Expiration date: 05/2026
Composition and form of issue:
Granules for suspension preparation for oral administration 1 pack contains:
nimesulide 100 mg
excipients: sucrose, orange flavor citric acid maltodextrin cetomacrogol 1000
in bags of 2 grams in a box of 9, 15 or 30 bags.
Description of dosage form:
Light yellow granular powder with orange flavor.
Characteristic:
NSAIDs from the sulfonanilide group.
Pharmacokinetics:
After ingestion is rapidly absorbed from the gastrointestinal tract. Cmax is reached after 1-2 h T1/2 — 2-3 hours, duration — 6 hours write mainly with urine (98% of the dose was excreted within 24 h).
Description of the pharmacological action:
Selectively inhibits cyclooxygenase II, inhibits the synthesis of PG in the inflammation focus. It has a less pronounced inhibitory effect on cyclooxygenase I (rarely causes side effects associated with inhibition of PG synthesis in healthy tissues).
Indications:
Rheumatism, Bekhterev's disease (spondyloarthritis ankylosing), osteoarthritis, synovitis, tendinitis, tendovaginitis, bursitis, pain syndrome (algodismenorrhea, post-traumatic pain), fever syndrome in infectious and inflammatory diseases, pain in the spine, neuralgia, myalgia, traumatic inflammation of soft tissues and musculoskeletal system.
Contraindications:
Hypersensitivity (including to any component of the drug, acetylsalicylic acid or other NSAIDs), severe bleeding in the digestive tract, ulcers disease stomach and duodenal ulcer, severe renal dysfunction, pregnancy, breastfeeding.
Application for pregnancy and breastfeeding:
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Side effect:
Nimesil is usually well tolerated, but at the beginning of the course of treatment or at high dosages, the following disorders may be observed.
From the Central nervous system: rarely-dizziness, headache, drowsiness, encephalopathy (Reye syndrome), fear, nervousness, nightmares.
If you reduce the dose and subsequent more careful about increasing the dose, these phenomena subside spontaneously.
On the part of the digestive tract: rarely — diarrhoea, nausea, vomiting, sometimes constipation, flatulence, gastritis rarely — dyspepsia, tarry stools, gastrointestinal bleeding, ulcers and perforation of the stomach.
From the respiratory system: rarely-shortness of breath, bronchospasm.
From the cardiovascular system: rarely-tachycardia, hypertension, hemorrhage, tides.
From the sensory organs: very rarely — impaired vision.
From the skin: hyperergic reactions (itching, redness of the skin, skin rash), sweating rarely — erythema, dermatitis is very rare — urticaria, swelling of the face, Stevens-Johnson syndrome, angioedema.
From the liver and biliary system: rarely — hepatitis, jaundice, cholestasis, may increase liver enzymes.
From the kidneys and urinary system: rarely — dysuria, hematuria, delayed urination is very rare — renal failure, oliguria, interstitial nephritis.
From the hematopoietic system: rarely-anemia, eosinophilia very rarely-thrombocytopenia, pancytopenia, purpura.
Drug interaction:
Nimesulide increases the effect of drugs that reduce blood clotting can lower the effect of furosemide. Nimesulide may increase the possibility of side effects when taking methotrexate. Increases the level of lithium in plasma. Due to the high degree of nimesulide binding to plasma proteins patients simultaneously treated with hydantoin and sulfonamides should be under the supervision of a physician, passing the examination after a short period of time. Nimesulide can enhance the effect of cyclosporine on the kidneys.
Method of application and doses:
Inside, after eating, adults, 100 mg 2 times a day (one sachet is poured into a beaker and dissolved in water). It is possible to temporarily increase the dose depending on the severity of symptoms and susceptibility of the patient. Elderly patients need dose adjustment.
Overdose:
Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding may occur.
Treatment: symptomatic and supportive therapy. There is no specific antidote.
Precautionary measures:
With caution is prescribed to patients of advanced age (especially if they have age-related weakness), in cardiovascular diseases, tendency to bleeding, disorders of the upper digestive tract, renal impairment (reduce dosage), on the background of treatment with anticoagulants and antiplatelet agents.
With extreme caution-patients with high blood PRESSURE and cardiac disorders.
Concurrent use of hydantoin and sulfonamides necessitates regular medical supervision. Be wary of during the drivers of vehicles and people skills relate to the high concentration of attention.
When appearing on the background of therapy of any visual impairment treatment should be discontinued.
Patients, taking along with Nimesilom medicines with a negative effect on the gastrointestinal tract, should be regularly monitored.
The composition of the drug includes sucrose, which should be taken into account in the treatment of patients with diabetes and persons observing a low-calorie diet.
