Enerion

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENERION® (ENERION®)

Composition:

Active substance: sulbutiamine;

One tablet contains 200 mg of sulbutiamine;

Excipients: anhydrous glucose, lactose monohydrate, magnesium stearate, corn starch, pregelatinized starch, talc;

Film coating: white wax, sodium carmellose, ethylcellulose, glycerol monooleate, polysorbate 80, povidone, colloidal anhydrous silicon dioxide, sodium bicarbonate, sucrose, Yellow West FCF (E 110), talc, titanium dioxide (E 171).

Pharmaceutical form. Film-coated tablets.

Main physico-chemical properties: film-coated tablet of orange color, biconvex in shape.

Pharmacotherapeutic group. Vitamins. Vitamin B1 preparations, including combinations with vitamins B6 and B12. Simple vitamin B1 preparations. Sulbutiamine. ATC code A11D A02.

Pharmacological Properties

Pharmacodynamics

Sulbutiamine is an original molecule synthesized through modifications of thiamine. Due to these modifications, sulbutiamine is able to cross the blood-brain barrier and accumulate in brain structures, resulting in the following effects of the drug:

• Improvement of motor coordination;
• Increased resistance to muscle fatigue;
• Enhanced resistance of the cerebral cortex to chronic hypoxia (oxygen deprivation);
• Improved concentration and memory capacity.

The efficacy of the drug Eneryon® has been demonstrated in numerous clinical placebo-controlled and comparative studies involving patients with functional asthenia of various etiologies, namely:

• Post-infectious asthenia occurring after acute viral and infectious respiratory diseases (bronchitis, tonsillitis, influenza), bacterial infections (Salmonella, Yersinia), tuberculosis, malaria, typhoid fever, infectious hepatitis;
• Asthenia arising on the background of somatic diseases;
• Asthenia associated with depression;
• Asthenia in elderly patients: clinical studies have demonstrated the efficacy of Eneryon® in cognitive impairments (reduced memory, attention, vigilance, and thinking) and difficulties in social adaptation (fatigue, communication disorders, personality and behavioral changes, sleep disturbances);
• Asthenia in students (physical and mental fatigue);
• Asthenia in athletes.

Pharmacokinetics

Sulbutiamine is rapidly absorbed; maximum plasma concentration is reached within 1–2 hours after administration.

The elimination half-life is approximately 5 hours. Sulbutiamine is excreted in the urine.

Clinical characteristics.

Indications.

Treatment of physical and mental asthenia associated with apathy and reduced activity.

This medicinal product does not eliminate the need for prescribing antidepressants if a depressive episode is confirmed in the patient.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Specific studies on the interaction of sulbutiamine with other medicinal products have not been conducted.

Concomitant use requiring attention

Diuretics: increases urinary excretion of thiamine (a metabolite of sulbutiamine).

Muscle relaxants: when used concomitantly with thiamine (a metabolite of sulbutiamine), the effect of these agents may be enhanced.

Special precautions for use.

Excipients

The medicinal product contains glucose, lactose, and sucrose.

This medicine should not be used in patients with rare hereditary fructose or galactose intolerance, Lapp lactase deficiency, sucrase-isomaltase deficiency, or glucose-galactose malabsorption.

This medicinal product contains the colouring agent Sunset Yellow FCF (E 110), which may cause allergic reactions (see section "Adverse reactions").

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of salbutiamine in pregnant women are lacking or limited (less than 300 cases).

Animal studies have not shown any direct or indirect toxic effects on reproductive function.

As a precautionary measure, it is advisable to avoid using salbutiamine during pregnancy.

Breastfeeding

It is unknown whether salbutiamine/metabolites are excreted in breast milk. Risk to newborns/infants cannot be excluded. Salbutiamine should not be used during breastfeeding.

Fertility

There are no data available on the effect on fertility.

Ability to affect reaction speed when driving or operating machinery.

No specific studies have been conducted on the effects of salbutiamine on the ability to drive a vehicle or operate machinery.

Dosage and method of administration.

For oral use.

The medicine is intended for use only in adults: 2–3 tablets per day. The tablets should be taken whole during breakfast and lunch, with plenty of water.

The duration of treatment should not exceed 4 weeks.

Children.

The medicine must not be used in children.

Overdose.

Symptoms

In case of ingestion of a large amount of the medicine, agitation with symptoms of euphoria and limb tremor may occur.

These symptoms are temporary.

Treatment

Depending on the physician's diagnosis, treatment of these symptoms may be symptomatic.

Adverse Reactions

The following adverse reactions have been reported during treatment with the medicinal product, categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from the available data).

Description of some adverse reactions

Due to the presence of the colouring agent "Yellow FCF" in the formulation, there is a risk of allergic reactions (see section "Special precautions for use").

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are obliged to report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

10 tablets in a blister pack made of aluminium foil and PVC film.

2 blisters per cardboard box.

Pharmaceutical classification.

Over-the-counter (without prescription).

Manufacturer.

Laboratoires Servier Industrie / Les Laboratoires Servier Industrie.

Manufacturer's address.

905 route de Saran, 45520 Gidy, France /
905 route de Saran, 45520 Gidy, France.

Marketing authorization holder.

Les Laboratoires Servier / Les Laboratoires Servier.

Address of the marketing authorization holder.

50, rue Carnot, 92284 Suresnes cedex, France /
50, rue Carnot, 92284 Suresnes cedex, France.

For any questions regarding this medicinal product, please contact the representative office of "LES LABORATOIRES SERVIER" in Ukraine by phone: (044) 490 3441, fax: (044) 490 3440.