Revision Year: 2012 Publisher: RAFA LABORATORIES LTD., P. O. Box 450, Jerusalem 91003 Registration number: 0132727286 Manufactured under license from Helsinn Healthcare SA, Switzerland
Treatment of acute pain.
Primary dysmenorrhoea.
Nimesulide should only be prescribed as second line treatment. The decision to prescribe nimesulide should be based on assessment of the individual patient’s overall risks (see section 4.3 and 4.4).
Mesulid should be used for the shortest possible duration, as required by the clinical situation. Moreover, undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms (see section 4.4).
The maximum duration of a treatment course with nimesulide is 15 days.
One 100mg caplet twice a day after meals.
In elderly patients there is no need to reduce the daily dosage (see section 5.2).
Mesulid is contraindicated in these patients (see also section 4.3).
On the basis of the kinetic profile in adults and on the pharmacodynamic characteristics of nimesulide, no dosage adjustment in these patients is necessary.
On the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min), while Mesulid is contraindicated in case of severe renal impairement (creatinine clearance<30 ml/min) (see sections 4.3 and 5.2).
The use of Mesulid is contraindicated in patients with hepatic impairment (see sections 4.3 and 5.2).
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of nimesulide by haemodialysis, but based on its high degree of plasma protein binding (up to 97.5%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal (60 to 100 g in adults) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, haemodialysis, or haemoperfusion may not be useful due to high protein binding. Renal and hepatic function should be monitored.
Store below 25°C.
Blister packs (10, 20, 30 caplets).
Not applicable.
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