Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
cyproterone acetate
Amneal Pharma Australia Pty Ltd
cyproterone acetate
Registered
_Cyproterone AN tablets – Consumer Medicine Information _ _ _ _Cyproterone AN CMI v2 _ _ _ _ _ _Page 1 _ CYPROTERONE AN TABLETS (100 MG TABLETS) _Cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CYPROTERONE AN. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking CYPROTERONE AN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CYPROTERONE AN IS USED FOR CYPROTERONE AN is an antiandrogenic hormone medication. Androgens such as testosterone are natural male sex hormones. In men, androgens may help cancer cells to grow in some types of prostate cancer. By blocking these hormones, CYPROTERONE AN may slow or stop the growth of cancer. CYPROTERONE AN may also be used in combination with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CYPROTERONE AN _WHEN YOU MUST NOT TAKE _ _IT _ _ _ Do not take CYPROTERONE AN if you have an allergy to: • cyproterone acetate, the active ingredient in CYPROTERONE AN • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE CYPROTERONE AN IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • liver disease, p Pročitajte cijeli dokument
_ _ _ _ _ _ _ _ _ Amneal Pharma Australia Pty Ltd _ Cyproterone AN 100 mg PI v3 Page 1 CYPROTERONE AN 100 MG _ _ _(CYPROTERONE ACETATE TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of this medicine is Cyproterone acetate CHEMICAL NAME: 6-chloro-17 -hydroxy-1 α, 2 α-methylene-pregna-4,6- diene-3,20- dione acetate. MOLECULAR FORMULA : C 24 H 29 ClO 4 . MOLECULAR WEIGHT_: _ 416.95. _CAS Number: _ 427-51-0. DESCRIPTION Cyproterone acetate is a white to pale yellow crystalline powder. Cyproterone acetate is very soluble in chloroform and dioxane, freely soluble in acetone and benzene, soluble in ethanol, methanol and ethyl acetate, sparingly soluble in hexane, and almost insoluble in water. _ _ _ _ _ _ _ _ _ Amneal Pharma Australia Pty Ltd _ Cyproterone AN 100 mg PI v3 Page 2 Each Cyproterone AN 100 mg tablet contains cyproterone acetate 100 mg. Excipients: lactose monohydrate, Povidone, microcrystalline cellulose, croscarmellose sodium and magnesium stearate, Actions: Anti-androgenic hormone preparation. PHARMACOLOGY Cyproterone acetate inhibits competitively the effect of androgens at androgen dependent target organs, e.g. it shields the prostate from the effect of androgens originating from the gonads and/or the adrenal cortex. Prostatic carcinoma and its metastases are in general androgen dependent, cyproterone acetate therefore exerts a direct anti-androgenic action on the tumour and its metastases. Cyproterone acetate in addition has a progestogenic action exerting a negative feedback effect centrally on the hypothalamic receptors, so leading to a reduction in gonadotropin release, and hence to diminished production of testicular androgens. Treatment with cyproterone acetate in men results in a reduction of sexual drive and potency and inhibition of gonadal function. These changes are reversible following discontinuation of the therapy. The antigonadotropic effect of cyproterone acetate is also exerted when the substance is combined with luteinising hormone releasing hormone (LHRH) agonists. Pročitajte cijeli dokument