Mucaltin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MUKALTIN

Composition:

Active ingredient: 1 tablet contains 50 mg of mucaltin calculated as dry substance;

Excipients: sodium hydrocarbonate, citric acid monohydrate, sucrose, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: tablets are grey or grey with a brownish tint, with speckles, having a biconvex surface.

Pharmacotherapeutic group. Expectorant agents. ATC code R05C A.

Pharmacological properties.

Pharmacodynamics.

Mucaltin is an effective expectorant whose action is due to its secretolytic and broncholytic properties. The drug exerts a moderate antitussive effect, reduces the number of coughing attacks and their intensity. It exhibits soothing, anti-inflammatory, and coating properties. Mucaltin normalizes altered bronchopulmonary secretion and improves sputum expectoration: it reduces sputum viscosity and adhesive properties, facilitates movement of sputum from the lower to the upper respiratory tract, and promotes its expectoration.

Pharmacokinetics.

Not studied.

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 mucaltin or to any of the excipients of the drug.

Interaction with other medicinal products and other forms of interaction. Currently, there are no data available on drug interactions with mucaltin. Do not administer simultaneously with cough suppressants (e.g., codeine).

Special precautions for use.

In some patients with chronic inflammatory lung diseases, at the beginning of mucaltin therapy, sputum viscosity may increase due to the release of accumulated sputum from the bronchial tree containing a large amount of debris, proteins, and inflammatory elements. Therefore, in cases of diffuse bronchial damage, significant changes in the physical and chemical properties of sputum, and impaired mucociliary clearance, mucaltin therapy should be combined with the administration of mucolytic agents (bromhexine and others).

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

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

This medicinal product contains 23.82 mg of sodium per dose. Caution is advised when administering to patients on a sodium-restricted diet.

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

Ability to affect reaction rate while driving or operating machinery. The drug does not affect the ability to drive 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. Dosage for children according to age: 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 1/3 of a glass of warm water; sugar or fruit syrup may be added at will.

Treatment duration ranges from 7 days to 1–2 months, depending on the form of the disease.

Children. The drug may be administered to children aged 1 year and older.

Overdose. Overdose is not possible when the specified therapeutic doses are used.

With prolonged use or exceeding the recommended doses, nausea and vomiting may occur.

Treatment is symptomatic.

Side effects.

In some cases, allergic reactions may occur, including rash, urticaria, and itching of the skin.

Shelf life. 3 years.

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

Keep out of reach of children.

Packaging. Tablets, 30 in bottles or containers; 30 in a bottle or container in a carton; 10 in non-cellular contour packaging; 10 in a blister; 10, 10×3, 10×10 in blisters in a carton.

Prescription status. Over-the-counter (without prescription).

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Limited Liability Company "Research Plant "GNCLC".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's location and address of business activity.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA")

Ukraine, 61057, Kharkiv region, city of Kharkiv, Vorobiova Street, building 8.

(Limited Liability Company "Research Plant "GNCLC")

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100.

(Limited Liability Company "FARMEKS GROUP")