DICLAC 150 MG PROLONGED-RELEASE 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:
DICLOFENAC SODIUM
Available from:
Rowex Ltd
Dosage:
150 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2000-03-20
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0711/009/004
Case No: 2025679
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
DICLAC 150 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 04/10/2006 until 26/05/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/10/2006_
_CRN 2025679_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclac 150 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150mg Diclofenac Sodium.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Round, flat, two - layered pink and white coloured, prolonged release tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of osteoarthritis
Relief of all grades of pain and inflammation in a wide range of conditions, including:
(i)
arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, psoriatic arthropathy;
(ii)
acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder)
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