COMPOSITION:

active substance: nimesulide;

1 g of gel contains nimesulide10 mg;

Excipients:

Benzyl alcohol, Propylene Glycol, Carbomer 940, Disodium Edetate, Sodium Hydroxide, Fragrance Cologne Comp 530, purified water.

INDICATIONS:

Topical treatment of pathological conditions of the musculoskeletal system, characterized by pain, inflammation and stiffness of movement, such as osteoarthritis, periarthritis, post-traumatic tendinitis, tendosynovitis, muscle sprain, severe physical load on joints.

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DOSAGE:

The drug is applied externally in adults. Before applying the gel, it is recommended to wash and dry the skin surface. Apply approximately 3 cm of gel on the painful areas in a thin layer and rub it in lightly; the frequency of application is 3-4 times per day. The duration of therapy is determined individually depending on its efficacy, and is no more than 4 weeks.

ADVERSE REACTIONS:

Local mild to moderate skin irritation:

erythema, rash, desquamation, allergic reactions. Rarely, anaphylactic reactions may occur in sensitive patients: Quincke’s edema, vasomotor rhinitis, asthma, bronchospasm.

Drug interactions:

When cutaneous application of the drug, no interaction with other medical products has been revealed. However, it should be taken into account that if nimesulide reaches the systemic circulation, it may induce the effect and toxicity of many medical agents by displacing them from binding to plasma proteins and thus increasing their free fraction in blood. Therefore, caution should be exercised when prescribing the drug concomitantly with anticoagulants, digoxin, phenytoin, lithium drugs, diuretics, antihypertensive drugs, other NSAIDs, cyclosporine, methotrexate, oral hypoglycemic drugs.

When concomitant application of several nonsteroidal anti-inflammatory drugs, local irritation is possible, such as urticaria, skin redness, desquamation.

Glucocorticoids and antirheumatic agents (gold drugs, aminoquinolines) induce the anti-inflammatory effect of Nimid.

Pregnancy and lactation:

Is not used.

Children:

Safety and efficacy of the drug in children has not been established.

PRECAUTIONS:

Medical supervision is necessary when applying the drug in elderly patients with impaired function of kidneys, liver, with congestive heart failure. In patients with gastroduodenal bleeding, active ulcers or severe blood clotting disorders, the drug should be used under close medical supervision.

Do not use simultaneously with other topical medications.

It is recommended to apply the gel only on o intact skin, avoiding contact with open wounds. Avoid contact with eyes and cutaneous membranes. Do not apply under airtight dressing.

To reduce the risk of adverse effects, use the minimum effective dose with the least duration of treatment. If the patient’s condition does not improve, he should seek medical advice.

Do not use in patients with hypersensitivity to NSAIDs. In case of hypersensitivity reactions, the treatment should be discontinued.

During the treatment period, the development of photosensitivity reactions is possible. To decrease the risk of photosensitivity, the patients should avoid UV-exposure and refrain from visiting solarium.

Overdose:

When applying the gel on large skin areas or in case of exceeding the recommended dose, systemic adverse effects, typical for nimesulide and other nonsteroidal anti-inflammatory drugs, are possible: dyspepsia, headache, dizziness, epigastric pain.

Treatment: dose reduction or discontinuation of the drug. The treatment is symptomatic.

Ability to influence reaction velocity while driving or operating any other mechanisms.

Has no effect.

CONTRAINDICATIONS:

Hypersensitivity to nimesulide or other components of the drug.

Dermatitis and skin infections. Damage of 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.

PHARMACOLOGICAL PROPERTIES:

Nonsteroidal anti-inflammatory drugs for topical application. Code АТС М02А А26.

Nimid® is a nonsteroidal anti-inflammatory drug (NSAID), a selective inhibitor of cyclooxygenase-2. By its anti-inflammatory activity, nimesulide in equimolar concentrations during the initial stage of inflammation is equivalent to indometacin and piroxicam. Nimesulide inhibits the synthesis of prostaglandins at site of inflammation and has almost no effect on the synthesis of regulatory prostaglandins in the stomach and kidneys. It inhibits the activity of platelet activating factor, tumor necrosis factor-α, proteinases, histamine and formation of free oxygen radicals. When applied topically, it reduces or eliminates pain in the area of application, including joint pain, at rest and in motion, reduces morning stiffness and swelling of the joints, helps increase the range of motion.

When cutaneous application of Nimid, gradual transdermal infusion of nimesulide is observed in the subcutaneous tissue and synovial fluid of the joint. The drug virtually does not reach the systemic circulation; this explains the absence of significant systemic effects.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

Opaque homogeneous light-yellow gel.

Shelf-life:

2 years.

Storage:

Store at the temperature not more than 25 °С, in the original package.

Keep out of reach of children.

Do not freeze.

Package:

30 g, 100 g in a tube, in a carton.

Conditions of supply:

Without prescription.