Herbion® iceland moss syrup

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HERBION® ICELANDIC MOSS SYRUP (Herbion® Iceland moss syrup)

Composition:

Active substance: 1 ml of syrup contains 6 mg of thick extract of Icelandic moss (Cetraria islandica (L.) Acharius s.l., thallus) (16-18:1); extraction solvent: purified water;

Excipients: sorbitol solution, non-crystallizing (E 420); xanthan gum; sodium benzoate (E 211); citric acid monohydrate; lemon flavor (contains ethanol); purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: slightly opalescent liquid, yellowish-brown to brown in color, with a characteristic odor and taste. A slight sediment may be observed, which is typical for natural substances.

Pharmacotherapeutic group. Antitussive agents, excluding combinations with expectorants.

ATC code: R05D.

Pharmacological properties.

Pharmacodynamics.

Herbion® Iceland moss syrup contains a concentrated extract of Iceland moss that exerts antitussive, immunostimulant, antibacterial, and anti-inflammatory effects. The main components of the Iceland moss extract are mucilage in the form of water-soluble polysaccharides, primarily lichenin and isolichenin, as well as bitter lichen acids. The polysaccharides exert a demulcent effect on the mucous membranes of the upper respiratory tract, forming a protective layer that has a soothing effect on mucosal surfaces, thereby reducing the cough reflex caused by external irritants and relieving dry, irritating cough. The mucilage also binds with water on the surface of the mucous membrane, thus providing a local demulcent action on irritated and dry mucous membranes of the oral cavity and throat.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

• Dry, irritating cough and hoarseness;
• dryness of mucous membranes in dry air of residential rooms or insufficiently humidified office spaces during the heating season, as well as with limited nasal breathing or during physical exercise;
• excessive strain on vocal cords.

Contraindications.

Hypersensitivity to the active substance or any of the excipients.

Interaction with other medicinal products and other forms of interaction.

There have been no reports of the effect of Herbion® Iceland moss syrup on the action of other drugs. No interaction studies have been conducted.

Special precautions for use

If dyspnea, fever, purulent or bloody sputum, hoarseness, or bloody nasal discharge occur, consult a physician.

If there is no improvement in condition within 4–5 days after starting treatment, consult a physician.

Herbion® Iceland moss syrup contains sorbitol. This medicinal product should not be used by patients with rare hereditary fructose intolerance.

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

Use during pregnancy or breastfeeding

As clinical data on the use of Iceland moss extract during pregnancy and lactation are limited, the syrup is not recommended for use in pregnant and breastfeeding women.

There are no data on the effect of this medicinal product on fertility.

Ability to influence reaction rate while driving or operating machinery

There are no data on a negative effect of Herbion® Iceland moss syrup on reaction speed while driving or operating machinery.

Method of administration and dosage.

Shake the bottle before use. Administer orally to adults and children using the measuring spoon provided.

Adults and children aged 16 years and older: 15 ml of syrup 4 times daily (corresponding to 360 mg of dry extract of Iceland moss per day).

Children aged 10 to 16 years: 10 ml of syrup 4 times daily (corresponding to 240 mg of dry extract of Iceland moss per day).

Children aged 4 to 10 years: 5 ml of syrup 4 times daily (corresponding to 120 mg of dry extract of Iceland moss per day).

Children aged 1 to 4 years: 2.5 ml of syrup 4 times daily (corresponding to 60 mg of dry extract of Iceland moss per day).

Herbion® Iceland moss syrup should be followed by drinking a large amount of tea or another warm beverage, but not sooner than 20 minutes after taking the medication, as the preparation is rapidly removed from the mucous membranes of the oral cavity and throat.

Duration of treatment depends on the course and severity of the disease and is determined individually by a physician. After disappearance of clinical symptoms, it is recommended to continue taking the medication for several more days.

Children. The medication can be administered to children aged 1 year and older.

Overdose.

Do not exceed the recommended doses. Cases of overdose have not been reported.

Side effects.

Allergic reactions may occur in isolated cases.

If any undesirable side effects occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 2 years.

The medicinal product should be used within 3 months after first opening the bottle.

Storage conditions.

Keep out of reach of children.

Do not refrigerate.

Packaging.

150 ml of syrup in a bottle, 1 bottle with a measuring spoon in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

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

Address of the manufacturer and location of business operations.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia.