Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspGel for external use.
    Composition:100 g of the preparation contains: active substance: diclofenac sodium - 5.0 g; auxiliary substances: isopropyl alcohol-45.0 g; purified water - 40.8 mg; macrogol-7-glycerol coccoate - 6.0 g; hypromellose - 3.0 g; aromatic oil "Bouquet" WN 4507 - 0,2 g
    Description:Round flat cylindrical tablets of white color, one surface of which is pink in color with white impregnations, with a facet on both sides. On the cross-section of the tablet are visible two layers: white and pink with white impregnations.
    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 (NSAID), which has pronounced analgesic and anti-inflammatory properties.

    Indiscriminately inhibiting cyclooxygenase 1 and 2 types (COX1 and COX2), violates the metabolism arachidonic acid and synthesis prostaglandins, which are the main link in development inflammation. Diclofenac is used to remove inflammation and elimination of pain syndrome, as well as reducing puffiness associated with inflammatory process.

    Pharmacokinetics:
    With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed. When applied to the area of ​​the affected joint, the concentration in the synovial fluid is higher than in
    blood plasma.
    Individual patient groups
    In patients with impaired renal function, no accumulation of diclofenac and its metabolites occurs.
    In patients with chronic hepatitis or subcompensated cirrhosis, pharmacokinetics and
    metabolism of diclofenac are comparable to those in healthy patients.
    Indications:
    - Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine; rheumatic soft tissue damage.
    - Muscular pain of rheumatic and non-rheumatic origin;
    - Traumatic injuries of soft tissues.
    Contraindications:hypersensitivity to the active substance and / or other constituents of the drug;
    - intolerance of other NSAIDs in history;
    - complete or incomplete combination of bronchial asthma,recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in anamnesis);
    - erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding, cerebrovascular or other bleeding;
    - inflammatory bowel disease (Crohn's disease, ulcerative colitis, proctitis) in the phase of exacerbation;
    - hemophilia and other bleeding disorders;
    - severe renal failure (CC less than 30 ml / min);
    - liver failure;
    - cardiac ischemia;
    - chronic heart failure (II-IV functional class according to NYHA (New York classification of the functional state of patients with chronic heart failure));
    - cerebrovascular diseases;
    - diseases of peripheral arteries;
    - increased risk of arterial thrombosis and thromboembolism;
    - early postoperative period after aortocoronary shunting;
    - lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
    - confirmed hyperkalemia;
    - pregnancy (III trimester);
    - the period of breastfeeding;
    - children's age (under 18 years).
    Carefully:
    - patients with arterial hypertension, dyslipidemia, hyperlipidemia, inflammatory
    diseases of the intestine outside the acute phase, liver disease in the history, hepatic
    porphyria, seasonal allergic rhinitis, chronic obstructive pulmonary disease,
    chronic infections of the respiratory tract, Quinck's edema, edema of the nasal mucosa (including those with nasal polyps), bronchial asthma, diabetes mellitus, systemic connective tissue diseases;
    - elderly patients with anemia and data on the development of ulcerative gastrointestinal lesions in history, perforation;
    - for infections caused by Helicobacter pylori;
    - with prolonged use of non-steroidal anti-inflammatory drugs, frequent use of alcohol;
    - with concomitant therapy with anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (prednisolone), selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline);
    - in patients receiving diuretics and other drugs that affect kidney function,as well as patients with a significant decrease in the volume of circulating blood of any etiology, for example, in periods before and after massive surgical interventions;
    - in elderly patients (including weakened patients, with low body weight), patients with severe physical illnesses, in smokers;
    - with renal failure (KK 30-60 ml / min).
    Pregnancy and lactation:The use of diclofenac in pregnant women has not been investigated. Therefore, it is not recommended to use the drug in pregnant women during the first and second trimester. Contraindicated in the use of diclofenac in pregnant women during the third trimester because of the possibility of developing weakness in the uterine labor activity and / or premature closure of the arterial duct. Studies in animals have shown no harmful effects on fetal / fetal and postnatal development. Diclofenac in small quantities penetrates into breast milk, so if you need to prescribe Diclac® during breastfeeding, you should decide whether to stop breastfeeding.
    Dosing and Administration:Outwardly.Adults and children over 6 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. A single dose of the drug - up to 2 g (about 4 cm with a fully open neck of the tube). After applying the product, the hands should be washed. The duration of treatment depends on the indications and the effect observed. After 2 weeks of use, consult a physician.
    Side effects:

    According to the World Health Organization (WHO)

    undesirable reactions are classified according to their frequency of development as follows: very often (>1/10), often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    From the gastrointestinal tract

    often: nausea, vomiting, diarrhea, indigestion, abdominal pain, bloating, anorexia;

    rarely: gastritis, vomiting with an admixture of blood, gastrointestinal bleeding, melena, stomach or bowel ulcers, possibly with complications (bleeding, perforation), frequent stools with a trace of blood, proctitis;

    rarely: esophagitis, esophageal motility disorder, nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease, constipation, stomatitis, glossitis, pancreatitis, exacerbation of hemorrhoids, intestinal adhesions.

    From the nervous system

    often: headache, dizziness;

    rarely: drowsiness;

    rarely: depression, anxiety, irritability, aseptic meningitis (more often in patients with systemic lupus erythematosus and other systemic connective tissue diseases), convulsions, weakness, disorientation, nightmarish dreams, memory impairment, tremor, cerebrovascular disorders, sensitivity disorders (including paresthesia).

    From the sense organs

    often: vertigo;

    rarely: noise in the ears, hearing impairment, blurred vision, diplopia, a violation of taste sensations.

    From the urinary system

    rarely: acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, papillary necrosis.

    On the part of the organs of hematopoiesis and lymphatic system

    rarely: anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia (thrombocytopenic purpura), eosinophilia, agranulocytosis.

    From the immune system

    rarely: allergic reactions, hypersensitivity (including hives, angioedema, bronchospasm).

    From the respiratory system

    rarely: bronchial asthma.

    From the side of the cardiovascular system

    infrequently: myocardial infarction, chronic heart failure;

    rarely: rise arterial pressure, vasculitis, a feeling of palpitations, extrasystole, chest pain cell.

    From the skin and subcutaneous tissue

    often: dermatitis (including contact dermatitis), erythema, eczema, pruritus, puffiness treated skin area, rash (papules, vesicles), peeling;

    rarely: bullous dermatitis, pustular eruptions

    rarely: photosensitization; generalized skin rash.

    From the side are baked and bile ducts

    often: increased activity of "liver" transaminases;

    rarely: jaundice, liver damage;

    rarely: hepatitis (possibly fulminant course), necrosis liver, cirrhosis, hepatorenal syndrome, hepatic failure.

    Other

    rarely: edema.

    Overdose:Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.
    Interaction:Diclac® can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.
    Special instructions:Diclac® should only be applied to intact skin, avoiding contact with open wounds. After applying, do not apply an occlusive dressing. Do not allow the product to get into the eyes and mucous membranes.

    Form release / dosage:
    Tablets of prolonged action 75 or 150 mg.
    Packaging:
    For a dosage of 75 mg:
    Primary packaging
    For 10 tablets in a blister of PVC / PVDC / A1 or PP / A1.
    Secondary packaging
    For 1, 2, 5 or 10 blisters together with instructions for use in a pack of cardboard.
    For a dosage of 150 mg:
    Primary packaging
    For 10 tablets in a blister from PP / A1.
    Secondary packaging
    For 1, 2, 5 or 10 blisters together with instructions for use in a pack of cardboard.
    Storage conditions:
    At a temperature not higher than 25 ° C in a place inaccessible to children.

    Shelf life:
    3 years. The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011215 / 01
    Date of registration:01.06.2010
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp17.02.2016
    Illustrated instructions
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