Enerion® (Enerion®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSulbutiamineSulbutiamine
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  • Enerion®
    pills inwards 
    Servier (Ireland) Industries Ltd.     Ireland
    • Dosage form: & nbspThe tablets covered with a cover.
    Composition:
    Active substance: Sulbutiamine .................... 200 mg
    Auxiliary substances: corn starch, dried starch paste, glucose (dextrose) anhydrous, lactose monohydrate, magnesium stearate, talc, sodium hydrogen carbonate, sodium carboxyl methyl cellulose, white beeswax, titanium dioxide (E171), ethylcellulose, sunset yellow (Sunset yellow FCF, El 10), glycerol monooleate, polysorbate 80, povidone, sucrose, silicon dioxide colloidal anhydrous.
    Description:Round, biconvex tablets, coated, orange. Insignificant heterogeneity of the surface (glossiness), staining and the presence of minor impregnations are allowed.
    Pharmacotherapeutic group:A remedy that regulates metabolic processes in the central nervous system.
    ATX: & nbsp

    A.11.D   Vitamin B1 and its combination with vitamins B6 and B12

    Pharmacodynamics:
    The preparation ENERION® is a synthetic compound close in structure to thiamine, compared to which the molecule has an open thiazole ring, an additional disulfide bond, a lipophilic ester. Due to this modification, sulbutiamine is readily soluble in fats, rapidly absorbed from the gastrointestinal tract and easily penetrates the blood-brain barrier.
    Unlike thiamine, it is able to accumulate in the cells of the reticular formation, the hippocampus and the dentate gyrus, as well as the Purkinje cells and the glomeruli of the granular layer of the cerebellar cortex. Against the background of the ENERION® preparation, coordination of movement improves and resistance to physical exertion increases, the stability of the cerebral cortex structures increases to a recurring anoxia. The drug is effective in the symptomatic treatment of functional asthenia.
    Pharmacokinetics:
    Sulbutiamine is quickly absorbed, the concentration of the drug in the blood plasma reaches a maximum (Cmax) in 1 -2 hours after admission.
    The half-life (T1 / 2) is about 5 hours. The drug is excreted in the urine.
    Indications:Symptomatic treatment of functional asthenia.
    Contraindications:Hypersensitivity to any of the components of the drug.
    Carefully:Persons under 18 years of age should not be prescribed because of a lack of clinical data.
    Pregnancy and lactation:According to the results of clinical studies, the drug does not affect the development of the fetus. However, due to the lack of sufficient clinical data, ENERION® is not recommended for use during pregnancy, and also during lactation,since at the present time it is not known whether sulbutiamine penetrate into breast milk.
    Dosing and Administration:
    Inside. Only for adults.
    The daily dose of the drug: 2-3 tablets (400 - 600 mg) in two divided doses (during breakfast and lunch) The duration of treatment should not exceed 4 weeks.
    Side effects:Allergic reactions (presence in the dye yellow sanset), digestive disorders, neuropsychiatric reactions (tremor, headache, agitation, general malaise).
    Overdose:Symptoms (excitation with the phenomena of euphoria and tremor of extremities) are transient in nature and do not require special treatment.
    Interaction:Absent.
    Special instructions:
    The composition of excipients of the drug includes lactose monohydrate. As a consequence, this drug is not recommended for persons with lactose insufficiency, galactosemia or glucose / galactose malabsorption syndrome.
    Effect on the ability to drive transp. cf. and fur:Does not affect.
    Form release / dosage:
    The tablets covered with a cover, 200 mg.

    Packaging:
    For 10 tablets per blister (PVC / Al). 2 blisters with instructions for medical use in a cardboard box.
    For 15 tablets per blister (PVC / Al).For 2 or 4 blisters with instructions for medical use in a cardboard box.
    Storage conditions:At a temperature not higher than 25 ° C in a place inaccessible to children.
    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011812 / 01
    Date of registration:18.11.2009
    The owner of the registration certificate:Servier (Ireland) Industries Ltd.Servier (Ireland) Industries Ltd. Ireland
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp26.08.2015
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