Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Alfuzosin hydrochloride
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
XATRAL ® SR (ZAR-TREL) _Alfuzosin (al-few-zo-sin)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Xatral SR tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine 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 XATRAL IS USED FOR Xatral belongs to a group of medicines called alpha1-receptor blockers. Xatral is used to treat a medical condition in men called Benign Prostatic Hyperplasia or BPH. BPH is a condition where the prostate gland (which is near your bladder) has become bigger making it more difficult for you to pass urine. This can lead to symptoms such as: • Weak or interrupted stream of urine • Feeling that you cannot empty your bladder completely • Delay before you start to pass urine • Needing to pass urine often, especially at night • Feeling that you must pass urine right away. Xatral works by relaxing the muscles in the prostate gland and increasing the flow of urine. Your doctor, however, may prescribe Xatral for another purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. There is no evidence that this medicine is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE XATRAL IF YOU HAVE LIVER DISEASE. DO NOT TAKE XATRAL IF YOU ARE CURRENTLY TAKING ANOTHER ALPHA- BLOCKER. These include prazosin (Minipress), terazosin (Hytrin) and tamsulosin (Flomaxtra). DO NOT TAKE XATRAL IF YOU HAVE A HISTORY OF FEELING DIZZY, TIRED OR SWEATING ON STANDING (ORTHOSTATIC HYPOTENSION). DO NOT TAKE XATRAL IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENT Prečítajte si celý dokument
PRODUCT INFORMATION May 2013 Xatral SR - alfuzosin hydrochloride xatral-sr-ccdsv10-piv8-28may13 P age 1 PRODUCT INFORMATION XATRAL ® SR NAME OF MEDICINE AUSTRALIAN APPROVED NAME Alfuzosin hydrochloride CHEMICAL STRUCTURE Molecular Formula: Molecular Weight: 425.9 Chemical Name: (+,-) N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride CAS REGISTRY NUMBER 81403-68-1 DESCRIPTION Xatral (alfuzosin hydrochloride) is an orally active quinazoline derivative. Alfuzosin hydrochloride is a white to off white crystalline powder. It is freely soluble in water. N N CH 3 O CH 3 O NH 2 N CH 3 NH O O .HCl PRODUCT INFORMATION May 2013 Xatral SR - alfuzosin hydrochloride xatral-sr-ccdsv10-piv8-28may13 P age 2 The 10MG PROLONGED RELEASE TABLETS are three layered, yellow and white biconvex tablets. Each tablet contains 10mg of alfuzosin hydrochloride as the active ingredient and ethylcellulose, hydrogenated castor oil, hypromellose, yellow iron oxide, magnesium stearate, microcrystalline cellulose, povidone, silica colloidal hydrated and mannitol as excipients. PHARMACOLOGY PHARMACODYNAMICS MECHANISM OF ACTION Alfuzosin is a selective antagonist of postsynaptic α1-adrenoreceptors. In vitro pharmacology studies have documented the antagonist properties of al Prečítajte si celý dokument