Mucaltin® forte

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

Composition:

Active substance: mukaltin;

1 tablet contains 100 mg of mukaltin;

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

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: greyish-brown tablets with speckles, round-shaped with a flat surface, a score line and beveled edges.

Pharmacotherapeutic group. Expectorant agents.

ATC code R05C A05.

Pharmacological properties.

Mucaltin® Forte is an effective expectorant whose action is provided by its 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 and improves sputum expectoration: decreases its viscosity and adhesive properties, facilitates movement of sputum from the lower to the upper respiratory tract, and promotes its expulsion.

Mucaltin® Forte is non-toxic and does not produce local irritant effects.

Clinical characteristics.

Indications.

Cough associated with acute and chronic respiratory tract diseases: bronchitis, pneumonia, bronchiectasis, bronchial asthma.

Contraindications.

Hypersensitivity to mucaltin or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Currently, there is no information available on drug interactions with Mucaltin® Forte. It should not be administered concurrently with cough suppressants (e.g., codeine).

The product may be taken simultaneously with other antitussive and expectorant agents.

Special precautions.

In some patients with chronic inflammatory lung diseases, at the beginning of treatment with Mucaltin® Forte, sputum viscosity may increase due to the release of accumulated sputum in the bronchial tree containing a large amount of debris, proteins, and inflammatory elements. Therefore, in cases of diffuse bronchial lesions, significant changes in the physicochemical properties of sputum, and impaired mucociliary transport, therapy with Mucaltin® Forte should be combined with mucolytic agents (e.g., bromhexine).

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

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

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

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

Dosage and Administration.

For adults and children aged 12 years and older: 1 tablet 3–4 times daily, taken before meals. The tablets should be chewed and washed down with a small amount of water.

Single dose for children aged 3 to 12 years: 1 tablet.

The duration of treatment is determined individually by a physician depending on the form of the disease and usually lasts from 7 days to 1–2 months.

Children.

The drug is contraindicated 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 medication 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.

Tablets, 10 in a blister pack, 2 or 10 blisters per carton.

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

Manufacturer.

JSC "Kyivmedpreparat".

Manufacturer's address.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.

Marketing Authorization Holder.

JSC "Halychpharm".

Address of the Marketing Authorization Holder.

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