Valerian tincture

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

Composition:

Active ingredient: valerian root tincture (Valerianae Radix);

1 vial contains valerian root tincture (Valerianae Radix) (1 : 5) (extractant – ethanol 70%) 25 ml or 50 ml;

Excipients: apart from the extractant, none present.

Pharmaceutical form. Tincture for oral administration.

Main physico-chemical properties: clear reddish-brown liquid with a characteristic odour. Sediment may form during storage.

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC Code N05CM09.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the roots and rhizomes of valerian (essential oil, valeric 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, etc.), cardiovascular system disorders (neurocirculatory dystonia).

Contraindications.

Hypersensitivity to the biologically active substances contained in the drug.

Depression and other conditions accompanied by central nervous system depression.

Interaction with other medicinal products and other types of interactions.

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 for use.

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

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

During treatment with this medicinal product, driving vehicles or operating machinery should be avoided.

Method of Administration and Dosage.

Adults: take 20–30 drops per dose, 3–4 times daily until a stable therapeutic effect is achieved.

Children aged 12 years and older: 1 drop per year of life, 3–4 times daily.

The duration of treatment is on average 1–1.5 months.

Children.

Do not use in children under 12 years of age due to the presence of alcohol in the formulation.

Overdose.

In case of overdose, possible symptoms include mental excitement, headache, dizziness, decreased hearing and visual acuity, palpitations, drowsiness, general weakness, abdominal pain, nausea, and intensification of other adverse reactions. Immediate discontinuation of the drug, timely emergency measures (gastric lavage, activated charcoal, etc.), and symptomatic treatment promote rapid resolution of clinical signs of overdose.

Side effects.

Central nervous system: emotional blunting, drowsiness, reduced work capacity, depression.

Gastrointestinal tract: nausea, spasmodic abdominal pain, weakness.

Immune system: possible allergic reactions (including skin redness, rash, itching, skin swelling).

If any adverse events occur, consult a physician immediately!

Shelf life. 5 years.

Do not use the medication after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 ml or 50 ml in bottles.

Availability.

Over-the-counter.

Manufacturer.

Private Joint-Stock Company "Biolyk".

Manufacturer's address and location of business activity.

131, Nezalezhnosti St., Ladizhin, Vinnytsia region, Ukraine, 24321.