INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARALIA TINCTURE (TINCTURA ARALIAE)

Composition:

Active substance: Aralia root tincture (Radices Araliae) (1:5) (extractant – 70% ethanol);

One vial contains Aralia root tincture (Radices Araliae) (1:5) (extractant – 70% ethanol) 25 ml or 50 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear yellow liquid with a pungent taste and characteristic odor. Formation of a precipitate during storage is permissible.

Pharmacotherapeutic group. Tonics. ATC code A13A.

Pharmacological properties.

Pharmacodynamics.

Preparations from aralia roots exert a stimulating effect on the central nervous system, gonadotropic, and some cardiotoxic effects.

Clinical characteristics.

Indications. Asthenoneurotic conditions, asthenia, physical and mental fatigue, impotence, hypotension – as part of complex therapy.

Contraindications. Hypersensitivity to the drug components. Increased excitability, insomnia, arterial hypertension, epilepsy.

Interaction with other medicinal products and other types of interactions.

Unknown.

Special precautions.

It is not recommended to take the medication in the second half of the day.

Use during pregnancy or breastfeeding.

Since ethanol is an ingredient of the medication, the tincture is not recommended for oral use in women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

When taking the tincture, patients should refrain from driving vehicles or operating potentially hazardous machinery.

Dosage and Administration.

The drug is taken orally, 30–40 drops before meals, 2–3 times daily. The duration of treatment is determined individually by a physician, depending on the course of the disease and individual sensitivity to the drug.

Children.

Since there is no experience with the use of the drug in children, it is not recommended for this age group of patients.

Overdose.

With prolonged and uncontrolled use of the drug, insomnia and increased arterial pressure may occur. Treatment is symptomatic.

Side effects.

Insomnia, increased blood pressure. In individual cases, allergic reactions may occur, including urticaria and itching.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Precipitation may occur during storage.

Packaging.

25 ml or 50 ml in glass or polymer bottles, closed with dropper stoppers and caps, or 50 ml in bottles closed with stoppers and caps.

1 bottle per pack or without a pack.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.