GLODU TINCTURE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HAWTHORN TINCTURE

Composition:
Hawthorn fruit tincture (Crataegi fructus);
Active substance: 1 bottle (jar) of the medicinal product contains hawthorn fruit tincture (Crataegi fructus) (1:10) (extractant – 70% ethanol) 50 ml or 100 ml;
Excipients: absent, except for the extractant;
1 ml of the medicinal product contains 0.65 ml of ethanol.

Pharmaceutical form:
Tincture.

Main physicochemical properties:
Clear yellowish-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 enhance blood circulation in the coronary vessels and cerebral vessels, increase myocardial sensitivity to cardiac glycosides, and reduce its excitability, resulting in a moderate strengthening of myocardial contractions.

Pharmacokinetics:
The medicinal product is well absorbed after oral administration. The effect develops within 30 minutes to 1 hour.

Clinical characteristics:

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

Contraindications:
Hypersensitivity to the components of the medicinal product.
Marked arterial hypotension and bradycardia.

Interaction with other medicinal products and other forms of interaction:
Hawthorn tincture potentiates the effect of cardiac glycosides and antiarrhythmic agents.
Concomitant use with alkaloid salts is not recommended due to the possibility of forming negative complexes.
The medicinal product should not be used concomitantly with cisapride.
May enhance the effect of sedatives, hypnotics, and antihypertensive agents.

Special precautions:
The medicinal product should not be taken during meals to avoid interaction with food components.

Use during pregnancy or breastfeeding:
Contraindicated.

Ability to influence reaction rate when driving or operating machinery:
The medicinal product contains ethyl alcohol and may cause drowsiness; therefore, during treatment, patients should refrain from driving vehicles or operating potentially hazardous machinery.

Method of administration and dosage:
For oral use, taken before meals.
Adults: 20 drops of tincture three times daily.
Children aged 12 years and older: 1 drop per year of age, three times daily, until a stable therapeutic effect is achieved.
Duration of treatment is determined individually by a physician.

Children:
Use of the medicinal product is contraindicated in children under 12 years of age.

Overdose:
Overdose may cause a decrease in arterial pressure, drowsiness, and bradycardia.
Administration of the medicinal product should be discontinued; treatment is symptomatic.

Adverse reactions:

• Immune system: Allergic reactions may occur (e.g., hyperemia, rash, itching, skin swelling).
• Cardiovascular system: Significant slowing of heart rate.
• Central nervous system: Drowsiness.

Shelf life:
3 years. Do not use the medicinal product 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:
50 ml or 100 ml in bottles, or 100 ml in jars.

Prescription status:
Over-the-counter.

Manufacturer:
Private Joint-Stock Company "Biolic".
Location and address of manufacturing site:
131, Nezalezhnosti St., Ladizhin, Vinnytsia region, 24321, Ukraine.