Instructions for use Soledum forte gastro-resistant capsules 200 mg blister No. 20
Composition
active ingredient: cineole;
1 gastro-resistant soft capsule contains 200 mg of cineole;
excipients:
capsule contents: medium chain triglycerides;
capsule shell: gelatin; glycerin (85%); sorbitol solution, non-crystallizing (E 420);
Film coating: ethylcellulose; ammonium hydroxide; medium chain triglycerides; oleic acid; sodium alginate; stearic acid; candelilla wax.
Dosage form
Gastro-resistant soft capsules.
Main physicochemical properties: soft transparent gelatin capsules of yellowish color, size 6.
Pharmacotherapeutic group
Expectorants.
ATX code R05C A13.
Pharmacological properties
Pharmacodynamics.
Soledum® forte is an anti-inflammatory and mucolytic drug used for adjunctive therapy of respiratory tract diseases.
Cineole is the main component of eucalyptus oil. It stimulates expectoration and secretion, and also has a weak hyperemic and local analgesic effect. In clinical studies, an increase in mucociliary clearance was demonstrated when taking cineole in the therapeutic dose range. It is believed that the expectorant effect is associated with a positive effect on such subjective parameters as sputum and shortness of breath. In addition, a weak antispasmodic effect of cineole was noted. In vitro studies have shown inhibition of the production of leukotriene B4 in monocytes and inhibition of other inflammatory mediators. Bronchial hyperreactivity was reduced.
Pharmacokinetics.
Data on the metabolism of cineole have been obtained only from animal experiments. In rabbits, cineole is metabolized to 2- and 3-hydroxy-cineole-glucuronide. Data on the biological efficacy of the metabolites are not available. Cineole is absorbed in significant quantities from the gastrointestinal tract. Cineole is excreted partly with exhaled air through the lungs and partly by the kidneys after hepatic metabolism. In rodents, high doses cause induction of microsomal enzymes.
Indication
As part of the complex treatment of symptoms of bronchitis and viral respiratory infections.
Concomitant therapy of chronic and inflammatory diseases of the respiratory tract (e.g. paranasal sinuses).
Contraindication
Soledum® forte is contraindicated in patients with established hypersensitivity to the active ingredient cineole or to any of the excipients of the drug, in case of whooping cough, croup, and in children under 12 years of age.
Interaction with other medicinal products and other types of interactions
In animal experiments, cineole stimulated the metabolism of liver enzymes. For this reason, high doses of cineole may reduce the effectiveness and/or duration of action of other drugs. However, in humans, when cineole is used appropriately, this effect has not been observed.
Application features
Soledum® forte should be used with extreme caution in any disease accompanied by severe hypersensitivity of the respiratory tract. In patients with bronchial asthma, Soledum® forte therapy should be carried out only under the supervision of a physician.
Soledum® forte should not be used in patients with rare hereditary problems of fructose intolerance.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
If symptoms of the disease last for more than one week or if shortness of breath, fever, and purulent or bloody sputum appear, you should immediately consult a doctor.
Use during pregnancy or breastfeeding
Pregnancy
No scientific studies have been conducted on the use of Soledum® forte in pregnant women. Soledum® forte should only be administered to pregnant women after a careful assessment of the risk-benefit ratio.
Breast-feeding
Due to the lipophilic properties of the active substance, the possibility of cineole passing into breast milk cannot be excluded. However, no systematic studies have been conducted on this subject, especially with regard to the potential development of adverse drug reactions. Essential oils may change the taste of milk and cause problems with breastfeeding. Breastfeeding women should consult a doctor before starting the use of Soledum® forte.
Ability to influence reaction speed when driving vehicles or other mechanisms
Soledum® forte does not affect the ability to drive vehicles or work with other automated systems.
Method of administration and doses
Dosage
| Age | Single dose | Total daily dose |
|---|
| Adolescents aged 12 years and over and adults | 1 capsule (equivalent to 200 mg cineole) | 2–4 capsules (equivalent to 400–800 mg cineole) |
Adolescents over 12 years of age and adults: 1 capsule 3 times a day.
In especially severe cases – 1 capsule 4 times a day.
Soledum® forte is safe to use in diabetes mellitus. For patients with diabetes mellitus, it should be noted that one capsule of Soledum® forte is equivalent to 0.0015 bread units.
Method of application
Soledum® forte capsules should be swallowed whole with a sufficient amount of lukewarm, non-hot liquid (preferably one glass [200 ml] of drinking water), approximately 30 minutes before meals. Patients with hypersensitivity to the stomach are recommended to take Soledum® forte during meals.
The patient should consult a doctor if symptoms persist after treatment for more than a week or if shortness of breath, fever, or purulent or bloody sputum is produced. The duration of therapy depends on the nature, severity and course of the disease.
Children
Children over 12 years old should take 1 capsule 3 times a day.
Overdose
There are no specific data on cineole. Intoxication with high doses of eucalyptus oil of unknown purity (median lethal dose when administered orally is 20 g) causes nervous system disorders such as: confusion, fatigue, weakness in the limbs, miosis and in more severe cases – coma and respiratory disorders.
Rapid regression of symptoms and return to baseline is expected, due to rapid elimination of the substance from the body. Further treatment options for Soledum® forte poisoning depend on the degree, course and signs of the disease in each individual case.
Side effects
Adverse reactions are listed below according to frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).
Immune system disorders: rarely - hypersensitivity reactions (e.g. facial swelling, itching, shortness of breath, cough) and dysphagia.
At the first signs of any hypersensitivity reaction, treatment with Soledum® forte should be discontinued immediately.
Gastrointestinal disorders: uncommon – digestive discomfort, e.g. nausea, diarrhoea; rare – dysphagia.
Expiration date
60 months.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging. Keep out of the reach of children.
Packaging
20 gastro-resistant soft capsules in a blister, 1 blister in a cardboard box.
25 gastro-resistant soft capsules in a blister, 2 or 4 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Klosterfrau Berlin GmbH/Klosterfrau Berlin GmbH
Artesan Pharma GmbH & Co. KG/Artesan Pharma GmbH & Co. KG
Location of the manufacturer and address of its place of business
Motzener Strasse 41, 12277 Berlin, Germany/Motzener Strasse 41, 12277 Berlin, Germany
Wendlandstrasse 1, Luechow (wendland), Lower Saxony, 29439, Germany/ Wendlandstrasse 1, Luechow (wendland), Lower Saxony, 29439, Germany
Applicant
Cassella-med GmbH & Co. KG/Cassella-med GmbH & Co. KG
Location of the applicant.
Gereonsmuhlengasse 1, 50670 Cologne, Germany/Gereonsmuhlengasse 1, 50670 Koln, Germany.
