Description

Release form

Gel for external use

pharmachologic effect

Nise 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.

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, radiculitis, inflammatory lesions of ligaments, tendons, ilias, bursitis).

Muscle pains of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and musculoskeletal system (damage and ruptures 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 infection 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.

Application during pregnancy and lactation

Contraindicated during pregnancy and lactation.

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 the gel under airtight dressings.

After applying the gel, wash your hands with soap and water.

Close the tube tightly after using the gel.

Structure

1 g contains nimesulide 10 mg

excipients: N-methyl-2-pyrrolidone, propylene glycol, macrogol, isopropanol, carbomer 940, butylhydroxyanisole, thimerosal, potassium phosphate, water, flavor

Method of administration and dosage

Outwardly.

Wash and dry the skin surface before applying the gel.

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 effects

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

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

When the gel is applied 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.

Drug interactions

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

Care should be taken with the simultaneous use of Nise with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic agents.

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

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ° C.

Do not freeze.

Keep out of the reach of children!

Shelf life

2 years.

Active substance

Nimesulide

Name ENG

NISE

Clinical and pharmacological group

NSAIDs for external use

ATX code

Nimesulide

Dosage

1% x 100g

Structure

1 g contains nimesulide 10 mg excipients: N-methyl-2-pyrrolidone, propylene glycol, macrogol, isopropanol, carbomer 940, butylhydroxyanisole, thimerosal, potassium phosphate, water, flavor

Indications

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory ligament damage, tendons, muscles, bursae). pains of rheumatic and non-rheumatic origin Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises)

INN / Active ingredient

Nimesulide

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 infection 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.

Storage conditions and periods

At a temperature not exceeding 25 degrees (do not freeze).

Expiration date: 2 years

Specifications