PEONY TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIVONYI TINCTURE (PAEONIAE TINCTURA)

Composition:

Active substance: tincture of Paeonia anomala herb, rhizomes with roots;

1 bottle contains tincture of Paeonia anomala herb, rhizomes with roots (Paeonia anomala herba, rhizoma cum radicibus) (1:10) (extraction solvent – 40% ethanol) – 50 ml or 100 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear light-brown liquid with a characteristic odour; formation of sediment during storage is permissible.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

The herb, rhizomes, and roots of anomalous peony (Paeonia anomala) contain phenols, tannins, and organic acids. Peony tincture increases the body's resistance to hypoxia, exerts a spasmolytic, anticonvulsant, and antimicrobial effect, and is capable of increasing gastric acidity.

Pharmacokinetics.

Not determined.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the medicinal product. Arterial hypotension.

Special safety precautions.

When large doses are used for prolonged periods, gastric acidity should be monitored in patients with a tendency towards its increase. Shake well before use.

Interaction with other medicinal products and other forms of interaction.

The drug may potentiate the effect of sedatives and hypnotics, tranquilizers, neuroleptics, and antidepressants with sedative action.

Special precautions for use.

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

Use during pregnancy or breastfeeding. Contraindicated during pregnancy (has abortive effect) and during breastfeeding.

Ability to affect reaction speed when driving or operating machinery. During treatment with Paeonia tincture, patients should refrain from driving vehicles or performing other tasks that require heightened attention and rapid mental and motor reactions.

Dosage and Administration.

Take the tincture 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 should be determined individually for each patient, depending on the nature, severity, and specific course of the disease, as well as on the stability of the therapeutic effect achieved and the drug's tolerability.

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

The patient should consult a physician if symptoms do not resolve during treatment or if adverse reactions occur that are not listed in the drug's instructions for medical use.

Children.

The use of the drug is not recommended in pediatric practice due to lack of application experience.

Overdose.

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

In the event of overdose, administration of the drug should be discontinued and symptomatic and supportive therapy should be administered (according to the patient's clinical condition).

Side effects.

Arterial hypotension, drowsiness, general weakness, as well as development of allergic reactions (including rash, itching, hyperemia, swelling).

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC in a place inaccessible to children.

Packaging.

50 ml or 100 ml in a bottle; 1 bottle per box; 50 ml or 100 ml in bottles.

Supply category. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business.

4, Korolova St., Stanyshivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.