ALTEIKA HALYCHPHARM

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALTEYKA HALYCHPHARM (ALTEYKA HALYCHPHARM)

Composition:

Active substance: 1 tablet contains 100 mg of dry extract of marshmallow herb (Althaea officinalis L.), 1:40 (extraction solvent – drinking water);

Excipients: magnesium carbonate light, aspartame (E 951), tartaric acid, povidone, sucrose (sucrose), calcium stearate, colloidal anhydrous silicon dioxide, flavoring agent (orange).

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: greyish-brown tablets with specks, round-shaped, flat surface, with a score line and bevel.

Pharmacotherapeutic group. Expectorants.

ATC code R05C A05.

Pharmacological properties.

Alteika Halychpharm is an effective expectorant whose action is ensured by secretolytic and broncholytic properties. The drug exerts a moderate antitussive effect, reduces the number of coughing episodes and their intensity. It normalizes altered bronchopulmonary secretion, improves sputum discharge: decreases its viscosity and adhesive properties, facilitates movement of sputum from the lower to the upper respiratory tract, and promotes its expectoration.

The medicinal product Alteika Halychpharm is non-toxic and does not produce local irritant effects.

Clinical characteristics.

Indications.

Cough associated with acute and chronic respiratory tract diseases accompanied by the production of thick and viscous bronchial secretions and/or impaired expectoration: bronchitis, pneumonia, bronchiectasis, bronchial asthma.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Currently, there is no information available on drug interactions with Alteika Halychpharm. Do not administer simultaneously with cough suppressants (e.g., codeine). The preparation may be used concurrently with other antitussive and expectorant agents.

Special precautions for use.

In some patients with chronic inflammatory lung diseases, mucus viscosity may initially increase during the start of treatment with Alteyka Halychpharm due to the release of accumulated mucus in the bronchial tree containing a large amount of debris, proteins, and inflammatory elements. Therefore, in cases of diffuse bronchial damage, significant changes in the physicochemical properties of mucus, and impaired mucociliary transport, therapy with Alteyka Halychpharm should be combined with mucolytic agents (e.g., bromhexine).

The product contains sucrose, which should be taken into account in patients with diabetes mellitus. The product should also not be administered to patients with the following rare hereditary conditions: fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

Due to the presence of aspartame in the medicinal product, it should not be used in patients with phenylketonuria.

Use during pregnancy or breastfeeding. There is no experience with the use of the medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery. The medicinal product does not affect the reaction rate while driving or operating other machinery.

Method of Administration and Dosage.

For adults and children aged 12 years and older: 1 tablet 4 times daily before meals. The tablets should be chewed and taken with a small amount of water.

Dosage for children aged 3 to 12 years: 1 tablet 3 times daily.

Duration of treatment: from 7 days to 1–2 months, depending on the form of the disease.

Children. The drug must not be used in children under 3 years of age.

Overdose.

Overdose is not possible when the recommended therapeutic doses are used. With prolonged use or overdose, nausea and vomiting may occur. Treatment is symptomatic.

Side effects.

In some cases, allergic reactions are possible, including urticaria and itching.

If any adverse reactions occur, discontinue use of the drug 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.

Packaging. 10 tablets per blister, 2 or 10 blisters per carton.

Supply category. Over-the-counter.

Manufacturer.

PJSC "Kyivmedpreparat".

Manufacturer's address and location of business operations.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.

Marketing authorization holder.

PJSC "Halychpharm".

Address of the marketing authorization holder.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.