Valeriana-vishfa

INSTRUCTION for medical use of the medicinal product VELERIANKA-VISHPHA (VALERIANKA-VISHPHA)

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;

Excipients: none, except the extraction solvent.

Pharmaceutical form. Oral tincture.

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

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC code N05CM09.

Pharmacological Properties.

Pharmacodynamics.

Biologically active substances contained in valerian rhizomes with roots (essential oil, valerianic acid, borneol, alkaloids, tannins, sugars) reduce excitation processes in the central nervous system and enhance the effects of other sedatives, hypnotics, analgesics, and spasmolytics. The medicinal product exerts a calming 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 and other disorders accompanied by suppression of central nervous system activity. Hypersensitivity to the biologically active substances contained in the medicinal product.

Interaction with other medicinal products and other forms of interaction.

The drug is capable of potentiating the effects of alcohol, cardiac agents, sedatives, hypnotics, analgesics, spasmolytics, antihypertensives, and anxiolytics.

Special precautions for use

The recommended guidelines for using the medicinal product must be strictly followed; otherwise, it may cause harm to health. The recommended doses of the medicinal product should not be exceeded.

Alcohol consumption should be avoided during treatment with this medicine.

Valeriana-Vishfa 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 patients with pronounced cerebral vascular atherosclerosis, the product should be used only under medical supervision.

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

Valeriana-Vishfa 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 its content of 70% ethanol.

Ability to influence reaction speed when driving or operating machinery

During treatment with this medicinal product, driving vehicles and operating 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. For children aged 12 years and older, the dosage is 1 drop per year of life, 3–4 times daily.

Patients should consult a physician if symptoms persist during treatment or if any adverse reactions occur.

Children

The medicinal product contains 70% ethanol; therefore, it is not recommended for use 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 agitation, general weakness, abdominal pain, nausea, decreased hearing and visual acuity, palpitations, and mental excitement.

In case of overdose, discontinue the use of the drug. Symptomatic treatment is recommended (gastric lavage, administration of activated charcoal).

Side effects.

The medicinal product is generally well tolerated; however, in some patients, reduced emotional responsiveness, drowsiness, decreased work capacity, depression, nausea, spasmodic abdominal pain, and weakness may occur.

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

If any adverse events occur, consult a physician immediately!

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

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 in glass or polymer bottles.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's name and address of business location.

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