Instructions for Enerion film-coated tablets 200 mg No. 20
Composition
active ingredient: sulbutiamine;
1 tablet contains 200 mg of salbutamol;
excipients: anhydrous glucose, lactose monohydrate, magnesium stearate, corn starch, pregelatinized starch, talc;
film coating: white wax, carmellose sodium, ethylcellulose, glycerol monooleate, polysorbate 80, povidone, colloidal anhydrous silica, sodium bicarbonate, sucrose, sunset yellow FCF (E 110), talc, titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: tablet, coated with a sugar shell, orange in color, biconvex in shape.
Pharmacotherapeutic group
Other agents acting on the nervous system. Psychostimulants. ATX code N07 X.
Pharmacological properties
Pharmacodynamics.
Salbutiamine is an original molecule synthesized by modifying thiamine. Thanks to these modifications, salbutiamine is able to penetrate the blood-brain barrier and accumulate in brain structures, which causes the following effects of the drug:
improving coordination of movements; increasing resistance to muscle fatigue; improving the resistance of the cerebral cortex to chronic hypoxia (oxygen starvation); improving concentration and memory.
The effectiveness of Enerion® has been proven in many clinical placebo-controlled and comparative studies involving patients with functional asthenia of various etiologies, namely:
· post-infectious asthenia, which occurs after acute viral and infectious diseases of the respiratory tract (bronchitis, tonsillitis, influenza), bacterial infections (Salmonella, Yersinia), tuberculosis, malaria, typhoid fever, infectious hepatitis;
· asthenia arising from somatic diseases;
· asthenia caused by depression;
· asthenia in elderly patients: clinical studies have proven the effectiveness of Enerion® in disorders of mental function (decreased memory, attention, alertness and thinking) and in difficulties with social adaptation (fatigue, communication, personality, behavioral and sleep disorders);
· asthenia in students (physical and mental fatigue);
· asthenia in athletes.
Pharmacokinetics.
Salbutiamine is rapidly absorbed, with peak plasma concentrations achieved 1-2 hours after administration.
The half-life is about 5 hours. Salbutiamine is excreted in the urine.
Indication
Treatment of physical and mental asthenia, accompanied by apathy and decreased activity.
Contraindication
History of hypersensitivity to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
No cases of interaction with other drugs have been reported.
Application features
The drug contains lactose, so patients with congenital galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency are not recommended to use it.
Use during pregnancy or breastfeeding
No fetal toxicity or teratogenic effects have been reported in clinical use. However, to exclude the risk of these complications and due to insufficient clinical data, the drug is not recommended for use during pregnancy.
The use of the drug should be avoided during breastfeeding due to the lack of data on its excretion into breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data is missing.
Method of administration and doses
The drug is prescribed only to adults.
For oral use.
The daily dose is 2-3 tablets, which should be taken in 2-3 doses during breakfast and lunch, respectively.
The duration of treatment should not exceed 4 weeks.
Children
The drug should not be used in children.
Overdose
In case of overdose, excitement with manifestations of euphoria and tremor of the limbs may be observed.
These symptoms are temporary and pass quickly without any consequences.
Adverse reactions
The following side effects have been reported during treatment with the drug, which are distributed by frequency as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), frequency unknown (cannot be estimated from the available information).
Gastrointestinal disorders.
Uncommon: nausea, vomiting.
Neurological disorders.
Uncommon: agitation, headache, weakness, tremor.
Changes in the skin and subcutaneous tissue.
Uncommon: rash.
The presence of the dye "Yellow Sunset FCF" in the composition of the drug may cause allergic reactions.
Expiration date
3 years.
Storage conditions
Store at temperatures up to 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister made of aluminum foil and PVC film.
2 blisters in a cardboard packaging box.
Vacation category
Without a prescription.
Producer
Servier Industry Laboratories/ Les Laboratoires Servier Іndustrie.
Location of the manufacturer.
905 route de Saran, 45520 Gidy, France/905 route de Saran, 45520 Gidy, France.
Applicant.
Le Laboratoire Servier/ Les Laboratoires Servier.
Location of the applicant.
50, rue Carnot, 92284 Suresnes cedex, France/50, rue Carnot, 92284 Suresnes cedex, France.
Applicant's representative in Ukraine.
Representative office of "Le Laboratoire Servier".
Location.
24 Vorovsky St.,
Kyiv, 01601, Ukraine,
tel.: (044) 490 3441
fax: (044) 490 3440.
