Product Name:
Diane-35 mg
Product Description:
Diane-35 mg is a combined oral contraceptive containing Cyproterone Acetate and Ethinyl Estradiol. In addition to preventing pregnancy, it has antiandrogenic effects that help in the treatment of moderate to severe acne, mild hirsutism, seborrhea, and androgenetic alopecia.
Indications / Benefits:
Contraception (pregnancy prevention).
Treatment of moderate to severe acne associated with androgen sensitivity.
Treatment of seborrhea.
Management of mild hirsutism.
Management of androgenetic alopecia.
Composition (according to CekBPOM):
Cyproterone Acetate 2 mg
Ethinyl Estradiol 0.035 mg
Drug Class (according to CekBPOM):
Prescription Drug (Oral Contraceptive, Antiandrogen and Estrogen combination).
Dosage Form (according to CekBPOM):
Sugar-coated tablet.
Packaging Form:
Box, 1 blister containing 21 tablets.
Strength:
Cyproterone Acetate 2 mg + Ethinyl Estradiol 0.035 mg per tablet.
Directions for Use:
Take 1 tablet daily for 21 consecutive days, followed by 7 tablet-free days, then continue with the next cycle. It is recommended to start on the first day of menstruation.
Warnings & Precautions:
Use only under doctor’s prescription.
Do not use with other hormonal contraceptives.
Not for pregnant or breastfeeding women.
Contraindicated in patients with severe liver disease, thromboembolism, or hormone-dependent tumors.
Monitor blood pressure and cardiovascular risk.
Temporary discontinuation may be required before major surgery or prolonged immobilization.
NIE (according to CekBPOM):
DKI0868204416A1
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