Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate
Viatris UK Healthcare Ltd
G03HA01
Cyproterone acetate
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402
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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyproterone Acetate Tablets 50 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of Cyproterone acetate. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For control of libido in severe hypersexuality and/or sexual deviation in the adult male. 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. Control of libido in severe hypersexuality and/or sexual deviation. _Adults and the elderly_ The usual dose is 1 tablet twice daily. The daily dose should be divided and taken after the morning and evening meals. _Children (under 18 years old)_ Not recommended. The management of patients with prostatic cancer _Adults and the elderly_ _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. _In long term palliative treatment where LHRH analogues or surgery are _ _contraindicated, not tolerated, or when oral therapy is preferred _ 200 – 300 mg/day. _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 – 150 mg/day. _Children _ Not recommended. 4.3 CONTRAINDICATIONS Cyproterone acetate is contraindicated for use in patients with liver diseases; malignant tumours (other than prostatic cancer); wasting diseases (because of transient catabolic action); a history of or existing thrombosis or embolism; severe diabetes with vascular changes; sickle-cell anaemia; severe c Read the complete document