Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate
Almus Pharmaceuticals Ltd
G03HA01
Cyproterone acetate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 05060057403624
PACKAGE LEAFLET: INFORMATION FOR THE USER CYPROTERONE ACETATE 100 MG TABLETS 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 any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do 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. WHAT IS IN THIS LEAFLET 1. What Cyproterone Acetate 100mg tablets is and what it is used for 2. What you need to know before you take Cyproterone Acetate 100mg tablets 3. How to take Cyproterone Acetate 100mg tablets 4. Possible side effects 5. How to store Cyproterone Acetate 100mg tablets 6. Contents of the pack and other information 1. WHAT CYPROTERONE ACETATE TABLETS IS AND WHAT IT IS USED FOR WHAT IS CYPROTERONE ACETATE TABLETS? Cyproterone Acetate tablets is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body. WHAT IS CYPROTERONE ACETATE TABLETS USED FOR? Cyproterone Acetate tablets is used in men to treat prostate cancer. THIS MEDICINE IS USED: 1. to reduce the possible worsening of the disease which may occur when you start other treatments used for prostate cancer 2. for long term treatment of prostate cancer when surgery or other medicines are not suitable 3. to treat hot flushes which may occur during treatments with other medicines used for prostate cancer or following surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYPROTERONE ACETATE TABLETS DO NOT TAKE CYPROTERONE ACETATE TABLETS: • If you have liver diseases (including previous or existing liver tumours (unless these are due to secondary cancers caused by prostate cancer), Dubin-Johnson Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyproterone Acetate 100 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg cyproterone acetate. Excipient: Lactose monohydrate. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Uncoated tablet. White, capsule shaped tablet with a breakline on one side and ‘CPA 100’ marked on the other side. 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, and (3) in the treatment of hot flushes in patients under treatment with LHRH analogues or who have had an orchidectomy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. _Adults and the elderly: _ The maximum daily dose is 300mg To suppress "flare" with initial LHRH Analogue therapy: : Initially 1 tablet of Cyproterone Acetate 100 mg twice daily (200 mg) alone for 5-7 days, followed by 1 tablet of Cyproterone acetate 100 mg twice daily (200 mg) for 3-4 weeks together with the LHRH analogue therapy in the dosage recommended by the marketing authorization holder (see SmPC of LHRH analogue). In long term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or when oral therapy is preferred: 200 - 300 mg/day. For the above two indications the dosage should be divided into 2-3 doses per day and taken after meals. In the treatment of hot flushes in patients under treatment with LHRH analogues or who have had an orchidectomy: 50 mg starting dose with upward titration if necessary within the range 50-150mg/day. For this indication the dosage should be divided into 1-3 doses per day and taken after meals _Children: _ Its use is not recommended in children and adolescents (under 18 years). Additional information on special population (applies to all indicat Aqra d-dokument sħiħ