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Dosage form: & nbspdrops for oral administration
Composition:

Active substances: ethyl bromoisovalerianate (ethyl ester of alpha-bromizovaleric acid) - 2,0 g, phenobarbital-1,826 g, peppermint leaves mint (peppermint oil) - 0.142 g;

Excipients: sodium hydroxide (sodium hydroxide), ethanol 95% (ethyl alcohol 95%), purified water.

Description:

Transparent colorless liquid with a specific aromatic odor.

Pharmacotherapeutic group:Sedative remedy
ATX: & nbsp
  • Sleeping and sedatives
  • Pharmacodynamics:

    Combined drug, the effect of which is due to the properties of its constituent substances. Soothing and vasodilating agent. Has a sedative and spasmolytic effect. Facilitates the onset of natural sleep. Ethyl bromoisovalerian has sedative (similar to the valerian effect) and spasmolytic effect, which is caused by irritation of the predominantly oral and nasopharyngeal receptors, a decrease in reflex excitability in the central parts of the nervous system, and increased inhibition in neurons of the cortex and subcortical structures of the brain, as well as a decrease in activity of the central vasomotor centers and direct local antispasmodic effect on smooth muscles.

    Phenobarbital strengthens the sedative effect of other components, helps reduce the excitability of the central nervous system and facilitates the onset of sleep.

    Peppermint oil has a reflex vasodilating, antispasmodicmild, choleretic, antiseptic. The mechanism of action is associated with the ability to irritate the "cold" receptors of the oral mucosa and reflexively expand primarily the vessels of the heart and brain. Eliminates the phenomena of flatulence due to irritation of the receptors of the mucous membrane of the gastrointestinal tract, strengthening the peristalsis of the intestine.

    Indications:

    As a sedative and vasodilator with functional disorders of the cardiovascular system (including tachycardia), insomnia, neuron-like conditions, accompanied by increased irritability, the state of excitation with pronounced vegetative manifestations.

    As spasmolytic drug - intestinal spasm.

    Contraindications:

    Hypersensitivity, severe hepatic and / or renal failure, lactation period, pregnancy, children's age (up to 3 years), alcoholism, craniocerebral trauma or brain disease.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Carefully:

    Children age over 3 years.

    Pregnancy and lactation:

    The appointment of the drug during pregnancy is possible only on strict indications. If it is necessary to prescribe the drug during pregnancy, one should compare the expected benefit to the mother and the potential risk to the fetus.

    If it is necessary to prescribe the drug during the period of breastfeeding, the question of stopping breastfeeding for the period of treatment should be resolved.

    Dosing and Administration:

    Inside, before eating, pre-dissolved in a small amount (30-50 ml) of water. The dose and duration of the drug is determined individually.

    Single dose in adults - 30 drops, if necessary (for example, with severe tachycardia), a single dose can be maximally increased to 40-50 drops. Multiplicity of admission-2-3 times a day.

    Children from 3 years for 1 reception - 1 drop per year of a child's life per day. The need for a repeated dose is determined by the doctor depending on the clinical picture of the disease.

    Side effects:

    Drowsiness, dizziness, slow heart rate, decreased ability to concentrate, allergic reactions.

    With long-term admission - the phenomenon of bromism, addiction, drug dependence, withdrawal syndrome.

    Overdose:

    Symptoms: depression of the central nervous system, nystagmus, ataxia, lowering of arterial pressure, excitation, chronic intoxication with bromine (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements).

    Treatment: symptomatic, with the suppression of the central nervous system - caffeine, nikethamide.

    Interaction:

    Drugs that depress the central nervous system increase the effect.

    Phenobarbital (inducer of microsomal oxidation) can reduce the effectiveness of drugs metabolized in the liver (including coumarin derivatives, griseofulvin, glucocorticosteroid, oral contraceptives); strengthens the action of local anesthetic, analgesic and hypnotic drugs.

    Special instructions:

    During the treatment period, it is necessary to refrain from driving and other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Drops for oral administration.

    Packaging:For 15 ml, 25 ml or 50 ml in bottles - droppers of orange glass, sealed with stoppers - droppers with polyethylene with screw caps. Each vial-dropper with instructions for use is placed in a pack of cardboard.
    Storage conditions:

    In the dark place at a temperature of 8 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    1 year 6 months. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N000198 / 01
    Date of registration:22.02.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp18.01.2018
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