Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspTablets of prolonged action, covered with a film membrane.
    Composition:
    One tablet contains:

    Active ingredient: Diclofenac sodium - 100 mg.

    Excipients: hydroxypropylmethylcellulose, calcium phosphate dibasic, lactose, polyvinylpyrrolidone K30, magnesium stearate, talc; Sheath: hydroxypropylmethylcellulose, polyethylene glycol 6000, diethyl phthalate, titanium dioxide, iron oxide red.
    Description:Reddish brown round, biconvex tablets.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:Diclofenac has anti-inflammatory, analgesic and antipyretic effects. Diclofenac oppresses the synthesis of prostaglandins and thus affects the pathogenesis of inflammation, the onset of pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac promotes a significant reduction in the severity of pain, morning stiffness, swelling of the joints,which improves the functional state of the patient. With injuries, in the postoperative period diclofenac reduces pain and inflammatory swelling.
    Pharmacokinetics:
    Diclofenac is quickly and completely absorbed after ingestion.

    The maximum concentration after taking retard 100 mg tablets is reached after 4 hours and is 0.5 μg / ml. 99% of diclofenac binds to plasma proteins, namely albumins. Diclofenac penetrates into the synovial fluid, where the maximum concentration reaches 2-4 hours later than in the plasma. When ingesting about 50% of diclofenac is metabolized in the liver "on the first pass." The systemic clearance of the active substance is approximately 263 ml / min. Half-life is 1-2 hours. Approximately 60% is excreted by the kidneys in the form of metabolites, less than 1% remains unchanged in the urine, the rest is excreted as metabolites with bile.
    Indications:
    Diclofenac is used for:

    - Acute arthritis of various genesis (including gout);

    - Chronic arthritis, especially with rheumatic arthritis (chronic polyarthritis);

    - Ankylosing spondylitis (Bechterew's disease) and other inflammatory-rheumatic diseases of the spine;

    - Arthrosis and spondyloarthrosis (inflammation in degenerative diseases of the joints and spine);

    - Rheumatism of soft tissues;

    Painful swelling and inflammation after trauma and surgical interventions;

    - Non-rheumatic inflammatory pain conditions.
    Contraindications:
    - Erosive-ulcerative lesions of the gastrointestinal tract in the phase of exacerbation;

    - Information about attacks of bronchial asthma, hives, acute rhinitis associated with the use of acetylsalicylic acid or other NSAIDs;

    - Hypersensitivity to diclofenac or components of the drug;

    - Disturbances of hemopoiesis of unclear etiology;

    - III trimester of pregnancy;

    - In children under 6 years of age (see Warnings).
    Carefully:With special caution appoint the drug to patients with liver, kidney and gastrointestinal disease history, with bronchial asthma, allergic ("hay") runny nose, polyps of the nasal mucosa, dyspeptic symptoms at the time of prescription, arterial hypertension, heart failure, immediately after serious surgical interventions, in the first and second trimesters of pregnancy and lactation period, as well as the elderly.Because of the high content of active ingredient, retard tablets of 100 mg are not recommended for children under 18 years of age.
    Dosing and Administration:It is established individually taking into account the severity of the disease. The maximum daily dose is 150 mg. Retard tablets are usually prescribed 1 time per day in a single dose of 100 mg. Tablets should be taken before eating without chewing, washing with water.
    Side effects:

    From the gastrointestinal tract: nausea, vomiting, diarrhea, epigastric pain, abdominal cramps, dyspepsia, flatulence, anorexia, constipation; In rare cases, the occurrence of erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract.

    From the nervous system: sometimes there is headache, dizziness, sleep disturbances (insomnia or drowsiness), excitement, in some cases, marked sensitivity disorders, disorientation, memory impairment, sight, hearing, taste sensations, tinnitus, cramps, irritability, tremor, mental disorders, depression, anxiety, aseptic meningitis.

    Allergic manifestations: sometimes a skin rash occurs, seldom - hives, individual cases of eczema, polymorphic erythema, erythroderma,rarely had attacks of bronchial asthma, systemic anaphylactic reactions, in some cases, vasculitis, pneumonitis.

    From the side of the kidneys: rarely edema, in acute cases, acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria.

    From the side of the liver: transient increase in transaminase activity in the blood, rarely - hepatitis, in some cases fulminant hepatitis.

    On the part of the hematopoiesis system: individual cases of development of thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia are described.

    From the side of the cardiovascular system: single cases of tachycardia, arterial hypertension, congestive heart failure were noted.

    Overdose:
    Symptoms: The clinical picture is determined by violations from the central nervous system (headache, dizziness, increased excitability, hyperventilation phenomena with increased convulsive readiness) and gastrointestinal disorders (abdominal pain, nausea, vomiting).

    Treatment: There is no specific antidote. In case of an overdose, intensive medical care and symptomatic treatment are necessary.
    Interaction:
    With simultaneous application of Diclofenac and:

    - Digoxin, phenytoin, or lithium preparations - the level of plasma levels of these drugs may increase;

    - Diuretics and antihypertensive drugs - the effect of these drugs may decrease;

    - Potassium-sparing diuretics - there may be hyperkalemia;

    - Other NSAIDs or glucocorticoids - increased risk of side effects from the gastrointestinal tract;

    - Acetylsalicylic acid - there may be a decrease in the concentration of Diclofenac in the blood serum;

    - Cyclosporine - may increase the toxic effect of the latter on the kidneys;

    - Antidiabetics - can cause hypo or hyperglycaemia. With this combination of funds, blood sugar levels need to be monitored;

    - Methotrexate within 24 hours before or after its administration - may lead to an increase in the concentration of methotrexate and to an increase in its toxic effect;

    - Anticoagulants - regular monitoring of blood coagulability is necessary.
    Special instructions:During the treatment with the drug should be a systematic control of the picture of peripheral blood, liver function, kidneys, examination of feces for the presence of blood.Patients taking the drug should refrain from types of action that require increased attention and rapid mental and motor reactions, alcohol consumption.
    Form release / dosage:Retard tablets, film-coated, 100 mg.
    Packaging:
    10 tablets in a blister pack. For 1, 2 or 5 blisters in a pack of cardboard along with instructions for medical use.
    Storage conditions:In a dry place at a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use the drug with expired shelf life.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014584 / 01-2002
    Date of registration:19.01.2009
    The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India
    Information update date: & nbsp25.02.2016
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