Nimulide, gel 1%, 30g

Composition

Active ingredient:

nimesulide 10 mg;

Auxiliary substances:

giprolose; carbomer;

ethyl alcohol 95% (purified);

purified water;

triacetin;

dimethylacetamide;

phosphoric acid;

flavor MSC-03;

flavor 0106-G

Pharmacological action

Nimulide is a non-narcotic anti-inflammatory agent (NSAID) of the sulfonanilide class, a selective COX-2 inhibitor. It has anti-inflammatory, analgesic, and antipyretic effects.

Nimesulide belongs to NSAIDs, the mechanism of action of which is associated with selective inhibition of COX-2 and the effect on a number of other factors — suppression of platelet activation factor, tumor necrosis factor alpha, suppression of proteinases and histamine.

 Selectively suppressing COX-2 reduces biosynthesis PG in the focus of inflammation, has a less pronounced depressing effect on COX-1 (less often causes side effects associated with inhibition of PG synthesis in healthy tissues).

Indications

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

• rheumatoid arthritis;
• articular syndrome with exacerbation of gout;
• psoriatic arthritis;
• ankylosing spondylitis;
• osteochondrosis with radicular syndrome;
• osteoarthritis;
• myalgia, rheumatic and non-rheumatic origin;
• inflammation of the ligaments, tendons, bursitis, including post-traumatic inflammation of soft tissue;
• pain syndrome of different Genesis (including in the postoperative period, for injuries the algomenorrhea, toothache, headache, arthralgia, sciatica);
• febrile syndrome in infectious and inflammatory diseases.

Use during pregnancy and lactation

It is contraindicated during pregnancy and lactation.

Contraindications

• hypersensitivity to nimesulide and other components of Nimulide; 
• acetylsalicylic acid or other NSAIDs;
• stomach and duodenal ulcers in the acute phase;
• severe liver and kidney function disorders.

Side effects

Systemic reactions:  heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, headache, dizziness, fluid retention, drowsiness, itching, urticaria, bronchospasm, allergic reactions (skin rash, anaphylactic shock), thrombocytopenia, leukopenia, anemia, agranulocytosis, increased activity of hepatic transaminases, prolongation of bleeding time, hematuria.

Local reactions (gel):  skin irritation, skin rash, flaking, pruritus, transient discoloration (not requiring discontinuation of the drug).

Interaction

The effect of medications that reduce blood clotting is enhanced when they are used simultaneously with nimesulide.

Nimesulide may reduce the effect of furosemide. Reduces the therapeutic effect of antihypertensive drugs. Nimesulide increases the occurrence of side effects when taking methotrexate at the same time.

The level of lithium in plasma increases with simultaneous use of lithium and nimesulide preparations.

Nimesulide may increase the nephrotoxic effect of cyclosporine on the kidneys.

Use with glucocorticosteroids, serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

How to take, course of use and dosage

For external use. Gel-treated areas of the skin should not be covered with occlusive dressings.

The gel can also not be rubbed heavily into the skin.

Approximately 3 cm of gel should be applied to the affected area 3-4 times a day. The dose, however, may vary depending on the size of the treated area and the patient’s response. The result of therapy is evaluated after 4 weeks.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding, hypertension, acute renal failure, and respiratory depression may occur.

Treatment:  symptomatic treatment of the patient is required, there is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting, provide activated charcoal (60-100 g per adult), osmotic laxatives. Forced diuresis and hemodialysis are ineffective due to the high binding of the drug to proteins.

Special instructions

Nimulide should be used with caution in patients who have experienced a tendency to bleed, in patients with diseases of the upper gastrointestinal tract, or in patients receiving anticoagulants.

Because Nimulide is partially excreted by the kidneys, and its dosage for patients with impaired renal function should be reduced, depending on creatinine clearance indicators. Given reports of visual impairment in patients taking other NSAIDs, treatment should be stopped immediately if any visual impairment occurs and the patient should be examined by an optometrist. P

reparate can cause fluid retention in the tissues, so patients with high blood pressure and cardiac disorders Nimulid should be used with extreme caution.

To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course. Influence on the ability to drive motor vehicles and manage mechanisms

Patients who have severe side effects: dizziness, drowsiness, blurred vision, should be careful when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Gel for external use.

Storage conditions

At a temperature not exceeding -25 °C

Shelf life

3 years

Active ingredient

Nimesulide

Dosage form

gel for external use

Description

Children over 12 years of age, For adults, Children as prescribed by a doctor

Indications

Osteoarthritis, Arthritis, Osteochondrosis, Rheumatoid Arthritis, Sciatica, Tendon Inflammation, Lumbago, Myositis, Sciatica, Sprains and Sprains, Gout, Osteoarthritis