Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Alfuzosin hydrochloride
Sanofi-Aventis Ireland Limited T/A SANOFI
G04CA; G04CA01
Alfuzosin hydrochloride
10mg milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; alfuzosin
Marketed
2000-05-26
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. 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. 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 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. Pronounced drop in blood pressure has been reported in post-marketing surveillance in patients with pre-existing risk factors (such as underlying cardiac diseases and/or concomitant treatment with anti-hypertensive medication). Read the complete document
Health Products Regulatory Authority 02 March 2020 CRN009N8S Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral 10mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alfuzosin hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, prolonged release. 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. 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. Pronounced drop in blood pressure has been reported in post-marketing surveillance in patients with pre-existing risk fa Read the complete document