Isla-mint

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ISLA-MINT® (ISLA-MINT)

Composition:

Active substance: aqueous extract of Icelandic moss;

1 tablet contains 100 mg of aqueous extract of Icelandic moss (Iceland moos) ((2-4):1); extraction solvent: water; contains sorbitol solution (1:2);

Excipients: non-crystallizing sorbitol solution (E 420); aspartame (E 951), gum arabic, peppermint oil, copper complexes of chlorophylls (E 141), light mineral oil, purified water;

1 tablet contains 0.385 g of carbohydrates, equivalent to 0.03 bread units.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: flat, irregularly round, lens-shaped, green, gum-like tablets with peppermint flavor; presence of air bubbles is acceptable.

Pharmacotherapeutic group.

Preparations used for throat disorders. ATC code R02A.

Pharmacological properties.

Pharmacodynamics.

The medicinal product contains an extract from the medicinal plant Cetraria islandica (Icelandic moss), which is known for its therapeutic effect in inflammatory diseases of the respiratory tract. The therapeutic effect of the medicinal product in catarrhal diseases of the respiratory tract is based on the antimicrobial activity and immunostimulating properties of the herbal extract it contains, as demonstrated by scientific research results. The polysaccharides contained in the product coat the mucous membranes of the airways and effectively protect them against harmful external factors and various types of irritants. Due to its protective properties, the medicinal product can also be used prophylactically, including during physical exercise.

Prophylactic use of the medicinal product can protect mucous membranes and may reduce susceptibility of the respiratory tract to infections. The medicinal product 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 agent). Increased strain on vocal cords (in singers, teachers, lecturers).

Dryness of mucous membranes due to dry air in residential rooms or insufficiently humidified office premises during the heating season, as well as in cases of restricted nasal breathing or during physical exercise.

Contraindications.

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

Fructose intolerance.

Interaction with other medicinal products and other forms of interaction.

Not known to date.

Special precautions for use.

In patients with phenylketonuria, it should be noted that the medicinal product contains the sweetener aspartame (E 951).

In patients with fructose intolerance, it should be noted that the medicinal product contains the sweetener sorbitol (E 420).

Plant extracts contained in the medicinal product may occasionally cause variations in the color and taste of this medicinal product, which do not affect its therapeutic efficacy.

Isla-Mint does not contain sugar and therefore can be administered to patients with diabetes mellitus.

1 tablet corresponds to 0.03 bread units = 0.385 g of carbohydrates.

Use during pregnancy or breastfeeding.

There are no reports of negative effects of the medicinal product during pregnancy or breastfeeding. However, specific studies in this patient group have not been conducted; therefore, the risk-benefit ratio should be carefully evaluated before using the drug.

Ability to affect reaction speed when driving or operating machinery.

When the drug is taken according to this instruction, no adverse effects are expected.

Method of Administration and Dosage.

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.

Isla-Mint can be used for a prolonged period.

Even after the symptoms have subsided, Isla-Mint should still be taken for several more days to achieve a sustained therapeutic effect.

If, after 4–5 days, the symptoms persist or worsen, or if shortness of breath, chills, purulent sputum, or sputum with blood appear, consult a physician immediately.

Children.

The medication 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.

Very rarely, the drug may have a laxative effect in sensitive patients, as it contains sorbitol.

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, in a place inaccessible to children.

Packaging.

10 pastilles in a blister; 3 blisters in a 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.