Gedeon Richter


Zuellig Pharma


Concise Prescribing Info
Ethinyl oestradiol 0.03 mg, chlormadinone acetate 2 mg
OC. Alternative treatment of moderate papulopustular acne. Signs/symptoms of endocrine disorder (endocrine acne) in women unresponsive to standard treatment.
Dosage/Direction for Use
1 tab daily at the same time everyday starting on the 1st day of menstruation for 21 consecutive days, followed by 7 tab-free days.
May be taken with or without food: Swallow whole, do not chew.
Hypersensitivity. History of DVT, pulmonary embolism, heart attack, stroke, liver tumour, breast or womb cancer, inflammation of the pancreas associated w/ severe increase in triglycerides, migraine. Diabetes, high BP (constantly >140/90 mmHg); protein C deficiency, liver inflammation (due to virus) or jaundice; bile flow disorder in connection w/ a previous pregnancy or oestrogen treatment; Dubin-Johnson or Rotor syndrome; severe stomache ache, enlarged liver or abdominal bleeding; porphyria, severe fat metabolism disorders; unusually severe, frequent or prolonged headache; sight or hearing disorders; paralysis; worsening of epileptic fits; severe depression; otosclerosis worsen during pregnancy; amenorrhea & vag bleeding w/ unknown cause; endometrial hyperplasia; risks of blood clotting disorders. Discontinue use at least 4 wk prior to surgery. Pregnancy & lactation.
Special Precautions
Heart & kidney diseases, migraine, epilepsy, asthma; history of phlebitis, liver disease; varicosis; multiple sclerosis; chorea minor; tetany; DM; fat metabolism disorders; overwt; high BP; endometriosis; myomatous uterus; mastopathy; otosclerosis. Avoid smoking.  Examine for blood clotting prior to use. Higher risk of blood clotting w/ combined OCs. Women >40 yr.
Adverse Reactions
Nausea, vag discharge, dysmenorrhea, amenorrhea, breakthrough bleeding, spotting, headache, breast pain, ovarian cyst, fibroadenomas, feeling of tension in the breasts, depression, irritability, nervousness, dizziness, migraine, visual disorders, vomiting, acne, abdominal pain, tiredness, feeling of heaviness in the legs, water retention, increase in wt & BP.
Drug Interactions
Increased biological breakdown of barbiturates, rifampicin, griseofulvin, phenylbutazone, barbexaclone, carbamazepine, phenytoin, primidone, St. John's wort. Reduced levels w/ ampicillin, tetracyclines, activated charcoal. Increased & prolonged effect of theophylline or caffeine. Altered effects of insulin or antidiabetics.
MIMS Class
ATC Classification
G03AA - Progestogens and estrogens, fixed combinations ; Used as systemic contraceptives.
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