Arida® dry mixture for cough for children

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARIDA® DRY COUGH MIXTURE FOR CHILDREN

Composition:

Active substances: 19.55 g of powder contain: dry extract of marshmallow root (Althaeae radix extractum siccum) – 4.0 g; sodium hydrogencarbonate – 2.0 g; dry extract of licorice root (Glycyrrhizae radix extractum siccum) – 1.0 g; ammonium chloride – 0.5 g; anise oil – 0.05 g;

Excipients: sodium benzoate, confectionery sugar.

Dosage form. Powder.

Main physicochemical properties: powder from light beige to grayish-brown in color with the odor of anise oil. During storage, caking of the powder into lumps or formation of a solid porous mass may occur, which should disintegrate upon dilution with water. The aqueous suspension of the preparation (1 : 10) ranges from light to dark brown in color.

Pharmacotherapeutic group.

Expectorant, secretomotor agent.

ATC code R05C A10.

Pharmacological properties.

Pharmacodynamics. The drug stimulates expectoration. The mechanism of action is due to facilitating mucus secretion and improving its elimination (increasing mucociliary clearance).

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

The drug is indicated as an antitussive, anti-inflammatory, and expectorant agent in the complex treatment of inflammatory diseases of the respiratory tract.

Contraindications.

Hypersensitivity to the components of the drug. Organic heart lesions (myocarditis, pericarditis, myocardial infarction); arterial hypertension; hepatic and renal dysfunction; hypokalemia; severe obesity.

Interaction with other medicinal products and other forms of interaction.

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

Concomitant use with antitussive agents is not recommended.

Instructions for use.

"Aridu® Cough Dry Mixture for Children" should be prescribed as part of combination therapy. To improve the liquefaction and expectoration of sputum, it is recommended to take large amounts of warm fluids orally during administration of expectorants, especially secretomotor agents. Diabetic patients should consult a physician before using this medicine.

Use during pregnancy or breastfeeding.

This medicine is indicated for children aged 1 to 18 years. During pregnancy or breastfeeding, treatment should be prescribed by a physician when the expected benefit to the woman outweighs the potential risk to the fetus/infant.

Ability to influence reaction rate while driving or operating machinery.

This medicine is indicated for children aged 1 to 18 years. The medicine does not affect the ability to drive vehicles or operate other machinery.

Dosage and Administration.

Before use, dissolve the powder in cooled boiled water up to the mark on the vial (200 mL).

Administer orally after meals. For children aged 1 to 6 years – 1 teaspoon of the mixture 4–5 times daily; for children aged 6 years and older – 1 dessert spoon 3–4 times daily. Shake the mixture well before use. The reconstituted powder should be stored for no longer than 10 days at a temperature not exceeding +8 °C.

The duration of treatment is determined individually by a physician, depending on the therapeutic response and the nature of concomitant therapy.

Children.

Recommended for use in children aged 1 to 18 years.

Overdose.

Nausea, vomiting. 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 effects is possible.

Side effects.

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

Allergic reactions (skin rashes, itching) may occur; hyperemia, swelling; increased salivation, irritation of gastric mucosa.

If any adverse events occur, consult a physician.

Shelf life. 1 year.

Storage conditions.

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

Keep out of reach of children.

Packaging.

19.55 g in a bottle No. 1.

Prescription status. Over-the-counter.

Manufacturer/Applicant.

Ternopharm LLC.

Manufacturer's address and place of business activity / Applicant's address.

Ternopharm LLC.

4 Fabrychna St., Ternopil, 46010, Ukraine.