Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Rowex Ltd
5 Milligram
Tablet Prolonged Release
2006-04-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/083/001 Case No: 2048650 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ALFU 5 MG PROLONGED RELEASE TABLET The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 21/05/2008 until 27/04/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/05/2008_ _CRN 2048650_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alfu 5mg prolonged release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg alfuzosin hydrochloride Excipients: Each tablet contains 55 mg 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. _A Read the complete document