ELEUTHEROCOCCUS EXTRACT LIQUID

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ELEUTHEROCOCCUS EXTRACT, LIQUID

Composition:

Active ingredient: liquid extract of rhizomes and roots of Eleutherococcus;

One vial contains: liquid extract of rhizomes and roots of Eleutherococcus (Eleutherococci rhizomata et radices) (1:1) (extraction agent – ethanol 40%) – 50 ml;

Excipients: apart from the extraction agent, none.

Pharmaceutical form. Liquid extract.

Main physico-chemical properties: dark brown liquid, transparent in a thin layer, with a characteristic, specific odor. Sediment may form during storage.

Pharmacotherapeutic group. Tonizing agents.

ATC code A13A.

Pharmacological properties.

Pharmacodynamics. Eleutherococcus 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 medicinal product enhances physical and mental performance, increases resistance to adverse environmental factors, improves visual acuity, promotes metabolism, and exerts mild stimulating 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. Vegetative neuroses, postoperative period; as part of combination therapy—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 forms of interaction.

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

Special precautions for use.

Liquid Eleutherococcus extract is a conventional herbal medicinal product intended for use according to indications supported by long-standing use.

Sediment formation may occur during prolonged storage; therefore, the bottle should be shaken several times before use. Blood pressure should be monitored during use of the medicinal product. The product may cause insomnia. Therefore, individuals who experience this effect should avoid taking the product in the evening.

Use during pregnancy or breastfeeding.

Since the medicinal product contains ethanol, it should not be administered to pregnant women or women who are 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 during treatment with this product.

Method of Administration and Dosage.

Shake well before use. Administer the medicinal product orally, 30 minutes before meals. Adults should take 20–30 drops once daily. For children aged 12 years and older, administer 1 drop per year of life once daily, diluted in a small amount of water, during the first half of the day (i.e., before 3:00 p.m.). The treatment course lasts 25–30 days; if necessary, it may be repeated after 1–2 weeks.

Patients should consult a physician if symptoms persist during treatment with this medicinal product or if any adverse reactions occur.

Children.

Use only as prescribed by a physician in children aged 12 years and older.

Overdose.

Possible symptoms include elevated arterial blood pressure, cardiac arrhythmia, increased excitability, sleep disturbances, gastrointestinal disturbances, and reduced work capacity. In such cases, administration of the medicinal product should be discontinued immediately and symptomatic therapy initiated: gastric lavage, administration of sorbents, and, in severe cases, administration of analeptics (corazole, cordiamine).

Adverse reactions.

Skin and subcutaneous tissue disorders: allergic reactions: skin redness, rash, itching.

Nervous system disorders: headache, excitement, sleep disturbances, irritability, anxiety, decreased work capacity.

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

Prolonged use (more than 2 months) may cause muscle spasm 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.

50 ml in glass or polymer bottles, in a carton or without a carton.

Dispensing category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and place of business.

LLC "Ternopharm".

4, Fabrychna St., Ternopil, 46010, Ukraine.