Instruction for use
Active ingredient: 1 single-dose pack of 2 g granules contains nimesulide 100 mg;
excipients: macrogol cetostearyl ether, sucrose, maltodextrin, anhydrous citric acid, orange flavoring.
Medicinal form. Granules for preparing a suspension for oral administration.
Pharmacotherapeutic group. Non steroidal anti-inflammatory drugs. PBX code M 01A X 17.
Indication. Treatment of acute pain. Symptomatic treatment of osteoarthritis with pain syndrome. Primary dysmenorrhea.
Contraindication. Known hypersensitivity to nimesulide or to any component of the drug. Hyperergic reactions that occurred in the past (bronchospasm, rhinitis, urticaria) due to the use of acetyl salicylic acid or other non-steroidal anti-inflammatory drugs. Hepatotoxic reactions to nimesulide that occurred in the past. Gastric ulcer or duodenal ulcer in the exacerbation phase, relapsing ulcers or bleeding in the digestive tract, cerebrovascular bleeding or other lesions that are accompanied by bleeding. Severe disorders of blood coagulation. Severe heart failure. Severe renal failure. Hepatic failure. Children under 12 years of age. Third trimester of pregnancy and breastfeeding period. Increased body temperature and flu-like symptoms, suspected of acute surgical pathology. Do not use at the same time as other drugs that can potentially cause hepatotoxic reactions. Alcoholism and drug addiction.
Method of administration and dose. Nemesil ® is prescribed after careful evaluation of the risk / benefit ratio. Apply the minimum effective dose within the shortest time to reduce side effects. The maximum duration of the treatment course is Nimesil - 15 days. Adults: and the elderly: 1 single-dose pack containing 100 mg nimesulide, 2 times a day (daily dose 200 mg). Children aged 12 years: no dosage correction is required. Patients with renal impairment: No dose adjustment is required for patients with mild or moderate renal insufficiency (clearance of creatinine 30-80 ml / min). The content of single-dose packets is poured into a glass, dissolved in water and taken internally after eating.
Overdose.Symptoms of acute overdose with non steroidal anti-inflammatory drugs (NSAIDs) are usually limited to: apathy, drowsiness, nausea, vomiting, pain in the epigastric area. These symptoms are usually reversible with supportive therapy. Possible occurrence of gastrointestinal bleeding, arterial hypertension, acute renal failure, respiratory depression, coma, however, such phenomena are rare. There were reports of anaphylactoid reactions in the use of therapeutic doses of NSAIDs and in case of overdose. There is no specific antidote. Treatment of overdose is symptomatic and supportive. There is no data on the withdrawal of nimesulide by hemodialysis, but if we take into account the high degree of binding of nimesulide to plasma proteins (up to 97.5%), then dialysis is unlikely to be effective. In the presence of symptoms of overdose or after a large dose of the drug for 4 hours. After receiving it, patients may be prescribed: artificial vomiting and / or activated charcoal (60-100 g for adults) and / or receiving osmotic laxatives. Forced diuresis, increased alkalinity of urine, hemodialysis and hemopoietic perfusion may be ineffective due to the high degree of binding of nimesulide to plasma proteins. It is necessary to control the function of the kidneys and liver.
Use during pregnancy or breastfeeding. Nimesulide should not be used during the first and second trimesters of pregnancy without urgent need. In the case of women who are planning a pregnancy or during the first and second trimesters of pregnancy, the lowest dose and the shortest duration of treatment should be used. In the third trimester of pregnancy and during breastfeeding, the use of nimesulide is contraindicated.
The use of nimesulide in children under 12 years of age is contraindicated.
Pharmacodynamics. Stomp is not a steroid anti-inflammatory drug of the methanesulfonanilide group, which exhibits anti-inflammatory, analgesic and antipyretic effects. The therapeutic effect of Nimesil® is due to its interaction with the arachidonic acid cascade and reduces biosynthesis of prostaglandins by inhibition of cyclooxygenase. Due to the selective action of Nimsil® on cyclooxygenase-2, synthesis of cytosolic prostaglandins in the stomach is not disturbed, which is very important for the incidence of side effects. In addition, Homecil® reduces the production of super-peroxide anions that are induced by neutrophil granulocytes and inhibits the formation of free radicals that occur during the inflammatory process.
Pharmacokinetics. In the human body, Nimesul® is well absorbed in oral administration, reaching its maximum plasma concentration in 2-3 hours. Up to 97.5% of nimesulide is bound to plasma proteins.
Nimesulide is actively metabolised in the liver with the participation of CYP2C9, the cytochrome P400 isoenzymes. The main metabolite is a paragidroxid derivative, which also has pharmacological activity. The half-life is 3.2 to 6 hours. Nimesulide is excreted in the body with urine - about 50% of the dose taken. About 29% of the administered dose is excreted in the feces in the metabolized form. Only 1-3% is excreted unchanged from the body. The pharmacokinetic profile of the elderly does not change.
Basic physical and chemical properties: light yellow, grainy powder with orange smell; after partial dissolution, the color of the solution is white or light yellow.
Expiration date. 3 years. Do not use the product after the expiration date indicated on the packaging!
Storage conditions. Special storage conditions are not required. Keep the product out of the reach of children!
Packaging. One-dose package of 2 g granules; by 9, or by 15, or by 30 packs in a cardboard box.