Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate
Stragen UK Ltd
G03HA01
Cyproterone acetate
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030402; GTIN: 5060098730000 5060098730017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CYPROTERONE ACETATE 50 MG TABLETS (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 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 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 tablets are and what they are used for 2. What you need to know before you take Cyproterone Acetate tablets 3. How to take Cyproterone Acetate tablets 4. Possible side effects 5. How to store Cyproterone Acetate tablets 6. Contents of the pack and other information 1. WHAT CYPROTERONE ACETATE TABLETS ARE AND WHAT THEY ARE USED FOR Cyproterone Acetate tablets are 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. Cyproterone Acetate tablets are used in men to treat prostate cancer and to control sexual desire in men who have an increased sex drive (hypersexuality) and/or sexual deviation. 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. 4. to control sexual desire in men who have an increased sex drive (hypersexuality) and/or sexual deviation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYPROTERONE ACETATE TABLETS Your doctor may ask you to sign a witnessed agreement to treatme Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyproterone Acetate 50 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg cyproterone acetate. Excipient with known effect lactose 104.447 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablets are white, round, scored on one side and embossed “50” on the reverse side 4.1 THERAPEUTIC INDICATIONS For control of libido in severe hypersexuality and/or sexual deviation in the adult male. 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 For oral administration only. Control of libido in severe hypersexuality and/or sexual deviation. _Adults and the elderly:_ The usual dose is started with 1 tablet Cyproterone Acetate 50 mg twice daily. When a satisfactory result has been achieved, one should try to maintain the therapeutic effect with the lowest possible dose. When establishing the maintenance dose or when discontinuing the preparation, it is recommended to reduce the dose gradually. The daily dose should be divided and taken after the morning and evening meals. The management of patients with prostatic cancer The maximum daily dose is 300mg _ADULTS AND THE ELDERLY:_ To suppress "flare" with initial LHRH Analogue therapy: Initially 2 tablets of Cyproterone Acetate 50 mg twice daily (200 mg) alone for 5-7 days, followed by 2 tablets of Cyproterone Acetate 50 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 w Belgenin tamamını okuyun