GLODU TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HAWTHORN TINCTURE

Composition:

Active ingredient: hawthorn fruit tincture (Crataegi fructus) (1:10) (extractant – 70 % ethanol);

1 bottle contains hawthorn fruit tincture (Crataegi fructus) (1:10) (extractant – 70 % ethanol) 25 ml or 100 ml;

Excipients, apart from extractant, are absent.

Pharmaceutical form. Tincture.

Main physicochemical properties: reddish-brown liquid. Sediment may form during storage.

Pharmacotherapeutic group. Agents used in cardiology.

ATC code C01EB04.

Pharmacological properties.

Pharmacodynamics. Biologically active substances contained in hawthorn fruits (flavonoids, choline, acetylcholine, tannins, phytosterols, triterpenic acids) enhance blood circulation in the coronary vessels and cerebral vessels, increase myocardial sensitivity to cardiac glycosides and reduce its excitability, resulting in a moderate enhancement of myocardial contractions.

Pharmacokinetics. The drug is well absorbed when administered orally. The effect occurs within 30 minutes – 1 hour.

Clinical characteristics.

Indications.

Functional disorders of the cardiovascular system (neurocirculatory dystonia), as well as an auxiliary medicinal agent in mild forms of cardiac arrhythmias (atrial fibrillation, paroxysmal tachycardia).

Contraindications.

Individual hypersensitivity to the components of the drug. Marked arterial hypotension and bradycardia.

Interaction with other medicinal products and other forms of interaction.

The drug may enhance the effects of cardiac glycosides, hypnotics, sedatives, and antihypertensive agents. Concomitant use with alkaloid salts is not recommended due to the possibility of forming adverse complexes. The drug should not be used together with cisapride.

Special precautions for use.

The drug is not recommended to be taken during meals to avoid interaction with food components.

Use during pregnancy or breastfeeding.

Since ethanol is a component of the drug, the tincture is not recommended for use in women during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

It is advisable to refrain from driving or operating machinery.

Method of Administration and Dosage.

Take orally before meals.

Recommended dosage: adults should take 20 drops of the tincture; children aged 12 years and older should take 1 drop per year of life, 3 times daily, until a stable therapeutic effect is achieved (normalization of arterial blood pressure, reduction of heart rate).

Children.

Since ethanol is a component of the preparation, the tincture is not recommended for children under 12 years of age.

Overdose.

In case of a significant overdose, symptoms such as drowsiness, bradycardia, and decreased arterial blood pressure may occur. These require immediate discontinuation of the drug and implementation of symptomatic therapy.

Adverse reactions.

Rarely observed: drowsiness, significant slowing of blood pressure, allergic reactions (including hyperemia, rash, itching, skin swelling).

Shelf life. 4 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

25 mL in dropper bottles, with or without carton; 100 mL in glass bottles, with or without carton.

Availability. Over-the-counter.

Manufacturer/Marketing Authorization Holder.

LLC "Ternopharm".

Manufacturer's address and place of business.

LLC "Ternopharm"

4 Fabrychna St., Ternopil, 46010, Ukraine.