Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
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).
Aponil should be used for the shortest possible duration, as required by the clinical situation of the patients.
The side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control the symptoms. (See section 4.4).
The maximum duration of a treatment course with nimesulide is 15 days.
The recommended dose is 100 mg nimesulide two times daily after meal.
No dose reduction is necessary in these patients (see section 5.2).
Nimesulide is contraindicated in these patients (see section 4.3).
Due to the pharmacokinetic profile in adults and pharmacodynamic characteristics of nimesulide, no dosage adjustment is necessary in these patients.
Due to the pharmacokinetic profile, no dosage reduction is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min). Nimesulide is contraindicated n patients with severe renal impairment (creatinine clearance <30ml/min) (see sections 4.3 and 5.2).
Nimesulide is contraindicated in patients with hepatic impairment. (See section. 4.3 and 5.2).
Oral use.
Symptoms that occur following acute overdosage with NSAIDs are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain.
These symptoms are generally 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.
Hypertension, congestive acute renal failure, respiratory depression and coma may rarely occur. Anaphylactoid reactions have been reported after NSAID therapy and they may occur after an overdose.
There is no available information about the removal of nimesulide by hemodialysis, but, due to the increased plasma protein binding (up to 97.5%) dialysis does not appear to be useful in cases of overdose.
Induction of vomiting and administration of activated charcoal (60-100 g in adults) and/or purgation by osmotic laxatives may be useful within the first 4 hours after ingestion.
Forced diuresis, alkalinisation of urine, hemodialysis or transfusion may not be useful due to the high degree of plasma protein binding.
Renal and hepatic function should be monitored.
36 months.
Store below 25°C, in the original packaging.
PVC-Aluminum blisters of 10, 20 and 30 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
