Nimulide - instructions for use, dose, side effects, contraindications

Excipients: giprolose, carbomer, ethanol 95% (purified alcohol), purified water, triacetin, dimethylacetamide, phosphoric acid, flavoring MSC- 03, the fragrance is 0106- G.

Description:Homogeneous translucent gel of yellowish color.

Pharmacotherapeutic group:nonsteroidal anti-inflammatory drug.

ATX: & nbsp

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

M.01.A.X.17 Nimesulide

Pharmacodynamics:

The active component of Nimulide is nimesulide - a non-steroidal anti-inflammatory drug (NSAID) that has the properties of a selective cyclooxygenase inhibitor II type. Nimesulide reduces the concentration of short-lived prostaglandin H₂, which is a substrate for kinin-stimulated prostaglandin E synthesis₂ in the hearth of inflammation. 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 diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, 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 and 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; disturbances of coagulation, elderly and children's age.

Dosing and Administration:

Nimulide is intended exclusively for external use 3-4 times a day.On the area of maximum soreness, it is necessary to apply approximately 3 cm a column of Nimulide gel and spread the evenly even layer of the fingers of the fingers with a gentle hand, without rubbing. After use, wash hands with soap and water. The amount of gel and frequency of application (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 effect

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:

It is not excluded pharmacokinetic interaction with drugs competing for communication with plasma proteins.

Caution should be exercised when using the Nimulide gel with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, hypotensive and hypoglycemic agents at the same time.

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

Special instructions:Nimulide should not be applied to mucous membranes, including conjunctiva, as well as to skin areas affected by dermatoses or infections. It is not recommended to apply to open wounds and skin lesions. Nimulide should not be strongly rubbed into the skin. Treated skin areas can not be covered with occlusive dressings. Tightly seal the tube after use.

Form release / dosage:

Gel for external use 1%.For 10, 20 and 30 g in tubes are aluminum or plastic. Each tube together with the instruction for use is placed in a cardboard box.

Packaging:tubes, aluminum (1) - packs, cardboard
plastic tubes (1) - packs, cardboard

Storage conditions:Store at a temperature of no higher than 25 ° C, away from open flame and protect from direct sunlight, with a tightly screwed lid. Do not store in the refrigerator. Keep out of the reach of children.

Shelf life:3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N011525 / 04

Date of registration:16.10.2008

The owner of the registration certificate:Panacea Biotech Co., Ltd.Panacea Biotech Co., Ltd. India

Manufacturer: & nbsp

PANACEA BIOTEC, Ltd. India

Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC

Information update date: & nbsp15.08.2015

Illustrated instructions

Instructions

Nimoolid (Nimulid)