Nimesil Nimesulide 100mg 30 Sachets – Made in Germany

Pharmacological group: Non-selective non-steroidal anti-inflammatory drugs (NSAIDs). ATX code M01A X17.

Composition:

Active ingredient: Nimesulide

1 single packet of 2 g of granules contains 100 mg of nimesulide. Excipients: macrogol cetostearyl ether, sucrose, maltodextrin, citric acid, orange flavor

Indications:

Treatment of acute pain, primary dysmenorrhea. Nimesil should only be used as a second-line drug. The decision to prescribe nimesulide should be made on the basis of an assessment of all risks for a particular patient.

Contraindications:

• Hypersensitivity to Nimesil, any other NSAID or to any of the excipients of the drug;
• A history of hyperergic reactions (for example, bronchospasm, rhinitis, urticaria) in connection with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• History of hepatotoxic reactions to Nimesil; Concomitant use of other substances with potential hepatotoxicity;
• Alcoholism and drug addiction; A history of gastrointestinal bleeding or perforation associated with previous use of NSAIDs;
• Peptic ulcer disease in the acute phase or a history of bleeding in the digestive tract, ulcers or perforation; Cerebrovascular bleeding or other hemorrhages, as well as diseases accompanied by bleeding;
• Severe bleeding disorders;
• Severe heart failure;
• Severe renal impairment;
• Liver dysfunction;
• Fever and / or flu-like symptoms;
• Age up to 12 years;
• Third trimester of pregnancy and lactation (see section “Use during pregnancy or lactation” and preclinical safety data);

Nimesulide can be taken through various forms, and oral form may work the best when taken for short durations. It is best to avoid it if you have any serious illnesses that are mentioned above.

Method of administration and dosage:

Dosage.

In order to reduce the incidence of adverse reactions, it is necessary to use the minimum effective dose for a short time (see Section “Peculiarities of use”). The maximum duration of the course of treatment with Nimesil is 15 days.

Adults. 1 packet (100 mg of Nimesil) 2 times a day after meals.

Elderly patients. Elderly patients do not need to reduce the daily dose (see section “Pharmacokinetics”).

Children. Medicines containing Nimesil are contraindicated in children under 12 years of age (see also the section “Contraindications”). Given the pharmacokinetic profile in adults and the pharmacodynamic characteristics of nimesulide, dose adjustment for children aged 12 to 18 years is not needed.

Impaired renal function. Given the pharmacokinetics, dose adjustment is not required in patients with mild or moderate renal impairment (creatinine clearance 30-80 ml / min), while in severe renal impairment (creatinine clearance <30 ml / min), Nimesil is contraindicated (see . section “Contraindications” and “Pharmacokinetics”).

Liver dysfunction. The use of the drug Nimesil is contraindicated in patients with impaired liver function (see section “Pharmacokinetics”). Adverse reactions can be minimized by using the drug for a short period of time necessary to control symptoms (see section “Peculiarities of use”).

Mode of application. Pour the contents of the package into a glass with still water. Stir with a spoon until an orange-scented suspension is obtained. Drink the suspension immediately after stirring.

The ability to influence the reaction rate when driving or operating machinery:

The study of the effect of drugs containing nimesulide on the ability to drive vehicles or other mechanisms has not been carried out, however, patients who experience dizziness, vertigo or drowsiness after taking nimesulide should refrain from driving vehicles or other mechanisms.

Overdose:

Symptoms of acute NSAID overdose are usually limited to the following: apathy, drowsiness, nausea, vomiting and epigastric pain, which are usually reversible with maintenance therapy. Gastrointestinal bleeding is possible. Rarely possible arterial hypertension, acute renal failure, respiratory depression and coma. There have been reports of anaphylactoid reactions when using therapeutic doses of NSAIDs, which can occur in case of overdose. In case of overdose of NSAIDs, patients should be provided with symptomatic and supportive treatment. There are no specific antidotes. There is no information on the withdrawal of nimesulide by hemodialysis, but if we take into account its high degree of binding to plasma proteins (up to 97.5%), it is unlikely that dialysis will be effective in overdose. In the presence of symptoms or after a severe overdose within 4 hours after taking the drug, patients can be prescribed vomiting and / or activated charcoal (60-100 g for adults), and / or an osmotic laxative. Forced diuresis, urinary obstruction, hemodialysis, or hemoperfusion may be ineffective due to the high degree of protein binding. Kidney and liver function should be monitored.

Shelf life: 3 years.

Storage conditions:

Store in its original packaging at a temperature not exceeding 25 °C.