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

Composition:1 g of gel contains active ingredient diclofenac diethylamine 11.60 mg (respectively diclofenac sodium 10 mg); auxiliary substances - isopropanol - 223.00 mg, carbomer 940 - 9.10 mg, polysorbate 80-9.10 mg, benzyl alcohol - 2.70 mg, sodium disulfite - 0.25 mg, sorbitol - 18.30 mg, trolamine - 16.2 mg, purified water - up to 1.00 g.

Description:Transparent colorless homogeneous gel.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug.

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:A non-steroidal anti-inflammatory agent, a derivative of phenylacetic acid, has an anti-inflammatory and analgesic effect. By indiscriminately inhibiting cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2), it affects the metabolism of arachidonic acid, reduces the amount of prostaglandins (Pg) in the inflammatory focus.

Pharmacokinetics:When topical application is partially absorbed through the skin, bioavailability - 6%. The connection with plasma proteins is 99.7%. It is excreted by the kidneys. In patients with polyarthritis who receive local therapy (in the area of the inflamed joint), the concentration in the synovial fluid and tissue is higher than the concentration in the plasma.

Indications:Inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, rheumatic soft tissue disorders, gouty arthritis); traumatically caused inflammation of the tendons, ligaments, muscles and joints (as a result of stretching, with the load and bruises).

Contraindications:Hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs. Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (in the anamnesis). Pregnancy (III trimester), lactation period, children's age (up to 12 years), violation of the integrity of the skin.

Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), severe violations of the liver and kidney function, chronic heart failure, impaired blood clotting (including hemophilia, prolonged bleeding time, a tendency to bleed); bronchial asthma, elderly age, pregnancy I and II trimester.

Pregnancy and lactation:Application in pregnancy (III trimester) and during lactation - is contraindicated.

Dosing and Administration:

Outwardly. For adults and children over 12 years old the drug is applied a thin layer over the inflammation focus 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. Single dose of the drug: 2 - 4 g (which by volume is comparable to the size of a large cherry).

After applying the product, you should wash your hands.

The duration of treatment depends on the indications and the therapeutic effect. After 2 weeks of use, consult a physician.

Side effects:

From the skin: eczema, photosensitivity, contact dermatitis (itching, hyperemia, swelling of the treated skin, papular-vesicular rashes, peeling).

Allergic reactions (itching and burning of the skin, erythematous skin rash, hives, angioedema, systemic anaphylactic reactions (including shock).

Overdose:Symptoms: Due to low systemic absorption when applying gel, an overdose is unlikely. With accidental ingestion, it is possible to develop systemic adverse reactions.Treatment: gastric lavage, induction of vomiting, Activated carbon, forced diuresis, symptomatic therapy. Dialysis is not effective due to the high degree of binding to diclofenac proteins (about 99%).

Interaction:The drug may enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Special instructions:

The gel is applied only to undamaged skin areas. After applying, do not apply an occlusive bandage.

When applied to large areas of the skin for a long time, the risk of systemic side effects increases.

Avoid contact with eyes, mucous membranes or open wounds. Use only as an external product.

Form release / dosage:

Gel for external use 1%.

Packaging:40 grams of gel in an aluminum tube, sealed with a screw-on plastic lid. The tube opening is protected by an aluminum membrane. The cap is a monolithic structure, including a device for piercing the membrane. Tuba, together with instructions for use, is placed in a cardboard box.

Storage conditions:At a temperature of 15 to 25 ° C. Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014852 / 01

Date of registration:27.10.2008

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp26.02.2016

Illustrated instructions

Instructions

Diclofenac (Diclofenac)