Isla-moos

INSTRUCTIONS for medical use of the medicinal product ISLA-MOOS (ISLA-MOOS®)

Composition:

Active substance: aqueous extract of Iceland moss;

One tablet contains 80 mg of aqueous extract of Iceland moss (Iceland moos) (0.4–0.8:1); extraction solvent: water; contains sucrose (1:1.7375);

Excipients: acacia (gum arabic), sucrose, light mineral oil, ammonia caramel (E 150 c), purified water;

One tablet contains 424 mg of sucrose, equivalent to 0.035 bread units.

Pharmaceutical form. Tablets.

Main physicochemical properties: flat, irregularly round, lens-shaped, brownish tablets of rubber-like consistency; presence of air bubbles is permissible.

Pharmacotherapeutic group.

Preparations used for throat disorders. ATC code R02A.

Pharmacological properties.

Pharmacodynamics.

The medicinal product Isa-Moos contains an extract from the medicinal plant Cetraria islandica (Iceland moss), which is well known for its therapeutic effects in inflammatory diseases of the respiratory tract.

The therapeutic effect of Isa-Moos in catarrhal diseases of the respiratory tract is based on the antimicrobial activity and immunostimulatory properties of the plant extract it contains, as demonstrated by scientific research. Isa-Moos has protective properties and can be used prophylactically, for example, in cases of increased sensitivity of the respiratory tract or under increased respiratory load (including during sports activities).

Polysaccharides coat the mucous membranes of the respiratory tract and effectively protect them against harmful external factors and various types of irritants.

Prophylactic use of Isa-Moos may reduce the susceptibility of the respiratory tract to various infections. The preparation does not irritate the stomach.

Pharmacokinetics. Data not available.

Clinical characteristics.

Indications.

Cough, including cough associated with bronchitis; hoarseness (laryngitis, pharyngitis); bronchial asthma (as an adjunctive therapy). Vocal strain (in singers, teachers, lecturers).

Dryness of mucous membranes in poorly humidified rooms during heating season, as well as in cases of limited nasal breathing or during physical exercise.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interactions.
Not known to date.

Special precautions for use

Plant extracts may sometimes cause changes in the color and taste of this medicinal product, which does not affect its therapeutic efficacy.

The medicinal product Isla-Moss should be used with caution in patients suffering from diabetes mellitus.

One pastille contains 424 mg of sucrose, equivalent to 0.035 bread units.

Use during pregnancy or breastfeeding

There is no evidence of negative effects of the drug during pregnancy or breastfeeding. Specific studies in these patient groups have not been conducted; therefore, the benefit-risk balance should be carefully evaluated before using the drug.

Ability to influence reaction speed when driving or operating machinery

When the drug is used according to the instructions for medical use, no negative effect on reaction speed is expected.

Dosage and Administration.

For adults and children aged 12 years and older: take 1 pastille every hour (up to 12 pastilles per day). For children aged 4 to 12 years: take 1 pastille every 2 hours (up to 6 pastilles per day), allowing them to dissolve slowly in the mouth.

Due to the good tolerability of the medicinal product Isla-Moos, it can be used for prolonged periods.

After symptoms have subsided, Isla-Moos should be continued for several more days to achieve a sustained therapeutic effect.

If symptoms persist or worsen after 4–5 days, or if dyspnea, fever, or purulent and bloody sputum occur, consult a physician immediately.

Children. The product is intended for children aged 4 years and older, as the pastilles must be held in the mouth and allowed to dissolve slowly.

Overdose. No cases of overdose have been reported.

Side effects.

In isolated cases, allergic reactions may occur.

Shelf life. 4 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 pastilles in a blister pack; 3 blisters per cardboard box.

Supply category. Over-the-counter.

Manufacturer.

Engelhard Arzneimittel GmbH & Co. KG.

Manufacturer's address and place of business.

Herzbergstrasse 3, 61138 Niederdorfelden, Germany.