GLODU TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HAWTHORN TINCTURE (TINCTURA CRATAEGI)

Composition:

Active substance: hawthorn fruit tincture (Crataegi fructus) (1:10) (extraction solvent – 70 % ethanol);

1 vial contains hawthorn fruit tincture (Crataegi fructus) (1:10) (extraction solvent – 70 % ethanol) – 25 ml or 50 ml or 80 ml or 100 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear red-violet or cherry-colored liquid. Formation of sediment during storage is permissible.

Pharmacotherapeutic group. Agents acting on the cardiovascular system. ATC code C01EB04.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in hawthorn fruits enhance 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. The preparation is well absorbed when taken orally. The effect occurs within 30 minutes – 1 hour.

Clinical characteristics.

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

Contraindications. Hypersensitivity to the components of the drug. Marked arterial hypotension and bradycardia.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

The drug is not recommended to be taken during meals to avoid interaction with food components. Patients with severe arterial hypotension and/or bradycardia should not use the drug without prior medical consultation.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

The drug contains ethanol and may cause drowsiness; therefore, during treatment with this drug, patients should refrain from driving or operating potentially hazardous machinery.

Dosage and Administration.

Take orally before meals. The recommended dose for adults is 20 drops of the tincture 3 times daily. For children aged 12 years and older, the dose is 1 drop per year of life, 3 times daily, until a stable therapeutic effect is achieved. The duration of treatment depends on the course of the disease and individual sensitivity to the drug, and is determined individually by a physician.

Children.

The drug is indicated for children aged 12 years and older.

Overdose.

Overdose may cause hypotension, drowsiness, and bradycardia. The drug should be discontinued; treatment is symptomatic.

Side effects.

Drowsiness, significant slowing of heart rate, allergic reactions (including hyperemia, rash, itching, skin swelling).

Shelf life. 4 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Sediment formation may occur during storage.

Packaging.

25 ml in glass bottles stoppered with plugs or dropper plugs and caps; 80 ml or 100 ml in glass bottles stoppered with plugs and caps, or in polymer bottles with caps; 25 ml in polymer bottles stoppered with dropper plugs and caps. 50 ml in glass bottles stoppered with plugs and caps or dropper plugs and caps; 50 ml in polymer bottles stoppered with dropper plugs and caps or caps with first-opening control. One bottle per pack or without a pack.

Category of supply. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

69063, Ukraine, Zaporizhzhia, Amosova Street, 75.

Applicant. JSC Pharmaceutical Factory "Viola".

Applicant's location.

69063, Ukraine, Zaporizhzhia, Amosova Street, 75.