Valerian rhizomes with roots

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIANA RHIZOMATA CUM RADICIBUS

Composition:

Active substance: 1 pack contains 40 g or 50 g of valerian rhizomes with roots (rhizomata cum radicibus valerianae).

Pharmaceutical form. Rhizomes with roots.

Main physico-chemical properties: fragments of roots and rhizomes of various shapes, from yellow-gray to light brownish-gray in color, passing through a sieve with 7 mm diameter openings. Odor is strong, aromatic. Taste is spicy, sweetishly bitter.

Pharmacotherapeutic group.

Sedatives and hypnotics. ATC code N05CM09.

Pharmacological properties.

Pharmacodynamics.

The active substances of the medicinal product 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 cardiac neuroses; gastrointestinal tract spasms (as part of complex therapy).

Contraindications.

Increased individual sensitivity to valerian or to other components of the medicinal product. Depression.

Interaction with other medicinal products and other types of interactions.

Valerian preparations may enhance the effects of alcohol, sedatives, hypnotics, analgesics, spasmolytics, and anxiolytic medicinal products.

Special precautions for use.

Prolonged use and high doses of the medicinal product may impair digestion, cause headache, stimulate the nervous system, and adversely affect heart function.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

Since valerian preparations may cause drowsiness and 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 let it steep in a water bath for 15 minutes. Allow to cool at room temperature for 45 minutes, then strain, squeezing out 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.

The duration of treatment is determined individually by a physician.

Children.

The preparation may be administered to 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: symptomatic therapy (gastric lavage, administration of 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 spasms, nausea, intestinal dysfunction, headache, bradycardia, arrhythmia, weakness, drowsiness, depression, and reduced work capacity are possible.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

The prepared infusion should be stored at a temperature between 8 °C and 15 °C for no more than 2 days.

Packaging.

40 g or 50 g per carton with inner packet.

Supply category.

Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

16, Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.