INDICATIONS
Ginette-35 is employed for oral contraception in women who require anti-androgen therapy. Cyproterone acetate can be utilized in partnership with ethinyl oestradiol to the control over idiopathic hirsutism.
For the management of severe acne, especially androgen-dependent acne accompanied by inflammation, seborrhoea or even the formation of nodes.
INSTRUCTIONS
Before commencing with Ginette-35, the right medical (including gynaecological) examination ought to be done and the patient's track record carefully evaluated. Regular medical examinations are recommended during use. Pregnancy must be excluded.
Disorders from the clotting system and family history of thrombo-embolic diseases, especially at the young age, should be excluded.
Androgen-producing tumours or perhaps an adrenal enzyme defect ought to be ruled out before prescribing Ginette-35 to the treatments for hirsutism.
Additional contraceptive precautions needs to be taken to the first two weeks of the first cycle or if a tablet is accidentally missed.
Spotting may occur but will usually stop spontaneously.
The patient is required to talk her doctor if prolonged and persistent bleeding occurs.
The tablet ought to be taken roughly at the same time every day, not exceeding 24 hours, for max effectiveness. The tablet might be taken with a meal to cut back nausea.
Missed doses: Take immediately, that is certainly within the next 12 hours at the latest, but not if it is nearly time for that next dose. Do not double doses. Take the next tablet in the usual time for it to prevent withdrawal bleeding. Additional non-hormonal contraceptive precaution ought to be taken.
In the case of diarrhoea or vomiting, additional non-hormonal contraception should be used in order to avoid pregnancy.
First cycle: The patient should take the first tablet around the first day with the cycle (the first day of the cycle being the first day in the menstrual bleeding). Thereafter, one tablet must be taken daily, following the sequence in the arrows, at the same time, until all of the tablets have been taken. The first tablet must be extracted from the silver section (from the calender pack), commencing with the appropriate day as indicated for the strip.
Subsequent cycles: A new pack ought to be started in the morning after completing the last pack, once again starting from the correct day within the silver section with the strip. This method ought to be followed so long as the contraception is desired.
For the management of androgen-dependent acne: Dosage regarding contraception.
DOSAGE
Take just as prescribed.
STORAGE
Store Ginette-35 below 86 degrees F (30 degrees C). Store faraway from heat, moisture, and lightweight. Do not store within the bathroom. Keep Ginette-35 out from the reach of youngsters and from pets.
The following side-effects may occur:
Woman who use oral contraceptives ought to be strongly advised to never smoke. Smoking enhances the chance of myocardial infarction.
Women smoking greater than 15 cigarettes each day have a minimum of a 20% increased likelihood of serious cardiovascular side-effects. This risk also increases with age and is quite marked in ladies over 35 years of age.
Not to be utilized in youngsters and men.
Do not use if:
Oral contraceptives must not be utilized during known or suspected pregnancy as it might cause severe harm to the foetus.
A combination oral contraceptive shouldn't be prescribed after having a recent evacuation of an hydatidiform mole until urine and plasma gonadotropin concentrations have returned to normal.
Lactation.
Hypersensitivity to the of the ingredients.
Known or suspected cancer of the breast.
Patients with liver diseases or malignant or wasting diseases.
It mustn't 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, heart disease, thrombophlebitis, deteriorating otosclerosis, a good pruritus during previous pregnancy, undiagnosed vaginal bleeding, herpes, recurrent cholestatic jaundice or porphyria.
Patients with classical migraine must avoid using a mixture oral contraceptive.
Relative contra-indications (these patient would require medical supervision):
Diabetes mellitus, tetany, hypertension, epilepsy, chorea, multiple sclerosis, renal dysfunction, asthma, mental depression, blue veins, cardiac dysfunction, gallbladder disease, patients who wear contact lenses and obese patients, or other conditions relying on fluid retention. The risk benefits ought to be considered in patients with endometriosis and uterine fibroids. It is advised the usage of Ginette-35 be discontinued if any from the following symptoms occur:
Airmail: 2-3 business weeks
EMS: 3-8 business days