Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
McDowell Pharmaceuticals
G04CA01
ALFUZOSIN HYDROCHLORIDE
10 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists
Authorised
2009-05-08
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 the UK:_ 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 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. 4.3 CONTRAINDICATIONS Hypersensitivity to alfuzosin or any component. History of orthostatic hypotension. Combination with other alpha 1 - blockers. Hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all alpha 1 -blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates. In some subjects postural hypotension may develop, with or without symptoms (dizziness, fatigue, sweating) within a few hours following administration. These effects are usually transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. In such cases, the patient should lie down until the symptoms have completely disappeared. The patient should be warned of the possible occurrence of such events. Care should be taken when alfuzosin is administered to patients Læs hele dokumentet