Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
ETORICOXIB
IPS Healthcare Limited
ETORICOXIB
30 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-03-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arcoxia 30mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg of etoricoxib. Also contains lactose 1.4 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the United Kingdom:_ Blue-green, apple-shaped biconvex tablets debossed '101' on one side and 'ACX 30' 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 _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. _Acute gouty arthritis_ The recommended dose is 120 mg once daily. Etoricoxib 120 mg should be used only for the acute symptomatic period. In clinical trials for acute gouty arthritis, etoricoxib was given for Olvassa el a teljes dokumentumot