Pays: Malte
Langue: anglais
Source: Medicines Authority
CYPROTERONE ACETATE
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
G03HA01
CYPROTERONE ACETATE 100 mg
TABLET
CYPROTERONE ACETATE 100 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2019-11-13
BP20089 PACKAGE LEAFLET: INFORMATION FOR THE USER ANDROCUR ® 100 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 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 Androcur is and what it is used for 2. What you need to know before you take Androcur 3. How to take Androcur 4. Possible side effects 5. How to store Androcur 6. Contents of the pack and other information 1. WHAT ANDROCUR IS AND WHAT IT IS USED FOR Androcur 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. Androcur is used in men to treat prostate cancer where surgery is not an option. Androcur is also used to control sexual desire in men who have a sexual deviation. You should only take Androcur, if your doctor considers that other interventions are inappropriate. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANDROCUR DO NOT TAKE ANDROCUR _FOR CONTROL OF SEXUAL DRIVE _ If you have: liver diseases (including previous or existing liver tumours), Dubin-Johnson or Rotor syndromes ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt wasting diseases (diseases involving an unintended loss of weight or muscle) severe depression which you have had for many months blood clots (thrombosis or embolism) or have ever had these severe diabetes that affects your blood circulation Lire le document complet
BP20089: BEC18296, BEC18319 Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Androcur 100 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg cyproterone acetate. Excipient with known effect Each tablet contains 184 mg lactose (as monohydrate), please see section 4.4 for further information. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablets. White to faintly yellowish capsule-shaped tablet imprinted on the upper surface with ‘LA’ on both sides of a score and with an equilateral hexagon on the lower surface. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Antiandrogen treatment in inoperable carcinoma of the prostate • Reduction of drive in sexual deviations in men, cyproterone acetate 100 mg can be used when other interventions are considered inappropriate 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _Posology 1 tablet twice to three times daily (= 200 – 300 mg). The maximum daily dose is 300mg. The tablets are to be taken with some liquid after meals. The therapy should not be discontinued nor the dose reduced once improvement or remission occurs. _To reduce the initial increase of androgens in combination therapy with GnRH agonists: _ Initially 1 tablet Androcur 100 twice daily (= 200 mg) alone for 5 – 7 days, followed by 1 tablet Androcur 100 twice daily (= 200 mg) for 3 – 4 weeks together with a GnRH agonist in the dosage recommended by the marketing authorisation holder (see prescribing information of GnRH agonist). _To treat hot flushes in patients under combination therapy with GnRH analogues or who have _ _had orchiectomy:_ ½ - 1½ tablets per day (50 – 150 mg) with upward titration up to 1 tablet three times daily (300 mg) if necessary. _Reduction of drive in sexual deviation: _ BP20089: BEC18296, BEC18319 Generally, treatment is started with 50 mg twice daily. It may be necessary to increase the dose to 100 mg twice daily, or even 100 mg three times daily fo Lire le document complet