GINETTE 35
Composition
Each pack contains
- 21 Yellow coloured active tablets. Each film coated tablet contains
- Ethinylestradiol 0.035 mg
- Cyproterone acetate BP 2 mg
- 7 White Placebo tablets
Colours: Quinoline Yellow and Titanium Dioxide
Pharmacological action
The substance cyptoterone acetate contained in Ginette 35 blocks the effect of endogenously produced and exogenously administered androgens at the target organs by means of competitive inhibition. The stimulating effect of male sex hormones on androgen-dependent structures and functions is weakened or abolished by cyproterone acetate.
Excessive sebaceous gland function is decreased.
Apart from the described anti-androgen effect, cyproterone acetate also has a progestational action. The ethinylestradiol in the combination inhibits ovulation and changes the cervical mucus and the endometrium rendering them unfavourable for sperm penetration and nidation of a fertilised ovum respectively.
Indications
Androgen-dependent acne, especially those forms which are accompanied by seborrhea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgen-dependent alopecia and mild forms of hirsutism.
Oral contraception in women requiring anti-androgen therapy and for treatment of symptoms of PCOS.
Contraindications
Pregnancy; lactation; severe disturbances of liver function; recurrent cholestatic jaundice; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours; existing or previous thromboembolic processes in arteries or veins and states which predispose to such diseases (e.g. Disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases); severe migraine or cerebrovascular insufficiency; sickle-cell anaemia; existing or treated cancer of the breast or the endometrium; undiagnosed vaginal bleeding; severe diabetes with vascular changes; disturbances of lipometabolism; a history of herpes of pregnancy; otosclerosis with deterioration in previous pregnancies.
Strict medical supervision is required in patients with diabetes or a tendency to diabetes, high blood pressure, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, prophyria, tetany, chorea minor; asthma, depression, or states in which fluid retention occurs.
Reasons for immediate discontinuation of Ginette 35
Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders ( e.g. Disturbances of vision or healing), first signs of thrombophlebitis or thromboembolic symptoms (for e.g. Unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), a feeling of pain and tightness in the chest, pending operations (six weeks beforehand), immobilisationn (for instance following accidents). In all these cases there may be an increased risk of thrombosis. Further reasons for discontinuation are onset of jaundice, onset of hepatitis, itching of the whole body, significant rise in blood pressure, pregnancy.
Warnings
Ginette 35 is not for use in men and should not be used in children.
Dosage and directions for use
Before starting Ginette 35, a thorough gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out and the family case history carefully noted. In addition, disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembotic diseases (eg. Deep vein thrombosis, stroke myocardial infarction) already at a young age. Pregnancy must be excluded. If the hirsutism has only recently appeared or has lately intensified to a considerable extent, an androgen-producing tumour or an adrenal enzyme defect must be excluded in the differential diagnosis.
Initial course
The first course of Ginette 35 is started on the first day of the cycle (the first day of the menstrual bleeding is counted as day 1 of the cycle). The first tablet should be taken from the starter section of the calendar pack by selecting the appropriate tablet for that day of the week (eg. "Mon" for Monday). The tablet is swallowed whole with a little liquid. It does not matter at what time of the day the tablet is taken, but once the patient has selected a particular time, the tablet should be taken as near as possible at the same time each day. A tablet is then taken every day in the direction shown by the arrows until the pack is empty.
If the patient is using hormonal contraceptives, the doctor should decide when she should start treatment. The same applies to patients who have just had a delivery or an abortion.
The first cycle may be somewhat shorter than usual, whereas all following cycles with last four weeks.
An additional, non-hormonal method of contraception (with the exception of the rhythm and temperature methods) should be employed during the first 14 days of the first treated cycle.
Subsequent courses
After the last tablet has been taken from the first pack, tablet-taking is continued from a new pack on the very next day. The first tablet must again be taken from the starter section of the calendar pack marked with the appropriate day of the week.
Length of use
The length of use depends on the severity of the clinical picture. In general, treatment should be carried out over several months. It is recommended that Ginette 35 be taken for at least another 3 to 4 cycles after the signs have subsided. Should there be a recurrence weeks or months after discontinuation of tablet-taking treatment with Ginette 35 may be resumed.
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, abdominal cramping or bloating and dizziness may occur. Nausea, vomiting, headaches, chloasma, skin pigmentation, vaginal candidiasis, gastrointestinal irritation, mass gain and peripheral oedema.
- Alterations in hair pattern, skin reactions and anemia 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 are cigarette smokers. The incidence is also increased in women who are obese, of 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 tumours.
Malignant liver tumors have also been reported. In cases of severe upper abdominal pain, liver enlargement or intra-abdominal haemorrhage, a liver tumor should be excluded.
An increase risk or 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.
Precautions
Before hormonal contraceptives are prescribed, the patient should undergo an appropriate medical examination and 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 antiboitcs, especially aminopenicillins eg. 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 Vitamic 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 precautions.
Treatment in symptomatic and supportive.
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