Spazmil-M (Spasmil-M)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppills
Composition:

One tablet contains:

active substances: metamizole sodium 500.00 mg, pituopenone hydrochloride 5.25 mg, fenpiperinium bromide 0.10 mg;

Excipients: cellulose microcrystalline (13.45 mg), wheat starch (38.20 mg), povidone K-25 (15.50 mg), talc (18.00 mg), magnesium stearate (8.30 mg), silicon dioxide colloid 6.20 mg), lactose monohydrate (10.00 mg), sodium hydrogen carbonate (5.00 mg).

Description:Round, flat tablets, from white to almost white, with a facet and a risk.
Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic agent + antispasmodic)
ATX: & nbsp
  • Spasmolytics in combination with analgesics
    • Pharmacodynamics:

    Combined drug with a pronounced antispasmodic and analgesic effect, which is caused by a combination of effects of individual components, as well as their mutual enhancement.

    Metamizol sodium is a derivative of pyrazolone with a pronounced analgesic, antipyretic effect and a weak anti-inflammatory effect.

    Pitophenone hydrochloride is myotropic antispasmodic. Has a direct effect on the smooth muscles of the internal organs, causing their relaxation (papaverin-like action).

    Fentipierinium bromide, being an m-holinoblokatorom, has an additional spasmolytic effect on smooth muscles.

    Indications:

    Pain in colic of the gastrointestinal tract, gall bladder, with renal colic, spastic dyskinesia of the biliary tract, dysmenorrhea, with spasms of the ureter; to eliminate spasm of smooth muscles in endoscopic and functional studies of the gastrointestinal and urogenital tract; with postoperative pain.

    Contraindications:

    Hypersensitivity to the drug components and other pyrazolone derivatives; diseases of the blood system; marked hepatic and / or renal insufficiency; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; severe angina; decompensated chronic heart failure; angle-closure glaucoma; hyperplasia of the prostate (with clinical manifestations); intestinal obstruction; megacolon; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history); lactation period; children's age till 15 years.

    Carefully:

    With a tendency to arterial hypotension; with renal and hepatic impairment; hypersensitivity to non-steroidal anti-inflammatory drugs.

    Pregnancy and lactation:

    Application during pregnancy and during lactation is contraindicated.

    Dosing and Administration:

    Tablets are taken orally, after eating, with a small amount of liquid.

    1-2 tablets 2-3 times a day.

    The maximum daily dose is 6 tablets.

    The drug is not recommended for more than 5 days without medical supervision.

    Side effects:

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

    From the urinary system: renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

    From the hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia.

    From the gastrointestinal tract: rapid suppression of appetite, dry mouth, nausea, vomiting, dyspepsia, abnormalities in liver enzymes.

    Other: decrease in arterial pressure, impaired vision, expressed in the form of accommodation paresis.

    Overdose:

    With prolonged use of the drug (more than 1 week), it is necessary to monitor the pattern of peripheral blood and the functional state of the liver and kidneys. If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.

    Symptoms: nausea, vomiting, gastralgia, oliguria, hypothermia, lowering of blood pressure, tachycardia, dyspnea, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal and / or hepatic insufficiency, convulsions, respiratory muscle paralysis.

    Treatment: gastric lavage, the use of activated carbon, the use of water-salt solutions, the implementation of forced diuresis, hemodialysis, with the development of convulsive syndrome - iv injection of diazepam and fast acting barbiturates.

    Interaction:

    Simultaneous use with other analgesics-antipyretics, tricyclic antidepressants, contraceptive hormonal agents and allopurinol may lead to an increase in the toxicity of metamizole sodium.

    When used simultaneously with cyclosporine, the concentration of the latter in the blood decreases.

    Metamizole sodium, displacing from the connection with plasma proteins, oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin, can cause an increase in their effect.

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

    Sedative and anxiolytic (tranquilizers) funds increase the analgesic effect of the drug.

    Thiamazole, cytostatics and other myelotoxic drugs increase the risk of developing leukopenia.

    The effect of the drug can be enhanced by simultaneous administration with codeine, H blockers2-gistaminovyh receptors and propranolol (the latter slows its inactivation).

    Ethanol increases the side effects of the drug.

    Special instructions:

    It is inadmissible to use the drug to stop acute pain in the abdomen (until finding out the cause).

    During the treatment with the drug is not recommended to drink alcohol.

    The composition of the drug as an auxiliary substance is wheat starch,which can be dangerous for patients with celiac disease.

    The formulation includes an auxiliary lactose. Patients with rare hereditary problems of intolerance to fructose, galactose intolerance, galactosemia or glucose-galactose malabsorption should not use this drug.

    Effect on the ability to drive transp. cf. and fur:

    Does not affect the driving of cars and the performance of work that requires concentration of attention.

    Form release / dosage:

    Pills.

    Packaging:

    For 10 tablets in a blister of white opaque PVC film and aluminum foil.

    For 1 or 2 blisters in a cardboard box with instructions for use.

    Storage conditions:

    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 expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001547
    Date of registration:29.02.2012
    Date of cancellation:2017-06-23
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria
    Information update date: & nbsp23.06.2017
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