Valerian rhizomes with roots

I N S T R U C T I O N for medical use of the medicinal product VALERIAN ROOTS WITH ROOTS (VALERIANAE RHIZOMATA CUM RADICIBUS)

Composition:

Active substance: valerian rhizomes with roots (Valerianae rhizomata cum radicibus);

1 pack contains: valerian rhizomes with roots (Valerianae rhizomata cum radicibus) 50 g or 100 g;

1 filter bag contains: valerian rhizomes with roots (Valerianae rhizomata cum radicibus) 1.5 g.

Pharmaceutical form. Rhizomes with roots.

Main physicochemical properties: fragments of roots and rhizomes of various shapes, from yellowish-gray to light brownish-gray, brown in color, with a characteristic odor.

Pharmacotherapeutic group. Sedatives and hypnotics. ATC code N05CM09.

Pharmacological properties.

Pharmacodynamics.

The biologically active substances of the drug exert a calming effect on the central nervous system, improve the function of the cardiovascular system, reduce arterial pressure, exhibit spasmolytic and mild choleretic effects, and enhance secretion of the gastrointestinal tract glands.

Clinical characteristics.

Indications.

Nervous excitement, insomnia; vegetative neuroses and neuroses of the cardiovascular system; gastrointestinal tract spasms (as part of combination therapy).

Contraindications.

Hypersensitivity to the biologically active substances of the drug. Depression.

Interaction with other medicinal products and other forms of interaction. Enhances the effects of alcohol, sedatives, hypnotics, antihypertensives, anxiolytics, and spasmolytic agents.

Special precautions for use.

When used for prolonged periods and in large quantities, the drug impairs digestion, causes headache, stimulates the nervous system, and worsens heart function.

Use during pregnancy or breastfeeding. Contraindicated.

Ability to affect reaction speed when driving or operating machinery. Since valerian preparations may cause drowsiness or a depressed state in some patients, caution should be exercised when driving or operating machinery during treatment.

Method of Administration and Dosage

Place 1 dessert spoon of rhizomes with roots into an enameled container, pour 200 mL of hot boiled water, cover with a lid, and steep in a boiling water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, and squeeze the residue into the strained infusion. Adjust the volume of the infusion to 200 mL with boiled water. Administer warm, 3–4 times daily, 30 minutes after meals: for adults and children aged 14 years and older – 1–2 tablespoons; for children aged 6–10 years – 1 teaspoon; for children aged 10–14 years – 1 dessert spoon. Shake the infusion before use.

Place 2 filter bags into a glass or enameled container, pour 200 mL of boiling water, cover, and steep for 15 minutes. Administer warm, 3–4 times daily, 30 minutes after meals: for adults and children aged 14 years and older – ⅓ cup; for children aged 6–10 years – 1–2 dessert spoons; for children aged 10–14 years – 2 tablespoons.

Store the prepared infusion at a temperature of 8–15°C for no more than 2 days.

The duration of treatment is determined individually by a physician for each patient.

Children. The drug is indicated for children aged 6 years and older, under medical prescription.

Overdose. Overdose or prolonged use (longer than 2 months) may cause feelings of depression, increased fatigue, drowsiness, dizziness, headache, nausea, bradycardia, and increased blood coagulation. Treatment is symptomatic (gastric lavage, activated charcoal, sodium sulfate).

Side effects.

In case of hypersensitivity to the drug, sleep disturbances and paradoxical stimulating effects may occur, as well as development of allergic reactions (including skin rash, itching, hyperemia, skin swelling). Abdominal cramps, nausea, intestinal dysfunction, headache, bradycardia, arrhythmia, weakness, drowsiness, depressed state, and reduced work capacity may also occur.

Shelf life. 3 years. Do not use after the expiry date stated on the packaging.

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

Packaging. 50 g or 100 g in cartons with an inner packet; 1.5 g in tea bags, 20 tea bags per carton or in a carton with an inner packet.

Prescription status. Over-the-counter.

Manufacturer/Applicant. JSC "Liktravy", Ukraine.

Address of manufacturer and location of business activity/applicant's address.
Ukraine, 10001, Zhytomyr Oblast, city of Zhytomyr, Kyivske Shose, building 21.