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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arcoxia 90mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90mg of etoricoxib.
Excipient:lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Hungary:_
White, apple-shaped, biconvex tablets debossed '202' on one side and 'ARCOXIA 90' 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 dose is 90 mg once daily
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