BELLA HEXAL (GINETTE-35) INDICATIONS
Bella Hexal 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.
BELLA HEXAL (GINETTE-35) INSTRUCTIONS
Before commencing with Bella Hexal, 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.
BELLA HEXAL (GINETTE-35) STORAGE
Take exactly as prescribed.
BELLA HEXAL (GINETTE-35) STORAGE
Store Bella Hexal below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bella Hexal out of the reach of children and away from pets.
Woman who use oral contraceptives should be strongly advised not to smoke. Smoking increases the risk of myocardial infarction.
Do not use if:
Oral contraceptives must not be used during known or suspected pregnancy as it may cause severe harm to the foetus.
- The onset of migraine or severe headache in a new patient.
- When there is a gradual or sudden loss of vision or hearing.
- At the first signs of thrombo-embolic disorders, e.g. pulmonary embolism, cerebrovascular insufficiency, thrombophlebitis, cerebral haemorrhage, retinal thrombosis, coronary or mesenteric thrombosis.
- 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.
- The product should be discontinued if persistent upper abdominal pain, hepatitis or jaundice develops.
- If the blood pressure rises markedly the product should be discontinued.
- Pregnancy.
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.
- 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.