Herbion^® plantain syrup (Syrup) Instructions for Use

Marketing Authorization Holder

Krka d.d., Novo mesto (Slovenia)

ATC Code

R05CA10 (Expectorants in combination)

Dosage Form

Herbion® plantain syrup

Syrup: 150 ml bottle with dosing spoon

Dosage Form, Packaging, and Composition

Syrup from brown to reddish-brown in color with a characteristic odor; slight opalescence is allowed.

Excipients: sucrose, methylparahydroxybenzoate (E218), orange flavor oil^#.

* 2.5 g of aqueous liquid extract of lanceolate plantain leaves and common mallow flowers is prepared from: lanceolate plantain leaves (Plantago lanceolata L.s.l., fam. Plantaginaceae) 0.25 g, common mallow flowers (Malva sylvestris L., fam. Malvaceae) 0.25 g, purified water (extractant).
** 65 mg of ascorbic acid in the form of 73.12 mg of sodium ascorbate.
^# orange flavor oil consists of flavoring substances, natural flavoring substances, antioxidant (E320).

150 ml – dark glass bottles (1) complete with a dosing spoon – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant and anti-inflammatory effects

Pharmacotherapeutic Group

Combined expectorant

Pharmacological Action

Herbal medicine. It has expectorant, anti-inflammatory, antimicrobial (bacteriostatic) action.

Indications

• Use as part of the complex therapy of inflammatory diseases of the upper respiratory tract that are accompanied by a dry cough.

• Use for the symptomatic relief of dry smoker’s cough.

ICD codes

Dosage Regimen

Administer orally three to five times per day.

Adjust the dose according to the patient’s age: for children aged 2 to 7 years, administer 1 dosing spoon (5 ml); for children aged 7 to 14 years, administer 1-2 dosing spoons (5-10 ml); for adults and children over 14 years, administer 2 dosing spoons (10 ml).

Continue the treatment course for a duration of two to three weeks.

Adverse Reactions

Monitor for allergic reactions, which are possible adverse effects.

Discontinue use immediately and seek medical attention if signs of hypersensitivity, such as skin rash, itching, or swelling, occur.

Contraindications

• Do not use in patients with known hypersensitivity to any component of the syrup, including the active substances or excipients.

• Do not administer to patients with diabetes mellitus due to the sucrose content.

• Do not use in children under 2 years of age.

Use in Pregnancy and Lactation

It is not recommended for use during pregnancy and breastfeeding.

Pediatric Use

Contraindication: children under 2 years of age.

Drug Interactions

Avoid concomitant use with antitussive drugs (e.g., codeine, dextromethorphan).

Avoid concurrent administration with other medicines that reduce sputum formation.

Concomitant use is contraindicated as it impedes the cough reflex and makes it difficult to cough up liquefied sputum, increasing the risk of respiratory complications.

Overdose

In case of suspected overdose, discontinue the medication immediately.

Symptoms of overdose may include gastrointestinal discomfort, such as nausea and diarrhea, due to excessive intake.

Provide symptomatic and supportive care, as there is no specific antidote.

Storage Conditions

Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.