Women who use etoricoxib must not breast feed (see sections 4.3 and 5.3).The use of etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.Patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.In clinical trials, etoricoxib was evaluated for safety in 9,295 individuals, including 6,757 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately 600 patients with OA or RA were treated for one year or longer).In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.In a clinical study for acute gouty arthritis, patients were treated with etoricoxib 120 mg once daily for eight days. Alternatively, you can find an example of a manufacturer's information leaflet in the reference section below. In the study, the incidence of discontinuations due to hypertension-related adverse events was statistically significantly higher for etoricoxib than for diclofenac. Pain relief was observed as early as four hours after initiation of treatment.In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provided significant improvements in spine pain, inflammation, stiffness and function. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.The recommended dose is 60 mg once daily. The table below contains some of the more common ones associated with etoricoxib. A significantly lower rate of overall upper GI events was observed with etoricoxib compared to diclofenac. All rights reserved. • Pregnancy and lactation (see sections 4.6 and 5.3). By blocking the effect of COX-2 enzymes, fewer prostaglandins are produced, which means pain and inflammation are eased.Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. ).Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. Blunt film coated tablets contains 30,60,90 or mg of Etoricoxib. 60 mg once daily, increased if necessary to 90 mg once daily. In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg). Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. 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).The recommended dose is 30 mg once daily. There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events. CV mortality, as well as overall mortality, was similar between the etoricoxib and diclofenac treatment groups. In this trial, only serious adverse events and discontinuations due to any adverse events were recorded.The EDGE and EDGE II studies compared the gastrointestinal tolerability of etoricoxib versusIn the pooled MEDAL Programme, 34,701 patients with OA or RA were treated for a mean duration of 17.9 months (maximum 42.3 months, median 16.3 months) with approximately 12,800 patients receiving treatment for more than 24 months. The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events. There was a decrease in pup body weight following exposure of pups to milk from dams administered etoricoxib during lactation.The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).Bottles: Keep the container tightly closed in order to protect from moisture.Blisters: Store in the original package in order to protect from moisture.Aluminium/aluminium blisters in packs containing 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets.Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.Aluminium/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets.Aluminium/aluminium blisters (unit doses) in packs of 5, 50 or 100 tablets.White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two 1-gram desiccant containers or 90 tablets and one 1-gram desiccant container.Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK