Eleutherococcus extract

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ELEUTHEROCOCCUS EXTRACT

Composition:

Active substance: liquid extract of rhizomes with roots of Eleutherococcus senticosus (Eleuterococcus senticosus) (1:1) (extractant – 40 % ethanol);

1 vial contains 20 ml, 25 ml, 30 ml or 50 ml of liquid extract of rhizomes with roots of Eleutherococcus senticosus (Eleuterococcus senticosus) (1:1) (extractant – 40 % ethanol).

Pharmaceutical form. Liquid extract.

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

Pharmacotherapeutic group. Tonic agent. ATC code A13A.

Pharmacological Properties.

Pharmacodynamics.

Eleutherococcus senticosus rhizomes with roots contain eleutherosides A, B, B1, C, D, E, F, and G, coumarin derivatives, flavonoids, essential oil, plant wax, resins, starch, and other components. Due to the presence of eleutherosides, the preparation enhances physical and mental performance, visual acuity, resistance to adverse environmental factors, improves metabolism, and exerts mild stimulatory gonadotropic and hypoglycemic effects.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications. Physical and mental fatigue, neurasthenia and psychasthenia, functional exhaustion of the central nervous system accompanied by reduced work capacity, irritability, and insomnia. Vegetative neuroses, postoperative period; in combination with other agents – in acute and chronic radiation sickness.

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

Interaction with other medicinal products and other types of interactions. The drug may potentiate the effect of agents stimulating the central nervous system, analeptics, and hypoglycemic agents, and may suppress the effect of sedative and hypnotic drugs (including barbiturates, tranquilizers, antiepileptic agents).

Special precautions.

Insomnia may occur if the drug is taken in the second half of the day.

Arterial pressure should be monitored during administration of the medicinal product.

Use during pregnancy or breastfeeding. The medicinal product contains 40% ethanol; therefore, it should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. The medicinal product contains 40% ethanol; therefore, caution should be exercised when driving or operating potentially hazardous machinery.

Dosage and Administration.

Shake before use. Take orally, 30 minutes before meals.

Adults should take 20–30 drops once daily. Children aged 12 years and older should take 1 drop per year of age once daily, diluted in a small amount of water. Administration should occur in the first half of the day (i.e., before 3:00 PM). The treatment course lasts 25–30 days and may be repeated after 1–2 weeks, if necessary.

Children. The drug is not recommended for children under 12 years of age due to its 40% ethanol content.

Overdose. Possible symptoms include elevated arterial blood pressure, sleep disturbances, cardiac arrhythmias, reduced work capacity, and increased excitability. In such cases, discontinue the drug immediately.

Treatment is symptomatic: gastric lavage, administration of sorbents; in severe cases – administration of analeptics (camphor, cordiamine).

Side effects.

The drug is usually well tolerated; however, allergic reactions (skin redness, rash, itching) may occur in hypersensitive patients.

Central nervous system: excitation, sleep disturbances, irritability, anxiety, decreased performance, headache.

Cardiovascular system: tachycardia, increased arterial pressure, cardiac rhythm disturbances.

With prolonged use (more than 2 months), the drug may cause muscle spasms and gastrointestinal disturbances.

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. 20 ml or 25 ml in glass bottles. 30 ml or 50 ml in glass or polymer bottles, in a carton or without a carton. 20 ml, 25 ml, 30 ml, or 50 ml in glass bottles stoppered with dropper caps and lids, in a carton or without a carton.

Prescription status.

Over-the-counter.

Manufacturer.

JSC Pharmaceutical Factory "Viola".

Manufacturer's address and location of business activity.

75 Amosova Street, Zaporizhzhia, Ukraine, 69063.