GLADIOLUS LEAVES AND FLOWERS

I N S T R U C T I O N for medical use of the medicinal product HAWTHORN LEAVES AND FLOWERS (CRATAEGI FOLIA ET FLORES)

Composition:

Active substance: hawthorn leaves and flowers (Crataegi folia et flores);

1 package contains: hawthorn leaves and flowers (Crataegi folia et flores) 50 g or 60 g;

1 filter bag contains: hawthorn leaves and flowers (Crataegi folia et flores) 1.5 g or 2.5 g.

Dosage form. Leaves and flowers.

Main physicochemical characteristics: crude material: a mixture of uncrushed flowers, buds, individual petals, stamens and their fragments, fragments of pedicels, leaves, petioles with admixtures of fragments of twigs of various shapes, greenish, reddish-brown, brownish-red or brownish-red, brown or grey-brown, from bright green to dark green, grey-green, brownish-white or yellowish-white in color;

coarse powder: a mixture of fragments of leaves, flowers, buds, petals, pedicels, stamens, petioles, twigs of various shapes, greenish, reddish-brown, brownish-red or brownish-red, brown or grey-brown, from bright green to dark green, grey-green, brownish-white or yellowish-white in color.

Pharmacotherapeutic group. Cardiological preparations. ATC code C01EB04.

Pharmacological properties.

Pharmacodynamics.

The biologically active substances of the drug exert cardiotonic, spasmolytic, hypotensive, and sedative effects; improve myocardial function, eliminate cardiac rhythm disturbances, enhance blood circulation in the coronary vessels of the heart and cerebral vessels, normalize arterial pressure, reduce permeability of blood vessel and capillary walls, and promote reduction of blood cholesterol levels.

Clinical characteristics.

Indications.

Functional cardiac disorders, angioneuroses, mild forms of arrhythmias, initial stages of arterial hypertension – as part of complex therapy.

Contraindications.

Marked arterial hypotension and bradycardia; hypersensitivity to the biologically active substances of the drug.

Interaction with other medicinal products and other types of interactions. Enhances the effects of hypnotics, sedatives, antiarrhythmic agents, and cardiac glycosides.

Usage notes.

Use during pregnancy or breastfeeding. Contraindicated.

Ability to affect reaction rate when driving or operating machinery. During treatment with this medicinal product, driving or operating machinery should be avoided due to the possible occurrence of somnolence.

Method of Administration and Dosage.

Loose leaf : Place 1 tablespoon of leaves and flowers into an enameled container, pour 200 ml of hot boiled water, cover and steep in a water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeezing the residue into the strained infusion. Adjust the volume of the infusion to 200 ml with boiled water. Administer warm: adults – ⅓ cup 3 times daily, 15–20 minutes before meals; children aged 14 years and older – ¼ cup 2–3 times daily, 15–20 minutes before meals. Shake the infusion before use.

2.5 g in tea bags: Place 2 tea bags into a glass or enameled container, pour 200 ml of boiling water, cover and steep for 15 minutes. Administer warm: adults – ⅓ cup 3 times daily, 15–20 minutes before meals; children aged 14 years and older – ¼ cup 2–3 times daily, 15–20 minutes before meals.

1.5 g in tea bags: Place 2 tea bags into a glass or enameled container, pour 200 ml of boiling water, cover and steep for 15 minutes. Administer warm: adults – ½ cup 3 times daily, 15–20 minutes before meals; children aged 14 years and older – ⅓ cup 3 times daily, 15–20 minutes before meals.

Store the prepared infusion at 8–15°C for no more than 2 days.

The duration of treatment is determined individually by a physician.

Children. The product is indicated for children aged 14 years and older.

Overdose. Symptoms of overdose include drowsiness, decreased heart rate, and reduced arterial blood pressure. If these symptoms occur, discontinue the product immediately; treatment is symptomatic.

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling). With prolonged use, drowsiness and decreased heart rate may occur.

Shelf life. 3 years. Do not use after the expiry date stated on the packaging.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging. 50 g or 60 g in packs with an inner pouch; 1.5 g or 2.5 g in a tea bag, 20 tea bags per pack or in a pack with an inner pouch.

Dispensing category. Over-the-counter.

Manufacturer/Applicant. JSC "Liktravy", Ukraine.

Manufacturer's address and place of business activity / Applicant's address.

Ukraine, 10001, Zhytomyr region, city of Zhytomyr, Kyivske shose, building 21.