Ginette-35 is used for oral contraception in women who require anti-androgen therapy. Cyproterone acetate may be used in conjunction with ethinyl oestradiol for the control of idiopathic hirsutism.
For the treatment of severe acne, especially androgen-dependent acne accompanied by inflammation, seborrhoea or the formation of nodes.
Before commencing with Ginette-35, an appropriate medical (including gynaecological) examination should be done and the patient’s medical history carefully evaluated. Regular medical examinations are recommended during use. Pregnancy should be excluded.
Disorders of the clotting system and family history of thrombo-embolic diseases, especially at a young age, should be excluded.
Androgen-producing tumours or an adrenal enzyme defect should be ruled out before prescribing Ginette-35 for the treatment of hirsutism.
Additional contraceptive precautions should be taken for the first 14 days of the first cycle or if a tablet is accidentally missed.
Spotting may occur but will usually stop spontaneously.
The patient is advised to consult her doctor if prolonged and persistent bleeding occurs.
The tablet should be taken roughly at the same time every day, not exceeding 24 hours, for maximum effectiveness. The tablet may be taken with a meal to reduce nausea.
Missed doses: Take as soon as possible, that is within the next 12 hours at the latest, but not when it is nearly time for the next dose. Do not double doses. Take the next tablet at the usual time to prevent withdrawal bleeding. Additional non-hormonal contraceptive precaution should be taken.
In the case of diarrhoea or vomiting, additional non-hormonal contraception should be employed in order to prevent pregnancy.
First cycle: The patient should take the first tablet on the first day of the cycle (the first day of the cycle being the first day of the menstrual bleeding). Thereafter, one tablet should be taken daily, following the sequence of the arrows, at the same time, until all the tablets have been taken. The first tablet should be taken from the silver section (of the calender pack), commencing with the appropriate day as indicated on the strip.
Subsequent cycles: A new pack should be started the very next day after completing the previous pack, once again starting from the appropriate day within the silver section of the strip. This method should be followed as long as the contraception is desired.
For the treatment of androgen-dependent acne: Dosage as for contraception.
Take exactly as prescribed.
Store Ginette-35 below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ginette-35 out of the reach of children and away from pets.