Enerion tablets 200mg, no. 20

Symptomatic treatment of functional asthenia.

Inside. For adults only.
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.

Active substance: Sulbutiamine - 200 mg

Excipients:
corn starch 12.0 mg, dried starch paste 40.0 mg, glucose (dextrose) anhydrous 20.0 mg, lactose monohydrate 65.5 mg, magnesium stearate 3.50 mg, talc 9.00 mg;

Shell composition: sodium bicarbonate 0.603 mg, sodium carboxymethyl cellulose 0.556 mg, white beeswax 0.201 mg, titanium dioxide (E171) 8.430 mg, ethyl cellulose 0.485 mg, sunset yellow FCF (E110) 3.000 mg, glycerol monooleate 0.242 mg, polysorbate 80 0.302 mg, povidone 0.692 mg, sucrose 106.956 mg, colloidal anhydrous silicon dioxide (Aerosil 130Ѓ) 0.404 mg, talc 28.210 mg.

Hypersensitivity to any component of the drug.

Carefully

The drug is not recommended for persons under 18 years of age due to the lack of clinical data.

Trade (proprietary) name of the drug : ENERIONЃ

International Non-Proprietary Name (INN) : Sulbutiamine

Dosage form : film-coated tablets.

Composition

Active substance: Sulbutiamine - 200 mg

Excipients:
corn starch 12.0 mg, dried starch paste 40.0 mg, glucose (dextrose) anhydrous 20.0 mg, lactose monohydrate 65.5 mg, magnesium stearate 3.50 mg, talc 9.00 mg;

Shell composition: sodium bicarbonate 0.603 mg, sodium carboxymethyl cellulose 0.556 mg, white beeswax 0.201 mg, titanium dioxide (E171) 8.430 mg, ethyl cellulose 0.485 mg, sunset yellow FCF (E110) 3.000 mg, glycerol monooleate 0.242 mg, polysorbate 80 0.302 mg, povidone 0.692 mg, sucrose 106.956 mg, anhydrous colloidal silicon dioxide (Aerosil 130Ѓ) 0.404 mg, talc 28.210 mg.

Description

Round, biconvex film-coated tablets, orange. Slight non-uniformity of the surface (in terms of glossiness), coloring and the presence of slight inclusions are allowed.

Pharmacotherapeutic group :

An agent that regulates metabolic processes in the central nervous system.

ATX code : A11DA02

Pharmacological properties

Pharmacodynamnka
The drug ENERION is a synthetic compound similar in structure to thiamine, in comparison with which the molecule has an open thiazole ring, an additional disulfide bond, and a lipophilic ester. Thanks to this modification, sulbutiamine is highly soluble in fats, rapidly absorbed from the gastrointestinal tract and easily penetrates the blood-brain barrier.
Unlike thiamine, it is able to accumulate in cells of the reticular formation, hippocampus and dentate gyrus, as well as Purkinje cells and glomeruli of the granular layer of the cerebellar cortex. Against the background of taking the drug ENERION, coordination of movement improves and resistance to physical exertion increases, the resistance of the structures of the cerebral cortex to repeated anoxia increases. The drug is effective in the symptomatic treatment of functional asthenia.

Pharmacokinetics
Sulbutiamine is rapidly absorbed, the concentration of the drug in the blood plasma reaches a maximum (Cmax) in 1-2 hours after administration.
The half-life (T1 / 2) is about 5 hours. The drug is excreted in the urine.

Indications for use

Symptomatic treatment of functional asthenia.

Contraindications

Hypersensitivity to any component of the drug.

Carefully

The drug is not recommended for persons under 18 years of age due to the 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 to be taken during pregnancy, as well as during breastfeeding, since it is currently not known whether sulbutiamine is able to pass into breast milk.

Method of administration and dosage

Inside. For adults only.
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 effect

Allergic reactions (the presence of yellow sunset dye), digestive disorders, neuropsychiatric reactions (tremor, headache, agitation, general malaise).

Overdose

Symptoms (agitation with euphoria and tremors of the extremities) are transient and do not require special treatment.

Interaction with other medicinal products

Absent.

special instructions

The excipients of the drug include lactose monohydrate. As a result, this drug is not recommended for people with lactose deficiency, galactosemia, or glucose / galactose malabsorption syndrome.

Influence on the ability to drive a car and perform work that requires a high speed of psychomotor reactions.

Does not affect.

Release form

Film-coated tablets, 200 mg.
10 tablets per blister (PVC / Al). 2 blisters with instructions for medical use in a cardboard box.
15 tablets per blister (PVC / Al). 2 or 4 blisters with instructions for medical use in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ? C, out of the reach of children.

Shelf life

3 years. Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies

Dispensed by prescription.