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Ginette-35 (Cyproterone) 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.








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Drug Name

Ginette-35 (Cyproterone)

Drug Uses

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.
Each blister strip of 28 tablets contains 21 active hormonal film-coated tablets, each with 0,035 mg ethinyl oestradiol and 2 mg cyproterone acetate, plus 7 inactive non-hormonal tablets.

How to use

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.

Drug Class and Mechanism

Cyproterone acetate is an androgen antagonist. It possesses progestogenic activity and suppresses the secretion of gonadotropins.
Cyproterone acetate causes the viscosity of the cervical mucous to increase, rendering it hostile to sperm penetration.
Ethinyl oestradiol is a synthetic oestrogen and in combination with cyproterone inhibits ovulation by suppressing the mid-cycle peak of the luteinising hormone released from the pituitary gland as well as the follicle-stimulating hormone.
The combination also alters the endometrium, and this may render the endometrium unfavourable for the implantation of the fertilised ovum. Sebaceous gland activity is suppressed by the cyproterone in the combination.

Missed Dose

If you miss a dose of Ginette-35, 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.

Storage

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.Warnings/Precautions

Woman who use oral contraceptives should be strongly advised not to smoke. Smoking increases the risk of myocardial infarction.
Women smoking more than 15 cigarettes per day have at least a 20% increased risk of serious cardiovascular side-effects. This risk also increases with age and is quite marked in women over 35 years of age.
Not to be used in children and men.

CONTRA-INDICATIONS:
Oral contraceptives must not be used during known or suspected pregnancy as it may cause severe harm to the foetus.
A combination oral contraceptive should not be prescribed after a recent evacuation of a hydatidiform mole until urine and plasma gonadotropin concentrations have returned to normal.
Lactation.
Hypersensitivity to any of the ingredients.
Known or suspected breast cancer.
Patients with liver diseases or malignant or wasting diseases.
It should not be given to patients with a history of thrombo-embolic disorders. This may include myocardial infarction, pulmonary embolism, venous thrombosis and stroke.
Contra-indicated in patients with severe chronic depression and sickle-cell anaemia.
Oral contraceptives are contra-indicated in patients with oestrogen-dependent neoplasms, functional ovarian cysts, the Dubin-Johnson or Rotor syndromes, disorders of lipid metabolism, markedly impaired liver function, cerebrovascular insufficiency, coronary artery disease, thrombophlebitis, deteriorating otosclerosis, a history of pruritus during previous pregnancy, undiagnosed vaginal bleeding, herpes, recurrent cholestatic jaundice or porphyria.
Patients with classical migraine should not use a combination oral contraceptive.
Relative contra-indications (these patient would require medical supervision):
Diabetes mellitus, tetany, hypertension, epilepsy, chorea, multiple sclerosis, renal dysfunction, asthma, mental depression, varicose veins, cardiac dysfunction, gallbladder disease, patients who wear contact lenses and obese patients, or other conditions