Giane Tablet (Cyproterone Acetate & Ethinylestradiol): Hormone Therapy for Severe Acne

Giane is a combined hormonal preparation containing Cyproterone acetate (2 mg), a potent antiandrogen and progestogen, and Ethinylestradiol (0.035 mg), a synthetic estrogen. This combination lowers active male hormone (androgen) levels in the body to treat severe skin conditions while maintaining regular menstrual cycles and preventing ovulation.

📋 Indications: Targeted Dermatological Care

Giane is indicated only for women experiencing:

• Severe acne that has completely failed to respond to oral antibiotics and other standard treatments.

• Acne accompanied by signs of androgenization (excess male hormones), such as severe oily skin (seborrhea) and mild excess hair growth (hirsutism).

• ⚠️ Important: It should not be prescribed solely for its birth control properties.

🥄 Dosage and the 21-Day Cyclic Regimen

Each blister pack contains 21 tablets. For maximum effectiveness, tablets must be taken at the same time every day with liquid.

• First Treatment Course: Take 1 tablet daily for 21 consecutive days, beginning on Day 1 of your menstrual cycle (the very first day of bleeding).

• The 7-Day Gap: After 21 days, stop taking the medication for 7 days. A withdrawal bleed (similar to a period) will normally occur during this week off.

• Subsequent Courses: Always start the next 21-day pack on the exact same day of the week you started your first pack, exactly 7 days after stopping, even if your bleeding is still going on.

• Duration: Treatment must be continued for several months, as noticeable skin improvements take at least 3 months. The drug is usually stopped 3 to 4 cycles after skin signs have fully cleared up.

What to Do for a Missed Dose

• Under 12 hours late: Take the missed tablet immediately and take the next one at your usual time.

• Over 12 hours late: Discard the missed tablet and take the remaining tablets in the pack at your normal times to prevent bleeding. You must use an additional nonhormonal birth control method (like condoms) until the pack is empty to avoid pregnancy.

⚠️ Serious Warnings & Cardiovascular Risks

• Smoking and Age Hazards: Taking estrogen/progestogen combinations significantly increases the risk of serious cardiovascular side effects, including heart attacks and blood clots. This danger increases drastically if you are over 35 years old or smoke heavily (15+ cigarettes/day). Women taking Giane should not smoke.

• Immediate Discontinuation: Stop taking Giane immediately and see a doctor at the very first sign of:

  • Blood clots or chest pain (thrombosis, myocardial ischemia).

  • Sudden visual disturbances, double vision, or swelling of the eye.

  • Severe, unusual headaches or worsening of migraines.

  • Jaundice (yellowing of the skin or eyes) or generalized body itching.

  • A significant rise in blood pressure.

🛑 Contraindications & Drug Interactions

Do not use Giane if you have or have a history of:

• Blood clots (thrombophlebitis, thromboembolic disorders), stroke, heart attack, or coronary artery disease.

• Active liver disease, jaundice, or liver tumors.

• Known or suspected breast, uterine, or estrogen-dependent cancers.

• Undiagnosed abnormal vaginal bleeding.

• Severe diabetes with blood vessel changes.

Key Drug Interactions

• Reduced Efficacy & Spotting: Antibiotics (Ampicillin, Penicillin, Tetracycline, Rifampicin) and certain medications (Carbamazepine, Phenytoin, Antihistamines) can drastically lower Giane’s effectiveness.

• Vitamin C Alert: High doses of Vitamin C can significantly increase your blood levels of Ethinylestradiol.

🤰 Pregnancy & Lactation

• Pregnancy: Strictly contraindicated. It can cause the feminization of male fetuses. Pregnancy must be completely ruled out before starting or continuing treatment.

• Lactation: Not recommended for breastfeeding mothers, as the hormones pass into breast milk and can lower its quantity and quality.

📦 Storage Conditions

• Store below 30°C in a dry place protected from light.

• Keep securely out of the reach of children.