Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspspray for external use
    Composition:

    1 dose (0.2 g) of the preparation contains:

    active substance - diclofenac sodium 8 mg;

    Excipients: propylene glycol 30 mg, isopropanol 20.5 mg, lecithin soy 19,996 mg, ethanol 6.644 mg, sodium dihydrogen phosphate dihydrate 0.24 mg, sodium hydrogen phosphate dodecahydrate 1.32 mg, disodium edetate 0.08 mg, peppermint edetate oil 0.4 mg , ascorbyl palmitate 0.04 mg, water 112.76 mg.

    Description:Transparent liquid of yellow color, with a characteristic smell of isopropanol and mint.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:Has anti-inflammatory, analgesic and antipyretic effect. By indiscriminately inhibiting cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2), it breaks the metabolism of arachidonic acid, reduces the amount of prostaglandins in the inflammatory focus. The most effective for inflammatory pain. The water-ethanol base additionally has a local anesthetic effect.
    Pharmacokinetics:

    After applying 1.5 grams of the drug to the skin, diclofenac is rapidly absorbed (system absorption is no more than 6%), resulting in a diclofenac concentration in the plasma of about 0.001 μg / ml in the first 30 minutes, then, within 24 hours, the maximum level of diclofenac is reached 0.003 μg / ml. The observed concentration of diclofenac is almost 50 times less than the concentration after oral administration of the equivalent dose of the drug.

    The binding of diclofenac to blood proteins is about 99%. 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.

    Diclofenac is predominantly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma.

    The metabolism of diclofenac is partly due to glucuronization of the unmodified molecule, but mainly through single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted into glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

    The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min. The final half-life is 1-2 hours. The half-life of metabolites, including two pharmacologically active metabolites, is also short-lived and is 1-3 hours. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer half-life, however, this the metabolite is completely inactive. Most of the diclofenac and its metabolites are excreted in the urine.

    Indications:

    Inflammatory diseases of the musculoskeletal system (soft tissue lesions); traumatically caused inflammation of the tendons, ligaments, muscles and joints (as a result of stretching, with the load and bruises). Pain syndrome (myalgia neuralgia, tendovaginitis, bursitis, soft tissue rheumatic diseases, degenerative diseases of the musculoskeletal system: deforming osteoarthritis, osteochondrosis).

    The drug is used in adults and children older than 15 years; is intended for symptomatic therapy, reducing pain and inflammation at the time of application, the progression of the disease is not affected.

    Contraindications:

    - hypersensitivity to diclofenac or to any other medicinal product froma group of non-steroidal anti-inflammatory drugs (NSAIDs), as well as any of the excipients of the drug;

    - Patients for whom the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) is accompanied by asthma attacks, hives, or acute rhinitis;

    - violation of the integrity of the skin at the site of application of the drug;

    - pregnancy (III trimester), the period of breastfeeding;

    - Children's age (up to 15 years).

    Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidney function, chronic heart failure, impaired blood clotting (including hemophilia, lengthening bleeding time, tendency to bleeding), elderly age, bronchial asthma, I and II trimesters of pregnancy.
    Pregnancy and lactation:

    During the first six months of pregnancy, you should not take the drug without special need and a large body surface area (more than 600 cm2). It is also not recommended to use the drug for a long time (more than three weeks). The drug is contraindicated in the last trimester of pregnancy.

    Like other NSAIDs, diclofenac in small amounts penetrates into breast milk. Nevertheless, the effect on the infant with the use of the drug Voltaren® spray in therapeutic doses is not expected. Due to the lack of controlled trials involving lactating women, the drug during breast-feeding should be used only on the advice of a doctor. In such cases, the Voltaren® spray preparation should not be applied to the mammary glands of nursing mothers, as well as to large areas of the skin or for a long period of time.

    Dosing and Administration:

    Outwardly. The drug should be applied only to the skin.

    With a single press on the dosing device, 0.2 g of the drug (1 dose) containing 8 mg of diclofenac is released.

    The required amount of the drug should be applied to the skin area of ​​the affected area. Depending on the area of ​​the skin area, you should make 4-5 clicks on the dispenser of the vial (0.8 - 1.0 g of the drug, contains 32-40 mg of diclofenac sodium). The drug should be gently rubbed into the skin. After this, wash your hands before completely removing the drug. After applying, you should wait a while before putting on your clothes.

    The procedure should be performed three times a day at regular intervals. The maximum single dose of the drug is 1.0 g of the drug (5 doses (clicks)).

    The maximum daily dose is 15 doses (clicks) (3.0 g of the drug contains 120 mg of diclofenac sodium).

    The drug should not be used for more than 7 days without a doctor's recommendation. If after 3 days of application the therapeutic effect is absent or the condition worsens, you should consult a doctor; After applying the drug, the hands should be washed if they are not a zone of pain localization.

    Side effects:

    Often recorded adverse reactions from the skin.

    Classification of incidence of adverse reactions:

    very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including individual messages and reactions with unknown frequency (can not be calculated based on available data). Immune system disorders:

    Very rarely: hypersensitivity (including urticaria), angioedema.

    Infectious and parasitic diseases:

    Very rarely: pustular rash.

    Disturbances from the respiratory system, chest and mediastinal organs:

    Very rarely: bronchial asthma.

    Disturbances from the skin and subcutaneous tissues:

    Often: rash, eczema, erythema, dermatitis (including contact dermatitis), itching *;

    Rarely: bullous dermatitis;

    Very rarely: the reaction of photosensitivity;

    Unknown: reaction at the application site, dry skin, burning sensation.

    * 3d in the clinical trial was recorded at 0.9%, 236 patients with ankle sprain were treated with 4-5 doses of Voltaren® spray 3 times a day (120 patients) or placebo (116 patients) on for 14 days.

    The frequency of undesirable effects can be reduced by applying the minimum effective dose over the period of the least possible duration. The total single dose of the drug should not exceed 1.0 g (equivalent to 5 doses (pressures)) of the spray.

    However, during long-term treatment (more than three weeks) and / or when applied to a large surface area (ie, more than 600 square centimeters of body surface area), there is the possibility of systemic adverse reactions.

    There can develop such reactions as abdominal pain, indigestion, disorders of the stomach and kidneys.

    Overdose:

    Symptoms: because of low systemic absorption when using a spray, an overdose is unlikely. When accidentally ingested, it is possible to develop systemic adverse reactions.

    Treatment: gastric lavage, induction of vomiting, Activated carbon, symptomatic therapy. Dialysis is ineffective due to the high degree of binding to diclofenac proteins (about 99%).

    Interaction:

    Systemic distribution of the drug in this dosage form is small, and therefore the risk of interaction with other drugs is very low.

    Voltaren® Spray can enhance the action of photosensitizing drugs.

    Joint use of the drug with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs is not recommended and is possible only on the advice of a doctor, since it may increase the risk of undesirable reactions.

    Special instructions:

    Avoid contact with eyes and mucous membranes, as well as oral administration of the drug.

    The drug should be used only on undamaged skin. Keep the bottle in an upright position.A patch of skin with the applied preparation is not recommended to be exposed to excessive sunlight to avoid the appearance of photosensitization.

    The use of the drug should be stopped immediately if skin rash occurs.

    Do not use together with sealed clothing and bandages. The preparation contains propylene glycol and mint pepper oil, which can cause skin irritation and allergic reactions.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms.
    Form release / dosage:Spray for external use dosed with 8 mg / dose.
    Packaging:

    For 12.5 g (57 doses) of the drug in a vial of 15 ml dark glass with a dosing device closed with a protective cap.

    For 25 g (114 doses) of the drug in a bottle of dark glass with a volume of 30 ml with a dosing device closed with a protective cap. 1 bottle with instructions for use in a cardboard pack.

    Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:

    3 years.

    After the first opening of the bottle: 6 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-000838
    Date of registration:10.10.2011 / 17.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNovartis Consumer Helms Ltd.Novartis Consumer Helms Ltd.
    Information update date: & nbsp05.03.2017
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