Nise, gel 1%, 50g

Composition

1 g of gel contains:

Active ingredient:

nimesulide 10 mg;

excipients:

N-methyl-2-pyrrolidone 250 mg,

propylene glycol 100 mg,

macrogol of 315.5 mg,

100 mg, isopropanol,

purified water,200 mg,

karbomer-940 20 mg,

butylhydroxyanisole 0.2 mg

thiomersal 0.1 mg,

potassium dihydrogen phosphate 0.2 mg,

flavoring (Narcissus-938) 4 mg.

Pharmacological properties

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug (NSAID)

ATX code:  M 01 AH 17

Pharmacological action

Nice ® gel is a new generation of nonsteroidal anti-inflammatory drugs (NSAIDs) from the class of sulfonamides. It has a local analgesic and anti-inflammatory effect.

Nimesulide is a selective competitive reversible cyclooxygenase type II (endoperoxide-prostaglandin-H2 synthetase) inhibitor. Reduces the concentration of short-lived prostaglandin H 2, a substrate for kinin-stimulated prostaglandin E 2 synthesis, in the focus of inflammation and in the ascending pathways of pain impulses in the spinal cord. Reducing the concentration of prostaglandin E2 (a mediator of inflammation and pain) reduces the activation of EP-type prostanoid receptors, which is manifested by analgesic and anti-inflammatory effects.

When applied topically, it relieves or disappears pain at the site of application of the gel, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Helps to increase the volume of movement.

Pharmacokinetics

When applying the gel, the concentration of the Active ingredient 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, were found in the blood.

Indications

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (joint syndrome with acute gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory damage to ligaments, tendons, bursitis, sciatica, lumbago).

Muscle pain of rheumatic and non-rheumatic origin.

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

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Contraindications

• Hypersensivity to the nimesulide and components of the drug;
• erosive-ulcerative lesions of the gastrointestinal tract in the acute stage, bleeding from the gastrointestinal tract, dermatitis, damage to the skin and infection of the skin in the area of application;
• severe renal (creatinine clearance less than 30 ml/min) or hepatic insufficiency, the provision in the history of the phenomenon of bronchospasm associated with the use of acetylsalicylic acid or other NSAIDs, pregnancy and lactation, children up to age 7 years.

With caution

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

Side effects

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

If you experience any adverse reactions, 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 adverse reactions is not excluded: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of “liver” transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Interaction

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

Caution should be exercised when concomitant use of Nice® 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.

How to take, course of use and dosage

Externally. Before applying the gel, wash and dry the skin surface. Apply a uniform thin layer of gel about 3 cm long to the area of maximum soreness, 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 reaction.

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

Overdose

Cases of overdose of the drug are not described. However, when applying large amounts of gel (exceeding 50 g) to large areas of the skin, overdose is not excluded. There is no specific antidote. You should consult a doctor.

Special instructions

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

Form of production

Gel Nize for external use.

Storage conditions

At a temperature not exceeding 25 ° C. Do not freeze it. Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Nimesulide

Dosage form

gel for external use

Description

For adults, Children as prescribed by a doctor, Children over 7 years of age

Indications

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