PEONY TINCTURE

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

Composition:

Active ingredient:

1 ml of the medicinal product contains 1 ml of tincture (1:10) of roots and rhizomes of Paeonia anomala (Paeoniae anomalae rhizoma et radix) and herb of Paeonia anomala (Paeoniae anomalae herba) (1/1) (extractant – ethanol 40% v/v);

Excipients: apart from the extractant, none present.

Pharmaceutical form. Tincture.

Main physico-chemical properties: clear liquid ranging from light brown to brown in color, with a characteristic odor. Formation of sediment during storage is 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 interaction.

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

Special precautions for use

"Peony Tincture" is a traditional herbal medicinal product to be used according to indications supported by long-term use.

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

This medicinal product contains 35% v/v ethanol (alcohol), i.e. 112–149 mg/dose (15–20 drops), equivalent to 2.8–3.7 ml of beer or 1.4–1.9 ml of wine per dose.

Harmful for patients suffering from alcoholism. Caution should be exercised when used in pregnant and breastfeeding women, children, patients with liver disorders, and patients with epilepsy.

When large doses of the medicinal product are used for prolonged periods, gastric acidity should be monitored in patients with a tendency towards increased acidity.

Shake well before 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 or operating machinery, or any other activities requiring heightened attention, or rapid mental and motor reactions.

Dosage and Administration.

Take orally 10–15 minutes before meals. The recommended dose for adults is 15–20 drops of the tincture 2–3 times daily.

If the medicinal product is sealed with a non-dropper stopper instead of a dropper cap, use a medical glass pipette; the administered dose remains unchanged.

The duration of treatment is determined individually by a physician for each patient, depending on the nature, severity, and course characteristics of the disease, stability of the achieved therapeutic effect, and drug tolerability.

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 disease symptoms do not resolve during treatment or if adverse reactions not listed in the instructions for medical use occur.

Children.

The medicinal product must not be used in pediatric practice.

Overdose.

Overdose may result in drowsiness, decreased arterial pressure, and dizziness.

In case of overdose, discontinue the drug 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, rash, itching, swelling.

Shelf life. 3 years.

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

Storage conditions.

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

Keep out of reach of children.

Packaging.

50 ml, 100 ml or 110 ml in bottles.

Supply category.

Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and place of business.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.