Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: CODAL-SYNTO Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus
Nimesulide is indicated for the treatment of:
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 sections 4.3 and 4.4).
Nimesulide tablets should be used for the shortest possible duration, as required by the clinical situation of the patients.
In addition, the side effects may be minimized by using the lowest 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 tablet (100mg) two times daily after meal.
No need to reduce dosage in elderly patients (see section 5.2).
Based on the pharmacokinetic behaviour of nimesulide, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min). The administration of nimesulide in patients with severe renal impairment (creatinine clearance <30ml/min) is contraindicated (see sections 4.3. and 5.2).
The use of nimesulide is contraindicated in patients with hepatic impairment (see sections 4.3 and 5.2).
Oral administration.
After overdosage of nimesulide symptoms are usually limited to somnolence, nausea, vomiting, epigastric pain. These symptoms are reversible after supportive treatment. Gastrointestinal bleeding may also occur. Hypertension, acute renal failure, dyspnoea and coma may appear very rarely. Anaphylactic reactions have been reported with therapeutic doses of nimesulide; they may appear after overdose.
Treatment is symptomatic and supportive. There is no specific antidote. Dialysis is unlikely to help the removal of the drug since it is highly bound (up to 97.5%) to plasma proteins. Induction of vomiting and administration of activated charcoal (60 to 100 g in adults) may be useful if performed during the first 4 hours after drug intake. Forced diuresis, alkalinisation of urine, hemodialysis, or hemoperfusion may not be useful because of the high proteins binding. Renal and hepatic function should be monitored closely.
36 months.
Stored below 25°C in the original packaging.
PVC-Aluminium blisters of 10 tablets in packs of 20 and 30 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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