Crataegi fructus (Herbal raw material) Instructions for Use

Marketing Authorization Holder

Lek S+, LLC (Russia)

ATC Code

C01EB04 (Hawthorn glycosides)

Active Substance

Crataegus fruit (BHP British Herbal Pharmacopoeia)

Dosage Forms

	Crataegus fruit	Herbal raw material – powder 2.8 g: filter bags 10 or 20 pcs.
		Whole herbal raw material: 30, 35, 50, 75, 100 or 140 g packs

Dosage Form, Packaging, and Composition

2.8 g – filter bags (10) – cardboard packs.
2.8 g – filter bags (20) – cardboard packs.

2.8 g – filter bags (10) – cardboard packs.

30 g – Paper bags (1) – cardboard packs.
35 g – Paper bags (1) – cardboard packs.
50 g – Paper bags (1) – cardboard packs.
75 g – Paper bags (1) – cardboard packs.
100 g – Paper bags (1) – cardboard packs.
140 g – Paper bags (1) – cardboard packs.

50 g – Paper bags.

Clinical-Pharmacological Group

Herbal preparation used for functional disorders of the cardiovascular system

Pharmacotherapeutic Group

Cardiotonic agent of plant origin

Pharmacological Action

It has a cardiotonic, spasmolytic, and mild sedative effect, exhibits hypotensive properties, and normalizes blood coagulation parameters.

Indications

• As part of complex therapy for functional disorders of cardiovascular activity (neurocirculatory dystonia, cardialgia).

ICD codes

Dosage Regimen

Approximately 15 g (1 tablespoon) of the fruit is placed in an enamel bowl, poured with 200 ml (1 glass) of hot boiled water, covered with a lid, and infused in a boiling water bath for 30 minutes.

It is then cooled at room temperature for 10 minutes, strained, and the remaining raw material is squeezed out. The volume of the resulting decoction is adjusted to 200 ml with boiled water.

Take orally, 1/2 glass 2-3 times/day 30 minutes before meals. The treatment course is 20-30 days.

The decoction is recommended to be shaken before use.

Adverse Reactions

Allergic reactions (urticaria, itching), bradycardia (with prolonged use), with use in large doses – decreased blood pressure, drowsiness.

Contraindications

• Pregnancy (first trimester);
• Children under 12 years of age;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

Use during pregnancy in the second and third trimesters and during breastfeeding.

Use is possible considering the expected benefit for the mother and the potential risk to the fetus and child. It is necessary to consult a doctor.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms.

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms).

Overdose

To date, no cases of overdose have been reported.

Drug Interactions

When used in combination with cardiac glycosides, the cardiotonic effect is enhanced; with beta-blockers – the hypotensive effect is enhanced.

Storage Conditions

Store the drug in a dry place, protected from light.

Shelf Life

Shelf life – 2 years.

The prepared aqueous extract – in a cool, dark place for no more than 2 days. Keep out of reach of children.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.