Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

General
Before starting therapy, a thorough general (along with examining the urine for sugar) gynaecological examination (including an examination of the breasts and a cytological cervical smear) must be conducted for the differential diagnosis of androgenisation signs and to detect risk conditions. Pregnancy has to be ruled out due to the risk of feminising male foetuses.

Treatment has to be in combination with a suitable oestrogen or a suitable progestogen- oestrogen combination (oral contraceptive ‘pill’), which supports the therapeutic effect of Androcur 10 mg in order to ensure necessary contraceptive protection and a good cycle control. Although cyproterone acetate also has a contraceptive effect in combination with an oestrogen or a suitable cyproterone acetate-oestrogen combination contraceptive, it should not be used exclusively for contraception but only used in women who have to be treated for their androgen-dependent skin disorders (see section 4.1). Women who are being treated with CPA in combination with an oestrogen and/or with a suitable oestrogen- progestogen combination, should not take any additional oral contraceptive during this treatment. Regular intake has to be observed in order to achieve contraceptive protection.
All of the instructions have to be observed, which pertain to the oestrogen or progestin- oestrogen combination used.

Absence of the withdrawal bleed

The absence of a withdrawal bleed during the seven-day break may be an indication of pregnancy. Therefore, in such a case, combination treatment may only be resumed when pregnancy has been ruled out with certainty.

Liver

The liver function should be monitored regularly during treatment. Liver function should be checked prior to the start of treatment, at regular intervals during treatment, as well as whenever symptoms or signs suggest hepatotoxicity. If the suspicion of hepatotoxicity has been confirmed, Androcur should be discontinued. Benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed as a result of using Androcur. A liver tumour should be considered in the differential diagnosis when severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur.

Meningioma
The occurrence of meningiomas (single and multiple) has been reported in connection with the use of cyproterone acetate mainly at doses of 25 mg per day and over. The risk of meningioma increases with increasing cumulative doses of cyproterone acetate (see section 5.1). High cumulative doses can be attained by long-term use (several years) or in cases of shorter duration with high daily doses.
Patients should be monitored for meningioma in accordance with clinical practice. If a patient treated with Androcur 10 mg tablets is diagnosed with meningioma, treatment with Androcur 10 mg tablets and other medicinal products containing cyproterone acetate must be discontinued permanently (see section ”Contraindications”).
There is some evidence to indicate that the risk for meningioma may reduce following cessation of treatment with cyproterone acetate.


Carbohydrate metabolism

Increased blood-sugar levels have been observed in diabetics treated with Androcur.
Carbohydrate metabolism should, therefore, be monitored carefully in women with Diabetes mellitus before and regularly during treatment with Androcur since the required dose of oral antidiabetic drugs or insulin can change. (see section 4.3.).

Combination therapy: Procedure in the event of intermenstrual bleeding 
Treatment should not be interrupted in the event of bleeding during the week cycle.
Spotting often subsides by itself. In the event of heavy or recurrent minor bleeding, a gynaecological examination is required to exclude organic disease.

Adrenocortical function: During treatment adrenocortical function should be checked regularly, as preclinical data suggest a possible suppression due to the corticoid-like effect of Androcur with high doses (see section 5.3).

Patients with the rare hereditary galactose intolerance, lactase deficiency or glucose- galactose malabsorption should not take Androcur 10 mg.

Effects on Driving

4.7     Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.