Plantago syrup

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRAVELER'S SYRUP (PLANTAIN SYRUP)

Composition:

Active substance: liquid extract of lanceolate plantain (Plantaginis lanceolatae folium) (1:1) (extraction agent – 20% ethanol);

100 ml of syrup contain 6.4 g of liquid extract of lanceolate plantain (Plantaginis lanceolatae folium) (1:1) (extraction agent – 20% ethanol);

Excipients: sugar; citric acid monohydrate; apple pectin; potassium sorbate; peppermint oil; purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: dark brown viscous liquid with a characteristic aromatic odor and sweet taste.

Pharmacotherapeutic group. Expectorants. ATC code R05C A.

Pharmacological Properties.

Pharmacodynamics.

The main active substances of Plantago lanceolata are mucilages, iridoid glycosides (aucubin, catalpol), phenolic acids (chlorogenic acid) and their glycosides (verbascoside), saponins, flavonoids, and tannins. Due to these substances, Plantago lanceolata has anti-inflammatory, secretolytic, and antibacterial properties. It liquefies sputum and promotes expectoration.

Pharmacokinetics.

Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

As part of complex therapy in infectious and inflammatory diseases of the respiratory tract.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Do not use simultaneously with antitussive agents, as this may interfere with the elimination of liquefied sputum.

Special precautions for use

If dyspnea, fever, or purulent sputum occurs during the use of this medicinal product, consult a physician.

"Podorozhnyka syrup" contains a small amount of ethanol (alcohol), less than 100 mg per dose.

The medicinal product contains 1.62% v/v ethanol. A 10 ml dose contains 127 mg of ethanol, equivalent to approximately 1.3 ml of wine and 3.2 ml of beer. A 15 ml dose contains 190 mg of ethanol, equivalent to 4.8 ml of beer and 2 ml of wine per dose. The medicinal product is harmful for patients suffering from alcoholism. Caution should be exercised when administering to pregnant and breastfeeding women, children, and patients in high-risk groups, such as those with liver disease or epilepsy. Concomitant use of other medicinal products containing ethanol should be avoided. Recommended doses should not be exceeded.

"Podorozhnyka syrup" contains sugar and therefore should be used with caution in patients with diabetes mellitus.

"Podorozhnyka syrup" contains less than 1 mmol (39 mg) of potassium per dose, i.e., practically potassium-free.

"Podorozhnyka syrup" contains citric acid and therefore should be used with caution in patients suffering from hyperacidic gastritis, peptic ulcer disease with increased acidity, or reflux esophagitis.

Use during pregnancy or breastfeeding

Due to the lack of clinical data, this medicinal product should not be used during pregnancy or breastfeeding.

Ability to influence reaction speed while driving or operating machinery

There are no data available on the effect of this medicinal product on the ability to drive or operate machinery when used at recommended doses.

Method of administration and dosage.

Take the medication every 2–3 hours with equal intervals between doses (5–7 times daily): children aged 3 to 6 years – 1/2 teaspoon (2.5 ml), children aged 6 to 12 years – 1 teaspoon (5 ml), adults and children aged 12 years and older – 1 tablespoon (15 ml). The duration of treatment is determined individually by a physician and averages 5–7 days. If the patient's condition does not improve during the course of treatment, medical advice should be sought.

Children.

Not recommended for children under 3 years of age.

Overdose.

In case of overdose, for example, accidental ingestion of the entire contents of the bottle, gastrointestinal disturbances may occur.

Side effects.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is an important procedure. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Allergic reactions (including hyperemia, rash, itching, skin swelling), burning sensation, diarrhea.

In case of any adverse reactions, discontinue use of the product and consult a physician immediately.

Shelf life. 3 years.

Shelf life after opening the bottle – 3 months.

Storage conditions.

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

Keep out of reach of children.

Packaging.

100 ml or 200 ml in a glass or polymer bottle, in a carton box, with or without a measuring cup.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.