VALERIANAE TINCTURE

INSTRUCTION FOR MEDICAL USE OF HERBAL TINCTURE OF LEONURUS (PUSTYRNIA)

Composition:

Active substance: 1 bottle contains 25 ml of herb of Leonurus tincture (tinctura herbae Leonuri) (1:5) (extractant – 70% ethanol).

Pharmaceutical form. Tincture.

Main physico-chemical properties: greenish-brown liquid with a weak aromatic odor. Sediment may form during storage of the tincture.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. The motherwort tincture has a similar mode of action to valerian preparations. The sedative effect results from enhancement of inhibition processes or reduction of excitation processes in the central nervous system. It does not produce hypnotic effects, but facilitates the onset of physiological sleep and deepens it. Does not lead to habituation or psychological dependence.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

Increased individual sensitivity to the components of the drug.

Severe arterial hypotension (reduced arterial pressure), bradycardia.

Interaction with other medicinal products and other forms of interaction.

Valerian tincture may potentiate the pharmacological effects of sedatives, hypnotics, analgesics, antihypertensive drugs, and cardiac glycosides, as well as enhance the effects of alcohol.

Any simultaneous use of other medicinal products should be reported to a physician.

Special precautions for use.

The preparation contains ethanol. It is not recommended to use the preparation for a prolonged period.

Use during pregnancy or breastfeeding.

Since ethanol is an ingredient of the preparation, the tincture is not recommended for use in women during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

When taking "Pustyrnyk tincture", caution should be exercised when driving vehicles or operating potentially hazardous machinery.

Dosage and Administration.

Take Pustyrnyk tincture orally after meals.

If the physician has not prescribed another treatment regimen, the recommended dose for adults is 30–50 drops of the tincture 3–4 times daily until a stable therapeutic effect is achieved. For children aged 12 years and older, the recommended dose is 1 drop per year of life, administered 3–4 times daily.

The duration of treatment is determined individually for each patient, taking into account the nature and severity of the pathological process, the characteristics of the disease course, drug tolerance, and the stability of the achieved therapeutic effect.

Children.

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

Overdose.

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

Increased sensitivity to the drug may occur.

Adverse reactions.

In case of increased sensitivity, local allergic reactions (including skin redness and swelling, rash, itching) as well as dizziness, drowsiness, fatigue, and decreased mental and physical performance may occur.

Shelf life. 4 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 or polymer bottles.

Dispensing category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and place of business.

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, http://www.ternopharm.com.ua