Peony tincture

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIVONII TINCTURE (PAEONIAE TINCTURA)

Composition:

Active substance: 1 bottle (jar) contains tincture (1:10) (Paeoniae anomalae rhizomata cum radicibus – Paeoniae anomalae herba 1:1), (extractant – ethanol 40% (v/v)) – 100 ml;

Excipients: apart from the extractant, none.

Pharmaceutical form. Tincture.

Main physico-chemical properties: light brown liquid with a specific odor. Opalescence and sediment are permissible.

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 herbal medicinal raw material.

Interaction with other medicinal products and other forms of interactions.

The medicinal product may potentiate the effects of sedatives, hypnotics, tranquilizers, neuroleptics, and antidepressants with sedative action.

Special precautions for use.

When large doses of the drug are administered for prolonged periods, gastric acidity should be monitored in patients prone to its increase.

Shake well before use.

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

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

During treatment, patients should refrain from driving vehicles or performing other tasks requiring increased attention and rapid mental or motor 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 the physician for each patient, depending on the nature, severity, and specific course of the disease, as well as on the stability of the achieved therapeutic effect 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 an interval (after 2–3 months).

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

Children.

The drug should not be used in pediatric practice.

Overdose.

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

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

Adverse reactions.

Central nervous system side effects: drowsiness, general weakness.

Cardiovascular system side effects: arterial hypotension.

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

Shelf life. 2 years.

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

Storage conditions.

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

Keep out of reach of children.

Packaging.

100 ml in a glass or polymer bottle. 1 bottle per cardboard box.

100 ml in a jar. 1 jar per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

JSC «CHEMICAL PHARMACEUTICAL PLANT «CHERVONA ZIRKA».

Manufacturer's address and place of business.

1 Gordienkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.