Country: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate
Kent Pharma (UK) Ltd
G03HA01
Cyproterone acetate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 5015201009016
PATIENT INFORMATION LEAFLET CYPROTERONE ACETATE 50 MG & 100 MG TABLETS (cyproterone acetate) The name of this medicine is Cyproterone Acetate 50 mg and 100 mg Tablets, which will be referred to as Cyproterone Tablets throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others; it may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet please tell your doctor or pharmacist. See section 4 IN THIS LEAFLET 1. What Cyproterone Tablets are and what they are used for 2. Before you take Cyproterone Tablets 3. How to take Cyproterone Tablets 4. Possible side effects 5. How to store Cyproterone Tablets 6. Further Information 1. WHAT CYPROTERONE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in your tablets is cyproterone acetate, which belongs to a group of medicines called anti-androgens. These work by blocking the actions of male sex hormones (androgens) which are released naturally in your body. They also reduce the production of androgens. It has been shown that the growth of tumours of the prostate gland may be dependent on male hormones. Since cyproterone acetate blocks the action of androgens and reduces the amount of androgens produced by the body, it can be used to help relieve the symptoms of a tumour of the prostate gland. It can also be taken by males to control an over active sex drive. 2. BEFORE YOU TAKE CYPROTERONE TABLETS DO NOT TAKE CYPROTERONE TABLETS IF YOU: • ARE ALLERGIC (HYPERSENSITIVE) to cyproterone acetate, or any of the OTHER INGREDIENTS in Cyproterone Tablets (these are listed in section 6, Further Information) • ARE UNDER 18 YEARS OF AGE • HAVE EVER BEEN DIAGNOSED WITH A MENINGIOMA (a generally benign tumor of the tissue layer be 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