ALTEIKA-TERNOPHARM

INSTRUCTIONS FOR MEDICINAL USE OF THE MEDICINAL PRODUCT Alteika-Ternofarm

Composition:

Active substance: dry extract of marshmallow root (4:1);

5 ml of syrup contain dry extract of marshmallow root (Althaeae radix extractum siccum) (4:1) (extractant – water), calculated as polysaccharides 7.5 mg;

Excipients: sodium methylparaben (E 219), sodium propylparaben (E 217), citric acid monohydrate, confectioner's sugar, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: syrup-like liquid, light brown to reddish-brown in color, with a specific odor. Sediment formation may occur during storage.

Pharmacotherapeutic group.

Preparations used for cough and colds. Expectorants. Marshmallow roots.

ATC code R05C A05.

Pharmacological properties.

Pharmacodynamics. Direct-acting expectorant. A herbal preparation whose main active ingredients are polysaccharides, as well as pectins, amino acids, starch, etc. The polysaccharides of the preparation are absorbed into the blood, partially excreted by the bronchial glands, and exert a coating, softening, and anti-inflammatory effect on the mucous membrane of the upper respiratory tract. They somewhat increase the secretion of the liquid component of bronchial mucus and normalize its rheological properties (viscosity, elasticity, adhesiveness). Enhances peristaltic movements of bronchioles and motor function of the ciliated epithelium of the bronchi, promoting the expulsion of sputum.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

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

Special precautions for use

The presence of sodium methylparaben (E 219) and sodium propylparaben (E 217) in the medicinal product may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

The medicinal product should not be used, as there is no information available regarding experience with the use of the drug during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery

The use of the drug generally does not affect reaction speed while driving or operating machinery.

Dosage and Administration.

The medicine should be taken before meals.

Adults and children aged 14 years and older: 15 ml of syrup 4–6 times daily.

Children aged 6–14 years: 10 ml of syrup 4–6 times daily.

Children aged 2–6 years: 5 ml of syrup 4–6 times daily.

For children aged 2 to 6 years, the prescribed dose of syrup should be diluted in a sufficient amount of boiled water (10–15 ml).

The duration of treatment is determined individually by a physician according to therapeutic response and usually lasts 7–14 days.

Children.

The medicine is indicated for children aged 2 years and older.

Overdose.

Cases of overdose have not been reported.

Side effects.

Allergic reactions, increased salivation, and irritation of the gastric mucosa are possible. If any adverse reactions occur, discontinue treatment with the medication and consult a physician.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

After opening, store for no more than 14 days at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml or 200 ml in a bottle; 1 bottle with a measuring spoon or measuring cup in a carton.

Availability.

Over-the-counter.

Manufacturer/Applicant.

TOV "Ternofarm".

Manufacturer's location and address of business activity / Applicant's location.

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua