XATRAL 10 Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
Chemilines Healthcare (Ireland) Limited
ATC code:
G04CA01
INN (International Name):
ALFUZOSIN HYDROCHLORIDE
Dosage:
10 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Alpha-adrenoreceptor antagonists
Authorization status:
Authorised
Authorization date:
2013-08-02
Summary of Product characteristics
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 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 -
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 d
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