Eleutherococ

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ELEUTHEROCOCCUS

Composition:

1 vial contains:

Active substance: liquid extract of Eleutherococcus senticosus rhizomes with roots (Rhizoma et radices Eleutherococci) (1:1) (extraction solvent – 40% ethanol) – 40 ml, 50 ml or 100 ml.

Pharmaceutical form. Liquid extract for oral administration, alcoholic.

Main physicochemical properties: dark brown liquid, transparent in a thin layer, with a characteristic odor. Formation of sediment during storage is permissible.

Pharmacotherapeutic group.

Tonizing agents. ATC code A13A.

Pharmacological properties.

Pharmacodynamics.

The rhizomes with roots of Eleutherococcus senticosus contain 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, Eleutherococcus increases physical and mental performance, enhances resistance to adverse environmental factors, improves visual acuity, stimulates the cardiovascular system, reduces stress responses, and exerts a certain stimulating gonadotropic and hypoglycemic effect.

Pharmacokinetics.

The medicinal product is well absorbed in the gastrointestinal tract and is mainly excreted from the body through 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, following major surgical interventions, and in acute and chronic radiation sickness.

Contraindications.

Hypersensitivity to any component of the medicinal product. Hyperthermic syndrome, arterial hypertension, increased excitability, acute infectious diseases, myocardial infarction, arrhythmias, insomnia, neurocirculatory dystonia, fever, epilepsy.

Interaction with other medicinal products and other forms of interaction.

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

Eleutherococcus extract may potentiate the effect of hypoglycemic agents.

Special precautions.

The recommended dosage regimen for the medicinal product must not be violated.

Arterial pressure should be monitored during treatment.

The product may cause insomnia. Therefore, patients who experience this effect should not take the product in the evening.

Shake well before use.

Eleutherococcus is a traditional medicinal product used according to indications supported by long-term use.

Use during pregnancy or breastfeeding.

Not recommended.

Ability to influence reaction speed when driving or operating machinery.

Due to the possibility of adverse reactions affecting the central nervous system and because the medicinal product contains 40% ethanol, driving or operating machinery that requires rapid psychomotor reactions should be avoided.

Method of Administration and Dosage.

Take Eleutherococcus internally 30 minutes before meals: adults—20–30 drops once daily; children aged 12 years and older—1 drop per year of age once daily, diluted in a small amount of water.

If the bottle does not have a dropper cap, use a glass medical pipette to measure the dose; the dosage remains unchanged.

The patient should consult a physician if symptoms do not improve during treatment or if adverse reactions occur that are not listed in the instructions for medical use of the drug.

The treatment course lasts 25–30 days; if necessary, the course may be repeated after 1–2 weeks (after consulting a physician).

Children.

Not recommended for children under 12 years of age.

Overdose.

Symptoms: possible increase in blood pressure, cardiac arrhythmia, increased excitability, sleep disturbances, gastrointestinal disturbances, reduced work capacity.

Treatment: immediate discontinuation of the drug and symptomatic therapy: gastric lavage, administration of sorbents, and in severe cases—administration of analeptics (corazole, cordiamine).

Adverse reactions.

Central nervous system: sleep disturbances, insomnia, irritability, anxiety, decreased work capacity, increased excitability, headache.

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

Skin: rash, redness of the skin, itching.

Prolonged use may cause muscle spasm and gastrointestinal disturbances.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all cases of suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

40 ml in glass bottles.

50 ml in glass or polymer bottles.

50 ml in a glass or polymer bottle in a cardboard box.

100 ml in glass bottles.

100 ml in a glass bottle in a cardboard box.

Availability. Over-the-counter.

Manufacturer. JSC "Lubnifarm".

Manufacturer's address and location of operations.

16, Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.