País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ETORICOXIB
Merck Sharp & Dohme Ireland (Human Health) Limited
120 Milligram
Film Coated Tablet
2009-04-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 120 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120mg of etoricoxib. Excipient: 120 mg: lactose 5.3 mg For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet/tablet. 120 mg Tablets: Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side and ‘ARCOXIA 120’ 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. For the short-term treatment of moderate pain associated with dental surgery. 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_ 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 dose is 90 mg once daily. _Ankylosing spondylitis_ The recommended dose is 90 mg once daily. For acute pain conditions, etoricoxib should be used only for the acu Leia o documento completo