BENPROTAN 5 Milligram Tablet Prolonged Release
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
23-04-2024
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Virkt innihaldsefni:
ALFUZOSIN HYDROCHLORIDE
Fáanlegur frá:
Clonmel Healthcare Ltd
INN (Alþjóðlegt nafn):
ALFUZOSIN HYDROCHLORIDE
Skammtar:
5 Milligram
Lyfjaform:
Tablet Prolonged Release
Leyfisstaða:
Withdrawn
Leyfisdagur:
2007-03-20
Vara einkenni
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0126/160/001
Case No: 2014768
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
CLONMEL HEALTHCARE LIMITED
WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BENPROTAN 5 MG PROLONGED RELEASE TABLETS
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 15/12/2006 until 14/12/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/12/2006_
_CRN 2014768_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benprotan 5 mg Prolonged Release Tablets
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
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