(PDF/144.78 KB) (PDF/138.48 KB) As a result, etoricoxib reduces inflammation and pain. However, a number of measures need to be introduced into the prescribing information for these medicines, to minimise the risks associated with their use. (PDF/342.12 KB) (PDF/321.32 KB) This included information from clinical trials that compared etoricoxib with placebo (dummy treatments) and with other medicines. (PDF/295.52 KB) This means that it blocks the action of COX-2, an enzyme that is involved in the inflammation process. (PDF/144.78 KB) Etoricoxib is indicated in adults and adolescents 16 years of age and older 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 company that makes etoricoxib-containing medicines should also look into ways to investigate their safety in patients with ankylosing spondylitis in more depth, such as setting up a registry of patients taking the medicines.This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines. (PDF/112.97 KB) EMA is in the process of making appropriate changes to this website. Swallow the tablet with a drink of water. (PDF/290.74 KB) (PDF/131.97 KB) (PDF/126.47 KB) (PDF/380.06 KB) If you are taking etoricoxib for gout, you will be prescribed a short course of 120 mg strength tablets to take once-daily for up to eight days. (PDF/279.67 KB) The CHMP also reviewed information provided by the company that makes the medicines.Based on the information available, the CHMP has concluded that:However, the CHMP concluded that more information is needed on the effectiveness of lower doses of etoricoxib, such as 60 mg once a day, for the treatment of both diseases. (PDF/305.39 KB) A COX-2 inhibitor, Etoricoxib is used in the treatment of rheumatoid arthritis, psoriatic arthritis, osteoarthritis, spondylitis, chronic low back pain, and gout. (PDF/297.11 KB) (PDF/325.3 KB) (PDF/276.75 KB) Up to 90 mg per day is used after dental operations as necessary. Consequently, the French medicines regulatory agency referred this issue to the EMEA under an 'Article 6(12)' referral, so that a Europe-wide consensus could be reached on whether the new indication should be granted.As the proposed dose of Arcoxia for ankylosing spondylitis is the same as the dose already used for rheumatoid arthritis, the French medicines regulatory authority also asked the CHMP to carry out a full assessment of the benefits and risks of all etoricoxib-containing medicines in the treatment of both ankylosing spondylitis and rheumatoid arthritis under an 'Article 31' referral. The European Medicines Agency (EMEA) has completed a review of the benefits and risks of etoricoxib-containing medicines. (PDF/168.88 KB) (PDF/115.53 KB) (PDF/215.79 KB) (PDF/398.26 KB) rheumatoid arthritis (at a dose of 90 mg once a day); short-term arthritis due to gout (at a dose of 120 mg once a day). (PDF/142.89 KB) By blocking COX-2, etoricoxib reduces the amount of prostaglandins produced and reduces pain and inflammation. People with rheumatoid arthritis or ankylosing spondylitis are prescribed 60 mg once-daily, although the dose can be increased to 90 mg if it becomes necessary. Double-blind, randomized, placebo and active comparator-controlled, 12-week study conducted at 67 sites in 28 countries.