ALTHEA ROOT SYRUP

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALTHEAE RADICIS SYRUP

Composition:

Active ingredient: dry extract of althaea root;

100 ml of syrup contain 0.15 g of dry extract of althaea root, calculated in terms of polysaccharides;

Excipients: methylparaben (E 218), propylparaben (E 216), ethanol 96%, sugar, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: syrup-like liquid ranging from light brown to reddish-brown in color, with a characteristic odor. Sediment may be present during storage.

Pharmacotherapeutic group.

Preparations used for cough and colds. Expectorants.

ATC code R05C A05.

Pharmacological properties.

Expectorant with direct action.

Pharmacodynamics.

A herbal preparation containing dry extract of Althaeae radix, whose main biologically active substances are polysaccharides, as well as pectins, amino acids, and starch. The polysaccharides of the preparation are absorbed into the bloodstream, partially excreted by bronchial glands, and exert a coating, softening, and anti-inflammatory effect on the mucous membranes of the upper respiratory tract, slightly increasing the secretion of the liquid component of bronchial mucus and normalizing its rheological properties (viscosity, elasticity, adhesiveness). It enhances peristaltic movements of bronchioles and the motor function of ciliated bronchial epithelium, promoting expectoration. The herbal polysaccharide mucilage of the preparation, coating the gastric mucosa, demonstrates cytoprotective and anti-inflammatory effects.

Pharmacokinetics.

Data on pharmacokinetic studies of the drug are not available.

Clinical characteristics.

Indications.

Complex treatment of acute and chronic respiratory tract inflammatory diseases: laryngitis, tracheitis, bronchitis, bronchial asthma, pertussis.

Contraindications.

Hypersensitivity to the components of the drug.

Precautionary measures during use.

When using the drug, follow the physician's recommendations.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with antitussive agents (e.g., codeine) is not recommended.

Special precautions for use.

The product contains sugar and therefore should not be used by patients with diabetes.

Use during pregnancy or breastfeeding.

Do not use.

Ability to affect the reaction rate when driving vehicles or operating other machinery.

Does not affect.

Method of administration and dosage.

Shake before use.

The medicine should be taken with food:

adults and children aged 14 years and older – 1 tablespoon (15 ml) 4–6 times daily;

children aged 6 to 14 years – 1 dessert spoon (10 ml) 4–6 times daily;

children aged 2 to 6 years – 1 teaspoon (5 ml) 4–6 times daily.

For children aged 2 to 6 years, the required amount of syrup should be diluted in a small quantity of boiled water (10–15 ml or 2–3 teaspoons).

The duration of treatment is determined individually by the physician depending on treatment efficacy; usually, the duration is 7–14 days.

Children.

The medicine contains 2% alcohol (0.02 ml of alcohol in 1 ml of syrup); therefore, for children aged 2 to 6 years, the medicine should be diluted in boiled water prior to administration.

Overdose.

Cases of overdose have not been reported.

Adverse reactions.

The medicinal product may cause allergic reactions (possibly delayed).

If any adverse reactions occur, discontinue treatment and consult a physician.

Shelf life.

2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. After opening, store for no more than 14 days at 4–8 °C.

Packaging.

100 ml or 200 ml in glass or polymer bottles, in a carton or without a carton. One bottle per carton with a measuring spoon or a measuring cup.

Dispensing category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Street, Zaporizhzhia, Ukraine, 69063.