BREXIDOL Tablets Effervescent 20mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
PIROXICAM BETADEX
Available from:
Chiesi Limited
Dosage:
20mg Milligram
Pharmaceutical form:
Tablets Effervescent
Authorization date:
2002-08-30
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0743/010/003
Case No: 2028971
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
TRINITY-CHIESI PHARMACEUTICALS
CHEADLE ROYAL BUSINESS PARK, HIGHFIELD, SK8 3GY, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BREXIDOL 20MG EFFERVESCENT 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 19/10/2006 until 31/08/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/10/2006_
_CRN 2028971_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brexidol 20mg Effervescent tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Effervescent tablet contains 20 mg piroxicam (as betadex).
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet
Pale yellow, circular tablet with a flattened end surface and a median score line on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of osteoarthritis.
As an anti-inflammatory analgesic in the treatment of:
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arthritis and related disorders (e.g., rheumatoid arthritis, ankylosing spondylitis)
-
acute musculoskeletal disorders (e.g., bursitis, tendinitis)
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acute gout
-
pr
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