Active substanceMetamizol sodium + Pitofenone + Fentpiverinia bromideMetamizol sodium + Pitofenone + Fentpiverinia bromide
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  • Dosage form: & nbspPills
    Composition:

    One tablet contains:

    metamizole sodium - 0.500 g, pituophenone hydrochloride - 5 mg, fenpiverinia bromide 0.1 mg;

    Excipients:

    calcium stearate 0.0062 g, potato starch 0.1087 g.

    Description:

    Tablets are white or white with a yellowish tinge color with a flat-cylindrical surface, a risk and a facet.

    Pharmacotherapeutic group:Analgesic agent (analgesic non-narcotic remedy + antispasmodic).
    ATX: & nbsp

    N.02.B.B.52   Metamizole sodium in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Renalgan® is a combined preparation with analgesic and antispasmodic action. Reduces tone and eliminates spasms of smooth muscles of internal organs. Metamizol sodium has analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone hydrochloride has a myotropic antispasmodic effect.Fenpiverinia bromide due to anticholinergic action has an additional relaxing effect on smooth muscles. The combination of the three components of the drug leads to mutual potentiation of their pharmacological effects.

    Pharmacokinetics:

    Metamizole sodium is well and rapidly absorbed into the gastrointestinal tract. In the intestinal wall it hydrolyzes with the formation of an active metabolite - unchanged metamizol sodium in the blood is absent. The association of the active metabolite with proteins is 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into the mother's milk.

    Indications:

    Renalgan® is used as an analgesic and antispastic agent with a mild or moderate pain syndrome with spasms of the muscles of the internal organs, including in cases of renal colic, spasms of the ureter and bladder, bile and intestinal colic, chronic colitis, algodismenorrhea. As an adjuvant can be used to reduce biyi after surgical and diagnostic interventions. Can be used as an analgesic for short-term symptomatic treatment for arthralgia, neuralgia, sciatica, myalgia (muscle strain).

    Contraindications:

    Hypersensitivity to the components of the drug, diseases of the blood system, suppression of bone marrow hematopoiesis, tachycardia, decompensated heart failure, ischemic heart disease (CHD), decompensated liver and kidney dysfunction, hepatic porphyria, angle-closure glaucoma, prostatic hypertrophy, intestinal obstruction, megacolon, collapse , deficiency of glucose-6-phosphate dehydrogenase, pregnancy period, lactation period, age up to 5 years.

    Carefully:

    Renal / hepatic insufficiency, bronchial asthma, a tendency to arterial hypotension, hypersensitivity to other non-steroidal anti-inflammatory drugs, bronchial asthma, urticaria or acute rhinitis triggered by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drug.

    Pregnancy and lactation:Contraindicated
    Dosing and Administration:

    The drug is taken orally, after eating, with water.

    Adults and children over the age of 15 appoint 1-2 tablets 2-3 times a day. The daily dose should not exceed 6 tablets. Duration of reception no more than 5 days.An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician.

    Dosage for children. Children should be given the drug only as prescribed by the doctor. Dosage for children 5-7 years - half the tablet, 8-12 years - three quarters of the tablet, 13-15 years - one tablet 2-3 times a day. Other dosage regimens are possible only after consultation with a physician.

    Side effects:

    In therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions are possible (skin rash, itching, very rarely anaphylactic shock), burning sensation in the epigastric region, dry mouth, headache, dizziness, lowering blood pressure, tachycardia, decreased sweating. With propensity to bronchospasm may provoke an attack. With prolonged admission, it is possible to develop thrombocytopenia, leukopenia, agranulocytosis, which can be manifested by an unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of vaginitis or proctitis.

    Overdose:

    Exceeding the dose can cause nausea, vomiting, lowering blood pressure, drowsiness, confusion, pain in the epigastric region, impaired liver and kidney function, convulsions.Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy.

    Interaction:

    The drug can affect the psychomotor ability of the patient with simultaneous reception with alcohol and drugs that depress the central nervous system, in view of increased sedative activity of alcohol-containing drugs. The simultaneous use of Renalgan ® with non-narcotic analgesics can lead to a mutual enhancement of toxic effects. Toxic effects of metamizole sodium are enhanced by the simultaneous administration of tricyclic antidepressants, oral contraceptives, allopurinol. Antagonists of histamine H2-receptors, barbiturates, codeine with simultaneous use enhance the effect of metamizole sodium.

    When co-administered with S-histamin blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine, m-choline blocking effect may be enhanced.

    Simultaneous use with chlorpromazine or other derivatives of phenothiazine may lead to the development of severe hyperthermia.

    Phenylbutazone and others.hepatoinducers at the same time reduce the effectiveness of metamizole sodium.

    Sedative and anxiolytic drugs (drugs) (tranquilizers) increase the analgesic effect of metamizole sodium.

    Radiocontrast drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizol sodium.

    With the simultaneous administration of cyclosporine, the concentration of the latter in the blood decreases.

    Metamizole sodium, displacing from the connection with the protein, oral hypoglycemic drugs, indirect anticoagulants, glucocorticoid agents and indomethacin, can increase the severity of their action.

    Thiamazole and cytostatics increase the risk of developing leukopenia.

    Special instructions:

    During drug treatment it is not recommended to use ethanol.

    With prolonged (more than a week) treatment requires monitoring of the functional state of the liver.

    If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.

    It is not allowed to use acute pains in the abdomen for relief (until the cause is clarified).

    Use in nursing mothers requires the cessation of breastfeeding.It is possible to stain urine in red by the release of a metabolite (it has no clinical significance).

    Effect on the ability to drive transp. cf. and fur:Care should be taken during the treatment of drivers of vehicles and persons engaged in potentially hazardous activities requiring quick physical and mental reactions.
    Form release / dosage:

    10 tablets per contour cellpolyvinyl filmchloride or color film and aluminum foil foil lt; RTI ID =

    By 1 or 2 contour cellular together with the application in a pack of cardboard.

    Packaging:packings, cellular, planimetric (1) -tacks, cardboard (10)
    packings, cellular, planimetric (2), cardboard
    Storage conditions:

    Store in a dry, protected from light location at a temperature not higher

    25 ° C.

    Keep out of the reach of children place.

    Shelf life:

    2 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007576/08
    Date of registration:19.09.2008
    The owner of the registration certificate:LEKHIM-KHARKOV, CJSC LEKHIM-KHARKOV, CJSC Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp17.07.2013
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