Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspGel for external use.
    Composition:
    Active substance:

    diclofenac diethylamine ...... 11.6 mg

    which is equivalent to diclofenac

    sodium ...................................... 10.0 mg

    Excipients: carbomer 940 8.0 mg, propylene glycol 200.0 mg, purified water sk. demand up to 1 g
    Description:Homogeneous opalescent gel of white or almost white color.
    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 (NSAID), which has pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation. Has a local anesthetic, anti-inflammatory and anti-edematous effect.

    With topical application, the gel is quickly absorbed and, penetrating into the subcutaneous tissue, muscle tissue and articular capsule, causes weakening or disappearance of pain in joints at rest and during movement.Reduces the morning stiffness and swelling of the joints, contributing to an increase in the volume of movements.
    Pharmacokinetics:When the gel is applied, systemic absorption is no more than 6%. When applied to the area of ​​the affected joint, the concentration in the synovial fluid is higher than in the blood plasma.
    Indications:
    - posttraumatic inflammation of soft tissues and joints (as a result of stretching, overstrain or bruises).

    - rheumatic diseases of soft tissues (tendovaginitis, bursitis, lesion of periarticular tissues).

    - pain syndrome and puffiness associated with diseases of the muscles and joints (rheumatoid arthritis, osteoarthritis, radiculitis, lumbago, sciatica, muscular pain of rheumatic and non-rheumatic origin).
    Contraindications:Hypersensitivity to diclofenac and other components of the drug; to acetylsalicylic acid or other NSAIDs, anamnestic data on an attack of bronchial obstruction, rhinitis; urticaria after taking 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:with exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, in old age, pregnancy (I and II trimester).
    Pregnancy and lactation:
    The drug should not be used in the III trimester of pregnancy.

    Experience in using the drug during lactation is not available. Use in the I and II trimesters of pregnancy is possible only after consulting a doctor.
    Dosing and Administration:Outwardly. Adults and children over 12 years of age, the gel is applied to the skin over the focus of inflammation 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 is 2 - 4 g (4 - 8 cm with a fully open neck of the tube). The maximum daily dose is 8 g. Children from 6 to 12 years of age should not be used more than 2 times a day, a single dose of the drug - up to 2 g. After applying the drug, the hands should be washed. The duration of the course of treatment depends on the indications and the effect noted. The duration of treatment without consulting a doctor should not exceed 2 weeks.
    Side effects:

    Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated area of ​​the skin, papular - vesicular rashes, peeling).

    Systemic reactions: generalized skin rash, allergic reactions (hives, angioedema, bronchospastic reactions).

    Overdose:Very low systemic absorption of the active ingredient of the drug when applied externally makes practically impossible overdose.
    Interaction:Diclofenac can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.
    Special instructions:Diclorean gel should be applied only to undamaged skin areas, avoiding getting on open wounds. After applying the gel, do not apply an occlusive bandage. Do not allow the drug to enter the eyes and mucous membranes.
    When using the drug together with other dosage forms of diclofenac, the maximum daily dose should be taken into account.
    When applied to large areas of the skin for a long time, the risk of systemic side effects, characteristic of NSAIDs, increases.
    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive and maintain moving mechanical equipment.
    Form release / dosage:
    Gel for external use 1%.
    Packaging:
    - For 20 grams in an aluminum tube, the neck of which is sealed with an aluminum membrane and with a screw cap made of polyethylene with a protrusion for perforating the membrane. One tube in a cardboard box together with instructions for use.

    - By 20 grams into a plastic laminated tube, the neck of which is sealed with aluminum foil, laminated with polyethylene and with a screw cap, made of polypropylene with a projection (or without a protrusion) for foil perforation. One tube in a cardboard box together with instructions for use.
    Storage conditions:
    At a temperature of no higher than 30 ° C. Do not freeze. 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 N011498 / 01
    Date of registration:09.07.2010
    The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
    Manufacturer: & nbsp
    Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India
    Information update date: & nbsp17.02.2016
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