PUSTYRNIK-VISHFA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PUSTYRNyk-Vishfa (leonurus−vishpha)

Composition:

Active substance: motherwort herb tincture;

1 vial contains motherwort herb tincture (Leonuricardiacaeherba) (1:5) (extraction solvent – 70% ethanol) – 25 ml;

Excipients: none.

Pharmaceutical form. Oral tincture.

Main physico-chemical properties: clear greenish-brown liquid. Formation of a precipitate may occur during storage.

Pharmacotherapeutic group. Sedative and hypnotic agents.

ATC code N05C M.

Pharmacological properties.

Pharmacodynamics. The medicinal product exerts a calming effect. Biologically active substances contained in the herb of Vitex agnus-castus (steroidal and flavonoid glycosides, essential oil, stachydrine, alkaloid leopurine, saponins, tannins) enhance inhibitory processes or reduce excitatory processes in the central nervous system. It does not exhibit hypnotic effects but facilitates the onset of physiological sleep and deepens it. It does not cause phenomena of habituation or psychological dependence.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Functional disorders of the cardiovascular system activity (hypertensive-type neurocirculatory dystonia), early stages of arterial hypertension, increased emotional excitability, irritability, mild forms of sleep disturbances.

Contraindications.

Increased individual hypersensitivity to the components of the drug. Pronounced arterial hypotension, bradycardia.

Interaction with other medicinal products and other types of interactions.

Pustyrnik-Vishfa may potentiate the pharmacological effects of sedatives, hypnotics, analgesics, antihypertensive drugs, and cardiac glycosides, as well as enhance the effect of alcohol.

When using any other medicinal products simultaneously, inform your doctor.

Special precautions for use

This medicinal product contains 70 vol.% ethanol (alcohol), i.e. 690.55 mg/dose. It is harmful for patients suffering from alcoholism. Caution is advised when administering to patients with liver disorders and to those with epilepsy.

Prolonged use of this medicinal product is not recommended due to its ethanol content.

Shake well before use.

Pußtrnik-Višfa is a traditional herbal medicinal product used according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

As the medicinal product contains ethanol, Pußtrnik-Višfa should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

When using this medicinal product, patients should refrain from potentially hazardous activities requiring heightened attention (e.g. driving vehicles or operating machinery).

Dosage and Administration.

Take orally after meals.

For adults: 30–50 drops of the tincture 3–4 times daily. For children aged 12 years and older: 1 drop of tincture per year of life.

The duration of treatment is determined individually for each patient, depending on the nature and severity of the pathological process, the course of the disease, individual tolerance to the drug, and the stability of the therapeutic effect achieved.

Consult a physician if symptoms do not resolve during treatment or if any adverse reactions occur.

Children.

Since ethanol is an ingredient of the medicinal product, the tincture should not be administered to children under 12 years of age.

Overdose.

In case of exceeding the recommended doses, symptoms such as dizziness, drowsiness, and decreased arterial pressure may occur. In the event of overdose, discontinue the drug and immediately initiate symptomatic and supportive therapy according to the patient's clinical condition.

Increased sensitivity to the drug may occur.

Side effects.

In cases of individual hypersensitivity to the drug, local allergic reactions (including skin redness and swelling, rash, itching) as well as dizziness, drowsiness, and feelings of fatigue, decreased mental and physical performance may occur.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 25 ml in bottles.

Availability. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

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