VALERIAN TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN TINCTURE (VALERIANAE TINCTURA)

Composition:

Active substance: valerian root tincture (Valerianae radix) (1:5) (extraction solvent – 70% ethanol);

1 vial contains valerian root tincture (Valerianae radix) (1:5) (extraction solvent – 70% ethanol) 25 ml.

Pharmaceutical form. Tincture.

Main physico-chemical properties: clear liquid ranging in color from yellowish-brown to reddish-brown, with a characteristic pleasant odor. The presence of sediment is permissible.

Pharmacotherapeutic group.

Hypnotics and sedatives. ATC code N05CM09.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the rhizomes with roots of valerian (essential oil, valerianic acid, borneol, alkaloids, tannins, sugars) reduce excitation in the central nervous system and enhance the effects of other sedative, hypnotic, analgesic, and spasmolytic agents.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Functional disorders of the central nervous system (increased emotional excitability, irritability, sleep disturbances, etc.), cardiovascular system disorders (neurocirculatory dystonia).

Contraindications.

Depression and other conditions accompanied by central nervous system depression. Hypersensitivity to the biologically active substances contained in the drug.

Special precautions.

The preparation contains alcohol. Prolonged use of the preparation is not recommended. During treatment, patients taking the tincture should refrain from driving vehicles and operating potentially hazardous machinery due to the presence of ethyl alcohol in the preparation.

Do not disregard the recommendations for use of the medicinal product—this may harm your health.

Interaction with other medicinal products and other forms of interaction.

Valerian tincture may potentiate the effects of cardiac, sedative, hypnotic, analgesic, and spasmolytic agents, enhance the effects of alcohol, antihypertensive, and anxiolytic agents.

Special precautions.

Use during pregnancy or breastfeeding.

Do not use the drug during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Avoid driving or operating machinery during drug administration.

Method of Administration and Dosage

Valerian tincture is taken orally. Adults are recommended to take 20–30 drops per dose, 3–4 times daily, until a stable therapeutic effect is achieved.

For children aged 12 years and older: 1 drop per year of age, 3–4 times daily.

The patient should consult a physician if symptoms of the disease do not resolve during treatment with the medicinal product or if adverse reactions not listed in the instructions occur.

The average duration of treatment is 1–1.5 months.

Children

Do not use in children under 12 years of age due to the ethanol content.

Overdose

In case of overdose, possible manifestations include mental excitement, development of pronounced adverse reactions: headache, dizziness, drowsiness, general weakness, abdominal pain, nausea, decreased hearing and visual acuity, and palpitations.

Immediate discontinuation of the drug, timely emergency measures (gastric lavage, administration of activated charcoal, etc.), and symptomatic treatment promote rapid resolution of clinical signs of overdose.

Side effects.

The drug is generally well tolerated; however, in some patients, reduced emotional responsiveness, drowsiness, decreased work capacity, depression, nausea, spasmodic abdominal pain, and weakness may occur. Allergic reactions are possible (including skin redness, rash, itching, skin swelling).

If any adverse events occur, consult a physician immediately!

Shelf life.

5 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 ml in bottles.

Supply category.

Over-the-counter.

Manufacturer.

PJSC "FITOPHARM".

Manufacturer's address.

84500, Bakhmut, Sibirtseva St., 2, Donetsk region, Ukraine.

Marketing authorization holder.

PJSC "FITOPHARM".

Address of the marketing authorization holder.

12 Almatinska St., Kyiv, 02092, Ukraine.