Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate
Bayer Plc
G03HA01
Cyproterone acetate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 5016703003014 5010605333163
V012_0 1 PACKAGE LEAFLET: INFORMATION FOR THE USER CYPROSTAT® 100 MG TABLET 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 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 Cyprostat is and what it is used for 2. What you need to know before you take Cyprostat 3. How to take Cyprostat 4. Possible side effects 5. How to store Cyprostat 6. Contents of the pack and other information 1. WHAT CYPROSTAT IS AND WHAT IT IS USED FOR WHAT IS CYPROSTAT? Cyprostat 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 CYPROSTAT USED FOR? Cyprostat 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 CYPROSTAT DO NOT TAKE CYPROSTAT: If you have liver diseases (including previous or existing liver tumours (unless these are due to secondary cancers caused by prostate cancer), Dubin-Johnson Syndrome or Rotor Syndrome) If you have any type of cancer (other than cancer of the prostate gland) If you have ever been diagnosed with a meningioma (a generally benign tumour of the tissue l Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyprostat® 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each white, scored tablet contains 100 mg cyproterone acetate. Excipient with known effect lactose 184.3 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oblong tablet, on one side scored and embossed with “LA” on both sides of the score, and embossed with a regular hexagon on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 orchidectomy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _Adults _ The maximum daily dose is 300 mg. For long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred the dosage is 200- 300 mg/day. Dosage for suppression of "flare" with initial LHRH analogue therapy: Initially 1 tablet of Cyprostat 100 mg twice daily (200 mg) alone for 5 - 7 days, followed by 1 tablet of Cyprostat 100 mg twice daily (200 mg) for 3 – 4 weeks together with the LHRH analogue therapy in the dosage recommended by the marketing authorisation holder (see SmPC of LHRH analogue). For the above two indications the dosage should be divided into 2 - 3 doses per day and taken with some liquid after meals. For the treatment of hot flushes in patients under treatment with LHRH analogues or who have had orchidectomy a 50 mg starting dose, with upward titration if necessary within the range 50-150 mg/day, is recommended. For this indication the dosage should be divided into 1 - 3 doses per day and taken with some liquid after meals. ADDITIONAL INFORMATION ON SPECIAL POPULATIONS _Paediatric population:_ Lestu allt skjalið