VALERIAN TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LEMON BALM TINCTURE

Composition:

Active substance: Leonurus tincture (Tinctura Leonuri) (1:5) (extractant – 70% ethanol);

1 vial contains Leonurus tincture (Tinctura Leonuri) (1:5) (extractant – 70% ethanol) – 25 ml or 50 ml.

Dosage form. Tincture.

Main physico-chemical properties: clear greenish-brown liquid. Formation of sediment during storage is permissible.

Pharmacotherapeutic group. Sedative and hypnotic agents. 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 have a hypnotic effect, but facilitates the onset of physiological sleep and deepens it. It does not cause phenomena of habituation or psychological dependence.

Pharmacokinetics.

Pharmacokinetics has not been studied.

Clinical characteristics.

Indications.

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

Contraindications.

Marked hypotension (reduced arterial pressure), bradycardia. Individual hypersensitivity to the components of the drug.

Special precautions.

Prolonged use of the drug is not recommended due to its ethanol content.

Interaction with other medicinal products and other forms of interactions.

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

Inform your doctor about any concomitant use of other medicinal products.

Special precautions for use.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate when driving or operating machinery.

When taking Valerian tincture, caution should be exercised regarding driving vehicles or operating potentially hazardous machinery.

Dosage and Administration.

Take Pustyrnyk tincture orally after meals. The recommended dose for adults is 30–50 drops of the tincture 3–4 times daily. For children aged 12 years and older, the dosage is calculated as 1 drop per year of life.

The duration of treatment is determined individually by a physician 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 ethyl alcohol, the tincture should not be administered orally to children under 12 years of age.

Overdose.

Exceeding the recommended dosage may result in dizziness, drowsiness, and decreased arterial blood pressure. In case of overdose, discontinue the use of the drug immediately and initiate symptomatic and supportive therapy according to the patient's clinical condition.

Increased sensitivity to the drug is possible.

Side effects.

In case of individual hypersensitivity, local allergic reactions (redness and swelling of the skin, rash, itching) as well as dizziness, drowsiness, feeling of fatigue, 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. Sedimentation may occur during storage.

Packaging.

25 ml in glass bottles stoppered with corks and caps or dropper caps and caps, in a carton or without a carton; 25 ml in polymer bottles closed with caps with a tamper-evident feature, in a carton or without a carton. 50 ml in glass bottles stoppered with corks and caps or dropper corks and caps, one 50 ml bottle stoppered with a dropper cork and cap, in a carton. 50 ml in polymer bottles closed with dropper caps and caps or caps with a tamper-evident feature, in a carton or without a carton.

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Availability category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.