Valerian rhizomes with roots

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN ROOTS WITH ROOTS (VALERIANAERADIX)

Composition:

Active substance: Valerianae radix (valerian roots and rhizomes);

One package contains 50 g of valerian roots and rhizomes (Valerianae radix); one filter bag contains 1.5 g of valerian roots and rhizomes (Valerianae radix).

Pharmaceutical form. Roots and rhizomes.

Main physico-chemical properties:

Ground raw material: fragments of roots and rhizomes of various shapes, light brown in color, passing through a sieve with 7 mm diameter openings. Odor is strong and pleasant. Taste is spicy, slightly sweetish and bitter.

Coarse powder: fragments of roots and rhizomes of various shapes, light brown in color, passing through a sieve with 3 mm diameter openings. Odor is strong and pleasant. Taste is spicy, slightly sweetish and bitter.

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 cardiovascular neuroses; gastrointestinal tract spasms (as part of complex therapy).

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

Enhances the effects of alcohol, sedatives, hypnotics, antihypertensive, anxiolytic, and spasmolytic agents.

Special precautions for use.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving vehicles or operating machinery.

Since valerian preparations may cause drowsiness and sedation in some patients, caution should be exercised when driving vehicles 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, then strain and squeeze the residue into the strained infusion. Adjust the volume of the infusion to 200 ml with boiled water. Use 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 packets into a glass or enameled container, pour 200 ml of boiling water, cover, and let steep for 15 minutes. Use 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.

The duration of treatment is determined individually by a physician.

Children.

The drug should be used in children aged 6 years and older only as prescribed by a physician.

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 excitatory 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 are possible.

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. Prepared infusion should be kept in a cool place for no more than 2 days.

Packaging.

50 g in packets, with insertion into a carton; 1.5 g in tea-filter bags, with 20 tea-filter bags placed into a carton.

Prescription status. Over-the-counter.

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity:

69050, Ukraine, Zaporizhzhia, Skladska St., 4.

Marketing authorization holder: JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder:

69063, Ukraine, Zaporizhzhia, Amosova Akademika St., 75.