Nimesulid
It reduces or eliminates pain at the site of application, including joint pain, and reduces morning stiffness and joint swelling.
Dose:
50 г, 100 г
Age limits:
From 18 years
Vacation сategory:
No prescription
For topical use
for joint and muscle pain.
Non-steroidal anti-inflammatory drugs for
topical use.
The drug is taken:
For the topical treatment of musculoskeletal conditions characterised by pain, inflammation and restricted movement, such as osteoarthritis, periarthritis, post-traumatic tendinitis, tenosynovitis, muscle strains, as well as severe physical strain on the joints.
Active substances
1 g of gel contains 10 mg of nimesulide;
active ingredient: nimesulide;
1 g of gel contains nimesulide 10 mg;
excipients: benzalkonium chloride, sodium hydroxide , propylene glycol, disodium edetate, carbomer 980, purified water.
Gel.
Main physicochemical properties: opaque, homogeneous gel of light yellow color.
: Topical agents for joint and muscle pain . Nonsteroidal anti -inflammatory drugs for topical use . Nimesulide.
ATX code M02A A26.
Pharmacodynamics. Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID), a selective inhibitor of cyclooxygenase-2. In terms of anti-inflammatory activity, nimesulide in equimolar concentration at the initial stage of inflammation is comparable to indomethacin and piroxicam. Inhibiting the synthesis of prostaglandins in the area of inflammation, nimesulide has practically no effect on the synthesis of regulatory prostaglandins in the stomach wall and kidneys. It suppresses the activity of platelet activating factor, tumor necrosis factor α, proteinases, histamine and the formation of free oxygen radicals. When applied externally, it causes a decrease or disappearance of pain at the site of application, including joint pain, and reduces morning stiffness and swelling of the joints.
Pharmacokinetics. When applied to the skin, gradual transdermal absorption of nimesulide into the subcutaneous tissue and synovial fluid of the joint is observed. The drug practically does not penetrate into the systemic bloodstream, which explains the absence of significant systemic effects.
For the local treatment of pathological conditions of the musculoskeletal system characterized by pain, inflammation and stiffness of movements, such as osteoarthritis, periarthritis, post-traumatic tendinitis, tendosynovitis, muscle strains, as well as during heavy physical exertion on the joints.
Hypersensitivity to nimesulide or to other components of the drug.
Dermatitis and infectious skin diseases. Damage to the epidermis.
Do not use in patients in whom acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis cause allergic reactions such as rhinitis, urticaria, or bronchospasm.
Third trimester of pregnancy.
When applied topically, the drug has not been found to interact with other medicinal products. However, it should be taken into account that, if it enters the systemic circulation, nimesulide may increase the effectiveness and toxicity of many medicinal products as a result of displacement from binding sites with plasma proteins and, thus, an increase in their free fraction in the blood. Based on this, the drug should be prescribed with caution simultaneously with anticoagulants, digoxin, phenytoin, lithium preparations, diuretics, antihypertensive drugs, other NSAIDs, cyclosporine, methotrexate, and oral hypoglycemic agents.
With simultaneous topical use of several nonsteroidal anti-inflammatory drugs, local irritation in the form of urticaria, skin redness, and peeling may develop.
Glucocorticoids and antirheumatic drugs (gold preparations, aminoquinolones) enhance the anti-inflammatory effect of Nimesulide.
Physician supervision is required when prescribing the drug to elderly patients with impaired renal or hepatic function, or with congestive heart failure. Patients with gastroduodenal bleeding, ulcers in the acute stage, or severe blood clotting disorders should also use the drug under physician supervision.
Do not use simultaneously with other medications for topical use.
It is recommended to apply the gel only to intact skin areas, avoiding contact with open wounds. Avoid contact with eyes and mucous membranes. Do not apply the gel under airtight dressings.
To reduce the risk of adverse reactions, it is necessary to use the minimum effective dose with the shortest duration of treatment. If the patient’s condition does not improve, he should definitely consult a doctor.
Do not use in patients with hypersensitivity to NSAIDs. If hypersensitivity reactions develop, treatment should be discontinued.
During treatment with the drug, photosensitivity reactions may develop. To reduce the risk of photosensitivity, patients should avoid UV radiation and visiting a solarium.
The medicine contains propylene glycol, which may cause skin irritation; benzalkonium chloride, which may cause irritation and skin reactions.
Pregnancy. There are no clinical data on the use of Nimesulide during pregnancy. Even if the systemic exposure is lower compared to that after oral administration, it is not known whether the systemic exposure of Nimesulide achieved after topical application could be harmful to the embryo/fetus. During the first and second trimester of pregnancy, Nimesulide should not be used unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, in particular Nimesulide, may cause cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding may occur in both the mother and the child, and labor may be prolonged. Therefore, Nimesulide is contraindicated during the last trimester of pregnancy (see section “Contraindications”).
Breastfeeding period: Do not use.
Does not affect.
For external use by adults. Before applying the gel, wash and dry the skin surface. Apply a strip of gel approximately 3 cm long to the painful areas of the body in a thin layer and rub in lightly, the frequency of application is 3–4 times a day.
The duration of the course of therapy is determined individually depending on the effectiveness of therapy and is no more than 4 weeks.
Do not use on children.
When applying the gel to large areas of skin or when exceeding the recommended doses, systemic side effects typical of nimesulide and other nonsteroidal anti-inflammatory drugs are possible: dyspepsia, headache, dizziness, pain in the epigastric region.
Treatment: dose reduction or discontinuation of the drug. Symptomatic therapy.
Skin: local skin irritation of mild to moderate severity : erythema, rash, peeling, itching, allergic reactions.
Immune system disorders: Hypersensitivity reactions, including anaphylactic reactions such as angioedema, vasomotor rhinitis, asthma and bronchospasm.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
3 years.
Store in original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Do not freeze.
50 g or 100 g in a tube; 1 tube in a pack.
Over-the-counter.
