SOLEHUM® FOR CHILDREN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLEDUM® JUNIOR

Composition:

Active substance: cineole;

1 gastro-resistant soft capsule contains 100 mg of cineole;

Excipients:

capsule contents: medium-chain triglycerides;

capsule shell: gelatin, glycerol (85%), non-crystallizing sorbitol solution (E 420);

film coating: ethylcellulose; ammonium hydroxide; medium-chain triglycerides; oleic acid; sodium alginate; stearic acid; candelilla wax.

Pharmaceutical form. Gastro-resistant soft capsules.

Main physico-chemical properties: soft, transparent, yellowish gelatin capsules, size 3.

Pharmacotherapeutic group. Expectorants.

ATC code R05C A13.

Pharmacological properties.

Pharmacodynamics.

Soledum® for children is an anti-inflammatory and mucolytic medicinal product used as an adjunctive therapy for respiratory tract diseases.

Cineole is the main component of eucalyptus oil. It stimulates expectoration and secretion, and also exerts a mild hyperemic and local analgesic effect. Clinical studies have demonstrated enhanced mucociliary clearance with cineole administration within the therapeutic dose range. The expectorant effect is considered to be related to a positive influence on subjective parameters such as sputum production and dyspnea. In addition, a weak spasmolytic effect of cineole has been observed. In vitro studies have shown inhibition of leukotriene B4 production in monocytes and suppression of other inflammatory mediators such as TNF-α and IL-1β. Bronchial hyperreactivity was reduced.

Pharmacokinetics.

In rabbits, cineole is metabolized to 2- and 3-hydroxy-cineole glucuronides. In humans, 2α-hydroxy-1,8-cineole and 3α-hydroxy-1,8-cineole have been identified as urinary metabolites. Data regarding the biological activity of these metabolites are lacking. Cineole is extensively absorbed from the gastrointestinal tract. It is partially eliminated via exhaled air from the lungs and partially via the kidneys after hepatic metabolism. In rodents, high doses cause induction of microsomal enzymes.

Clinical characteristics.

Indications. In complex treatment of symptoms of bronchitis and viral respiratory tract infections.

Adjunctive therapy of chronic and inflammatory diseases of the respiratory tract (e.g. paranasal sinuses).

Contraindications. Solvedum® for children is contraindicated in individuals with known hypersensitivity to the active substance cineole or to any of the excipients of the medicinal product, in cases of whooping cough, croup, and in children under 2 years of age.

Interaction with other medicinal products and other forms of interaction.

In animal experiments, cineole stimulated liver enzyme metabolism. For this reason, high doses of cineole may reduce the efficacy and/or duration of action of other medicinal products. However, in humans, such an effect has not been observed with appropriate use of cineole.

Special precautions for use.

Soleum® for children should be used with particular caution in any disease accompanied by pronounced hypersensitivity of the respiratory tract. In patients with bronchial asthma, treatment with Soleum® for children should be carried out only under medical supervision.

Soleum® for children should not be used in patients with rare hereditary fructose intolerance.

If symptoms persist for more than one week, or if respiratory distress, fever, or purulent or bloody sputum occur, the patient should seek immediate medical advice.

Use during pregnancy or breastfeeding.

The medicine is intended for use in children aged 2 to 12 years.

Ability to affect reaction speed when driving vehicles or operating machinery.

The medicine is intended for use in children aged 2 to 12 years.

Dosage and Administration.

Solegum® for children capsules should be swallowed whole with an adequate amount of liquid at moderate temperature (preferably one glass [200 ml] of drinking water), approximately 30 minutes before a meal. For patients with increased gastric sensitivity, it is recommended to take Solegum® for children during meals.

The duration of therapy depends on the nature, severity, and course of the disease.

For diabetic patients, it should be noted that one capsule of the medicinal product Solegum® for children is equivalent to 0.0013 bread units.

For children aged 2 to 12 years, take 1 capsule three times daily.

Immediate medical consultation is required if symptoms persist for more than one week or if respiratory distress, fever, purulent or bloody sputum occur.

Children.

Due to insufficient scientific data on the use of Soladum® in children, treatment of patients under 8 years of age should be carried out under medical supervision.

Overdose.

There are no specific data regarding cineole. In cases of intoxication with high doses of eucalyptus oil of unknown purity (average lethal dose upon oral administration – 20 g), nervous system disorders may occur, such as: confusion, fatigue, weakness in limbs, miosis, and in more severe cases – coma and respiratory disturbances.

Rapid regression of symptoms and return to the initial state are expected due to the rapid elimination of the substance from the body. Treatment of poisoning with Soladum® for children is administered depending on the severity, course, and clinical signs of intoxication in each individual case.

Adverse Reactions

The adverse reactions are listed below according to their frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

Gastrointestinal disorders (e.g., nausea, diarrhea) may occur uncommonly. Rare cases of hypersensitivity reactions (such as facial swelling, itching, cough) and dysphagia have been reported.

If any signs of hypersensitivity occur, treatment with Soludum® for children should be discontinued immediately.

Shelf life. 36 months.

Storage conditions. Store at a temperature not exceeding 30 °C in the original packaging. Keep out of reach of children.

Packaging.

20 gastro-resistant soft capsules in a blister, 1 blister per cardboard box.

25 gastro-resistant soft capsules in a blister, 2 or 4 blisters per cardboard box.

Availability. Over-the-counter.

Manufacturer.

Klosterfrau Berlin GmbH
Artesan Pharma GmbH & Co. KG

Manufacturer's address.

Motzener Strasse 41, 12277 Berlin, Germany
Wendlandstrasse 1, Luechow (Wendland), Lower Saxony, 29439, Germany

Marketing Authorization Holder.

Cassella-med GmbH & Co. KG

Address of the Marketing Authorization Holder.

Gereonsmühlengasse 1, 50670 Cologne, Germany