Eleutherococcus extract liquid

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ELEUTHEROCOCCUS LIQUID EXTRACT (ELEUTHEROCOCCI EXTRACTUM FLUIDUM)

Composition:

Active substance: 1 vial contains 50 ml of liquid extract of Eleutherococcus senticosus rhizomes with roots (Rhizomata et radices eleutherococci) (1:1), extraction solvent – ethanol 40%.

Excipients: None, except the extraction solvent.

Pharmaceutical form. Oral extract.

Main physicochemical properties: Dark brown liquid, slightly pungent taste, characteristic odor. Formation of a slight sediment during storage is permissible.

Pharmacotherapeutic group. Tonics. ATC code A13A.

Pharmacological Properties.

Pharmacodynamics.

The rhizomes with roots of Eleutherococcus senticosus contain eleutherosides A, B, B1, C, D, E, F, 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, visual acuity, resistance to adverse environmental factors, improves metabolism, and exerts a mild stimulating gonadotropic and hypoglycemic effect.

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 forms of interactions.

The drug may potentiate the effect of agents that stimulate the central nervous system, 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.

The instructions for using the medicinal product must not be violated.

The medicinal product should be taken in the first half of the day, as it may cause insomnia.

Arterial pressure should be monitored during treatment with this 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 vehicles or operating potentially hazardous machinery during treatment.

Dosage and Administration.

Shake before use. Administer the medication orally 30 minutes before meals. The recommended dose for adults is 20–30 drops once daily; for children aged 12 years and older — 1 drop per year of age, once daily. The medication should be taken in the first half of the day (i.e., before 3:00 PM), diluted in a small amount of water. The treatment course lasts 25–30 days; if necessary, repeat after 1–2 weeks.

If symptoms do not resolve during treatment or if any adverse reactions occur, consult a physician.

Children.

Do not administer the medication to children under 12 years of age, as it contains 40% ethanol.

Overdose.

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

Side effects.

The medicinal product is usually well tolerated; however, allergic reactions (skin redness, rash, itching, etc.) may develop in patients with hypersensitivity.

From the central nervous system: excitation, sleep disturbances, irritability, anxiety, decreased work capacity, headache.

From the cardiovascular system: tachycardia, increased arterial pressure, cardiac rhythm disturbances.

With prolonged use (over 2 months), muscle spasms and gastrointestinal disturbances are possible.

Shelf life. 4 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store at a temperature not exceeding 25 °C in the original packaging and in a place inaccessible to children.

Packaging. 50 ml in bottles.

Availability category.

Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business.

4 Korolova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.