Giane 35

Giane 35

cyproterone + ethinylestradiol


Renata Limited


Concise Prescribing Info
Ethinylestradiol 0.035 mg, cyproterone acetate 2 mg
Women of reproductive age w/ moderate to severe acne related to androgen-sensitivity (w/ or w/o seborrhea) &/or hirsutism. Use only after topical therapy or systemic antibiotic treatments have failed.
Dosage/Direction for Use
1 tab daily from 1st day of menstruation for 21 days followed by 7 tab-free days.
May be taken with or without food.
Hypersensitivity. Venous or arterial thrombosis; prodromi of thrombosis (eg, transient ischemic attack, angina pectoris); DM w/ vascular involvement; severe or multiple risk factor for venous or arterial thrombosis; severe hepatic disease; benign or malignant liver tumours; known or suspected malignant conditions of the genital organs or breasts; undiagnosed vag bleeding. Pregnancy & lactation.
Special Precautions
Migrainous headaches, thrombophlebitis or thromboembolism, hepatitis, increased epileptic seizures, significant rise of BP. Diabetes, HTN, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, minor chorea, history of phlebitis. Risk of venous & arterial thromboses (eg, stroke, MI). Not used in men.
Adverse Reactions
Hypersensitivity, breast tenderness, headache, migraine, depressive moods, contact lens intolerance, nausea, vomiting, various skin disorders, fluid retention, libido, vag secretions & body wt changes.
Drug Interactions
Increased clearance w/ hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbamazepine, topiramate, felbamate, griseofulvin. Contraceptive failure w/ antibiotics eg, ampicillins & tetracyclines.
ATC Classification
G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.
Giane 35 tab
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