 hours have passed, take the missed tablet immediately and the next tablet at the usual time, even if two tablets are taken in one day. Additional contraceptive precautions (e.g., barrier methods) should be used for the next 7 days if the missed tablet occurred in the first week of the pack. If vomiting or diarrhea occurs within 3–4 hours of intake, it should be treated as a missed dose.

Overdose

Serious ill effects have not been reported following acute overdose. Symptoms may include nausea, vomiting, and withdrawal bleeding. There is no specific antidote; treatment should be symptomatic and supportive. Medical attention should be sought in cases of accidental ingestion by children or large intentional overdose.

Storage

Store below 25°C in a dry place, protected from light. Keep out of reach of children. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified health provider with any questions regarding a medical condition. Prescription and use must be based on individual patient assessment and in accordance with local prescribing information and guidelines.

Reviews

Clinical studies and post-marketing surveillance indicate that Ginette 35 is effective in reducing acne lesions and regulating cycles in hyperandrogenic women. Many patients report significant improvement in skin condition and reduced hirsutism after 3–6 months of use. Some users note side effects such as mood changes or weight gain, which often subside after the initial cycles. Long-term satisfaction is generally high among appropriately selected patients, though regular monitoring is advised to manage potential risks.