VALERIANA

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN

Composition:

Active ingredient: 1 vial contains Valerian tincture (Tincturae Valerianae) (1:5) (extraction solvent — ethanol 70.0% v/v) 25 ml or 100 ml;

Excipients: none.

Pharmaceutical form. Oral tincture.

Main physicochemical characteristics: yellow-brown to red-brown liquid with a characteristic odor.

Sediment formation may occur during storage.

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC code N05CM09.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the rhizomes and roots of valerian (essential oil, valeric acid, borneol, alkaloids, tannins, sugars) reduce excitation processes 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 disorders), cardiovascular system disorders (neurocirculatory dystonia).

Contraindications.

Individual hypersensitivity to biologically active substances contained in the preparation. Depression and other disorders accompanied by suppression of central nervous system activity.

Interaction with other medicinal products and other types of interactions.

Valerian tincture is capable of potentiating the effects of cardiac, sedative, hypnotic, analgesic, and spasmolytic agents.

Special precautions for use.

Use during pregnancy or breastfeeding.

Since the medicinal product contains ethanol, it should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

During treatment with Valeriana, driving vehicles or operating machinery should be avoided, as the medicinal product contains ethanol and may cause adverse effects on the central nervous system.

Method of administration and dosage.

Take orally after meals. Shake before use. 1 ml contains 20 drops.

The recommended dose for adults is 20–30 drops of the tincture 3–4 times daily. For children aged 12 years and older, the dose is 1 drop per year of age, 3–4 times daily.

If the bottle does not have a dropper cap, use a medical glass pipette to measure the dose; the dosage remains unchanged.

Children.

The product contains 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 vision acuity, palpitations.

In case of overdose, discontinue the drug. Treatment is symptomatic (gastric lavage, activated charcoal).

Adverse reactions.

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

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

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 glass dropper bottles.

100 mL in glass bottles.

100 mL in a glass bottle; 1 bottle in a cardboard package.

Availability category. Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

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