Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETORICOXIB
G & A Licensing Limited
90 Milligram
Film Coated Tablet
2010-06-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 90 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90mg of etoricoxib. Excipients: Contains lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) _Product imported from Italy_ White, apple-shaped, biconvex tablet “debossed “202” on one side and plain on the other side. 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 ARCOXIA is administered orally and may be taken with or without food. The onset of the effect of the medicinal product may be faster when ARCOXIA is administered without food. This should be considered when rapid symptomatic relief is needed. 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_ The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. _Rheumatoid arthritis_ The recommended Read the complete document