Valerian tincture

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN TINCTURE (VALERIANA 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 or 50 ml;

Excipients: none, except the extraction solvent.

Pharmaceutical form. Tincture for oral administration.

Main physicochemical properties: clear reddish-brown liquid with a characteristic odor.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code N05CM09.

Pharmacological Properties.

Pharmacodynamics.

Biologically active substances contained in valerian rhizomes with roots (essential oil, valerenic acid, borneol, alkaloids, tannins, sugars) reduce the excitation process in the central nervous system. The drug exerts a sedative and spasmolytic effect.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

Depression and other conditions accompanied by suppression of central nervous system activity; individual hypersensitivity to biologically active substances contained in the drug.

Interaction with other medicinal products and other forms of interactions.

Valerian tincture is capable of potentiating the effects of alcohol, cardiac drugs, sedatives, hypnotics, analgesics, spasmolytics, antihypertensives, and anxiolytics.

Special precautions for use.

Do not disregard the recommendations regarding the use of the medicinal product, as this may harm your health. Do not exceed the recommended doses of the medicinal product.

Alcohol consumption should be avoided during treatment with this medicinal product.

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

Valerian may produce a moderate depressant effect; therefore, concomitant use of this medicinal product with synthetic sedatives is not recommended due to potential potentiation of the effect.

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

Sediment formation may occur during storage. The preparation should be shaken before use.

Valerian tincture is a traditional medicinal product used according to indications supported by long-term use.

Use during pregnancy or breastfeeding.

The medicinal product should not be used during pregnancy or breastfeeding due to the presence of 70% ethanol.

Ability to influence reaction speed when driving or operating machinery.

During treatment with this medicinal product, driving and operating vehicles or potentially hazardous machinery should be avoided due to the presence of 70% ethanol and the possibility of developing adverse effects on the central nervous system.

Dosage and Administration

Take orally after meals.

Adults are recommended to take 20–30 drops of the tincture 3–4 times daily until a stable therapeutic effect is achieved; children aged 12 years and older – 1 drop per year of age, 3–4 times daily.

Patients should consult a physician if symptoms do not improve during treatment or if any adverse reactions occur.

Children

The medicinal product contains 70% ethanol and therefore should not be used in children under 12 years of age.

Overdose

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

In case of overdose, discontinue use of the medicinal product. Symptomatic therapy is recommended (gastric lavage, administration of activated charcoal).

Side effects.

Rarely observed: suppression of emotional responses, drowsiness, reduced work capacity, depression, nausea, spasmodic abdominal pain, weakness.

Possible allergic reactions (redness, rash, itching, and swelling of the skin).

If any adverse effects occur, consult a physician immediately!

Shelf life.

5 years.

Do not use the medicinal product 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.

25 ml or 50 ml in bottles; 25 ml or 50 ml in a bottle, 1 bottle per carton.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business.

4, Korolyova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.