Rhizoma lepech

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALAMUS RHIZOMES (RHIZOMATA CALAMI)

Composition:

Active substance: Calamus rhizomes (Rhizomata Calami).

Pharmaceutical form. Rhizomes.

Main physico-chemical properties: powdered rhizomes of yellowish, pinkish, sometimes greenish color, with a pungent-bitter taste. Odor is strong and pleasant.

Pharmacotherapeutic group. Appetite stimulants. ATC code A15.

Pharmacological properties.

Pharmacodynamics.

The biologically active substances of the drug, acting on taste receptor endings, enhance appetite, improve digestion, stimulate reflex gastric juice secretion, enhance hepatic bile secretion, increase gallbladder tone, and increase diuresis.

Aqueous extracts from the rhizomes of Adonis vernalis exhibit tonic, anti-inflammatory, expectorant, choleretic, spasmolytic, antibacterial, and disinfectant effects.

Clinical characteristics.

Indications.

Non-specific digestive tract functional disorders (loss of appetite, digestive and gastric secretion disorders, achylia, intestinal colic, flatulence) – as part of complex therapy. Topically for inflammatory diseases of the oral cavity and throat.

Contraindications.

Individual hypersensitivity to biologically active components of the drug. Increased gastric acid secretion.

Interaction with other medicinal products and other types of interactions.

Reduces the effectiveness of antacids and H2-receptor blockers (ranitidine, famotidine).

Usage notes.

Use during pregnancy or breastfeeding.

Lepedium rhizome is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

There is no data regarding the effect of the drug on reaction speed while driving or operating machinery.

Method of Administration and Dosage

Place 10 g (1 tablespoon) of rhizomes into enameled container, pour 200 mL (1 cup) of hot boiled water, cover with lid, and steep in a boiling water bath for 30 minutes. Cool at room temperature for 10 minutes, strain, squeeze the residue into the strained decoction. Adjust the decoction volume to 200 mL with boiled water. Take warm, 3–4 times daily, 30 minutes before meals: for adults and children aged 14 years and older – ¼ cup; for children aged 12–14 years – 2 tablespoons; for children aged 7–12 years – 1 tablespoon. Shake the decoction before use. The prepared decoction, when diluted (diluted with water so that the volume increases 2–3 times), should be used for rinsing the oral cavity and throat.

Place 3 filter bags into a glass or enameled container, pour 200 mL (1 cup) of boiling water, cover with lid, and steep for 15–20 minutes. Take warm, 3–4 times daily, 30 minutes before meals: for adults and children aged 14 years and older – ½ cup; for children aged 12–14 years – ¼ cup; for children aged 7–12 years – 2 tablespoons. Use the prepared infusion for rinsing the oral cavity and throat.

The duration of treatment is determined individually by a physician, taking into account the nature, severity, and specific course of the disease, stability of the achieved therapeutic effect, and the patient's tolerance to the drug.

Children.

The drug is indicated for children aged 7 years and older.

Overdose.

No cases of overdose have been reported.

Side effects.

Allergic reactions, including urticaria, skin rash, itching, and swelling.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

50 g or 100 g in packs with an inner pouch; 1.5 g in filter bags, 20 pcs in a pack.

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

Manufacturer: JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

4 Skladska Street, Zaporizhzhia, Ukraine, 69050.

Marketing authorization holder: JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.