Naize - instructions for use, doses, side effects, contraindications

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

Description:

Transparent gel is light yellow or yellow, free from foreign particles.

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

ATX: & nbsp

M.01.A.X Other non-steroidal anti-inflammatory drugs

M.01.A.X.17 Nimesulide

Pharmacodynamics:

Naise® gel is a non-steroidal anti-inflammatory drug (NSAID) of the new generation from the class of sulfonamides.Has a local anesthetic and anti-inflammatory effect.

Nimesulide is a selective competitive reversible inhibitor of cyclooxygenase type II (endoperoxide-prostaglandin-H2g synthetase). Reduces the concentration of short-lived prostaglandin H2, a substrate for kinin-stimulated prostaglandin E2 synthesis, in the inflammatory focus and in the ascending ways of pain impulses in the spinal cord. Decrease in the concentration of prostaglandin E2 (a mediator of inflammation and pain) reduces the activation of prostanoid EP receptors, which is manifested by analgesic and anti-inflammatory effects.

When topical application causes the weakening or disappearance of pain in the place of application of the gel, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Promotes an increase in the volume of movements.

Pharmacokinetics:When applying the gel, the concentration of the active substance in the systemic blood flow is extremely low. The maximum concentration after a single application is noted towards the end of the first day, its value is more than 300 times lower than that for oral dosage forms of nimesulide.Traces of the main metabolite of nimesulide - 4-hydroxynimidesulide in the blood are not detected.

Indications:

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (for example, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory lesions of ligaments, tendons, bursitis, sciatica, lumbago). Muscular pain of rheumatic and non-rheumatic origin. Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

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

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

Dosing and Administration:

Outwardly. Before applying the gel, wash and dry the surface of the skin. In a uniform thin layer, apply a gel column about 3 cm long to the area of maximum soreness, not rubbing, 3-4 times a day.

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

Do not apply 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, discontinue use and consult a physician.

When applying the gel to large areas of the skin or with prolonged use, development of systemic adverse reactions is possible: 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.

Overdose:Cases of drug overdose are not described. However, when large amounts of gel (exceeding 50 g) are applied to large areas of the skin, an overdose can not be ruled out. There is no specific antidote. It is necessary to consult a doctor.

Interaction:

Pharmacokinetic interaction with drugs competing for binding to blood plasma proteins is not ruled out.

Caution should be exercised while using Nize® with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, hypotensive and anti-diabetic agents.

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

Special instructions:

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

Form release / dosage:

Gel for external use 1%.

Packaging:By 20 g, 50 g or 100 g in a tube of laminated aluminum, equipped with a membrane to control the first opening. 1 tube in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Do not freeze.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012824 / 02

Date of registration:20.06.2008 / 20.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

Dr. Reddy`c Laboratoris Ltd. India

Information update date: & nbsp29.05.2018

Illustrated instructions

Instructions

Naise® (Nise®)