DON-35-H® Tablets

DON-35-H® Tablets
Generic Name:
Cyproterone Acetate + Ethinylestradiol
Therapeutic Group:
Gynecology / Hormonal Therapy
Drug Category:
Anti-androgen + Combined Oral Contraceptive (Estrogen + Progestogen)
Content / Composition:
Each film-coated tablet contains:
* Cyproterone Acetate …… 2 mg
* Ethinylestradiol …… 35 mcg
Indications:
Indicated for hormonal and androgen-related conditions in women, including:
* Hormonal contraception
* Acne (moderate to severe) related to androgen sensitivity
* Hirsutism (excess facial/body hair)
* Polycystic Ovary Syndrome (PCOS)
* Regulation of menstrual cycles
* Seborrhea
Dosage:
Adults (women of reproductive age):
* One tablet daily for 21 consecutive days, followed by 7 days break
* Start next pack after the 7-day interval
* Take at the same time each day
Contraindications:
* Pregnancy or suspected pregnancy
* History of thromboembolic disorders (DVT, PE)
* Severe liver disease
* Hormone-dependent malignancies (e.g., breast cancer)
* Uncontrolled hypertension
* Undiagnosed vaginal bleeding
* Smoking in women over 35 years (relative/strong caution)
Administration:
For oral use.
Swallow with water.
Take regularly at the same time each day for maximum effectiveness.
Interaction:
Use caution with:
* Enzyme-inducing drugs (rifampicin, phenytoin, carbamazepine) – reduce effectiveness
* Antibiotics (may affect hormonal levels)
* Anticoagulants
* Herbal products like St. John’s Wort
Compatibility:
Compatible with gynecological treatments under medical supervision.
Additional contraceptive precautions may be needed when used with interacting drugs.
Stability / Storage:
Store below 25°C.
Protect from light and moisture.
Keep out of reach of children.
Precautions:
* Increased risk of thromboembolism (especially in smokers)
* Monitor blood pressure regularly
* Use cautiously in diabetic patients
* Discontinue if signs of thrombosis appear
* Not recommended during pregnancy
* Requires medical evaluation before initiation
Side Effects:
Common:
* Nausea
* Breast tenderness
* Headache
* Weight changes
Others:
* Mood changes
* Spotting or breakthrough bleeding
* Reduced libido
Rare but serious:
* Thromboembolic events
* Liver dysfunction
* Severe allergic reactions
Website Note:
Hormonal contraceptive and anti-androgen therapy.
Use strictly under medical supervision.
Not suitable for self-medication.