Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspGel for external use.
    Composition:
    In 1 g of the drug contained-

    Active substance: Diclofenac sodium 10 mg.

    Excipients: lactic acid 4U%, isopropanol (isopropyl alcohol), ethanol (ethyl alcohol 95%), sodium disulfite technical, carbopol (carbomer), trolamine, water for injection.
    Description:Colorless or with a yellowish or creamy tinge translucent gel.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:Active component diclofenac - non-steroidal anti-inflammatory drug, which has pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase 1 and type I, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation. Diclofenac It is used to eliminate the pain syndrome and reduce the swelling associated with the inflammatory process.With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed.
    Indications:
    - Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine; rheumatic soft tissue damage.

    - Muscular pain of rheumatic and non-rheumatic origin.

    - Traumatic injuries of soft tissues.
    Contraindications:Hypersensitivity to diclofenac, or other components of the drug, acetylsalicylic acid or other NSAIDs, bronchial asthma, urticaria or acute rhinitis, triggered by the use of acetylsalicylic acid or other NSAIDs; pregnancy (III trimester), lactation period, children's age (up to 6 years), violation of the integrity of the skin.
    Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidney function, chronic heart failure, bronchial asthma, elderly age, children under 12 years, pregnancy I and II trimester, bleeding disorders (in tons hemophilia, lengthening of bleeding time, tendency to bleeding).
    Pregnancy and lactation:The drug should not be used in the III trimester of pregnancy. Experience in the use of diclofenac during lactation is not available. Use in I and P trimesters is possible only after consulting a doctor.
    Dosing and Administration:Outwardly. Adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug - 2-4 g (4-8 cm with a fully open neck of the tube). Children from 6 to 12 years should use no more than 2 g of the drug up to 2 times a day. The duration of treatment without consulting a doctor should not exceed 10 days.
    Side effects:
    Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated area of ​​the skin, papules, vesicles, peeling).

    Systemic reactions: Generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions), photosensitization.
    Overdose:Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.
    Interaction:Diclofenac can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.
    Special instructions:Diclofenac Should be applied only to intact skin, avoiding contact with open wounds. After applying, do not apply an occlusive dressing. Do not allow the product to get into the eyes and mucous membranes. Avoid UV radiation.
    Form release / dosage:
    Gel for external use 1%.
    Packaging:
    For 15 grams and 25 grams in aluminum tubes with an inner coating lacquer or 25 grams in cans of BDS type from orange glass with pull-on lids.

    Each tube or jar, together with instructions for medical use, is placed in a cardboard pack.
    Storage conditions:List B. In a dry place, at a temperature of no higher than 25 ° C. In a place inaccessible to children.
    Shelf life:2 years. Do not use after the expiry date printed on the package!
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-001972/07
    Date of registration:07.08.2007 / 06.10.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOCHEMICAL JSC BIOCHEMICAL JSC Russia
    Information update date: & nbsp10.03.2016
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