ZOFORA

Piroxicam is indicated in the symptomatic treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis. Due to its tolerability profile (see sections 4.2, 4.3 and 4.4), piroxicam must not be used as first-line treatment when NSAID treatment is indicated.

The decision to prescribe a specialty containing piroxicam must be based on the assessment of all specific risks for each patient (see sections 4.3 and 4.4).

Warn patients of the possible onset of dizziness and drowsiness.

Clinical studies and epidemiological data suggest that the use of some NSAIDs (particularly when used at high doses and over a long duration) may be associated with a slight increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke) (see section 4.4).

The most commonly observed adverse effects are gastrointestinal in nature. Peptic ulcers, perforations or gastrointestinal bleeding, sometimes fatal, can occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melæna, hematemesis, exacerbation of colitis or Crohn's disease (see section 4.4) have been reported following the administration of NSAIDs. Less frequently, gastritis has been observed.

Edema, hypertension and heart failure have been reported in association with NSAID treatment.

The table below presents the adverse effects by medical discipline and by frequency. Within each frequency group, adverse effects are ranked in decreasing order of severity.

Reporting of suspected adverse effects

Reporting suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr.