XATRAL 10 Milligram Tablet Prolonged Release
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
27-05-2024
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Viambatanisho vya kazi:
ALFUZOSIN HYDROCHLORIDE
Inapatikana kutoka:
McDowell Pharmaceuticals
ATC kanuni:
G04CA01
INN (Jina la Kimataifa):
ALFUZOSIN HYDROCHLORIDE
Kipimo:
10 Milligram
Dawa fomu:
Tablet Prolonged Release
Dawa ya aina:
Product subject to prescription which may be renewed (B)
Eneo la matibabu:
Alpha-adrenoreceptor antagonists
Idhini hali ya:
Authorised
Idhini ya tarehe:
2009-05-08
Tabia za bidhaa
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
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