Instructions for Enerion:
Description Enerion:
Orange coated tablets, round, biconvex, slight heterogeneity of the surface (in terms of glossiness), coloration and the presence of slight inclusions is allowed.
1 tab.
sulbutiamine 200 mg
Excipients:
corn starch, dried starch paste
glucose (dextrose) anhydrous
lactose monohydrate
magnesium stearate
talc
Shell composition:
sodium bicarbonate
sodium carmellose
white beeswax
titanium dioxide (E171)
ethylcellulose
sunset yellow dye FCF (E110)
glycerol monooleate
polysorbate 80
povidone K-30
sucrose
anhydrous colloidal silicon dioxide (Aerosil 130 ® )
Clinical and pharmacological groups Enerion:
A drug Enerion that regulates metabolic processes in the central nervous system
Active substance Enerion:
sulbutiamine
Pharmaco-therapeutic group Enerion:
An agent that regulates metabolic processes in the central nervous system
Storage conditions Enerion:
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
pharmachologic effect Enerion:
Pharmacodynamics
Sulbutiamine is an original compound obtained from thiamine by a number of structural modifications of the thiamine nucleus: the formation of a disulfide bond, the introduction of a lipophilic ester, and the opening of the thiazole ring.
Thanks to this modification, sulbutiamine:
well soluble in fats, which allows it to be quickly absorbed from the gastrointestinal tract and easily penetrate the BBB;
is able to accumulate in the cells of the reticular formation, the hippocampus and the dentate gyrus, as well as the cells of Purkinje fibers and the glomeruli of the granular layer of the cerebellar cortex, which is confirmed by histochemical analysis.
In a placebo-controlled studies in humans, as well as active control studies have provided evidence of drug efficacy Enerion ® in the symptomatic treatment of functional asthenia.
Sulbutiamine is metabolized to thiamine (vitamin B 1 ). In combination with adenosine triphosphate (ATP), thiamine forms thiamine diphosphate (carboxylase or thiamine pyrophosphate), which takes part in carbohydrate metabolism as a coenzyme.
Indications Enerion:
states of fatigue in adults, accompanied by increased fatigue, decreased performance, weakness.
Method of application, course and dosage
Inside. For adults only.
The daily dose of the drug: 2-3 tablets (400-600 mg) in 2 divided doses (during breakfast and lunch):
1 tablet with breakfast and 1 tablet with lunch;
or 1 tablet with breakfast and 2 tablets with lunch;
or 2 tablets with breakfast and 1 tablet with lunch.
The tablets should be swallowed whole with water.
The duration of treatment should not exceed 4 weeks.
Do not exceed the recommended dose and duration of the drug.
The patient should be warned that if the condition worsens or does not improve after 4 weeks, consult a doctor.
Overdose Enerion:
No cases of overdose with sulbutiamine have been reported.
Possible symptoms: agitation with euphoria and tremors of the extremities, which are transient and do not require special treatment.
In case of overdose, the patient should immediately consult a doctor.
Treatment: symptomatic.
Drug interactions Enerion:
Clinical studies to study the interaction of sulbutiamine with other drugs have not been conducted.
Interactions to be considered:
drugs that block neuromuscular transmission (muscle relaxants): the effect of these drugs can increase when taken simultaneously with thiamine (a metabolite of sulbutiamine);
diuretics: urinary excretion of thiamine (sulbutiamine metabolite) increases.
Application during pregnancy and lactation
Data on the use of sulbutiamine in women during pregnancy are limited. As a precautionary measure, use during pregnancy and breastfeeding is contraindicated.
Side effect Enerion:
The frequency of adverse reactions that may occur during therapy is shown in the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rare (<1/10 000); unspecified frequency (frequency cannot be estimated from available data).
Contraindications for use Enerion:
age up to 18 years (due to lack of clinical data);
pregnancy;
period of breastfeeding;
lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency, fructose intolerance (see the section "Special instructions") due to the content of glucose, lactose and sucrose in the composition of excipients;
hypersensitivity to the active substance (sulbutiamine) or any of the components of the drug.
Carefully
The composition of the medicinal product includes FCF sunset dye (E110). It can cause the development of allergic reactions (see the section "Special instructions" and
special instructions Enerion:
The excipients of the preparation include glucose, lactose and sucrose. As a result, Enerion ® is contraindicated for use in persons with lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome, sucrose-isomaltase deficiency, fructose intolerance.
Carefully
The composition of the medicinal product contains the dye FCF (E110) sunset, which can cause the development of allergic reactions (see the section "Side effects").
Distortion of laboratory test results
The drug Enerion is metabolized to thiamine, which can affect the test results:
determination of uric acid by phosphoric-tungsten method: the drug can cause false positive results;
urinalysis for urobilinogen with Ehrlich's reagent can give false positive results;
Thiamine in high doses can interfere with the spectrophotometric determination of theophylline in blood serum by the method of Shack and Waxler.
Influence on the ability to drive vehicles and mechanisms