Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspThe tablets are covered with an enteric membrane.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Indications:
    - Diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis; ankylosing spondylitis (Bekhterev's disease); rheumatic affections of soft tissues; osteoarthritis of peripheral joints and spine, including with radicular syndrome; arthritis in Reiter's illness; tendovaginitis, bursitis);

    - pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboschialgia, posttraumatic pain syndrome, accompanied by inflammation, postoperative pain, headache, migraine, algodismenorea, adnexitis, proctitis, toothache;

    - in the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome: pharyngitis, tonsillitis, otitis media.
    Contraindications:Hypersensitivity (including other NSAIDs), erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), bleeding from the gastrointestinal tract, bronchial asthma, triggered by the use of acetylsalicylic acid, a combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and drugs of pyrazolone series, hematopoiesis disorders, hemostasis disorders (including hemophilia), pregnancy, lactation period, children's age (up to 6 years) .
    Carefully:Anemia, bronchial asthma, decompensated chronic heart failure, arterial hypertension, edematous syndrome, hepatic and / or renal insufficiency, alcoholism, inflammatory bowel disease, erosive and ulcerative diseases of the gastrointestinal tract without exacerbation, diabetes mellitus, condition after extensive surgical interventions, inducible acute hepatic porphyria, elderly age, diverticulitis, systemic connective tissue diseases, children's age (6-12 years).
    Dosing and Administration:
    Inside, during or after a meal, without chewing, with a small amount of water. Adults and adolescents - 25-50 mg 2-3 times a day. When the optimal therapeutic effect is achieved, the dose is gradually reduced and switched to maintenance treatment at a dose of 50 mg / day. The maximum daily dose is 150 mg.

    Children older than 6 years of age, the drug is prescribed at the rate of 2 mg / kg of body weight per day, divided into 2-3 admission.

    With juvenile rheumatoid arthritis, the daily dose can be increased to 3 mg / kg body weight.
    Side effects:

    On the part of the digestive system. More often 1% - abdominal pain, sensation of bloating, diarrhea, nausea, constipation, flatulence, increased level of "liver" transaminases, peptic ulcer, including with possible complications (perforation, bleeding), gastrointestinal bleeding without ulcers. Less often 1% - vomiting, jaundice, melena, the appearance of blood in the stool, the defeat of the esophagus, aphthous stomatitis, dryness of the mucous membranes (including the oral cavity), hepatitis (possibly lightning), liver necrosis, cirrhosis, hepatorenal syndrome, appetite change, pancreatitis, cholecystopancreatitis, colitis, u

    From the nervous system. More often 1% - a headache, dizziness. Less 1% - insomnia, drowsiness, depression, irritability; aseptic meningitis (usually in patients with systemic lupus erythematosus and other connective tissue diseases), cramps, weakness, disorientation, nightmares, feeling of fear., spasm, weakness.

    From the sense organs. More often 1% - noise in ears. Less than 1% - blurred vision, taste disturbance, reversible or irreversible hearing loss, scotoma.

    From the skin. More often 1% - a skin rash, itching of the skin. Less than 1% - areata, urticaria, eczema, chronic dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity melkotochechnye hemorrhage.

    From the genitourinary system. More often 1% - fluid retention. Less than 1% - nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal insufficiency, azotemia.

    From the organs of hematopoiesis and the immune system. Less 1% - anemia (including hemolytic and aplastic), leukopenia,thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, worsening of the course of infectious processes (including the development of necrotizing fasciitis).

    From the respiratory system. Less than 1% - cough, bronchospasm, laryngeal edema, pneumonitis.

    From the cardiovascular system. Less than 1% - increased blood pressure, congestive heart failure, extrasystole, chest pain.

    Allergic reactions. Less often 1% - anaphylactoid reactions, anaphylactic shock (usually develops rapidly) swelling of the lips and tongue, allergic vasculitis.

    Overdose:
    Symptoms: vomiting, dizziness, headache, dyspnea, confusion, in children - myoclonic cramps, nausea, abdominal pain, bleeding, impaired liver and kidney function.

    Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy, forced diuresis. Hemodialysis is ineffective.
    Interaction:
    Increases the concentration in the plasma digoxin, lithium, cyclosporine, methotrexate.

    Reduces the effects of diuretic, hypotensive and hypnotics.

    Against the background of potassium-sparing diuretics, the risk of pescherkalemia increases, against the background of anticoagulants, antiaggregants and thrombolytic drugs - the risk of bleeding.

    Increases the likelihood of side effects of other non-steroidal anti-inflammatory drugs and glucocorticosteroids (bleeding in the gastrointestinal tract), toxicity of methotrexate and cyclosporine

    Acetylsalicylic acid reduces the concentration of diclofenac in the blood. The combination with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.

    With simultaneous use with oral antidiabetic drugs reduces their hypoglycemic effect.

    Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.

    Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.

    Simultaneous administration with ethanol, colchicine, corticotropin and preparations of St. John's wort increases the risk of bleeding in the gastrointestinal tract.

    Preparations that cause photosensitization, increase the sensitizing effect of diclofenac to UV irradiation.

    Drugs that block tubular secretion, increase the concentration of diclofenac in plasma.
    Special instructions:
    In order to quickly achieve the desired therapeutic effect diclofenac take 30 minutes before meals. In other cases, take before, during or after a meal without chewing, drinking with a sufficient amount of water.

    Because of the important role of prostaglandins in maintaining renal blood flow, caution should be exercised in appointing patients with cardiac or renal insufficiency, as well as in the treatment of elderly people taking diuretics and patients who for any reason have a decrease in circulating blood volume for example, after major surgery). If in such cases appoint diclofenac, recommend as a precautionary measure to monitor kidney function.

    In patients with renal insufficiency with JS less than 10 ml / min. the equilibrium concentration of metabolites in plasma should theoretically be significantly higher than in patients with normal renal function,however, this is not really observed, since in this situation the excretion of metabolites with bile is enhanced.

    In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis), the kinetics and metabolism do not differ from similar processes in patients with normal liver function. When performing long-term therapy, it is necessary to monitor the function of the liver, the picture of peripheral blood.

    During the treatment period, the speed of mental and motor reactions may decrease. It is recommended to refrain from driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
    Form release / dosage:
    Tablets, covered with enteric coating, 25 mg each.
    Packaging:
    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. 3 contour mesh packages together with instructions for use are placed in a pack of cardboard.
    Storage conditions:List B. In a dry, the dark place at a temperature of no higher than 25 ° C. 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:On prescription
    Registration number:P N000523 / 01
    Date of registration:07.08.2007
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.03.2016
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