XATGER Tablet Prolonged Release 5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
Dosage:
5 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2006-10-13
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatger 5mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg alfuzosin hydrochloride
Excipients:
Each tablets contains 52.3mg of lactose as lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White, round, bevelled-edge, uncoated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe functional symptoms of benign prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The prolonged-release tablet should be swallowed whole with a sufficient amount of fluid.
The tablet can be taken with or without food.
_ADULTS_
1 prolonged-release tablet 5 mg twice daily (morning and evening), not exceeding 10 mg/day. The first dose should be
taken at bedtime.
_ELDERLY (OVER 65 YEARS)_
Pharmacokinetic and clinical safety data demonstrate that no dose reduction is necessary for elderly patients. A lower
initial dose may, however, be considered for patients with increased risk of undesirable effects.
_REDUCED RENAL FUNCTION_
Mild to moderate renal insufficiency
1 prolonged-release tablet 5 mg daily. The first dose should be taken at bedtime. The dose may be adjusted according to
clinical response.
Severe renal insufficiency
Xatger 5 mg should not be given to patients with severely impaired renal function (creatinine clearance < 30 ml/min) as
there are no clinical safety data available for this patient group (see section 4.4).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/08/2011_
_CRN 2104671_
_page number: 1_
_Hepatic insufficiency_
Xatger given as 5mg prolonged release tablets is contraindicat
Read the complete document
