| Product dosage: 2.035mg | |||
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Synonyms | |||
Ginette 35: Comprehensive Hormonal Therapy for PCOS and Acne
Ginette 35 is a combined oral contraceptive pill indicated for the treatment of moderate to severe acne in women unresponsive to topical antibiotics and anti-acne treatments, and for the management of signs of androgenization, such as those seen in polycystic ovary syndrome (PCOS). It contains a balanced formulation of cyproterone acetate and ethinylestradiol, offering both contraceptive efficacy and therapeutic benefits for specific dermatological and endocrine conditions. This product is prescribed under medical supervision and requires thorough patient evaluation prior to initiation.
Features
- Active ingredients: 2 mg cyproterone acetate and 0.035 mg ethinylestradiol
- Pharmaceutical form: film-coated tablets in a calendar blister pack
- 21-day active regimen followed by a 7-day hormone-free interval
- Antiandrogenic and estrogenic activity
- Prescription-only medication
Benefits
- Effectively reduces sebum production and improves moderate to severe acne lesions
- Regulates menstrual cycles in women with hyperandrogenism or PCOS
- Provides reliable contraception with a Pearl Index of approximately 0.1–0.9
- May improve hirsutism and other androgen-dependent symptoms
- Helps restore hormonal balance in appropriate patient populations
- Reduces the need for additional acne or hormonal treatments
Common use
Ginette 35 is primarily prescribed for women seeking treatment for acne vulgaris that has proven resistant to conventional topical therapies, particularly when there is evidence of hormonal involvement. It is also used in the management of PCOS-related symptoms such as oligomenorrhea, hirsutism, and seborrhea. Its use is generally reserved for women of reproductive age who also desire contraception.
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. Withdrawal bleeding usually occurs during this break. A new pack should be started on the 8th day, regardless of whether bleeding has stopped. It is recommended to begin taking Ginette 35 on the first day of the menstrual cycle. If switching from another hormonal contraceptive, specific guidelines should be followed as directed by a healthcare provider.
Precautions
- Not intended for use during pregnancy or lactation
- Blood pressure should be monitored before and during treatment
- Women with a history of depression should be closely observed
- Caution is advised in patients with diabetes, hyperlipidemia, or liver disorders
- Regular gynecological and breast examinations are recommended
- Smoking increases the risk of serious cardiovascular side effects, especially in women over 35
Contraindications
- Thrombophlebitis or thromboembolic disorders
- History of cerebrovascular or coronary artery disease
- Known or suspected carcinoma of the breast or estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Severe hepatic disease or liver tumors
- Hypersensitivity to any component of the formulation
- Migraine with focal aura
Possible side effects
Common side effects may include nausea, headache, breast tenderness, mood changes, and breakthrough bleeding, especially during the first few cycles. Less frequently, weight changes, decreased libido, chloasma, and contact lens intolerance may occur. Serious adverse effects, though rare, include venous thromboembolism, stroke, myocardial infarction, and hepatic tumors. Any unusual symptoms should be reported immediately to a healthcare provider.
Drug interaction
Ginette 35 may interact with drugs such as antibiotics (e.g., rifampicin), anticonvulsants (e.g., phenytoin, carbamazepine), St. John’s wort, and certain HIV medications, potentially reducing its efficacy. Concurrent use with other hormone therapies or liver enzyme-inducing agents should be avoided or managed with additional contraceptive precautions.
Missed dose
If a tablet is forgotten for less than 12 hours, contraceptive protection is not reduced; the missed tablet should be taken as soon as remembered, and the next one at the usual time. If more than 12 hours have passed, the missed tablet should be taken immediately, even if it means taking two tablets in one day, and additional barrier contraception should be used for the next 7 days. Specific advice depends on which week the tablet was missed; consult the package leaflet or a healthcare provider.
Overdose
Serious effects of overdose are not expected, but nausea, vomiting, and withdrawal bleeding may occur. There is no specific antidote; symptomatic treatment is recommended. Medical attention should be sought if large amounts have been ingested.
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 medical professionals and informed patients and should not replace personalized advice from a qualified healthcare provider. Ginette 35 is a prescription medication and must be used under medical supervision. Individual response and risks vary; a thorough benefit-risk assessment is necessary before initiation.
Reviews
Clinical studies and patient reports indicate that Ginette 35 is effective in reducing acne lesions and regulating cycles in hyperandrogenic women. Many users report significant dermatological improvement within 3–6 months. However, experiences with side effects such as mood changes or weight gain vary. Long-term satisfaction often depends on proper patient selection and management of expectations.
