Instructions Nimesulide gel 10 mg/g tube 100 g
Composition
active ingredient: nimesulide;
1 g of gel contains nimesulide 10 mg;
Excipients: benzalkonium chloride, propylene glycol, carbomer 980, disodium edetate, sodium hydroxide, purified water.
Dosage form
Gel for external use.
Main physicochemical properties: opaque, homogeneous gel of light yellow color.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs for topical use.
ATX code M02A A26.
Pharmacological properties
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 in 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. Inhibits 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, 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.
Indication
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 tendonitis, tendosynovitis, muscle strains, heavy physical exertion on the joints.
Contraindication
Hypersensitivity to nimesulide or to other components of the drug. Dermatitis and infectious skin diseases. Epidermal damage.
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.
Do not use in the third trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
When applied topically, the drug has not been found to interact with other drugs. However, it should be taken into account that if it enters the systemic circulation, nimesulide may increase the effectiveness and toxicity of many drugs as a result of displacement from the binding sites with blood 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, 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.
Application features
Physician supervision is required when prescribing the drug to elderly patients with impaired renal or hepatic function, 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.
Use during pregnancy or breastfeeding
There are no clinical data on the use of Nimesulide during pregnancy. Even if the systemic exposure is lower compared to oral administration, it is not known whether the systemic exposure of Nimesulide achieved after topical administration 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").
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
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.
Children. Do not use in children.
Overdose
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, epigastric pain.
Treatment: dose reduction or discontinuation of the drug. Symptomatic therapy.
Adverse reactions
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 of suspected adverse reactions
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this 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 a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
30 g, 40 g or 100 g in tubes.
30 g, 40 g or 100 g in a tube, 1 tube in a cardboard pack.
Vacation category
Without a prescription.
Producer
JSC "Lubnypharm".
Location of the manufacturer and address of the place of its activity. Ukraine, 37500, Poltava region, Lubny, Barvinkova st., 16.
