Enerion^® (Tablets) Instructions for Use

Marketing Authorization Holder

Les Laboratoires Servier (France)

Manufactured By

Les Laboratoires Servier Industrie (France)

ATC Code

A11DA02 (Sulbutiamine)

Active Substance

Sulbutiamine (Rec.INN registered by WHO)

Dosage Form

Enerion®

Film-coated tablets, 200 mg: 20, 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets orange in color, round, biconvex, with slight surface heterogeneity (in terms of glossiness), staining, and the presence of minor inclusions allowed.

Excipients: corn starch, dried starch paste, anhydrous glucose (dextrose), lactose monohydrate, magnesium stearate, talc.

Shell composition: sodium bicarbonate, carmellose sodium, white beeswax, titanium dioxide (E171), ethylcellulose, dye sunset yellow FCF (E110), glycerol monooleate, polysorbate 80, povidone K-30, sucrose, colloidal anhydrous silicon dioxide (Aerosil 130^®), talc.

10 pcs. – blisters (2) – cardboard packs, with first opening control (if necessary).
15 pcs. – blisters (2) – cardboard packs, with first opening control (if necessary).
15 pcs. – blisters (4) – cardboard packs, with first opening control (if necessary).

Clinical-Pharmacological Group

Drug regulating metabolic processes in the CNS

Pharmacotherapeutic Group

Vitamins; vitamin B₁ and its combinations with vitamins B₆ and B₁₂; vitamin B₁

Pharmacological Action

A drug regulating metabolic processes in the CNS – a synthetic compound structurally similar to thiamine (has an open thiazole cycle, an additional disulfide bond, and a lipophilic ester). It is highly effective in the symptomatic treatment of patients with functional asthenic conditions.

Pharmacokinetics

Absorption from the gastrointestinal tract is high, C_max is determined 1-2 hours after administration. T_1/2 is about 5 hours. It is excreted by the kidneys.

It is highly soluble in fats and easily penetrates the blood-brain barrier. Unlike thiamine, it is able to accumulate in the cells of the reticular formation, hippocampus, and dentate gyrus, as well as in Purkinje cells and glomeruli of the granular layer of the cerebellar cortex.

Indications

Asthenic conditions in hypo- and avitaminosis, prolonged diseases, after surgical interventions.

ICD codes

Dosage Regimen

Administer the tablets orally.

The recommended daily dose is 400 mg to 600 mg.

Divide the total daily dose into two administrations.

Take one 200 mg tablet twice daily, typically in the morning and at lunchtime.

Adhere strictly to a maximum treatment duration of four weeks.

Do not exceed the recommended daily dose.

Avoid taking the medication in the evening due to potential effects on sleep.

Do not use in children and adolescents under 18 years of age.

Discontinue use and consult a physician if adverse reactions occur.

Adverse Reactions

Nervous system disorders: infrequently – tremor, headache, agitation.

Gastrointestinal disorders: infrequently – nausea, vomiting; frequency unknown – abdominal pain, diarrhea.

Skin and subcutaneous tissue disorders: infrequently – rash.

General disorders: infrequently – general malaise.

Contraindications

Hypersensitivity to sulbutiamine; children and adolescents under 18 years of age; pregnancy, lactation (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Sulbutiamine is metabolized to thiamine. When using sulbutiamine, the results of laboratory tests may be distorted: determination of uric acid by the phosphotungstic method – Sulbutiamine may cause false-positive results; urine analysis for urobilinogen with Ehrlich’s reagent – Sulbutiamine may give false-positive results; thiamine in large doses may affect the spectrophotometric determination of theophylline in blood serum by the Schack and Waxler method.

Effect on ability to drive vehicles and machinery

During the use of sulbutiamine, patients should exercise caution when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Sulbutiamine is metabolized to thiamine.

With simultaneous use with thiamine, the effect of agents blocking neuromuscular transmission (muscle relaxants) may increase.

With simultaneous use of diuretics, the urinary excretion of thiamine increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.