Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
G & A Licensing Limited
10 Milligram
Tablet Prolonged Release
2008-09-26
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 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, prolonged release. _Product imported from France 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 catheterisation for Acute Urinary Retention related to BPH. 4.2 POSOLOGY AND METHOD OF 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. 4.3 CONTRAINDICATIONS Hypersensitivity to alfuzosin or any component. History of orthostatic hypotension. Combination with other - blockers. Hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE WARNINGS As with all alpha 1 -blockers in some subjects, in particular patients receiving antihypertensive medications, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are usually transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. The patient should be warned of the possible occurrence of such events. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/12/2011_ _C Прочитать полный документ