Nimesulide, gel 1% 20 g

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (osteoarthritis osteochondrosis with radicular syndrome radiculitis inflammatory ligamentous tendon lesions bursitis sciatica lumbago).

Muscle pain of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and torn ligaments bruises).

The drug is intended as symptomatic therapy to reduce pain and inflammation at the time of use has no effect on the progression of the disease.

Active ingredient

Composition

Active ingredient:

nimesulide – 1.00 g;

Promoters:

methylpyrrolidone – 25.00 g,

isopropanol – 10.00 g,

propylene glycol – 10.00 g,

carbomer – 1.20 g,

macrogoal-400 – 31.55 g,

lavender oil – 0.25 g,

tromethamol – 0.09 g,

water – up to 100.00 g.

* Note. If necessary, to achieve the optimum pH of the gel the content of tromethamol can be changed in the range from 0,02 g to 0,15 g per 100 g.

How to take, the dosage

Externally. Wash and dry the skin surface before applying the gel.

Adults and children over 12 years of age apply a column of gel about 3 cm in an even, thin layer to the area of maximum soreness without rubbing 3-4 times a day.

Do not rub the gel intensely or use under an occlusive dressing.

Do not use the gel for more than 10 days without consulting a doctor.

Interaction

Pharmacokinetic interaction with drugs competing for binding to plasma proteins is not excluded.

Caution should be exercised when using nimesulide concomitantly with digoxin phenytoin lithium drugs diuretics cyclosporine methotrexate other NSAIDs hypotensive and antidiabetic agents.

You should consult your doctor before using the gel if you are using the above medications or are under a doctor’s care.

Special Instructions

The gel should not be applied to the mucous membranes of the eyes, damaged and infected skin areas affected by skin diseases and open wounds.

A strong burning sensation may occur upon application of the product which disappears within a few days. During application and before cleansing hands, do not touch sensitive areas of the skin. If accidental contact of the gel with mucous membranes or sensitive skin areas should be rinsed with copious amounts of water.

The gel should be used with caution in patients at increased risk of adverse reactions caused by salicylates.

The product should not be used under an occlusive dressing.

Synopsis

Contraindications

Hypersensitivity to nimesulide and drug components.

The complete or incomplete combination of bronchial asthma angioedema or urticaria recurrent polyposis of the nose and sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including a history).

Erotic ulcerative lesions of the gastrointestinal tract in the acute stage of bleeding from the gastrointestinal tract.

Dermatoses lesions of the epidermis and skin infections in the area of application.

Developed renal (creatinine clearance less than 30 ml/min) or hepatic insufficiency.

Pregnancy and breastfeeding children under 12 years of age.

Hepatic failure; renal failure (creatinine clearance 30-60 ml/min); gastrointestinal erosive ulcerative lesions in history (including peptic ulcer disease of the stomach and 12 duodenum); blood clotting disorders (including hemophilia, prolongation of bleeding time, susceptibility to bleeding) bleeding from the gastrointestinal tract in the history; significant heart failure; arterial hypertension; type 2 diabetes; old age and childhood.

Side effects

The drug is generally well tolerated when used externally.

The undesired effects are listed below according to anatomophysiological classification and frequency of occurrence. The frequency of side effects is determined by WHO and is graded as follows: very common (> 1/10) (>1/100 < 1/10) (>1/1000 < 1/100) (>1/10000 < 1/1000) (< 1/10000); not established.

Skin and subcutaneous tissue disorders: infrequent – itching; very rare – urticaria peeling transient change in skin color (not requiring withdrawal of the drug).

In case of any adverse reactions, discontinue use of the drug and consult a physician.

If the gel is applied to large areas of skin or if it is used for a long time, systemic adverse reactions may occur: heartburn nausea vomiting diarrhea gastralgia gastrointestinal mucosa ulceration increased activity of “liver” transaminases; headache dizziness; fluid retention hematuria; allergic reactions (anaphylactic shock skin rash); thrombocytopenia leukopenia anemia agranulocytosis prolonged bleeding time.

Overdose

Pregnancy use

Similarities