Sedal-M® (Sedal-M®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCodeine + Caffeine + Metamizol sodium + Paracetamol + PhenobarbitalCodeine + Caffeine + Metamizol sodium + Paracetamol + Phenobarbital
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    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substances: paracetamol 300.00 mg, metamizole sodium 150.00 mg, caffeine 50.00 mg, phenobarbital 15.00 mg, codeine phosphate hemihydrate 10.20 mg (equivalent to 10.00 mg of codeine phosphate)

    Excipients: lactose monohydrate (37.80 mg), starch corn (20.00 mg), sodium carboxymethyl starch (Type A) (20.00 mg), povidone K-25 (30.00 mg), magnesium stearate (7.00 mg), talcum powder (10.00 mg).

    Description:

    Flat, round tablets of white or almost white color with a smooth surface, with a facet and a risk.

    Pharmacotherapeutic group:Analgesic agent (analgesic opioid + NSAID + analgesic non-narcotic + psychostimulant + barbiturate)
    ATX: & nbsp

    N.02.B.B.72   Metamizole sodium in combination with psycholeptics

    Pharmacodynamics:

    The combined preparation, has analgesic, antipyretic and antimigraine action. Eliminates the symptoms of "colds" and flu. Paracetamol has antipyretic, analgesic effect.
    Metamizole     - non-steroidal anti-inflammatory drug, has an anesthetic,    spasmolytic effect on the smooth muscles of the urinary and biliary tract. Caffeine has a general tonic effect (reduces drowsiness and fatigue, increases mental and physical performance, increases the heart rate, increases blood pressure in hypotension). Codeine has an analgesic effect and improves the tolerance of pain; phenobarbital - sedative and spasmolytic action.

    Indications:

    Weak and moderately expressed pain syndrome of different genesis: headache, toothache, migraine, pain in muscles and joints, neuralgia, with painful menstruation, with radiculitis, with traumatic and postoperative pain.

    Sedal-M is also used to reduce high fever with "colds", other infectious and inflammatory diseases and flu.

    Contraindications:

    Hypersensitivity to the components of the drug. Pronounced violations of the liver and kidneys; peptic ulcer of the stomach and duodenum (in the stage of exacerbation);bronchospasm; conditions accompanied by respiratory depression, blood diseases (leukopenia, hemolytic anemia); increased intracranial pressure, craniocerebral trauma; acute myocardial infarction; heart rhythm disturbances; high blood pressure; deficiency of glucose-6-phosphate dehydrogenase; alcoholic intoxication; pregnancy and lactation; children's age (up to 12 years).

    Carefully:FROM caution: apply in patients with impaired renal or hepatic function, with gastric ulcer and duodenal ulcer in remission, in the elderly.
    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Inside with eating, squeezed with liquid. Is taken when one tablet is needed. If there is no satisfactory effect, you can take 1 tablet 4 times a day. The maximum single dose - 2 tablets, and the daily - 6 tablets.

    The drug should not be taken more than 5 days with an appointment as an anesthetic and more than 3 days as an antipyretic. The doctor adjusts the dose and the interval between doses.

    Side effects:

    Allergic reactions (rash, itching, urticaria), dizziness, drowsiness, decreased speed of psychomotor reactions, leukopenia, granulocytopenia, agranulocytosis, palpitation, nausea and vomiting, constipation. With prolonged uncontrolled admission in high doses, it is possible: a violation of the liver and kidney function; addiction (weakening of the analgesic effect); drug dependence (codeine). All side effects of the drug, including those not listed in this manual, should be reported to your doctor.

    Overdose:

    When an overdose of the drug comes the oppression of the central nervous system, expressed by dizziness, drowsiness, slowing down of reflexes, sometimes by dry mouth, respiratory depression, considerable weakness, and sometimes loss of consciousness.

    Treatment: induce vomiting, rinse the stomach with water, take Activated carbon and conduct symptomatic treatment.

    Interaction:

    Pharmacodynamic: simultaneous use of the drug with other non-narcotic analgesics may lead to an increase in toxic effects. Tricyclic antidepressants, oral contraceptives, allopurinol increase the toxicity of metamizole sodium.Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium. At repeated reception paracetamol can enhance the effect of anticoagulants (derivatives of dicumarin). Sedatives and tranquilizers increase the sedative effect of Sedal-M®.

    Pharmacokinetic: adsorbents, astringents and enveloping agents can reduce the absorption of codeine that is part of the drug in the gastrointestinal tract.

    Simultaneous use of metamizole sodium with cyclosporine reduces the level of the latter in blood plasma. Caffeine accelerates the absorption of ergotamine. Metoclopramide accelerates the absorption of paracetamol.

    Special instructions:

    At long (more than 5 days) the use of the drug requires control of the picture of peripheral blood and the functional state of the liver.

    Taking the drug may make it difficult to establish a diagnosis with abdominal pain syndrome, including with an "acute" abdomen. In patients with atopic bronchial asthma, pollinosis, there is an increased risk of developing hypersensitivity reactions. Can change the results of tests of doping control athletes.

    Due to the fact that lactose is included in the preparation, patients with rare hereditary problems of intolerance to fructose, galactose, galactoseemia or glucose-galactose malabsorption should not be taken Sedal-M®.

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

    Most of the components act on the central nervous system, altering the psychomotor reactions, so it is not recommended to take the drug while driving a car and working on cars that require increased attention.

    Form release / dosage:

    Pills.

    Packaging:For 10 tablets in blisters of PVC film and aluminum foil. For 1 or 2 blisters together with instructions for use in a cardboard bundle.
    Storage conditions:

    In dry, 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 the drug after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013053 / 01
    Date of registration:31.08.2007
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Manufacturer: & nbsp
    Information update date: & nbsp03.09.2012
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