ACOXXEL Film Coated Tablet 30 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
ETORICOXIB
Available from:
Merck Sharp & Dohme Ireland (Human Health) Limited
Dosage:
30 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-09-16
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Acoxxel 30mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg of etoricoxib.
Excipient:
30 mg: lactose 1.4 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
30 mg Tablets: Blue-green, apple-shaped biconvex tablets marked ‘ACX 30’ on one side and ‘101’ on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and
signs of inflammation associated with acute gouty arthritis.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's
overall risks (see sections 4.3, 4.4).
4.2 Posology and method of administration
Posology
As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration
possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to
therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Osteoarthritis
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