Paeonia tincture

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PEONY TINCTURE

Composition:

Active substance: tincture of equal proportions of the herb of anomalous peony, rhizomes and roots of anomalous peony (1:10) (Paeoniae anomala herba – Paeoniae anomala rhizomata et radices 1:1), (extractant – ethanol 40%) – 50 ml;

Excipients: apart from the extractant, none.

Pharmaceutical form. Tincture.

Main physicochemical properties: light brown liquid with a bitter astringent taste and a characteristic odour. Sediment formation may occur during storage.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. The herb, rhizomes, and roots of Paeonia anomala contain phenols, tannins, and organic acids. Paeonia tincture has spasmolytic and anticonvulsant properties, as well as the ability to increase gastric acidity and enhance the body's resistance to hypoxia.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Functional disorders of the central nervous system (hypertensive type neurocirculatory dystonia, neurotic states).

Contraindications.

Arterial hypotension. Individual hypersensitivity to biologically active substances contained in the medicinal plant raw material.

Interaction with other medicinal products and other forms of interaction.

The medicinal product may potentiate the effect of sedatives and hypnotics, tranquilizers, neuroleptics, antidepressants with sedative action, as well as enhance the effect of alcohol.

Special precautions for use.

When large doses of the medicinal product are used for a prolonged period, gastric acidity should be monitored in patients predisposed to its increase.

Shake well before use.

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

Use during pregnancy or breastfeeding.

The use of this medicinal product is contraindicated during pregnancy (it has abortifacient effects) and breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

During treatment with "Tincture of Paeonia", patients should refrain from driving vehicles or performing other tasks requiring heightened attention, and rapid psychomotor reactions.

Method of Administration and Dosage.

Take "Paeonia Tincture" orally, 10–15 minutes before meals, after diluting in a small amount of water. The recommended dose for adults is 15–20 drops of the tincture 2–3 times daily. The duration of treatment is determined individually by a physician for each patient, depending on the nature, severity, and specific features of the disease course, stability of the achieved therapeutic effect, and tolerability of the medicinal product.

The recommended treatment duration is 2 weeks. If necessary, the course of treatment may be repeated after a break (after 2–3 months).

The patient should consult a physician if symptoms of the disease do not resolve during treatment or if any adverse reactions occur.

Children.

There is no experience with the use of this medicinal product in children; therefore, it is not recommended for use in pediatric practice.

Overdose.

Overdosing may cause drowsiness, decreased arterial blood pressure, and dizziness.

In case of overdose, discontinue the use of the medicinal product and administer symptomatic therapy (according to the patient's clinical condition).

Side effects.

Central nervous system: drowsiness, general weakness.

Cardiovascular system: arterial hypotension.

Local allergic reactions: skin hyperemia and rash, itching, swelling.

Shelf life. 2 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

50 ml in glass or polymer bottles.

Supply category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address / Applicant's address.

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

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