Expiration date: 01/2025
Release form and composition:
Gel for external use 1% transparent, light yellow or yellow color, free of foreign particles.
Auxiliary substance: N-methyl-2-pyrrolidone, propylene glycol, macrogol, isopropanol, carbomer 940, butylhydroxyanisole, thimerosal, potassium phosphate, water, flavor.20 g - tubes aluminum (1) - packs of cardboard.
Pharmacological action:NSAIDs for external use. It has a local analgesic and anti-inflammatory effect.Nimesulide is a selective competitive reversible COX-2 (endoperoxide-prostaglandin-H2-synthetase) inhibitor. Reduces the concentration of short-lived prostaglandin H2, a substrate for kinin-stimulated synthesis of prostanglandin E2, in the focus of inflammation and in the ascending pathways of pain impulses in the spinal cord.Reducing the concentration of prostanglandin E2 (a mediator of inflammation and pain) reduces the activation of prostanoid EP-type receptors, which is manifested by analgesic and anti-inflammatory effects.When applied topically, it reduces or disappears pain at the site of application of the gel, including joint pain at rest and when moving, reduces morning stiffness and swelling of the joints. Helps to increase the volume of movement.
Pharmacokinetics:Data on the pharmacokinetics of the drug are not provided.
Indications:- joint syndrome in rheumatism and gout exacerbation - rheumatoid arthritis - psoriatic arthritis - ankylosing spondylarthritis - osteoarthritis - osteochondrosis with radicular syndrome - sciatica - inflammation of ligaments, tendons, bursitis - sciatica - lumbago - myalgia of rheumatic and non - rheumatic origin-post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and torn ligaments, bruises).
Dosage regimen:Before applying the gel, you should wash and dry the surface of the skin. Apply a strip of gel approximately 3 cm long to the area of maximum soreness 3-4 times/day in a uniform thin layer, without rubbing.The amount of gel and the frequency of its application (no more than 4 times/day) varies depending on the size of the treated skin area and the patient's reaction.The maximum dose is 5 mg/kg/day (30 g/day). The duration of use of the drug is no more than 10 days without consulting a doctor.
Side effect:When applying the gel to large areas of the skin, systemic adverse reactions may develop.From the digestive system: heartburn, nausea, vomiting, pain in the stomach, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract, increased activity of liver transaminases.From the Central nervous system: headache, dizziness.From the hematopoietic system: thrombocytopenia, leukopenia, anemia, agranulocytosis, prolonged bleeding time.From the urinary system: fluid retention, hematuria.Allergic reactions: skin rash, anaphylactic shock.Local reactions: itching, hives, peeling, transient skin discoloration (does not require discontinuation of the drug).If any adverse reactions occur, stop using the drug and consult your doctor.
Contraindications:- pregnancy - lactation (breast-feeding)- dermatoses, damage to the epidermis, skin infections in the area of application - hypersensitivity to nimesulide and other components of the drug.With caution, the drug should be prescribed for erosive and ulcerative lesions of the gastrointestinal tract, liver failure, renal failure (Cct30 ml/min), congestive heart failure, arterial hypertension, aspirin asthma, type 2 diabetes (insulin-dependent), in children under 12 years of age.
Pregnancy and lactation: Nise is contraindicated for use during pregnancy and lactation.
Special instruction:The drug should be applied only to undamaged areas of the skin, avoiding contact with open wounds. Avoid contact with the gel in the eyes and other mucous membranes, as well as use with airtight bandages.After applying the gel, wash your hands with soap and water. The tube should be tightly closed after using the gel.
Overdose: Currently, no cases of overdose of the drug Nise have been reported.If you apply more than 50 g of gel to large areas of the skin, you may develop an overdose (systemic adverse reactions).There is no specific antidote. You should immediately consult a doctor.
Drug interaction:Possible manifestations of pharmacokinetic interaction (due to the competition of drugs for binding to proteins) with simultaneous ingestion of the drug Nise with digoxin, phenytoin, lithium preparations, diuretics, antihypertensive drugs, other NSAIDs, anticoagulants, cyclosporine, methotrexate, oral hypoglycemic agents.
Storage conditions and terms: list B. the Drug should be stored out of the reach of children at a temperature not exceeding 25°C and should not be frozen. Shelf life - 2 years.
