COMPOSITION:

active substance: nimesulide;

1 g of gel contains nimesulide10 mg;

Excipients:

Benzyl alcohol

Propylene Glycol

Carbomer 940

Disodium Edetate

Sodium Hydroxide

Fragrance Cologne Comp 530

purified water.

INDICATIONS:

Topical treatment of pathological conditions of the musculoskeletal system

characterized by pain

inflammation and stiffness of movement

such as osteoarthritis

periarthritis

post-traumatic tendinitis

tendosynovitis

muscle sprain

severe physical load on joints.

.

DOSAGE:

The drug is applied externally in adults. Before applying the gel

it is recommended to wash and dry the skin surface. Apply approximately 3 cm of gel on the painful areas in a thin layer and rub it in lightly; the frequency of application is 3-4 times per day. The duration of therapy is determined individually depending on its efficacy

and is no more than 4 weeks.

ADVERSE REACTIONS:

Local mild to moderate skin irritation:

erythema

rash

desquamation

allergic reactions. Rarely

anaphylactic reactions may occur in sensitive patients: Quincke’s edema

vasomotor rhinitis

asthma

bronchospasm.

Drug interactions:

When cutaneous application of the drug

no interaction with other medical products has been revealed. However

it should be taken into account that if nimesulide reaches the systemic circulation

it may induce the effect and toxicity of many medical agents by displacing them from binding to plasma proteins and thus increasing their free fraction in blood. Therefore

caution should be exercised when prescribing the drug concomitantly with anticoagulants

digoxin

phenytoin

lithium drugs

diuretics

antihypertensive drugs

other NSAIDs

cyclosporine

methotrexate

oral hypoglycemic drugs.

When concomitant application of several nonsteroidal anti-inflammatory drugs

local irritation is possible

such as urticaria

skin redness

desquamation.

Glucocorticoids and antirheumatic agents (gold drugs

aminoquinolines) induce the anti-inflammatory effect of Nimid.

Pregnancy and lactation:

Is not used.

Children:

Safety and efficacy of the drug in children has not been established.

PRECAUTIONS:

Medical supervision is necessary when applying the drug in elderly patients with impaired function of kidneys

liver

with congestive heart failure. In patients with gastroduodenal bleeding

active ulcers or severe blood clotting disorders

the drug should be used under close medical supervision.

Do not use simultaneously with other topical medications.

It is recommended to apply the gel only on o intact skin

avoiding contact with open wounds. Avoid contact with eyes and cutaneous membranes. Do not apply under airtight dressing.

To reduce the risk of adverse effects

use the minimum effective dose with the least duration of treatment. If the patient’s condition does not improve

he should seek medical advice.

Do not use in patients with hypersensitivity to NSAIDs. In case of hypersensitivity reactions

the treatment should be discontinued.

During the treatment period

the development of photosensitivity reactions is possible. To decrease the risk of photosensitivity

the patients should avoid UV-exposure and refrain from visiting solarium.

Overdose:

When applying the gel on large skin areas or in case of exceeding the recommended dose

systemic adverse effects

typical for nimesulide and other nonsteroidal anti-inflammatory drugs

are possible: dyspepsia

headache

dizziness

epigastric pain.

Treatment: dose reduction or discontinuation of the drug. The treatment is symptomatic.

Ability to influence reaction velocity while driving or operating any other mechanisms.

Has no effect.

CONTRAINDICATIONS:

Hypersensitivity to nimesulide or other components of the drug.

Dermatitis and skin infections. Damage of epidermis. Do not use in patients in whom acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis

cause allergic reactions such as rhinitis

urticaria or bronchospasm.

PHARMACOLOGICAL PROPERTIES:

Nonsteroidal anti-inflammatory drugs for topical application. Code АТС М02А А26.

Nimid® is a nonsteroidal anti-inflammatory drug (NSAID)

a selective inhibitor of cyclooxygenase-2. By its anti-inflammatory activity

nimesulide in equimolar concentrations during the initial stage of inflammation is equivalent to indometacin and piroxicam. Nimesulide inhibits the synthesis of prostaglandins at site of inflammation and has almost no effect on the synthesis of regulatory prostaglandins in the stomach and kidneys. It inhibits the activity of platelet activating factor

tumor necrosis factor-α

proteinases

histamine and formation of free oxygen radicals. When applied topically

it reduces or eliminates pain in the area of application

including joint pain

at rest and in motion

reduces morning stiffness and swelling of the joints

helps increase the range of motion.

When cutaneous application of Nimid

gradual transdermal infusion of nimesulide is observed in the subcutaneous tissue and synovial fluid of the joint. The drug virtually does not reach the systemic circulation; this explains the absence of significant systemic effects.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

Opaque homogeneous light-yellow gel.

Shelf-life:

2 years.

Storage:

Store at the temperature not more than 25 °С

in the original package.

Keep out of reach of children.

Do not freeze.

Package:

30 g

100 g in a tube

in a carton.

Conditions of supply:

Without prescription.