Moderate to severe acne and/or hirsutism in women of childbearing age who are sensitive to androgens; Contraception

Acne Products; Estrogen and Progestin Combination

Cyproterone:
Absorption: Oral: Complete
Metabolism: Hepatic; primary metabolite is 15beta-hydroxy-cyproterone acetate
Distribution: Vd: IM: 20.6 L/kg
Bioavailability: Oral: 88%
Half-life elimination: Oral: 38 ± 5 hours
Excretion: Feces (60%); urine (33%; mainly as unconjugated metabolites)
Ethinyl estradiol:
Absorption: Rapid
Bioavailability: 43% to 55%
Distribution: Vd: 2 to 4 L/kg
Protein binding: >95% to albumin
Metabolism: Hepatic via oxidation and conjugation in GI tract; hydroxylated via CYP3A4 to metabolites; first-pass effect; enterohepatic recirculation; reversibly converted to estrone and estriol
Half-life elimination: 19 to 24 hours
Excretion: Urine (as estradiol, estrone, and estriol); feces

Hypersensitivity to ethinyl estradiol, cyproterone, or any component of the formulation;
breast cancer or other estrogen- or progestin-dependent neoplasms;
history of or actual thrombophlebitis or thromboembolic disorders, cerebrovascular disorders, or myocardial infarction or coronary arterial disease;
severe diabetes with vascular changes;
hepatic tumors or disease;
history of cholestatic jaundice; pregnancy;
undiagnosed abnormal vaginal bleeding;
ocular lesions arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields;
history of otosclerosis with deterioration during pregnancy;
concomitant use with other estrogen/progesterone combinations or estrogens or progestins alone

X (All Trimesters)

Infant risk has been demonstrated.

Cardiovascular: Varicosity (3%), edema (2%)Central nervous system: Headache (5%), nervousness (4%), depression (3%), dizziness (1%)Dermatologic: Chloasma (4%)Endocrine & metabolic: Change in libido (3%)Gastrointestinal: Nausea (2%)Genitourinary: Dysmenorrhea (10%), breast tenderness (7%)

Take one tablet daily for 21 consecutive days. After seven days without taking the medicine, start the next pack.

Not indicated for chilhood age.

There are no dosage adjustments provided in the manufacturer’s labeling.

There are no dosage adjustments provided in the manufacturer’s labeling.

This product should be packaged in a tightly closed container and stored in a cool (15-30°C) dry place out of reach of children.