Nise gel for external use 1%, 50 g

• Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (articular syndrome during exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory lesions of the ligaments, tendons, ilias, bursitis).

• Muscle pains of rheumatic and non-rheumatic origin.

• Post-traumatic inflammation of soft tissues and musculoskeletal system (damage and rupture of ligaments, bruises).

Outwardly. Before applying the gel, wash and dry the skin surface. Apply a column of gel approximately 3 cm long in a uniform thin layer to the area of ??maximum pain, without rubbing, 3-4 times a day.

The amount of gel and the frequency of its application (no more than 4 times a day) may vary depending on the size of the treated area and the patient's response.

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

1 g of gel contains:

active substance: nimesulide 10 mg;

excipients: N-methyl-2-pyrrolidone 250 mg, propylene glycol 100 mg, macrogol 315.5 mg, isopropanol 100 mg, purified water 200 mg, carbomer-940 20 mg, butylhydroxyanisole 0.2 mg, thiomersal 0.1 mg, potassium dihydrogen phosphate 0.2 mg, flavor (Narcissus-938) 4 mg.

• Hypersensitivity to nimesulide and drug components;

• erosive and ulcerative lesions of the gastrointestinal tract in the acute stage,

• bleeding from the gastrointestinal tract,

• dermatoses,

• damage to the epidermis and skin infections in the area of ??application;

• severe renal (creatinine clearance less than 30 ml / min.) or hepatic impairment,

• an indication of a history of bronchospasm associated with the use of acetylsalicylic acid or other NSAIDs,

• pregnancy and lactation,

• children up to age 7 years.

Carefully

Liver failure; renal failure; severe heart failure; arterial hypertension; type 2 diabetes mellitus; elderly and children's age.

Trade name: NiseЃ

International non-proprietary name:

nimesulide

Chemical name: N- (4-nitro-2-phenoxyphenyl) methanesulfonanilide

Dosage form:

gel for external use

Composition:

1 g of gel contains:

active substance: nimesulide 10 mg;

excipients: N-methyl-2-pyrrolidone 250 mg, propylene glycol 100 mg, macrogol 315.5 mg, isopropanol 100 mg, purified water 200 mg, carbomer-940 20 mg, butylhydroxyanisole 0.2 mg, thiomersal 0.1 mg, potassium dihydrogen phosphate 0.2 mg, flavor (Narcissus-938) 4 mg.

Description: transparent gel of light yellow or yellow color, free from foreign particles.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID)

ATX code: ћ01ј’17

pharmachologic effect

NiseЃ gel is a new generation non-steroidal anti-inflammatory drug (NSAID) from the sulfonamide class. It has a local anesthetic and anti-inflammatory effect.

Nimesulide is a selective competitive reversible type II cyclooxygenase inhibitor (endoperoxide prostaglandin H2 synthetase). Reduces the concentration of short-lived prostaglandin H2, a substrate for kinin-stimulated synthesis of prostaglandin E2, in the focus of inflammation and in the ascending pathways of pain impulses in the spinal cord. A decrease in the concentration of prostaglandin E2 (a mediator of inflammation and pain) reduces the activation of prostanoid receptors of the EP type, which manifests itself in analgesic and anti-inflammatory effects.

When applied topically, it causes a weakening or disappearance of pain at the site of application of the gel, including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints. Promotes increased range of motion.

Pharmacokinetics

When the gel is applied, the concentration of the active substance in the systemic circulation is extremely low. The maximum concentration after a single application is noted by the end of the first day, its value is more than 300 times lower than that for oral dosage forms of nimesulide. No traces of the main metabolite of nimesulide, 4-hydroxynimesulide, are found in the blood.

Indications

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (articular syndrome during exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory lesions of the ligaments, tendons, ilias, bursitis).

Muscle pains of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and musculoskeletal system (damage and rupture of ligaments, bruises).

Contraindications

Hypersensitivity to nimesulide and drug components; erosive and ulcerative lesions of the gastrointestinal tract in the stage of exacerbation, bleeding from the gastrointestinal tract, dermatoses, damage to the epidermis and infections of the skin in the area of ??application; severe renal (creatinine clearance less than 30 ml / min.) or hepatic failure, an indication in the history of bronchospasm phenomena associated with the use of acetylsalicylic acid or other NSAIDs, pregnancy and lactation, children under 7 years of age.

Carefully

Liver failure; renal failure; severe heart failure; arterial hypertension; type 2 diabetes mellitus; elderly and children's age.

Method of administration and dosage

Outwardly. Before applying the gel, wash and dry the skin surface. Apply a column of gel approximately 3 cm long in a uniform thin layer to the area of ??maximum pain, without rubbing, 3-4 times a day.

The amount of gel and the frequency of its application (no more than 4 times a day) may vary depending on the size of the treated area and the patient's response.

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

Side effect

Local reactions: itching, urticaria, peeling, transient discoloration of the skin (not requiring discontinuation of the drug).

If any adverse reactions occur, you should stop using the drug and consult your doctor.

When applying the gel to large areas of the skin or with prolonged use, the development of systemic side reactions is not excluded: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal tract mucosa, increased activity of 'hepatic' transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolonged bleeding time.

Overdose

Cases of drug overdose have not been described. However, when large amounts of gel (exceeding 50 g) are applied to large areas of the skin, an overdose may develop. There is no specific antidote. You need to see a doctor.

Interaction with other medicinal products

Pharmacokinetic interaction with drugs competing for the connection with blood plasma proteins is not excluded.

Caution should be exercised while using NiseЃ with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic agents.

Before using the gel, you should consult with your doctor if you are using these products or are under medical supervision.

special instructions

The drug is recommended to be applied only to intact skin areas, avoiding contact with open wounds. Avoid getting the gel in the eyes and other mucous membranes. Do not use gel under airtight dressings. After applying the gel, wash your hands with soap and water. Close the tube tightly after using the gel.

Thomas issue

Gel for external use 1%. 20 g or 50 g each in a laminated aluminum tube equipped with a membrane for first opening control. The tube is packed in a cardboard box with instructions for use.

Shelf life

2 years.

Do not use the drug after the expiration date printed on the package.

Storage conditions

List B.

In a dry, dark place at a temperature not exceeding 25 ? C. Do not freeze.

Keep out of the reach of children!

Conditions of dispensing from pharmacies

Without recipe.