מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Clear Pharmacy
ALFUZOSIN HYDROCHLORIDE
10 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATON FOR THE USER XATRAL® 10MG PROLONGED RELEASE TABLETS _alfuzosin hydrochloride _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Xatral 10mg Prolonged Release Tablets is and what it is used for 2. Before you take Xatral 10mg Prolonged Release Tablets 3. How to take Xatral 10mg Prolonged Release Tablets 4. Possible side effects 5. How to store Xatral 10mg Prolonged Release Tablets 6. Further information 1. WHAT XATRAL 10MG PROLONGED RELEASE TABLETS IS AND WHAT IT IS USED FOR The name of your tablet is Xatral. It contains a medicine called alfuzosin hydrochloride. This belongs to a group of medicines called alpha- blockers. Xatral 10mg Prolonged Release Tablets can be used to treat the symptoms of Benign Prostatic Hypertrophy (BPH). This is when the prostate gland enlarges (hypertrophy) but the growth is not cancerous (it is benign). It can cause problems in passing water (urine). This happens mainly in older men. The prostate gland lies underneath the bladder. It surrounds the urethra. This is the tube that takes your water to the outside of the body. If the prostate gets bigger, it presses on the urethra making it smaller. This makes it difficult to pass water. Your tablets work by relaxing the prostate gland קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral 10mg Prolonged Release Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alfuzosin hydrochloride. Excipient: hydrogenated castor oil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, prolonged release. _Product imported from the UK and Italy:_ Round biconvex three layer tablet: one white layer between two yellow layers. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the functional symptoms of benign prostatic hypertrophy. Adjunctive therapy with urethral catheterization for Acute Urinary Retention related to BPH. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Xatral 10mg prolonged release tablets are for oral administration. Xatral 10mg Prolonged Release Tablets should be swallowed whole. BPH: The recommended dose is one 10mg tablet once daily to be taken after a meal. AUR: One 10mg tablet daily after a meal to be taken from the first day of catheterisation. Paediatric population: Efficacy of Xatral has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore, Xatral is not indicated for use in paediatric population. 4.3 CONTRAINDICATIONS • Hypersensitivity to the alfuzosin or any component. • History of orthostatic hypotension. • Combination with other alpha 1 -blockers. • Hepatic insufficiency. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/09/2013_ _CRN 2128900_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all alpha1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates. In some subjects postural hypotension may develop, with or without symptoms (dizziness, fa קרא את המסמך השלם