ARICEPT Film Coated Tablet 5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
G & A Licensing Limited
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-07-04
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1447/010/001
Case No: 2049132
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
G & A LICENSING LTD
BALLYMURRAY, CO. ROSCOMMON, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ARICEPT 5MG FILM-COATED 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 04/07/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/07/2008_
_CRN 2049132_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ARICEPT 5mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg donepezil hydrochloride, equivalent to 4.56mg donepezil free base.
Also contains lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece:_
White, round, biconvex tablets embossed ‘ARICEPT’ on one side and ‘5’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ARICEPT Tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults/Elderly:
Treatment is initiated at
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