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Digestive SystemDyspepsiaelevated liver enzymesgross bleeding/perforationheartburnulcersgastric/duodenaldry mouthesophagitisgastritisglossitishematemesishepatitisjaundicemelenarectal bleedingeructationliver failurepancreatitis.

FELDENE has been administered concomitantly with fixed doses of gold and corticosteroidsThe existence of asteroid sparingeffect has not been adequately studied to date.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptomssee section 4.4

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascularCVthrombotic eventsincluding myocardial infarctionMIand strokewhich can be fatalBased on available datait is unclear that the risk for CV thrombotic events is similar for all NSAIDsThe relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV diseaseHoweverpatients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic eventsdue to their increased baseline rateSome observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatmentThe increase in CV thrombotic risk has been observed most consistently at higher doses.

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