Mucaltin

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

Composition:

Active substance: 5 ml of syrup contain 7.5 mg of dry extract of Althaea root (Althaeae radix) (extractant – water), calculated as 20.0% polysaccharide content;

Excipients: methylparahydroxybenzoate (E 218) (preservative), refined sugar, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: syrup-like liquid ranging from yellowish-brown to reddish-brown in color, with a specific odor. Sediment may be present upon storage.

Pharmacotherapeutic group. Medicinal products used for cough and colds. Expectorants.

ATC code R05C A05.

Pharmacological properties.

Pharmacodynamics.

The syrup based on the extract of marshmallow root is a complex herbal remedy containing polysaccharides as the main active substance, as well as pectins, amino acids, and starch. The medicinal product exerts bronchial secretory, expectorant, and demulcent effects. It reflexively stimulates the secretion of bronchial and salivary glands. It enhances mucus production and normalizes its rheological properties (viscosity, elasticity, adhesiveness), strengthens bronchiolar peristaltic movements and ciliary epithelium motor function in the bronchi, produces cytoprotective and anti-inflammatory effects, and promotes tissue regeneration.

Pharmacokin游戏副本ics.

Not studied.

Clinical characteristics.

Indications.

Cough associated with acute and chronic respiratory tract diseases: bronchitis, laryngitis, tracheitis, bronchial asthma, pertussis.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

Do not violate the instructions for use of the medicinal product.

Sediment formation may occur during storage. Shake well before use.

If dyspnea, fever, or purulent sputum develops during treatment, seek immediate medical advice.

The absorption of concurrently administered medicinal products may be reduced. Other medicinal products should be taken either 1 hour before or 1 hour after administration of the extract of Althaea root.

Use with caution in patients with diabetes mellitus.

The presence of methylparahydroxybenzoate (E 218) in the formulation may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

There is no information available regarding the experience of using this medicinal product during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The use of this medicinal product does not affect the ability to drive or operate machinery.

Dosage and Administration.

Mukaltin®, syrup, 100 or 200 ml in a bottle or jar

Shake well before use. Administer the medicinal product before meals: for adults and children aged 14 years and older — 15 ml of syrup 4–6 times daily.

For children aged 6 to 14 years — 10 ml of syrup 4–6 times daily; for children aged 2 to 6 years — 5 ml of syrup 4–6 times daily.

Mukaltin®, syrup, 15 ml in sachets

Before administration, gently knead the sachet. Administer the medicinal product before meals: for adults and children aged 14 years and older — 1 sachet (15 ml of syrup) 4–6 times daily.

For children aged 2 to 14 years, use Mukaltin®, syrup, 100 or 200 ml in a bottle or jar.

The duration of treatment is determined individually by a physician, depending on treatment efficacy, and usually lasts 7–14 days.

Children.

The medicinal product may be used in children aged 2 years and older.

Overdose.

Cases of overdose are unknown.

Side effects.

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

Reporting of adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life.

3 years.

The medicinal product must not be used after the expiry date stated on the packaging.

Storage conditions.

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

After opening, store for no more than 14 days at 4–8 °C.

Keep out of reach and sight of children.

Packaging.

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

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

15 ml in sachets; 20 sachets in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer.

PJSC "Halychpharm".

Manufacturer's location and address of business activity.

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