Nimesil is a selective inhibitor of COX-2; nonsteroidal anti-inflammatory drug (NSAIDs).
Release form and composition
Dosage form - granules for the preparation of oral suspension: light yellow granular powder with an orange smell (2 g in paper laminated sachets, in a cardboard pack of 9, 15 or 30 sachets).
The active ingredient of the drug is nimesulide: in 1 sachet - 100 mg.
Excipients: maltodextrin, sucrose, anhydrous citric acid, ketomacrogol 1000, orange flavoring.
Indications for use
- Acute pain: toothache, bursitis, tendinitis, back pain and back pain due to injury, dislocation of the joint or sprains;
- Pain syndrome in osteoarthritis;
Nimesil is intended for symptomatic therapy, relief of pain and reduction of inflammation at the time of application, has no effect on the progression of the disease.
- Peptic ulcer and 12 duodenal ulcer in the acute phase, the presence of an ulcer in history, perforation or bleeding in the gastrointestinal tract;
- Exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease);
- Severe heart failure;
- The period after coronary artery bypass surgery;
- Severe blood clotting disorders;
- Hepatic insufficiency or any active liver disease;
- Confirmed hyperkalemia, severe renal failure (creatinine clearance <30 ml / minute);
- A history of cerebrovascular or other bleeding or diseases involving bleeding;
- Fever in infectious and inflammatory diseases;
- Complete or partial combination of asthma, recurrent nasal polyposis / paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history of);
- Fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltose deficiency;
- Hepatotoxic reactions to nimesulide in history;
- A history of hyperergic reactions, such as rhinitis, bronchospasm, urticaria, associated with the use of acetylsalicylic acid or other NSAIDs, including nimesulide;
- Alcoholism and drug addiction;
- Pregnancy and lactation;
- Children's age up to 12 years;
- Concomitant use of drugs with potential hepatotoxicity, for example, paracetamol, other analgesic or nonsteroidal anti-inflammatory drugs;
- Hypersensitivity to the components of Nimesil.
- Severe hypertension;
- Heart failure;
- Type 2 diabetes;
- Cerebrovascular diseases;
- Coronary heart disease;
- Creatinine clearance <60 ml / minute;
- Peripheral artery diseases;
- Dyslipidemia or hyperlipidemia;
- Helicobacter pylori infections;
- Ulcer lesions of the gastrointestinal tract in history;
- Severe somatic diseases;
- Elderly age;
- Prolonged previous use of NSAIDs;
- Concomitant therapy with the following drugs: oral glucocorticosteroids (for example, prednisone), antiplatelet agents (including clopidogrel and acetylsalicylic acid), anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors (including fluoxetine, citalopram, and sertralin).
Dosing and Administration
Nimesil should be taken orally after meals.
Immediately before taking the contents of the package pour in a glass and dissolve 100 ml of water.
Adults and children over 12 years old are prescribed 1 sachet 2 times a day.
The maximum duration of treatment is 15 days.
Nimesulide is partially excreted by the kidneys, so patients with impaired renal function should reduce the dose depending on the level of urination.
- Digestive system: often - nausea, vomiting and diarrhea; infrequently - flatulence, constipation and gastritis; rarely - stomatitis, dyspepsia, abdominal pain, gastrointestinal bleeding, tarry stools, ulcers and / or perforation of the stomach or duodenum; very rarely - cholestasis, jaundice, increased activity of liver enzymes, hepatitis, including fulminant;
- Hematopoietic system: rarely - hemorrhagic syndrome, anemia and eosinophilia; very rarely - pancytopenia, thrombocytopenia, thrombocytopenic purpura;
- Central nervous system: infrequently - vertigo; rarely - nervousness, fear; very rarely - drowsiness, headache, Reye's syndrome (encephalopathy);
- Cardiovascular system: infrequently - hot flashes, blood pressure lability, tachycardia, arterial hypertension;
- Respiratory system: infrequently - shortness of breath; very rarely - bronchospasm, exacerbation of bronchial asthma;
- Urinary system: rarely - urinary retention, hematuria, dysuria; very rarely - interstitial nephritis, oliguria, renal failure;
- Organ of vision: rarely - blurred vision;
- Allergic reactions: infrequently - excessive sweating, rash, itching; rarely, erythema, hypersensitivity reactions, dermatitis; very rarely - erythema multiforme, angioedema, Stevens-Johnson syndrome, urticaria, anaphylactoid reactions, toxic epidermal necrolysis;
- Other: rarely - asthenia, malaise, hyperkalemia; very rarely - hypothermia.
The decision on the appointment of Nimesil in each case should be based on an individual assessment of the balance between benefits and possible risks.
To reduce the likelihood of side effects, the drug is recommended to be used in the minimum effective dose of the minimum short course.
Nimesulide can cause fluid retention in the tissues, so patients with impaired cardiac activity and high blood pressure should use Nimesil with extreme caution.
The preparation contains sucrose (0.15-0.18 XE per 100 mg), which should be taken into account for diabetics and people on a low-calorie diet.
In the event of the onset of cold symptoms (acute respiratory viral infection), the drug should be promptly discontinued.
The effect of Nimesil on the reaction rate and ability to concentrate was not studied, therefore during treatment it is recommended to be careful when driving and performing potentially hazardous types of work.
- Lithium preparations: the concentration of lithium in the blood plasma and its toxicity increase;
- Glucocorticosteroids: increases the risk of bleeding, gastric or intestinal ulcers;
- Antiplatelet agents and selective serotonin reuptake inhibitors (for example, fluoxetine): the risk of gastrointestinal bleeding increases;
- Anticoagulants (for example, warfarin): their effect increases;
- Drugs that are substrates of CYP2C9 isoenzyme: their concentration in the blood plasma increases;
- Diuretics, antihypertensive drugs: their effect is weakened;
- Cyclosporins: their nephrotoxicity increases.
Terms and conditions of storage
Store at temperatures up to 25 ºC in a dry, dark place out of reach of children.
Shelf life - 2 years.