Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspGel for external use.
    Composition:
    The active substance - diclofenac sodium - 10 mg;

    auxiliary substances - lactic acid 0.44 mg (in terms of 100% substance), isopropanol 150 mg, ethanol -150 mg, sodium disulfite 0.5 mg, carbomer - up to 15 mg, trolamine - up to 30 mg (to produce a gel with a pH of 7.0 to 8.5), water - up to 1 g.
    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 cycloxygenase types 1 and 2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation. Diklovit® is used to eliminate pain syndrome and reduce swelling associated with the inflammatory process. When applied externally, it causes weakening or disappearance of pain in joints at rest and during movement.Reduces the morning stiffness and swelling of the joints, contributes to an increase in the volume of movements in the affected joints. The hydroalcoholic base of the gel additionally has a local anesthetic effect.
    Pharmacokinetics:At application the system: absorption makes no more than 6%. 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 chronic arthritis, ankylosing spondylitis, rheumatic soft tissue damage, gouty arthritis).

    Pain syndrome and inflammation of tendons, ligaments, muscles and joints as a result of stretching, with strain and bruises.

    Pain syndrome and puffiness associated with diseases of the muscles and joints (lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis, degenerative diseases of the musculoskeletal system: deforming osteoarthritis, osteochondrosis).
    Contraindications:Hypersensitivity, including to other non-steroidal anti-inflammatory drugs, violation of the integrity of the skin at the site of the intended application, younger children (up to 6 years), pregnancy (III trimester).
    Carefully:Hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), severe violations of the liver and kidney function, chronic heart failure; bronchial asthma, urticaria or acute rhinitis, triggered by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; disorders of blood clotting (including hemophilia, lengthening of bleeding time, propensity to bleeding), elderly age (over 80 years), pregnancy (I-II trimester), lactation period.
    Pregnancy and lactation:
    The drug is contraindicated for use in the III trimester of pregnancy. Use in I-II trimesters is possible if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

    Experience in using the drug during lactation is not available.
    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. A single dose of gel - 2-4 g (which in volume is comparable to the size of a large cherry or walnut).

    Children from 6 to 12 years of age should not be used more than 2 times a day, a single dose of the drug to 2 g. After applying the gel, you should wash your hands.

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

    To increase the effect, on the recommendation of the doctor, Diklovit® gel can be used in conjunction with systemic non-steroidal anti-inflammatory drugs (for example, with other Diklovita® dosage forms).
    Side effects:Local reactions: eczema, photosensitivity, contact dermatitis (pruritus, hyperemia, edema of the treated area of ​​the skin, papular-vesicular rashes, peeling). Allergic reactions (hives, angioedema, bronchospastic reactions, generalized skin rash, anaphylactic reactions (including shock)).
    Overdose:Due to low systemic absorption when applying gel, an overdose is unlikely. With accidental ingestion, it is possible to develop systemic adverse reactions. Treatment of an overdose with accidental ingestion: gastric lavage, induction of vomiting, Activated carbon, forced diuresis, symptomatic therapy.Dialysis is not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%).
    Interaction:Diklovit® can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs is not described.
    Special instructions:
    The gel is applied only to undamaged skin areas. After applying, do not apply an occlusive dressing.

    Avoid contact with eyes, mucous membranes or open wounds. 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 and / or for a long time, the risk of developing systemic side effects, characteristic of non-steroidal anti-inflammatory drugs, increases.
    Form release / dosage:Gel for external use 1%.
    Packaging:
    For 20, 30, 40 and 50 g in tubes of aluminum or polyethylene laminate, 1 tube is placed in a pack of cardboard with instructions for medical use of the drug.
    Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:2 years.Do not use the product after the expiration date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N000635 / 02
    Date of registration:10.10.2008
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Information update date: & nbsp27.02.2016
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