INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MUCALTIN® (MUCALTIN)

Composition:

Active ingredient: 1 tablet contains 50 mg of mukaltin;

Excipients: lactose monohydrate, sodium croscarmellose, magnesium carbonate heavy, aspartame, talc, calcium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical properties: greyish-brown tablets with specks, flat cylindrical, with a score line and chamfer.

Pharmacotherapeutic group. Expectorants. ATC code R05C A05.

Pharmacological properties.

Mucaltin® is an effective expectorant whose action is due to its secretolytic and bronchodilatory properties. The drug exerts a moderate antitussive effect, reducing the frequency and intensity of coughing episodes. It has soothing, anti-inflammatory, and demulcent properties. Mucaltin® normalizes altered bronchopulmonary secretion, improves sputum expectoration: reduces its viscosity and adhesive properties, facilitates movement of sputum from the lower to the upper respiratory tract, and promotes its expulsion.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to mucaltin or to any of the excipients of the drug.

Interaction with other medicinal products and other forms of interaction.

Currently, data on drug interactions of Mucaltin® are lacking. Do not administer simultaneously with cough-suppressant agents (e.g., codeine).

Special precautions.

In some patients with chronic inflammatory lung diseases, mucus viscosity may increase at the beginning of Mucaltin® treatment due to the release of accumulated mucus in the bronchial tree, which contains 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, Mucaltin® therapy should be combined with mucolytic agents (bromhexine and others).

It is advisable to take single doses of the drug every 4 hours.

Use during pregnancy or breastfeeding.

There is no experience with the use of the drug during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The drug does not impair the ability to drive vehicles or operate other machinery.

Method of administration and dosage.

Do not chew the tablets; swallow with a large amount of water.

For adults and children aged 12 years and older, administer 2 tablets 4 times daily before meals. Dosages for children, depending on age, are as follows: 1–3 years – 1 tablet 3 times daily; 3–12 years – 1 tablet 4 times daily.

When administering to children, the tablet may be dissolved in ⅓ of a glass of warm water; a sugar or fruit syrup may be added at the patient's discretion.

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

Children. The drug is indicated for children aged 1 year and older.

Overdose.

Overdose is not possible when the recommended therapeutic doses are used. However, with prolonged use or exceeding the recommended doses, nausea and vomiting may occur.

Treatment — symptomatic.

Side effects.

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

Shelf life. 4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in a strip; 10 tablets in a strip, 3 strips per pack; 30 tablets in a container, 1 container per pack; 10 tablets in a blister; 10 tablets in a blister, 3 blisters per pack.

Availability category. Over-the-counter.

Manufacturer. JSC "Halychpharm".

Manufacturer's location and address of business activity.

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