Herbion® iceland moss

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Herbion® Iceland Moss (Herbion® Iceland moss)

Composition:

Active ingredient: dry extract of Iceland moss;

1 lozenge contains 3 mg of dry extract of Iceland moss (Cetraria islandica (L.) Acharius s.l., thallus) (30–40 : 1), equivalent to 90–120 mg of Iceland moss;

Extraction solvent: water;

Excipients: isomalt (E 953), colloidal anhydrous silicon dioxide, ascorbic acid, mannitol, malic acid, sucralose, natural orange flavor, natural lemon flavor (contains butylated hydroxyanisole), coloring agent "Turmeric oil".

Pharmaceutical form. Lozenges.

Main physico-chemical properties: nearly round lozenges with beveled edges and uneven surface, ranging in color from yellow to yellowish-brown. The presence of darker specks, light spots, air bubbles, and slightly irregular edges is permissible.

Pharmacotherapeutic group. Medicinal products used for cough and colds. Antitussives, excluding combination preparations containing expectorants. ATC code R05D.

Pharmacological properties.

Pharmacodynamics.

A traditional herbal medicinal product of plant origin.

The effect has not been established in clinical studies. It is based on pharmacological data and long-term empirical experience. The main components of the extract are mucilages containing polysaccharides, which are presumed to coat the mucous membranes of the upper respiratory tract and form a protective layer. Thus, the cough reflex provoked by external irritants is suppressed, resulting in relief from dry, irritating cough. It is also presumed that the mucilage binds water on the surface of the mucous membrane, thereby moisturizing the irritated and dry mucous membranes of the oral cavity and pharynx.

Pharmacokinetics.

There are no available data on the pharmacokinetic properties of the dry extract of Iceland moss.

Clinical characteristics.

Indications

Herbion® Iceland Moss, lozenges, is a traditional herbal medicinal product of plant origin used as a demulcent for the symptomatic treatment of irritation of the mouth or throat and associated dry cough.

Contraindications

Hypersensitivity to the active substance or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction

There have been no reports.

Special precautions for use.

Herbion® Iceland Moss, lozenges, is a traditional herbal medicinal product for use according to indications supported by long-standing use.

If shortness of breath, fever, or purulent sputum occur during treatment with this medicinal product, consult a physician.

Absorption of concomitant medicinal products may be prolonged. As a precaution, lozenges should not be taken within half an hour or one hour before or after taking other medicinal products.

Children

Use in children under 12 years of age is not recommended, as appropriate dosage adjustment is not possible with this dosage form.

Isomalt (E 953)

This medicinal product should not be used in patients with rare hereditary fructose intolerance.

Butylated hydroxyanisole (E 320)

May cause local skin reactions (e.g., contact dermatitis) or irritation of eyes and mucous membranes.

Use during pregnancy or breastfeeding.

Pregnancy

Safety during pregnancy has not been established. Due to insufficient data, use during pregnancy is not recommended.

Breastfeeding

Safety during lactation has not been established. Due to insufficient data, use during breastfeeding is not recommended.

Fertility

There are no data on the effect on fertility.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage

Adults and children aged 12 years and older: 1 lozenge 8 times daily (corresponds to 24 mg of dry extract of Iceland moss per day, equivalent to 720–960 mg of Iceland moss).

Children

Use in children under 12 years of age is not recommended (see section "Special Instructions").

Elderly patients

Dose adjustment is not required.

Patients with renal and/or hepatic impairment

Pharmacokinetic studies are lacking.

Method of Administration

Oromucosal. Dissolve the lozenge in the oral cavity.

Food or drink should not be consumed immediately after dissolving the lozenge, as this may lead to too rapid removal of the medicinal product from the mucous membranes of the oral cavity and throat. Lozenges should not be used during meals.

Duration of Use

The patient should consult a physician if symptoms persist for more than 1 week after initiation of treatment or if adverse reactions occur that are not listed in the instructions for medical use of the medicinal product.

Children

Use in children aged 12 years and older.

Overdose

No cases of overdose have been reported with this medicinal product.

Adverse reactions.

Adverse reactions that may occur during treatment with Gerbion® Iceland Moss 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 based on available data).

If adverse reactions occur, consult a physician.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives should report all cases of suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

No special storage conditions are required for this medicinal product. Keep out of reach of children.

Packaging.

8 lozenges per blister, 2 or 3 blisters per carton.

Supply classification. Over-the-counter.

Manufacturer.

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

Manufacturer's address and site of operations.

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