Herbion® ivy

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Herbon® Ivy (Herbion® ivy)

Composition:

Active ingredient: dry extract of ivy leaves;

Each lozenge contains 35 mg of dry extract of ivy leaves (5−7.5:1) (Hedera helix L., folium extractum siccum);

Extraction solvent: ethanol 30% (m/m);

Excipients: isomaltite (type M) (E 953), citric acid, natural caramel flavor (containing propylene glycol), natural citrus flavor (containing butylhydroxyanisole), sucralose, peppermint oil.

Medicinal form. Lozenges.

Main physico-chemical properties: round lozenges with beveled, slightly serrated edges and uneven surface, light brown to brown in color, with possible inclusions of yellow to brownish particles, lighter spots, and air bubbles.

Pharmacotherapeutic group. Agents used for cough and colds. Expectorant. ATC code R05CA12.

Pharmacological properties.

Pharmacodynamics.

Herbion® Ivy, lozenges, is a herbal medicinal product based on dry extract of ivy leaves, which acts as a mucolytic, spasmolytic and bronchodilatory agent. The main components of the dry extract of ivy leaves are triterpene saponins, primarily hederacoside C and alpha-hederin.

Alpha-hederin inhibits endocytosis of beta2-adrenergic receptors, thereby increasing the activity of beta2-adrenergic cells in the bronchial mucosa and lung epithelium. This leads to a reduction in intracellular calcium levels in the bronchial mucosa, resulting in bronchial relaxation. Due to stimulation of beta2-adrenergic receptors, alveolar epithelial cells of type II produce more surfactant, which reduces mucus viscosity. Thus, expectoration and coughing are facilitated.

Pharmacokinetics.

There are no available data on the pharmacokinetic properties of the dry extract of ivy leaves.

Clinical characteristics.

Indications

Herbion® Ivy, lozenges, is a herbal medicinal product used as an expectorant in productive cough in adults and children aged 6 years and older.

Contraindications

Hypersensitivity to the active substance or to other plants of the Araliaceae family, or to any of the excipients of the product; children under 6 years of age.

Interaction with other medicinal products and other forms of interaction

There have been no reports of the influence of ivy leaf dry extract on other medicinal products. No interaction studies have been conducted.

Special precautions for use.

If you experience shortness of breath, fever, or purulent sputum, consult a physician.

Concomitant use with antitussive agents such as codeine or dextromethorphan is not recommended without consulting a physician. Use with caution in patients with gastritis or peptic ulcer.

Lozenges are contraindicated in children under 6 years of age, as proper dose adjustment is not feasible with this dosage form. For children aged 2 to 5 years, syrup is available. Products containing dry extract of ivy leaves are contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms, which is characteristic of all secretolytic agents.

Herbion® Ivy lozenges are sugar-free.

Herbion® Ivy lozenges contain isomalt (E 953). If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Use during pregnancy or breastfeeding.

The use of this medicinal product during pregnancy or breastfeeding is not recommended due to insufficient data.

Ability to influence reaction speed when driving or operating machinery.

No studies on the effect on the ability to drive or operate machinery have been conducted.

Dosage and Administration.

Adults and children aged 12 years and older: 1 lozenge 3 times daily (corresponding to 105 mg of dry ivy leaf extract per day).

Children aged 6 to 11 years: 1 lozenge 2 times daily (corresponding to 70 mg of dry ivy leaf extract per day).

Patients with renal or hepatic impairment

Data regarding dose adjustment are lacking.

Administration

The lozenge should be slowly dissolved in the mouth.

During treatment with this medicinal product, it is recommended to drink plenty of water or other warm, non-caffeinated beverages.

The lozenge should not be sucked immediately before or during meals.

If symptoms persist for more than 1 week after starting treatment, consult a physician.

Children

The product is contraindicated in children under 6 years of age.

Overdose

Exceeding the recommended daily dose by more than twice may cause nausea, vomiting, diarrhea, and agitation. Treatment is symptomatic.

Cases of overdose have been reported in a 4-year-old child following accidental ingestion of a large amount of ivy extract (approximately 7−10 lozenges, corresponding to 1.8 g of ivy leaves), which was accompanied by aggression and diarrhea.

Adverse reactions.

Adverse reactions that may occur during treatment with Herbion® Ivy lozenges are grouped according to frequency:

very common ≥ 1/10;

common ≥ 1/100 − < 1/10;

uncommon ≥ 1/1000 − < 1/100;

rare ≥ 1/10000 − < 1/1000;

very rare < 1/10000;

frequency not known (cannot be estimated from the available data).

In case of severe adverse reactions, treatment should be discontinued.

Reporting of expected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Information on any suspected adverse reactions should be reported in accordance with the requirements of legislation.

Shelf life.

3 years.

Storage conditions.

Store at temperatures not above 25 °C in the original packaging to protect from moisture. Keep out of reach and sight of children.

Packaging.

8 pastilles in a blister, 1, 2, 3 or 4 blisters in a cardboard box.

Classification by prescription. Over-the-counter.

Manufacturer.

KRKA, d.d., Novo mesto / KRKA, d.d., Novo mesto.

Address of manufacturer and place of business.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia / Smarjeska cesta 6, 8501 Novo mesto, Slovenia.