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INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BAYBERRY COMMON SHOOTS (CORMUS LEDI PALUSTRIS)

Composition:

Active substance: bayberry common shoots (Cormus Ledi palustris);

1 pack contains bayberry common shoots (Cormus Ledi palustris) – 50 g.

Dosage form. Shoots.

Main physicochemical properties: fragments of stems, leaves, and fruits of various shapes. Color is green, dark green, orange-brown, greyish-brown. Odor is sharp, specific. Taste is not defined.

Pharmacotherapeutic group. Expectorants. ATC code R05C A.

Pharmacological properties.

Pharmacodynamics.

Bearberry shoots contain the glycoside arbutin, flavonoids, tannins, and essential oil (up to 7.5%). The oil includes sesquiterpenoids, ledol, palustrol, cymol, and geranyl acetate. Due to the presence of these substances, preparations from common bearberry have spasmolytic, expectorant, diaphoretic, diuretic, disinfectant, and sedative properties; they dilate blood vessels and reduce arterial pressure, while increasing the tone of smooth muscles.

Clinical characteristics.

Indications.

As an expectorant and antitussive agent in the complex therapy of acute and chronic diseases of the upper respiratory tract (bronchitis, tracheitis, laryngitis, whooping cough), bronchial asthma.

Contraindications.

Hypersensitivity to components of the herbal raw material. Increased excitability.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, it may enhance the effect of sedatives and agents that suppress the central nervous system. Should not be used together with cough suppressants.

Special precautions.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy, as it has stimulant properties and affects uterine muscles, increasing uterine tone. Use of the drug during breastfeeding is permitted only after careful evaluation by a physician of the benefit to the mother versus the risk to the infant.

Ability to influence reaction rate when driving or operating machinery.

Not described.

Method of administration and dosage.

Place 2 tablespoons (10 g) of shoots into an enameled container, pour 200 ml (1 cup) of boiling water over them, cover with a lid, and heat in boiling water (using a water bath) for 15 minutes. Allow to cool at room temperature for 45 minutes, then strain. Squeeze the remaining raw material into the strained infusion and adjust the volume of the infusion with boiled water to the initial volume of 200 ml. For adults and children aged 12 years and older, take ¼ cup of warm infusion 2–3 times daily after meals.

The duration of treatment is determined individually by a physician and depends on the course of the disease, its severity, and the nature of combined therapy. Shake the infusion well before use.

Children.

Common bogbean is a poisonous plant. Due to the impossibility of precise dosing, the preparation should not be used in children under 12 years of age.

Overdose.

Large doses may cause excessive excitation, and in severe cases, depression of the central nervous system.

Side effects.

Allergic reactions are possible, including skin rash.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children, in the original packaging at a temperature not exceeding 25 °C. Prepared infusion should be stored in a cool place (8–15 °C) for no more than 2 days.

Packaging.

50 g in packets, placed in a carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

69050, Ukraine, Zaporizhzhia, Skladska Street, 4.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

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