PUSTYRNIKA TINCTURE

INSTRUCTION
for medical use of medicinal product

LEONURUS TINCTURE

Composition:

active ingredient: Leonurus herb tincture (Herba Leonuri);

1 bottle contains Leonurus herb tincture (Herba Leonuri) (1:5) (extractant – 70% ethanol) 25 ml or 40 ml or 50 ml or 100 ml.

Pharmaceutical form. Tincture.

Main physico-chemical properties: clear greenish-brown liquid with a weak specific odor. Formation of sediment during storage is allowed.

Pharmacotherapeutic group.

Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

The action of Leonurus tincture is similar to that of valerian preparations. The sedative effect occurs due to enhancement of inhibition processes or reduction of excitation processes in the central nervous system. It does not cause hypnotic effects, but facilitates the onset of physiological sleep and deepens it. Does not cause habituation or psychological dependence. Pharmacokinetics.

Not determined.

Clinical characteristics.

Indications.

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

Contraindications.

Increased individual sensitivity to the components of the drug.

Marked arterial hypotension (reduced arterial pressure), bradycardia.

Special precautions.

Long-term use of the drug is not recommended due to its ethanol content.

Interaction with other medicinal products and other forms of interactions.

Leonurus tincture may potentiate the pharmacological effects of sedatives, hypnotics, analgesics, antihypertensives, and cardiac glycosides, as well as enhance the effects of alcohol.

Patients should inform their physician about concomitant use of any other medicinal products.

Special precautions.

Use during pregnancy or breastfeeding.

Since the preparation contains ethanol, the tincture is not recommended for oral use in women during pregnancy and breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

When taking the medicine, avoid driving vehicles and operating potentially hazardous machinery.

Method of administration and dosage.

Balm mint tincture is taken orally after meals.

Adults are recommended to take 30–50 drops of the tincture 3–4 times daily until a stable therapeutic effect is achieved; children aged 12 years and older – at a dosage of 1 drop 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, drug tolerance, and the stability of the therapeutic effect achieved.

Children.

Since the preparation contains ethanol, the tincture is not recommended for oral use in children under 12 years of age.

Overdose.

Exceeding the recommended doses may lead to dizziness, drowsiness, and decreased arterial blood pressure. In case of overdose, discontinue the drug and initiate immediate symptomatic and supportive therapy according to the patient's clinical condition.

Increased sensitivity to the drug may occur.

Adverse reactions.

In case of individual hypersensitivity, local allergic reactions (skin redness, swelling, rash, itching) may occur, as well as dizziness, drowsiness, fatigue, and reduced mental and physical performance.

Shelf life.

4 years.

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

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging, in a place inaccessible to children. Sediment may form during storage.

Packaging.

25 ml, 40 ml, 50 ml, 100 ml in bottles.

Prescription status.

Over-the-counter.

Manufacturer.

PP "Kilaff".

Location of manufacturer and its registered office address.

6 Kharkivska Street, Sumy, Sumy region, 40035, Ukraine.