Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspGel for external use.
    Composition:
    1 g of gel contains:

    Active substance:

    Diclofenac diethylamine (equivalent to the content of diclofenac sodium) -50 mg

    Excipients: chlorocresol 1.0 mg, paraffin liquid 50.0 mg, carbomer 940 20.0 mg, trolamine 20.0 mg, disodium edetate 5.0 mg, propylene glycol 150.0 mg, isopropanol 150.0 mg, benzyl alcohol 10.0 mg, sodium sulfite 2.0 mg, polysorbate-80 14.5 mg, lavender oil 6.0 mg, water purified to 1.0 g.
    Description:Semi-transparent gel almost white with a characteristic odor.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:A non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid, has an anti-inflammatory and analgesic effect. Indiscriminately inhibiting cyclooxygenase 1 and cyclooxygenase 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins, including. in the hearth of inflammation. When applied, it causes weakening or disappearance of pain in the place of application of the gel, pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints.Promotes an increase in the volume of movements in the affected joints.
    Pharmacokinetics:With the recommended method of applying the drug systemic absorption is not more than 6% of diclofenac. The connection with plasma proteins is 99.7%. It is excreted by the kidneys. When applied to the area of ​​the affected joint, the concentration in the synovial fluid is higher than in the plasma.
    Indications:
    Inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile arthritis, ankylosing spondylitis, gouty arthritis); traumatically caused inflammation of the tendons, ligaments, muscles and joints (as a result of stretching, with the load and bruises).

    Pain syndrome (lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis, rheumatic lesions of soft tissues); degenerative diseases of the musculoskeletal system (deforming osteoarthritis, osteochondrosis).
    Contraindications:The use of the drug is contraindicated for hypersensitivity to diclofenac, acetylsalicylic acid or other NSAIDs; anamnestic data on an attack of bronchial obstruction, rhinitis, hives after taking acetylsalicylic acid or other NSAIDs; in childhood (up to 6 years); in violation ofthe integrity of the skin at the site of the intended application.
    Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, clotting disorders (including hemophilia, lengthening bleeding time, tendency to bleeding), elderly age.
    Pregnancy and lactation:The drug should not be used in the III trimester of pregnancy. Use in I and II trimesters is possible only after consulting a doctor if the expected benefit to the mother exceeds the potential risk to the fetus. Experience in using the drug during lactation is not available. It is necessary to avoid applying the drug to the area of ​​the mammary glands.
    Dosing and Administration:
    Outwardly. Adults and children over 12 years of age, the drug is applied to the skin 2-3 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. Single dose - up to 2 g (about 4 cm with a fully open neck of the tube).
    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 1 g (about 2 cm with a fully open neck of the tube).
    After applying the gel, you should wash your hands.
    The duration of treatment depends on the indications and the effect observed.
    The duration of treatment without consulting a doctor should not exceed 2 weeks.
    Side effects:
    The resulting side effects depend on individual sensitivity, the magnitude of the dose used and the duration of treatment.

    Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness and swelling of the treated area of ​​the skin, rash, peeling).

    Systemic side effects due to resorptive action: generalized skin rash, bronchospasm, angioedema.

    If any side effects occur, incl. not specified in the instructions, you must stop using the gel and consult a doctor.
    Overdose:Due to low systemic absorption when applying gel, an overdose is unlikely.
    Interaction:Diclofenac can enhance the effect of drugs that cause photosensitivity. You should consult your doctor before applying Diclofenac if you are using other non-steroidal anti-inflammatory drugs.
    Special instructions:Apply the product only to intact skin areas.After applying, do not apply an occlusive bandage. With prolonged use and / or application on extensive surfaces, it is possible to develop systemic side effects due to resorptive action. Avoid contact with eyes, mucous membranes or open wounds. Apply only externally.
    Effect on the ability to drive transp. cf. and fur:Does not affect.
    Form release / dosage:
    Gel for external use 5%.
    Packaging:By 20 g, 30 g, 50 g or 100 g of gel in an aluminum tube. 1 tube with instructions for use in a cardboard pack.
    Storage conditions:
    In dry, the dark place 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 the product after the date shown on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001379
    Date of registration:20.12.2011
    Date of cancellation:2016-12-20
    The owner of the registration certificate:Agio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspAgio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd.
    Information update date: & nbsp09.02.2016
    Illustrated instructions
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