ALLOPURINOL 300 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
ALLOPURINOL
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
INN (International Name):
ALLOPURINOL
Dosage:
300 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2010-03-18
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)
PA0577/013/002
Case No: 2031808
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDERMOTT LABORATORIES LTD T/A GERARD LABORATORIES
35/36 BALDOYLE INDUSTRIAL ESTATE, GRANGE ROAD, DUBLIN 13, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ALLOPURINOL 300 MG 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 05/12/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/12/2007_
_CRN 2031808_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allopurinol 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg allopurinol.
Excipients: Lactose monohydrate
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Round, biconvex, white tablets with breakline. ‘ALL 300’ on one side and twin triangle logo on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has
already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical r
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