Valerian tincture

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN TINCTURE

Composition:

Active substance: 1 bottle contains valerian root and rhizome tincture (Valerianae rhizoma cum radicibus) (1 : 5) (extraction solvent – 70% ethanol) – 25 ml;

Excipients: none.

1 ml contains 20 drops.

Pharmaceutical form. Tincture.

Main physicochemical properties: reddish-brown liquid with a characteristic aromatic odor. Sediment may form during storage.

Pharmacotherapeutic group. Sedatives and hypnotics.

ATC code N05CM09.

Pharmacological properties.

Pharmacodynamics. Biologically active substances contained in the roots and rhizomes of valerian (essential oil, valerenic acid, borneol, alkaloids, tannins, sugars) reduce excitation processes in the central nervous system and enhance the effects of other sedatives, hypnotics, analgesics, and spasmolytics.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

"Valerian tincture" is capable of enhancing the effects of alcohol, cardiac, sedative, hypnotic, analgesic, spasmolytic, antihypertensive, and anxiolytic agents.

Special precautions for use.

Do not violate the recommended guidelines for using the medicinal product, as this may harm your health.

Do not exceed the recommended doses of the drug.

Alcohol consumption should be avoided during treatment with this medication.

The medicinal product contains ethanol! Prolonged use of the drug is not recommended.

Valerian may produce a moderate depressant effect; therefore, concomitant use of the drug with synthetic sedatives is not recommended due to potential enhancement of the sedative effect.

In cases of pronounced cerebral atherosclerosis, the drug should be used only under medical supervision.

Use during pregnancy or breastfeeding.

Since the product contains ethanol, the tincture is not recommended for use in women during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

During treatment, patients taking the tincture should refrain from driving or operating machinery due to the ethanol content.

Dosage and Administration.

Take orally. The recommended dose for adults is 20–30 drops of the tincture 3–4 times daily until a stable therapeutic effect is achieved. For children aged 12 years and older, the dose is calculated as 1 drop per year of age, administered 3–4 times daily.

Children.

The product contains ethanol and therefore is not recommended for children under 12 years of age.

Overdose.

Significant exceeding of the recommended doses may lead to pronounced adverse reactions: headache, dizziness, drowsiness, general weakness, abdominal pain, nausea, decreased hearing and vision acuity, palpitations, and mental excitation.

Treatment. In case of overdose, discontinue the drug immediately. Symptomatic therapy (gastric lavage, activated charcoal) should be administered.

Side effects.

"Valerian tincture" is generally well tolerated, however, in some patients depression, suppression of emotional responses, drowsiness, reduced work capacity, nausea, spasmodic abdominal pain, and weakness may occur.

Allergic reactions are possible (including skin redness, rash, itching, skin swelling).

Shelf life. 5 years.

Storage conditions.

Store in a place protected from light at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

25 ml in glass dropper bottles or in polymer bottles; 1 bottle per cardboard pack;

25 ml in glass dropper bottles or in polymer bottles.

Availability. Over-the-counter.

Manufacturer/Applicant.

Ternopharm LLC.

Manufacturer's address and place of business.

46010, Ternopil, Fabrychna St., 4, Ukraine.