Ginette 35 is a prescription-only combined oral contraceptive and antiandrogen medication, widely recognized for its dual-action efficacy in managing polycystic ovary syndrome (PCOS) and moderate to severe androgen-dependent acne in women. It contains a balanced formulation of ethinylestradiol and cyproterone acetate, which work synergistically to regulate hormonal imbalances, suppress excessive sebum production, and restore ovulatory cycles. This medication is indicated for women of reproductive age who require both contraceptive protection and targeted endocrine therapy, under strict medical supervision. Its use is supported by extensive clinical evidence and decades of therapeutic application across numerous healthcare systems.

Features

• Active ingredients: 2 mg cyproterone acetate and 0.035 mg ethinylestradiol per tablet
• Pharmaceutical form: film-coated oral tablets in a 21-day blister pack
• Hormonal class: combined estrogen-progestogen preparation with antiandrogenic properties
• Standard pack size: 21 tablets, often prescribed in multiples for extended treatment cycles
• Manufacturer: licensed under various pharmaceutical regulators including EMA and country-specific agencies
• Prescription status: strictly prescription-only in most jurisdictions

Benefits

• Effectively reduces clinical signs of hyperandrogenism, including hirsutism and treatment-resistant acne
• Regulates menstrual cycles and alleviates symptoms associated with PCOS such as oligomenorrhea or amenorrhea
• Provides reliable contraception with a Pearl Index of approximately 0.2–0.5 when taken correctly
• Demonstrates antiandrogenic activity by competitively blocking androgen receptors and reducing sebaceous gland activity
• Helps prevent ovarian cyst formation and may reduce long-term metabolic risks associated with untreated PCOS
• Improves quality of life through visible dermatological improvements and normalized menstrual function

Common use

Ginette 35 is primarily prescribed for the management of polycystic ovary syndrome (PCOS) in women presenting with symptoms such as acne, seborrhea, mild hirsutism, and menstrual irregularities. It is also indicated for the treatment of moderate to severe acne vulgaris that has proven resistant to topical antibiotics or retinoids, particularly when hormonal etiology is suspected. It is not intended for use as a general contraceptive alone unless these specific endocrine conditions are present. Treatment is usually initiated in women who are not pregnant, have no contraindications to combined hormonal contraceptives, and require long-term hormonal regulation.

Dosage and direction

One tablet is taken orally at the same time each day for 21 consecutive days, followed by a 7-day tablet-free interval. Menstrual-like withdrawal bleeding usually occurs during this break. A new blister pack should be started on the 8th day, regardless of whether bleeding has stopped. Treatment should begin on day 1 of the menstrual cycle. If switching from another hormonal contraceptive, specific transition protocols must be followed under medical guidance. For acne and PCOS, a minimum of 3–6 months of continuous use is typically required before significant clinical improvement is observed. Long-term use may be recommended based on therapeutic response and tolerability.

Precautions

• Cardiovascular risk assessment is mandatory before prescription, including blood pressure measurement and evaluation of personal/family history of thromboembolism
• Liver function should be monitored periodically during prolonged therapy
• Not recommended for smokers over age 35 due to increased thrombotic risk
• May affect glucose tolerance and lipid metabolism; periodic metabolic screening is advised
• Caution required in women with a history of depression, migraines, or epilepsy
• Reduced efficacy may occur with concomitant use of enzyme-inducing drugs; alternative contraception may be required
• Regular gynecological examinations are recommended during long-term treatment

Contraindications

• Presence or history of venous or arterial thrombosis/thromboembolism
• Known or suspected hormone-dependent malignancies (e.g., breast or genital tract cancer)
• Severe hepatic disease, liver tumors, or history of jaundice during pregnancy
• Undiagnosed abnormal genital bleeding
• Hypersensitivity to any component of the formulation
• Pancreatitis with severe hypertriglyceridemia
• Pregnancy or breastfeeding
• Migraine with focal neurological symptoms

Possible side effects

Common (≥1/100):

• Headache, nausea, breast tenderness
• Mood changes, decreased libido
• Breakthrough bleeding or spotting during initial cycles

Uncommon (≥1/1000):

• Hypertension, gallbladder disease
• Chloasma, contact lens intolerance
• Mild hair loss or changes in hair texture

Rare (<1/1000):

• Venous thromboembolism, hepatic adenomas
• Ischemic stroke, myocardial infarction
• Gallstone formation, hypersensitivity reactions

Drug interaction

• Enzyme inducers (e.g., rifampicin, phenytoin, St. John’s wort) may reduce efficacy
• Antibiotics such as ampicillin or tetracycline may interfere with enterohepatic circulation
• Cyclosporine, theophylline, and lamotrigine levels may be affected
• Anticoagulant therapy may require dosage adjustment
• Concomitant use with other antiandrogens or hormonal therapies is not recommended

Missed dose

If a tablet is missed for less than 12 hours: Take the missed tablet immediately and continue the schedule as usual. If missed for more than 12 hours: Take the missed tablet as soon as remembered, even if it means taking two tablets in one day. Use additional barrier contraception for the next 7 days. If more than one tablet is missed, consult the prescribing physician or package insert for specific instructions based on the cycle week.

Overdose

No serious adverse effects have been reported following acute overdose. Symptoms may include nausea, vomiting, and withdrawal bleeding. There is no specific antidote; symptomatic treatment is recommended. Medical supervision should be sought, particularly in cases of accidental ingestion by children.

Storage

Store below 25°C in the original blister pack to protect from light and moisture. Keep out of reach of children. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is provided for educational purposes only and does not replace professional medical advice. Ginette 35 is a prescription medication and should only be used under the supervision of a qualified healthcare provider. Individual response to therapy may vary. Always consult your physician for diagnosis, treatment decisions, and management of side effects.

Reviews

Clinical studies and patient reports consistently indicate high satisfaction rates among women using Ginette 35 for PCOS and acne management. Users frequently report significant improvement in skin condition within 3–6 months, regularization of menstrual cycles, and reduction in hirsutism. Some note initial side effects such as mild nausea or breast tenderness, which often subside after the first few cycles. Long-term users appreciate the dual benefit of reliable contraception and endocrine management. Critical reviews occasionally mention weight fluctuations or mood changes, emphasizing the importance of individualized medical supervision throughout treatment.