Land: Malta
Språk: engelska
Källa: Medicines Authority
CYPROTERONE ACETATE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
G03HA01
CYPROTERONE ACETATE 50 mg
TABLET
CYPROTERONE ACETATE 50 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2006-08-23
PACKAGE LEAFLET: INFORMATION FOR THE USER CYPROTERONE ACETATE 50MG TABLETS CYPROTERONE ACETATE 100MG TABLETS CYPROTERONE ACETATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Cyproterone Tablets are and what they are used for 2. What you need to know before you take Cyproterone Tablets 3. How to take Cyproterone Tablets 4. Possible side effects 5. How to store Cyproterone Tablets 6. Contents of the pack and other information 1. WHAT CYPROTERONE TABLETS ARE AND WHAT THEY ARE USED FOR Cyproterone acetate belongs to a group of medicines called anti-androgens. These medicines work by blocking the actions of male sex hormones (androgens) and reducing the amount of male sex hormones produced by the body. Cyproterone Tablets are used either on their own or in conjunction with other hormone treatments to treat patients with certain prostate gland problems. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYPROTERONE TABLETS DO NOT TAKE CYPROTERONE TABLETS: • if you have ever been diagnosed with meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your physician if you are in doubt. • if you are allergic to cyproterone acetate or any of the other ingredients of this medicines (listed in section 6) • suffer from Läs hela dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyproterone acetate 50mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cyproterone acetate 50mg For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet For oral administration 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of patients with prostatic cancer (1) To suppress “flare” with initial LHRH analogue therapy (2) In long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred (3) In the treatment of hot flushes in patients under treatment with LHRH analogues or who have had orchidectomy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For use only in the adult male. (1) To suppress “flare” with initial LHRH analogue therapy: 300 mg/day which may be reduced to 200 mg if the higher dose is not tolerated (2) In long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred: 200-300 mg/day (3) In the treatment of hot flushes in patients under treatment with LHRH analogues or who have had orchidectomy: 2 50 mg starting dose with upward titration if necessary within the range 50-150 mg/day _Elderly men: _The dosage is dependent on the clinical indication and not the age of the patient, although greater monitoring for possible adverse effects may be necessary in the elderly. _ _ 4.3 CONTRAINDICATIONS _ _ Must not be used in patients with meningioma or a history of meningioma. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Liver disease (including Dubin-Johnson syndrome and Rotor syndrome) Malignant or wasting diseases (except for prost Läs hela dokumentet