INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo GINETTE

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

GINETTE
(Tablets)

COMPOSITION:
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.

PHARMACOLOGICAL CLASSIFICATION:
A 21.8.2 Progesterones with oestrogens.

PHARMACOLOGICAL ACTION:
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.

INDICATIONS:
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.

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 influenced by fluid retention. The risk benefits should be considered in patients with endometriosis and uterine fibroids.
It is advised that the use of GINETTE be discontinued if any of the following symptoms occur:
1. The onset of migraine or severe headache in a new patient.
2. When there is a gradual or sudden loss of vision or hearing.
3. At the first signs of thrombo-embolic disorders, e.g. pulmonary embolism, cerebrovascular insufficiency, thrombophlebitis, cerebral haemorrhage, retinal thrombosis, coronary or mesenteric thrombosis.
4. Surgery or prolonged bed rest as this may increase the risk of thrombo-embolic episodes. It is recommended that oral contraceptives be discontinued 4 to 6 weeks before major surgery.
5. The product should be discontinued if persistent upper abdominal pain, hepatitis or jaundice develops.
6. If the blood pressure rises markedly the product should be discontinued.
7. Pregnancy.

WARNINGS:
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.

DOSAGE AND DIRECTIONS FOR USE:
Before commencing with GINETTE, 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 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following side-effects may occur:
Breast changes including tenderness, enlargement and secretion.
Changes in menstrual flow (spotting, breakthrough bleeding, amenorrhoea) temporary intermenstrual bleeding, changes in libido, depressive moods, abdominal cramping or bloating and dizziness may occur. Nausea, vomiting, headaches, chloasma, skin pigmentation, vaginal candidiasis, gastro-intestinal irritation, mass gain and peripheral oedema.
Alterations in hair pattern, skin reactions and anaemia have been reported.
Gallbladder obstruction, or hepatitis may occur.
In women using combined oral contraceptives the incidence of circulatory system diseases is significantly higher than those of controls, and the mortality is slightly increased. Cerebrovascular accidents, coronary thrombosis and venous thrombosis are more likely to occur in women over 35 years of age, particularly if they have used contraceptives for 5 years or longer or are cigarette smokers. The incidence is also increased in women who are obese, or if they suffer from hypertension.
The incidence of circulatory system diseases is also higher in women suffering from diabetes, hypercholesterolaemia and familial hyperlipoproteinaemia. Thrombosis may be more common in women with blood groups A, B or AB.
Hypertension may occur. Regular blood pressure checks, including a pre-treatment check, are advised. There may be changes in carbohydrate and lipid metabolism.
Liver functions may be impaired. There appear to be an increased incidence of benign liver tumours.
Malignant liver tumours have also been reported. In cases of severe upper abdominal pain, liver enlargement or intra-abdominal haemorrhage, a liver tumour should be excluded.
An increased risk of cervical cancer is reported although other factors may be involved. Intolerance to contact lenses has been reported and vision may deteriorate in myopic patients.
Prolonged amenorrhoea following the use of oral contraceptives may occur. The incidence is in the order of 1% of users. Where oligomenorrhoea or amenorrhoea have occurred in the past, caution is advised.
Special Precautions:
Before hormonal contraceptives are prescribed, the patient should undergo an appropriate medical examination end her medical history should be carefully evaluated. Regular medical examinations should be done during the use of oral contraceptives.
Oral contraceptive failure may occur with the concomitant use of griseofulvin, rifampicin, and other antibiotics, especially aminopenicillins (e.g. Ampicillin, amoxicillin, pivampicillin) and tetracyclines.
Additional non-hormonal contraception should be recommended for the duration of antibiotic therapy and for seven days afterwards. Those on long-term antibiotic therapy need only take extra precautions for the first two weeks of the antibiotic therapy. Breakthrough bleeding or spotting are possible signs of diminished contraceptive effectiveness.
Pregnancy have been reported in women taking anti-epileptics (barbiturates, primidone, phenytoin, carbamazepine).
There is evidence that the overall effect of a large supplement of Vitamin C is to convert a low oestrogen oral contraceptive to a high-dose oral contraceptive. Breakthrough bleeding may occur with the withdrawal of high doses of Vitamin C.
The effectiveness of some anticoagulants, antidepressants and antidiabetics may be reduced and the plasma concentration of cyclosporin may be increased with concomitant use. The effectiveness of anti-hypertensives, beta blockers and diuretics may also be reduced and the plasma concentrations of theophylline may be increased during concomitant use. Some laboratory tests may be changed, in particular hormone tests, blood coagulation, thyroid function, glucose tolerance, liver function tests and serum triglycerides.
Under no circumstances should the oral contraception be stopped without having adopted alternative contraception.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
21 yellow film-coated biconvex tablets and 7 larger, white film-coated biconvex non-hormonal tablets.

PRESENTATION:
Carton containing a blister strip containing 21 yellow film-coated biconvex tablets and 7 white film-coated biconvex tablets (calender pack).

STORAGE INSTRUCTIONS:
Store in a cool dry place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
33/21.8.2/0185

NAME AND BUSINESS ADDRESS OF APPLICANT:
Cipla Medpro (Pty) Ltd.
Rosen Heights, Pasita Street,
Rosen Park, Bellville, 7530 R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 2002.

Cipla-Medpro logo

179NA
IY-1

New addition to this site: February 2004
Source: Community Pharmacy

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