Valerian tincture

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

Composition:

Active substance: tincture of valerian rhizomes with roots (Rhizomata cum radicibus Valerianae) (1:5) (extractant – 70% ethanol);

1 vial contains tincture of valerian rhizomes with roots (Rhizomata cum radicibus Valerianae) (1:5) (extractant – 70% ethanol) – 25 ml or 50 ml.

Pharmaceutical form. Tincture.

Main physico-chemical properties: clear reddish-brown liquid with a characteristic pleasant odor. Formation of sediment is permissible.

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), cardiovascular system disorders (neurocirculatory dystonia).

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

Special precautions. During treatment, patients taking the tincture should refrain from driving vehicles and operating potentially hazardous machinery due to the presence of ethyl alcohol in the preparation.

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

Interaction with other medicinal products and other types of interactions.

Valerian tincture enhances the effects of cardiac, sedative, hypnotic, analgesic, and spasmolytic agents.

Special precautions.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

During the use of this medicinal product, driving and operating potentially hazardous machinery should be avoided.

Dosage and Administration.

Take Valerian tincture 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 1 drop per year of life, administered 3–4 times daily.

Children.

Since the preparation contains ethanol, the tincture is not recommended for oral use in 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 visual acuity, palpitations, and mental excitement.

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

Side effects

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

If any adverse effects occur, consult a physician immediately!

Shelf life. 5 years.

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

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 25 ml or 50 ml in glass bottles stoppered with a plug and cap or with a dropper plug and cap; one 25 ml bottle stoppered with a plug and cap or with a dropper plug and cap, in a carton; one 50 ml bottle stoppered with a dropper plug and cap, in a carton.

25 ml or 50 ml in polymer bottles stoppered with dropper plugs and caps; 25 ml or 50 ml in a polymer bottle stoppered with a dropper plug and cap, one bottle per carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.
69063, Ukraine, Zaporizhzhia, Amosova Akademika St., 75.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.
69063, Ukraine, Zaporizhzhia, Amosova Akademika St., 75.