XATRAL Tablet Prolonged Release 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
Clear Pharmacy
Dosage:
10 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2010-10-22
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.
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 10 mg prolonged release tablets are for oral administration.
Xatral 10 mg 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 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
WARNINGS
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/03/2012_
_CRN 2113004_
_page number: 1
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