GLYCYRRHIZAE RADIX SYRUP

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LICORICE ROOT SYRUP

Composition:

Active substance: concentrated licorice root extract (Extractum Glycyrrhizae spissum) (3:1) (extraction solvent – purified water);

100 g of syrup contain concentrated licorice root extract (Extractum Glycyrrhizae spissum) (3:1) (extraction solvent – purified water) – 4 g;

Excipients: ethanol 96%, sugar, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: viscous brown liquid with a characteristic odour. Sediment formation may occur during storage.

Pharmacotherapeutic group. Medicinal products used in cough and colds. Expectorants. ATC code R05C A.

Pharmacological Properties.

Pharmacodynamics.

The roots of Glycyrrhiza glabra contain glycyrrhizin, potassium and calcium salts of glycyrrhizic acid, and flavonoid glycosides (liquiritin, liquiritigenin, liquiritoside). The expectorant effect of licorice preparations is associated with glycyrrhizin content, which stimulates the activity of the ciliated epithelium of the trachea and bronchi and enhances secretory function of the mucous membranes of the upper respiratory tract.

The spasmolytic effect of the drug on smooth muscles of the respiratory tract is due to the presence of flavonoid compounds, among which liquiritoside is the most active. The anti-inflammatory (corticosteroid-like) effect is attributed to glycyrrhizic acid, released during hydrolysis of glycyrrhizin.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

In complex therapy of infectious-inflammatory diseases of the respiratory tract accompanied by difficult expectoration and cough (acute and chronic bronchitis, tracheobronchitis, pneumonia, bronchiectasis).

As an adjunctive agent in chronic hyperacid gastritis.

Contraindications.

Hypersensitivity to any component of the drug, diabetes mellitus, liver and kidney dysfunction, arterial hypertension, hypokalemia, severe obesity.

Interaction with other medicinal products and other types of interactions.

Hypokalemia (due to excessive use of licorice root) may be potentiated when used concomitantly with cardiac glycosides, antiarrhythmic agents, and drugs affecting cardiac rhythm (e.g., quinidine).

When used in combination with drugs that may cause hypokalemia (thiazide and loop diuretics, adrenocorticosteroids, and laxatives), disturbances in electrolyte balance may occur. Therefore, prolonged simultaneous use of Licorice Root Syrup with the above-mentioned medicinal products should be avoided.

Licorice Root Syrup may antagonize the effects of antihypertensive drugs.

When using any other medicinal products concurrently, consult a physician.

Special precautions for use.

The syrup contains sugar, therefore it should not be used in patients with diabetes mellitus.

This medicinal product contains not less than 5 vol.% ethanol (alcohol), i.e. 600 mg/dose, equivalent to 15 ml of beer or 6 ml of wine per dose. It is harmful for patients suffering from alcoholism. Caution should be exercised when administering to children aged 12 years and older and in patients with epilepsy.

Prolonged use of the drug is not recommended, as it may lead to disturbances in water-electrolyte balance and edema.

Concurrent use with diuretics, cardiac glycosides, corticosteroids, stimulant laxatives, or other medicinal products that may cause electrolyte imbalance is not recommended (see section "Interaction with other medicinal products and other forms of interaction").

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy, as licorice root increases estrogen levels, thereby disrupting hormonal balance. It stimulates uterine activity. In high doses, it exerts embryotoxic effects. The drug is contraindicated during breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

During treatment with this drug, patients should refrain from driving vehicles or operating potentially hazardous machinery.

Method of Administration and Dosage.

For adults and children aged 12 years and older: take 1 tablespoon (15 ml) of syrup after meals 3–4 times daily.

The duration of treatment is determined individually by a physician for each patient, taking into account the severity and specific features of the disease course, stability of the achieved therapeutic effect, and the drug's tolerability.

Children. The drug is not prescribed for children under 12 years of age.

Overdose.

Cases of overdose have been reported with prolonged use (more than 4 weeks) and/or intake of excessive doses of licorice-containing preparations, manifesting as fluid retention, hypokalemia, hypertension, cardiac arrhythmias, and hypertensive encephalopathy. In case of overdose, adverse effects may be intensified. Treatment is symptomatic.

Adverse reactions.

Allergic reactions including skin rash, itching, hyperemia of the skin, and swelling may occur in individuals with increased sensitivity.

Prolonged use of licorice preparations in excessive doses may cause electrolyte imbalance and lead to edema formation, hypokalemia; in some cases, increased arterial pressure, hypokalemic myopathy, and myoglobinuria are possible.

If any adverse events occur, the patient must discontinue the medication and consult a physician immediately!

Shelf life. 2 years. Do not use the medication after the expiry date stated on the packaging.

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

Keep out of reach of children.

Packaging. 100 g in glass or polymer bottles without carton box or in a carton box with a measuring spoon or measuring cup, or without a measuring device; 200 g in glass bottles without carton box or in a carton box with a measuring spoon or measuring cup, or without a measuring device; 200 g in polymer bottles with or without a dispenser, without carton box or in a carton box with a measuring spoon or measuring cup, or without a measuring device.

Prescription status.

Over-the-counter.

Manufacturer.

JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Akademyka Street, Zaporizhzhia, Ukraine, 69063.