Soledum® Capsules
Product Characteristics
Dear patient!Please read the following package leaflet attentively, because it contains important information about what to pay attention to when using this medicinal product. In case of questions, please consult your doctor or pharmacist.
SOLEDUM® CAPSULES
Active ingredient: cineole 100 mg
Composition
1 enteric-coated capsule contains:
Active ingredient:
100 mg cineole.
Other ingredients:
Middle-chain triglycerides, karion 83 dry substance (contains sorbitol), gelatine, glycerol 85 %,
hydrochloric acid 25 %, methacrylic acid ethyl acrylate copolymer (1:1) (Ph.Eur.)
propylene glycol, polysorbate 80, glycerol monostearate.
One Soledum® Capsule corresponds to 0.00127 bread exchange units.
Dosage form and pack sizes
Enteric-coated capsules 100 mg.
Original pack containing 50 enteric-coated capsules (N2)
Original pack containing 100 enteric-coated capsules (N3)
Medicinal product for inflammatory diseases of the respiratory tract.
Pharmaceutical entrepreneur
Cassella-med
Gereonsmuehlengasse 1, 50670 D-Koeln
Germany
Phone: +49-(0)221-120157
Fax: +49-(0)221-1652-513
E-Mail: cmed@cassella-med.de
(In case of questions, please turn to Cassella-med.)
Manufacturer
Klosterfrau Berlin Ltd.
Motzener Str. 41, D-12277 Berlin
Germany
Phone: +49-(0)30-720070
Fax: +49-(0)30-72007234
Indications
Acute, chronic and inflammatory respiratory tract diseases. Common cold, colds with cough and rhinitis. Acute and chronic bronchitis. Sinusitis.
When symptoms persist longer than a week, with shortness of breath, fever or purulent or bloody expectoration, please consult a doctor.
Contra-indications
When not to take Soledum® Capsules?
Soledum® Capsules must not be taken if there is a known hypersensitivity to the active ingredient cineole or to any of the other ingredients.
What to take care of during pregnancy and lactation?
On the basis of investigations, there are no objections against the use of Soledum® Capsules during pregnancy and lactation. As a general safety precaution, Soledum® Capsules should not be administered during the first trimenon of pregnancy. Cineole is not distributed into breast milk.
Precautionary measures for the application and warnings
Which security measures have to be regarded?
There is no need for any special security measures when taking Soledum® Capsules.
Interactions with other products
What to pay attention to when simultaneously taking other medicinal products?
Please consider that this information might also be applicable in case of recently administered medicinal products.
It can not be ruled out that cineole might accelerate the decomposition of other pharmaceutical agents in the liver, which might cause their effects to be diminished and/or shortened. However, no such effect has so far been seen following regular administration of cineole to humans
Dosage, method and duration of administration
The following information applies as far as your doctor has not prescribed Soledum® Capsules differently. Please comply with the instructions as otherwise Soledum® Capsules can not have proper effects!
How much of Soledum® Capsules should you take and how often should you take them?
Adults and children over 10 years of age take 2 capsules three times a day. In particularly persistent cases 2 capsules four times a day. Two capsules twice a day generally suffice for subsequent or continuous treatment. Children under 10 years of age: 1 capsule three times a day.
Soledum® Capsules are also suitable for diabetics.
How and when should you take Soledum® Capsules?
Soledum® Capsules shall be swallowed whole with a sufficient quantity of not too hot liquid preferably half an hour before meals. With a sensitive stomach it is advisable to take Soledum® Capsules with meals.
How long should you take Soledum® Capsules?
The duration of treatment depends on the nature, severity and clinical course of the disease. Please consult a doctor when symptoms persist longer than a week, with shortness of breath, fever or purulent or bloody expectoration.
Misuse and overdosage
What to do if Soledum® Capsules were taken in too high amounts (intended or accidental overdosage)?
For Soledum® Capsules, no poisoning or overdosage symptoms are known so far. In case of suspected overdosage with Soledum® Capsules, please inform your doctor. Your doctor is able to decide on the appropriate measures where necessary, depending on the severity of the poisoning symptoms.
Possible symptoms of overdosage might be central nervous impairment such as clouding of consciousness, fatigue, weakness in the limbs, contraction of the pupils (myosis) and in severe cases, deep unconsciousness (coma) and impaired breathing.
What to pay attention to if you have taken too few Soledum® Capsules or if you have forgotten one dose?
After a forgotten single dose you shall not take double of the amount. The treatment has to be continued as described above or as prescribed by the doctor.
Side effects
Which side effects can occur when taking Soledum® Capsules?
Gastrointestinal symptoms (nausea, diarrhoea) may occasionally occur. Hypersensitive reactions (facial oedema, itching, respiratory distress, cough) as well as difficulties in swallowing have rarely been reported.
If you observe side effects which are not mentioned in this package leaflet please communicate them to your doctor or pharmacist.
At the first signs of a hypersensitivity reaction Soledum® Capsules must not be taken again.
Information about the storage of the medicinal product
The expiration date of this package is printed on the folding carton and the push-through pack.
Do not use the package after this date!
Do not store above 30 °C.
State of the information
March 2007
Keep medicinal product out of reach of children!
Without prescription, for sale in pharmacies only.
Characteristics
Soledum® Capsules contain pure cineole of plant origin. The natural substance cineole, isolated from eucalyptus oil, has secretolytic and anti-inflammatory effects. Cineole is easily absorbed into the body and, being transported by the bloodstream, exerts ist effects in the bronchial system.
For the modern medicament Soledum® Capsules the natural substance Cinoel is won by a particularly manufacturing process. The transparency of the caps can slightly vary for technical reasons. This has however neither influence on the effectiveness nor on the good compatibility of the preparation.
Soledum® Capsules fluidify inflammatory secretions as well as thick mucus in the airways and act against inflammatory processes in the respiratory tract. An accumulation of secretions is prevented, expectoration is alleviated and the cleansing function of the cilia in the bronchial system and in the nose is supported, thus ventilation of the airways is improved. In the upper airways the obstruction of nasal breathing in common cold and the dizziness in the head disappear.
Soledum® Capsules relieve the afflicting urge to cough, loosen the secretions in the airways and enable easy breathing. Because of their small size the capsules can be comfortably taken
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