Cough mixture for children

INSTRUCTIONS
for medical use of medicinal product

COUGH MIXTURE FOR CHILDREN
(MIXTURA CONTRA TUSSIM PRO INFANTIBUS)

Composition:

Active ingredients: dry root extract of marshmallow (Althaea officinalis L.) (1:10), dry root extract of licorice (Glycyrrhiza glabra L.) (1:8);

One bottle contains: dry root extract of marshmallow (1:10) 4.0 g, dry root extract of licorice (1:8) 1.0 g;

Excipients: anise oil, sodium bicarbonate, sodium benzoate, ammonium chloride, sugar.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: brownish-gray powder with the smell of anise oil.

Pharmacotherapeutic group.

Expectorants. ATC code R05C A10.

Pharmacological properties.

“Cough Mixture for Children” belongs to medicinal products that stimulate expectoration. The mechanism of action is associated with enhanced physiological activity of ciliated epithelium and peristaltic movement of bronchioles, promoting the movement of sputum from lower to upper respiratory tract and its elimination. This effect is combined with increased secretion of bronchial glands and some reduction in sputum viscosity.

Clinical characteristics.

Indications.

In complex therapy of infectious-inflammatory diseases of the respiratory tract accompanied by cough and difficult sputum expectoration.

Contraindications.

Hypersensitivity to components of the medicinal product. Organic heart lesions (myocarditis, pericarditis, myocardial infarction); arterial hypertension; hepatic and renal dysfunction; hypokalemia; severe obesity. Children under 2 years of age.

Interaction with other medicinal products and other types of interactions.

Do not use with antitussive agents.

Concomitant use with cardiac glycosides, antiarrhythmic agents (quinidine), thiazide and loop diuretics, adrenocorticosteroids, and laxatives may enhance hypokalemia.

Inform your doctor about concomitant use of any other medicinal products.

Special precautions.

Cough Mixture for Children should be prescribed as part of complex therapy. To improve sputum liquefaction and expectoration, it is recommended to drink large amounts of warm fluid when taking expectorants, especially secretomotor agents.

Patients with diabetes mellitus should consult a physician before using this medicinal product.

Use during pregnancy or breastfeeding.

The medicinal product is intended for use in children.

Ability to affect reaction rate when driving or operating machinery.

Does not affect psychomotor reaction speed.

Method and dosage.

Before use, dissolve the medicinal product in cooled boiled water up to the mark on the bottle (200 ml). Take orally after meals: children aged 2 to
6 years – 1 teaspoon (5 ml) 4–5 times daily; children aged 6 to 18 years –
1 dessert spoon (10 ml) 3–4 times daily. Shake the mixture well before use. Treatment duration is determined individually by a physician and usually lasts 5–7 days.

Children.

Not recommended for children under 2 years of age.

Overdose.

Overdose and prolonged use (more than 2 months) may cause disturbances in water-electrolyte balance, potentially leading to hypokalemic myopathy and myoglobinuria. Exacerbation of adverse reactions is possible.

Symptoms: nausea, vomiting.

Treatment: discontinue the drug, gastric lavage.

Adverse reactions.

Prolonged use of licorice-containing preparations in excessive doses may cause disturbances in water-electrolyte balance and lead to hypokalemia; in individual cases, increased blood pressure, hypokalemic myopathy, and myoglobinuria are possible.

May cause allergic reactions (skin rashes, itching); hyperemia, swelling; increased salivation, gastric mucosa irritation.

If any adverse events occur, consult a physician.

Shelf life.

1.5 years.

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

Storage conditions.

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

Keep out of reach of children.

Store the reconstituted medicinal product for up to 10 days at 2–8 °C.

Packaging. 19.55 g in a bottle. 1 bottle in a cardboard pack.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "Biolyk".

Location of the manufacturer and its address of business activity.

131, Nezalezhnosti St., Ladizhin, Vinnytsia region, 24321, Ukraine.

Applicant.

LLC "Ukrainian Pharmaceutical Company".

Location of the applicant.

1U, Starosilska St., Kyiv, 02660, Ukraine.