Nimesulide is a prescription drug. The harmonized indications in the EU are:
- acute pain;
- primary dysmenorrhoea.
Nimesulide should be used as second line treatment. The decision to prescribe nimesulide should be based on assessment of the individual patient's overall risks.
In 2005 EMEA recommended that the prescription of NSAIDs for the treatment of painful conditions should always be based on their overall safety profiles (for instance potential gastro-intestinal concerns) as set out in the product information, and individual risk factors. However, all patients should take the lowest effective dose of NSAIDs for the shortest time necessary to control symptoms (EMEA 2005).
The approved oral dose of Nimesulide is 100 mg twice daily, for no more than 15 days.
Nimesulide is contraindicated in children below 12 years and in patients suffering from liver problems. A specific warning is for patients who develop fever and /or flu-like symptoms, which should discontinue treatment.
Original Nimesulide is commercially available in Europe as tablets (100 mg), granules for oral suspension (100 mg), suppositories (200 mg) and gel (3%).