Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate
Wockhardt UK Ltd
G03HA01
Cyproterone acetate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 5012727903743
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 Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyproterone Acetate 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg cyproterone acetate. Excipient with known effect : lactose 208.894mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White oblong tablets, with a break bar on both sides, embossed “C1” on one 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 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 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: _Cyproterone Acetate is not recommended for use i Læs hele dokumentet