CRATAEGUS HERB

INSTRUCTION for medical use of the medicinal product MOTHERWORT HERB (LEONURICARDIACAE HERBA)

Composition:

Active substance: motherwort herb (Leonuri cardiacae herba);

One pack contains motherwort herb (Leonuri cardiacae herba) – 50 g or 100 g; one filter bag contains motherwort herb (Leonuri cardiacae herba) – 1.5 g.

Pharmaceutical form. Herb.

Main physico-chemical properties:

Ground material: fragments of stems, leaves and inflorescences passing through a sieve with apertures of 7 mm diameter. Color is grayish-green. Odor is weak. Taste is bitter;

Coarse powder: fragments of stems, leaves and inflorescences ground to a size of 2–3 mm. Color is grayish-green. Odor is weak. Taste is bitter.

Pharmacotherapeutic group. Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

The biologically active substances of the drug exert pronounced sedative, spasmolytic, hypotensive, and cardiotoxic effects; they slow heart rate, increase the force of cardiac contractions, while simultaneously reducing the myocardium's oxygen demand.

Clinical characteristics.

Indications.

Mild arterial hypertension; excessive nervous excitability; neuroses and neurosis-like conditions (as part of complex therapy).

Contraindications.

Hypersensitivity to the biologically active substances of the drug. Arterial hypotension, bradycardia.

Interaction with other medicinal products and other types of interactions. When used concomitantly, it may enhance the effects of ethanol, sedatives or hypnotics, cardiac glycosides, analgesics, and antihypertensive drugs.

Special precautions for use.

Use during pregnancy or breastfeeding.

Use only after consulting a physician, who must assess the benefit/risks ratio for the fetus/child.

Effect on the ability to drive or operate machinery.
The drug should be used with caution when driving or operating machinery due to the possible occurrence of drowsiness or dizziness.

Dosage and Administration.

Place 4 tablespoons (15 g) of the herb into an enameled container, pour 200 ml (1 cup) of hot boiled water, cover with a lid and heat in a boiling water bath for 15 minutes, stirring frequently. Allow to cool for 45 minutes at room temperature, then strain and squeeze the residue. Adjust the volume of the resulting infusion with boiled water to the initial volume of 200 ml.

Administer orally, 1 hour before meals. Adults should take 1 tablespoon 3–4 times daily. Children aged 12 years and older should take ⅓ cup twice daily.

Place 2 filter bags into a glass or enameled container, pour 200 ml (1 cup) of boiling water, cover and let steep for 15 minutes. Take according to the above schedule.

The duration of treatment is determined individually by a physician and depends on the therapeutic effect and individual sensitivity to the drug.

Children.

Do not use in children under 12 years of age.

Overdose.

In case of overdose, symptoms may include increased fatigue, drowsiness, dizziness, and decreased arterial blood pressure. Treatment is symptomatic.

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling), gastrointestinal disturbances, increased fatigue, drowsiness, dizziness.

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 25 °C, in a place inaccessible to children. Prepared infusion should be stored at 8–15 °C for no more than 2 days.

Packaging.

50 g or 100 g in packs with an inner pouch; 1.5 g in tea bags, pack of 20.

Availability. Over-the-counter (without prescription).

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's name and address of business location:

69050, Zaporizhzhia, Skladska St., 4, Ukraine.

Marketing Authorization Holder: JSC Pharmaceutical Factory "Viola".

Address of Marketing Authorization Holder:

69063, Zaporizhzhia, Amosova Akademika St., 75, Ukraine.