PEONY TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PEONY TINCTURE

Composition:

Active substance: tincture of herb, rhizomes with roots of peony anomalous (Paeoniae anomala herba, rhizomata cum radicibus);

1 bottle or jar of the preparation contains 100 ml of tincture of herb, rhizomes with roots of peony anomalous (Paeoniae anomala herba, rhizomata cum radicibus) (1 : 10) (extraction solvent — ethanol 40%).

Pharmaceutical form. Tincture.

Main physicochemical properties: clear light-brown liquid with a specific odor. Sediment formation during storage is permissible.

Pharmacotherapeutic group. Hypnotics and sedatives.

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 interactions.

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.

"Paeonia tincture" is a traditional herbal medicinal product for use according to indications supported by long-standing use.

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

When large doses are taken for prolonged periods, gastric acidity should be monitored in patients with a tendency towards its increase.

Shake well before use.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

During treatment, patients should refrain from driving or operating machinery, or from any work requiring high concentration, mental alertness, or rapid psychomotor reactions.

Method of Administration and Dosage

Take orally, 10–15 minutes before meals. 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 characteristics of the disease, stability of the therapeutic effect achieved, and the patient's tolerance to the drug.

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 adverse reactions not listed in the instructions for medical use of the drug occur.

Children

The medicinal product is not intended for use in pediatric practice.

Overdose

In case of exceeding the recommended doses, drowsiness, decreased arterial blood pressure, and dizziness may occur.

In case of overdose, administration of the drug should be discontinued and symptomatic therapy should be administered (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.

Reporting of adverse reactions.

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

Shelf life.

3 years.

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

Storage conditions.

Keep out of the reach of children.

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

Packaging.

100 ml in bottles or jars.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

Private Joint-Stock Company "Biolyk".

Manufacturer's address and location of operations.

131 Sh., Nezalezhnosti St., Ladizhyn, Vinnytsia region, 24321, Ukraine.

Marketing Authorization Holder.

Private Joint-Stock Company "Biolyk".

Address of the Marketing Authorization Holder.

118, Nezalezhnosti St., Ladizhyn, Vinnytsia region, 24321, Ukraine.