Herbion® plantain syrup

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HERBION® PLANTAIN SYRUP (HERBION® PLANTAIN SYRUP)

Composition:

Active ingredient: liquid extract of leaves of Plantago lanceolata and flowers of Malva sylvestris, ascorbic acid;

5 ml of syrup (1 measuring spoon) contain: 2.50 g of liquid extract (extractant – water) of Plantago lanceolata leaves (Folium Plantago lanceolata L. s.l.) and Malva sylvestris flowers (Flos Malva sylvestris L.); ascorbic acid – 65 mg;

Excipients: sucrose, methylparahydroxybenzoate (E 218), orange flavoring oil.

Pharmaceutical form. Syrup.

Main physico-chemical properties: brown or reddish-brown syrup with a characteristic odor and taste. A slight sediment may be present, which is typical for natural substances.

Pharmacotherapeutic group.
Medicinal products used in cough and colds. ATC code R05X.

Pharmacological properties.

Pharmacodynamics.

Gerbeion**®** Plantain Syrup contains an extract of a mixture of leaves of Plantago lanceolata, flowers of Malva sylvestris, and ascorbic acid.

It is believed that the mucilage from the leaves of Plantago lanceolata and flowers of Malva sylvestris, as well as the iridoid glycosides (aucubin) from the leaves of Plantago lanceolata, play an important role in the action of the medicinal product. Since the syrup contains mucilage extracts, it acts as a demulcent in dry, irritating cough associated with inflammation of the upper respiratory tract. The viscous substance forms a thin protective layer on the mucous membranes of the oral cavity and throat, mechanically shielding the mucous membranes from irritants that trigger the cough reflex. Thus, it reduces cough caused by irritation of the respiratory mucosa during inflammatory processes induced by various environmental irritants.

Ascorbic acid participates in numerous metabolic processes in the body; it stimulates the body's immune response and supports cellular regeneration.

Pharmacokinetics.

No studies on the absorption, distribution, and metabolism of the two active substances in the syrup have been conducted due to uncertainty regarding which active ingredient contributes to the effect and to what extent.

The polysaccharides of the mucilage from both components are neither absorbed nor metabolized but act locally on the mucous membranes as a protective layer.

Absorption of ascorbic acid begins through the mucous membranes of the oral cavity and continues in the duodenum and small intestine. It is distributed into all tissues and cells. In the human body, ascorbic acid is reversibly oxidized to oxalic acid and ascorbate-2-sulfate, which are excreted in urine. Excess ascorbic acid is excreted unchanged in urine.

Clinical characteristics.

Indications.

• Dry cough associated with infectious and inflammatory diseases of the upper respiratory tract;
• dry cough in smokers.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients of the medicinal product. Nephrolithiasis. Gastroesophageal reflux disease, including reflux esophagitis, hyperacidic gastritis, gastric and duodenal ulcers. Severe kidney diseases.

Interaction with other medicinal products and other forms of interaction.

Plantago lanceolata leaf and Malva sylvestris flower.

Not known.

Ascorbic acid.

Concomitant use with antacids containing aluminium may increase urinary excretion of aluminium. This combination is not recommended, especially in patients with a history of kidney disease.

Ascorbic acid enhances iron absorption.

Concomitant use with deferoxamine promotes iron excretion. Administration of high doses of ascorbic acid in patients receiving deferoxamine may lead to cardiac disorders (such as cardiomyopathy and congestive heart failure). In case of such combination, the daily dose of ascorbic acid should not exceed 200 mg; careful monitoring of cardiac function is recommended. Ascorbic acid should not be administered to patients with heart failure who are being treated with deferoxamine. Ascorbic acid should not be used during the first month of deferoxamine treatment.

Oral intake of high doses of ascorbic acid (1 g) inhibits the disulfiram–alcohol reaction in patients with alcoholism undergoing treatment with disulfiram.

Ascorbic acid reduces amphetamine absorption due to its effect on gastric pH.

Ascorbic acid increases total clearance of ethanol.

High doses of ascorbic acid impair renal excretion of mexiletine by altering urine pH. Close monitoring is required when mexiletine is used concomitantly with high doses of ascorbic acid.

High doses of ascorbic acid may affect urine pH and increase the risk of crystalluria during sulfonamide therapy.

Special precautions for use

Herbion® Plantain Syrup contains sucrose and therefore is not recommended for patients with diabetes mellitus.

If dyspnea, fever, purulent sputum, hemoptysis, or worsening of symptoms occur during treatment, consult a physician.

Do not exceed the recommended doses.

High doses of ascorbic acid increase urinary excretion of oxalates, thus increasing the risk of calcium oxalate kidney stone formation. The risk is extremely low in healthy patients, especially when ascorbic acid intake is less than 1 g per day. In patients with nephrolithiasis or hyperoxaluria, the daily dose of ascorbic acid should not exceed 1 g, taking into account dietary intake and nutritional supplements.

When using high doses of ascorbic acid, kidney function should be monitored. The product should be used with caution in patients with a history of kidney disease, considering vitamin C content in food and dietary supplements.

Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency.

High-dose vitamin C should not be administered to patients with increased blood coagulability, thrombophlebitis, or a tendency to thrombosis.

Since ascorbic acid enhances iron absorption, its use in high doses may be hazardous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, or sideroblastic anemia. Patients with high iron levels in the body should receive the product in minimal doses.

Ascorbic acid may interfere with laboratory test results, for example, glucose and bilirubin levels, and activities of transaminases and lactate dehydrogenase.

Special information about excipients

Herbion® Plantain Syrup contains sucrose. Therefore, patients with rare hereditary conditions of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.

Methyl 4-hydroxybenzoate (E 218) may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

Since the safety of using this medicine during pregnancy or breastfeeding has not been established, its use during these periods is not recommended.

There are no data on the effect on fertility.

Ability to influence reaction rate when driving or operating machinery

There are no data on the effect of the medicinal product on the ability to drive or operate machinery.

Dosage and Administration.

For adults and children aged 14 years and older: 2 measuring spoons of syrup 3–5 times daily.
For children aged 7 to 14 years: 1–2 measuring spoons of syrup 3 times daily.
For children aged 3 to 7 years: 1 measuring spoon of syrup 3 times daily.

The duration of treatment is determined individually by a physician.

If symptoms persist beyond 1 week of use, consult a physician regarding further therapy.

Patients should avoid eating or drinking immediately after taking the medication, as food and beverages may accelerate the removal of the drug from the mucous membranes of the oral cavity and throat.

The syrup should be shaken well before use.

During treatment, it is recommended to drink plenty of tea or other warm fluids.

Children

The syrup is not recommended for children under 3 years of age without prior medical consultation.

Overdose.

There have been no reports of overdose cases.

Ascorbic acid is well tolerated. It is a water-soluble vitamin, and excess amounts are excreted in urine. Overdose may lead to changes in renal excretion of ascorbic and uric acids during urinary acidification, with a risk of oxalate stone formation. High doses of ascorbic acid may cause stomach discomfort, heartburn, vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug. Treatment is symptomatic.

Significant exceeding of recommended doses (vitamin C dose exceeding 1 g per day) may lead to renal failure, sleep disturbances, sensation of warmth, fatigue, disturbances in zinc and copper metabolism, increased excitability, erythrocytopenia, and neutrophilic leukocytosis. Prolonged use of high-dose ascorbic acid may suppress the function of pancreatic islet apparatus; therefore, its functional capacity should be monitored. When administering high doses of ascorbic acid, arterial blood pressure should be monitored due to its stimulatory effect on corticosteroid hormone production.

Treatment is symptomatic.

Adverse Reactions.

Immune system side effects: hypersensitivity reactions (itching, urticaria, eczema), angioneurotic edema, anaphylactic shock.

Methyl 4-hydroxybenzoate (E 218) may cause allergic reactions (possibly delayed).

Nervous system side effects: headache.

Renal and urinary system side effects.

When ascorbic acid is administered in doses exceeding 1 g per day – oxaluria, kidney stone formation, renal tubular damage.

Blood system side effects.

Administration of ascorbic acid in doses exceeding 1 g per day in patients with glucose-6-phosphate dehydrogenase deficiency may cause hemolysis of erythrocytes (hemolytic anemia).

If severe adverse effects occur, treatment should be discontinued.

Shelf life.

3 years.

After opening the bottle, the syrup should be used within 3 months.

Storage conditions.

This medicinal product does not require special storage conditions.

After opening the bottle, store the product at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

150 ml of syrup in a bottle, together with a plastic measuring spoon, in a cardboard box.

Prescription status. Over-the-counter (without prescription).

Manufacturer.

KRKA, d.d., Novo mesto, Slovenia.

Manufacturer's address and location of business operations.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia.