Eleutherococcus

INSTRUCTION for medical use of the medicinal product ELEUTHEROCOCCUS

Composition:

Active substance: 1 vial contains: extract of rhizomes with roots of Eleutherococcus senticosus (Rhizoma cum radicibus Eleutherococci) (0.7:1) (extraction solvent – ethanol 40%) – 30 ml or 50 ml.

Pharmaceutical form. Liquid extract for oral use, alcoholic.

Main physicochemical properties: dark brown liquid, transparent in a thin layer, with a characteristic odor. Sediment formation may occur upon storage.

Pharmacotherapeutic group. Tonics. ATC code A13A.

Pharmacological properties.

Pharmacodynamics.

The rhizome with roots contains eleutherosides A, B, B1, C, D, E, F, and G, coumarin derivatives, flavonoids, essential oil, plant wax, resins, and starch. Due to the presence of eleutherosides, the preparation enhances physical and mental performance, increases resistance to adverse environmental factors, improves visual acuity, stimulates the cardiovascular system, reduces stress reactions, and has a certain stimulating effect on gonadotropic activity and a hypoglycemic effect.

Pharmacokinetics.

The preparation is well absorbed in the gastrointestinal tract and is mainly excreted from the body via the kidneys.

Clinical characteristics.

Indications.

Physical and mental fatigue, neurasthenia and psychasthenia, arterial hypotension, functional exhaustion of the central nervous system accompanied by reduced work capacity, irritability, and insomnia.

As part of complex therapy in neurocirculatory dystonia, after severe surgical interventions, in acute and chronic radiation sickness.

Contraindications.

Hypersensitivity to the components of the drug. Hyperthermic syndrome, arterial hypertension, increased excitability, acute infectious diseases, myocardial infarction, arrhythmias, insomnia, neurocirculatory dystonia, fever, epilepsy.

Interaction with other medicinal products and other types of interactions.

The drug enhances the effect of central nervous system stimulants and analeptics, and acts as a physiological antagonist to agents that suppress the central nervous system (including barbiturates, tranquilizers, antiepileptic drugs).

Eleutherococcus extract may potentiate the effect of hypoglycemic agents.

Special precautions for use.

Arterial pressure should be monitored during administration of the drug. The drug may cause insomnia. Therefore, individuals who experience this effect should not take the drug in the evening.

Shake well before use.

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy or breastfeeding due to its ethanol content.

Ability to affect reaction speed when driving or operating machinery.

The drug contains 40% ethanol; therefore, driving or operating complex machinery requiring heightened attention should be avoided.

Dosage and Administration.

Administer the drug orally, 30 minutes before meals. Adults should take 20–40 drops 2–3 times daily. For children aged 12 years and older, administer at a dosage of 1 drop per year of age, twice daily. Treatment duration is 25–30 days; if necessary, repeat after 1–2 weeks.

Children.

The drug is not recommended for children under 12 years of age.

Overdose.

Overdose is characterized by acute alcohol intoxication. Possible symptoms include increased arterial blood pressure, cardiac arrhythmia, increased excitability, sleep disturbances, and gastrointestinal disturbances.

Treatment: immediately discontinue the drug and initiate symptomatic therapy: gastric lavage, administration of adsorbents, and in severe cases—administration of analeptics (corazole, cordiamine). Oxygen therapy is effective; artificial respiration may be required.

Side effects.

Central nervous system: insomnia, increased excitability, headache;

Cardiovascular system: increased blood pressure, cardiac arrhythmia, tachycardia;

Allergic reactions: skin rash, redness, itching.

Prolonged use may cause muscle spasm, gastrointestinal disturbances.

Shelf life.

4 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 ml or 50 ml in bottles.

Supply category.

Over-the-counter.

Manufacturer.

LLC "EVRAZIYA".

Manufacturer's address and place of business.

Ukraine, 38600, Poltava region, Kotelnia district, town of Kotelva, Rynkova Street, 32.

Marketing Authorization Holder.

LLC "EVRAZIYA".

Address of the Marketing Authorization Holder.

Ukraine, 38600, Poltava region, Kotelnia district, town of Kotelva, Poltava Highway, 210A.