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Dosage form: & nbsppills
Composition:

1 the tablet contains:

active substances: ethyl bromizovalerianate (ethyl ester of α-bromoisovaleric acid) - 12.42 mg, phenobarbital - 11.34 mg, peppermint mint oil - 0.88 mg; Excipients: lactose monohydrate - 285.25 mg, magnesium stearate - 4.00 mg, betadix (beta-cyclodextrin) - 85.71 mg, acesulfame potassium - 0.40 mg.

Description:Round biconvex tablets of white color.
Pharmacotherapeutic group:Sedative remedy
ATX: & nbsp
  • Other sleeping pills and sedatives
  • Pharmacodynamics:

    Combined drug, has a sedative and spasmolytic effect, facilitates the onset of natural sleep.

    Ethyl bromoisovalerian has a sedative and spasmolytic effect due to irritation, mainly of the oral and nasopharyngeal receptors, a decrease in reflex excitability in the neutral parts of the nervous system and an increase in inhibition in neurons of the cortex and subcortical structures of the brain, as well as a decrease in the activity of the central vasomotor centers and direct local antispasmodic effect on smooth musculature.

    Phenobarbital has sedative (in small doses), hypnotic, miorelaxing and spasmolytic action, helps to reduce excitation of the central nervous system (CNS) and facilitates the onset of sleep, enhances the sedative effect of other components.

    Mints of peppery leaves the oil has a reflex vasodilating, spasmolytic, mild choleretic, antiseptic action. 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 (GIT), enhances intestinal peristalsis.
    Pharmacokinetics:

    Data on the pharmacokinetics of ethyl bromoisovalerianate and components of peppermint mint are absent.

    Ingestion phenobarbital absorbed slowly, completely. The maximum concentration in blood plasma is determined after 1-2 hours, the connection with plasma proteins - 50%, in newborns - 30-40%. Metabolized in the liver, induces microsomal isoenzymes of the liver CYP3A4, CYP3A5, CYP3A7 (the rate of enzymatic reactions increases 10-12 times). Cumulates in the body. The half-life is 2-4 days. It is excreted by the kidneys in the form of glucuronide, about 25% - in unchanged form, penetrates into breast milk and through the placental barrier.

    Indications:

    As a symptomatic (soothing and vasodilating) remedy for functional disorders of the cardiovascular system, with neurosis-like conditions, accompanied by increased irritability, disturbance of falling asleep, tachycardia, arousal state with pronounced vegetative manifestations; as an antispasmodic - for intestinal spasms.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - Severe violations of the liver and / or kidney function;

    - hepatic porphyria;

    - age under 18 years (efficiency and safety not established);

    - pregnancy, the period of breastfeeding;

    - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

    Carefully:

    Impaired liver and / or kidney function.

    If you have any of the listed diseases / conditions, always consult a doctor before taking the drug.

    Pregnancy and lactation:

    The use of Corvalol Forte during pregnancy and during breastfeeding is contraindicated, since the drug contains phenobarbital, which penetrates the placenta and has a teratogenic effect, has a negative effect on the formation and further functioning of the central nervous system of the fetus and newborn; penetrates into breast milk, it is possible the development of physical dependence in the newborn. If it is necessary to use during the period of difficult feeding, the question of stopping breastfeeding should be resolved.

    Dosing and Administration:

    The drug should be administered orally, with water, before meals.

    Adults appoint usually 1 tablet 2 times a day. With tachycardia, it is possible to increase the single dose to 2 tablets. The maximum daily dose of the drug is 4 tablets. Dosage and duration of treatment are set by the doctor individually for each patient.

    Side effects:

    Drowsiness, dizziness, slow heart rate, decreased ability to concentrate, allergic reactions. There may be violations from the gastrointestinal tract. These phenomena occur with a decrease in the dose of the drug or discontinuation of the drug.

    With prolonged use of the drug, there may be drug dependence, addiction, the "withdrawal" syndrome, as well as the accumulation of bromine in the body and the development of bromine phenomena (depressive mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements).

    If any of the side effects listed in the instruction are aggravated, or you notice any other side effects, not specified in the instructions, inform the doctor about it.

    Overdose:

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

    Treatment: discontinuation of the drug, gastric lavage and symptomatic therapy, with CNS depression - caffeine, nikethamide.

    Interaction:

    Drugs that depress the central nervous system, enhance the effect of the drug. Phenobarbital (inducer of microsomal oxidation) can reduce the effectiveness of drugs metabolized in the liver (incl.derivatives of coumarin, griseofulvin, glucocorticosteroids, oral contraceptives); strengthens the action of local anesthetic, analgesic and hypnotic drugs. The drug increases the toxicity of methotrexate.

    The effect of the drug is enhanced by the use of valproic acid preparations.
    Special instructions:

    The experience of using the drug in children under 18 years is absent.

    During the use of the drug should not drink alcohol.

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

    The preparation contains phenobarbitalTherefore, patients taking Corvalol Fort should refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms, dispatcher, operator).

    Form release / dosage:

    Pills.

    Packaging:

    For 10 tablets in a blister of a polyvinyl chloride light barrier film and aluminum foil printed lacquered.

    For 1.3 or 5 blisters together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004336
    Date of registration:13.06.2017
    Expiration Date:13.06.2022
    The owner of the registration certificate:FARMAK, PAO FARMAK, PAO Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp23.10.2017
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