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

    One tablet contains:

    active substances - metamizole sodium monohydrate in terms of metamizol sodium - 500.00 mg, pituopenone hydrochloride - 5.00 mg, fenpiperinium bromide - 0.10 mg;

    Excipients - lactose monohydrate - 50.00 mg, sodium hydrogen carbonate - 12.23 mg, talc - 22.50 mg, magnesium stearate - 7.50 mg, corn starch - 152.67 mg.

    Description:

    Round tablets white or white with a yellowish hue, flat, with 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:

    Combined analgesic and antispasmodic. Metamizole - a derivative of pyrazolone, has an analgesic, antipyretic and anti-inflammatory effect.Pitophenone has a direct myotropic antispasmodic effect on smooth muscles (papaverin-like action). Fentiverinia bromide has m-holinoblokiruyuschim action and has an additional myotropic antispasmodic effect on smooth muscles. The combination of the three components of the drug has a combined analgesic effect, contributes to the reduction of somatic and psychological symptoms associated with meteorological sensitivity.

    Pharmacokinetics:
    Indications:

    Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of ureter and bladder; biliary colic, intestinal colic; dyskinesia biliary tract, postcholecystectomy syndrome, chronic colitis; algodismenorea, diseases of the pelvic organs; for short-term treatment: arthralgia, myalgia, neuralgia, ischialgia. As an auxiliary: pain syndrome after surgical interventions and diagnostic procedures.

    Contraindications:

    Hypersensitivity (including the derivatives of pyrazolone), oppression of bone marrow hematopoiesis,expressed hepatic and / or renal failure, deficiency of glucose-6-phosphate dehydrogenase, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, tachyarrhythmia, severe angina, asthma, chronic heart failure, angle-closure glaucoma, prostatic hyperplasia (with clinical manifestations), ileus , megacolon, severe hypotension, pregnancy, lactation, children under 6 years.

    Carefully:

    Renal / hepatic insufficiency, bronchial asthma, propensity to arterial hypotension, hypersensitivity to other non-steroidal anti-inflammatory drugs (NSAIDs) or non-narcotic analgesics; urticaria, or acute rhinitis, triggered by the use of acetylsalicylic acid or other NSAIDs.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    Inside: after eating, without chewing, washing with water.

    Recommended daily doses:

    For adults and children over 15 years: 1-2 tablets 2-3 times a day. The maximum daily dose of 6 tablets.

    In children, the drug is used only as directed by a doctor.

    For children:

    From 13 to 15 years - 1 tablet 2-3 times a day. The maximum daily dose

    - 6 tablets (1.5 tablets 4 times a day).

    From 9 to 12 years - on Yg tablets 2-3 times a day. The maximum daily dose

    - 4 tablets (1 tablet 4 times a day).

    From 6 to 8 years old Yg tablets 2 times a day. The maximum daily dose

    - 2 tablets (by Yg tablets 4 times a day).

    Duration of intake should not exceed more than 5 days.

    Side effects:

    Allergic reactions: urticaria (including conjunctiva and mucous membranes of the nasopharynx), angioedema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

    From the urinary system: a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

    From the side of the cardiovascular system, lowering of blood pressure.

    On the part of the organs of hematopoiesis, thrombocytopenia, leukopenia, agranulocytosis (can be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of phenomena of vaginitis or proctitis).

    Anticholinergic effects: dryness of the oral mucosa, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.

    Overdose:

    Symptoms, vomiting, lowering blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions.

    Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

    Interaction:

    Due to each of the components of the drug.

    Metamizol. When used simultaneously with blockers hl-histamine receptors, butyrophenone and phenothiazine derivatives, tricyclic antidepressants, amantadine and quinidine, m-cholinoblocking action may be enhanced.

    Enhances the effects of ethanol. Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

    Tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of the drug.

    Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes with simultaneous use reduce the effectiveness of metamizole.

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

    Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole.

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

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

    Thiamazole and cytostatics increase the risk of developing leukopenia.

    The effect is enhanced codeine, b2-histamine receptor blockers and propranolol (slows the inactivation of metamizole).

    Cherry and currant juice enhances the absorption of metamizole in the gastrointestinal tract (GIT) and promotes an increase in the concentration of its active metabolites in the plasma.

    The pitofenon. Strengthens the effect of myotropic antispasmodics (drotaverin, papaverine, mebeverin, otilonium bromide), antisecretory drugs (ranitidine, famotidine).

    Fenpierverinium. When combined, increases the hypotensive effect of calcium channel blockers (nifedipine, amlodipine), clonidine and dibazole.

    Special instructions:

    During treatment with the drug is not recommended to take ethanol.

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

    It is inadmissible to use acute pains in the abdomen for relief (until the cause is clarified).

    Intolerance is very rare, but the threat of developing an anaphylactic shock after intravenous administration of the drug is relatively higher than after taking the drug inside. Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

    When treating patients receiving cytotoxic drugs, metamizole should be administered only under medical supervision. 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:

    During treatment, care should be taken for drivers of vehicles and persons involved in potentially hazardous activities,requiring rapid physical and mental response.

    Form release / dosage:

    Pills.

    For 10 tablets in a planar cell package.

    For 1, 2 or 5 contour cell packs together with instructions for medical use in the pack (№10x1, №10x2, 10x5).

    Packaging:packings, cellular, planimetric (1) -tacks, cardboard (10)
    packings, cellular, planimetric (2), cardboard
    packings, cellular, planimetric (5), cardboard
    Storage conditions:

    In a dry, protected from light 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 expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002044
    Date of registration:10.04.2013
    Expiration Date:10.04.2018
    The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus
    Manufacturer: & nbsp
    Information update date: & nbsp10.04.2013
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