VALERIAN TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN TINCTURE

Composition:

Active substance: valerian root tincture (Radicis Valerianae);

1 bottle contains valerian root tincture (Radicis Valerianae) (1:5) (extractant – 70% ethanol) 25 ml or 30 ml;

Excipients: none

Pharmaceutical form. Tincture.

Main physicochemical properties: clear liquid, ranging in color from yellow-red to reddish-brown, with characteristic odor. Formation of sediment is permissible.

Pharmacotherapeutic group. Sedative and hypnotic agents. ATC code N05CM09.

Pharmacological Properties.

Pharmacodynamics.

Biologically active substances contained in valerian roots 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, sleep disturbances), cardiovascular system disorders (neurocirculatory dystonia).

Contraindications.

Depression or other conditions accompanied by suppression of central nervous system activity, individual intolerance to any component of the drug.

Interaction with other medicinal products and other forms of interactions.

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

Special precautions for use.

Do not exceed the recommended doses of the drug.

Alcohol consumption should be avoided during the use of this drug.

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

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

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

Specific sensitivity to the smell of valerian may occur.

Use during pregnancy and breastfeeding.

As the drug contains ethanol, the tincture should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

During treatment with this drug, driving vehicles or operating potentially hazardous machinery should be avoided, as the drug contains ethanol and may cause adverse effects on the central nervous system.

Dosage and Administration.

Valerian tincture is intended for oral use. Adults are recommended to take 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 dosage is calculated as 1 drop per year of life, 3–4 times daily.

The duration of treatment is usually determined individually by a physician.

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

Overdose.

In case of overdose, pronounced adverse reactions may develop: mental agitation, increased fatigue, headache, dizziness, drowsiness, general weakness, abdominal spasms and pain, nausea, decreased hearing and visual acuity, palpitations.

In the event of overdose, administration of the drug must be stopped immediately, and emergency measures (gastric lavage, activated charcoal, etc.) should be promptly initiated, along with symptomatic treatment.

Cases of withdrawal syndrome (delirium) have been reported after ingestion of very high doses of valerian tincture over several years (approximately 30 g per day).

Side effects.

The drug is generally well tolerated; however, in some patients the following may occur: suppression of emotional responses, drowsiness, reduced work capacity, depression, nausea, spasmodic abdominal pain, weakness. Allergic reactions are possible (e.g., skin redness, rash, itching, skin swelling).

If any adverse events occur, consult a physician.

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 dropper bottles;

25 ml in dropper bottles; 1 dropper bottle per carton;

30 ml in bottles or in bottles with dropper caps, or in bottles with tamper-evident closures;

30 ml in bottle or in bottles with dropper caps, or in bottles with tamper-evident closures; 1 bottle per carton.

Availability. Over-the-counter.

Manufacturer.

Subsidiary enterprise "Agrofirm "Yan" of the private enterprise "Yan".

Manufacturer's address and location of business activity.

41, Lenina Street, Nemyrinky, Ruzhyn District, Zhytomyr Oblast, 13643, Ukraine.

Date of last review.