Soledum 200 mg capsules

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Soledum 200 mg capsules contain the active ingredient cineole.

Application

What are Soledum® 200 mg capsules and what are they used for?

For dissolving mucus in acute colds of the respiratory tract such as productive cough.
For additional treatment of chronic or inflammatory colds such as of the paranasal sinuses and bronchitis.

If you do not feel better or even worse after 1 week, contact your doctor.

How is it used?

What are Soledum 200 mg capsules and what are they used for?

Soledum 200 mg capsules contain the active ingredient cineole. Soledum 200 mg capsules are an anti-inflammatory and expectorant medicine for treating the symptoms of bronchitis and colds of the respiratory tract and for additional treatment of chronic and inflammatory diseases of the respiratory tract, e.g. of the paranasal sinuses (sinusitis).

This medicine is used in adults and adolescents aged 12 and over.

If you do not feel better or even worse after 7 days, contact your doctor.

What should you consider before taking it?

What should you consider before taking Soledum 200 mg capsules?

Soledum 200 mg capsules must not be taken,
- if you are allergic (hypersensitive) to 1,8-cineole, eucalyptus oil or any of the other ingredients of this medicine listed in section 6
- in whooping cough and pseudocroup
- by infants and toddlers under 2 years of age

Warnings and precautions
Please talk to your doctor or pharmacist before taking Soledum 200 mg capsules.

Special care must be taken when taking it in diseases that are associated with pronounced hypersensitivity of the respiratory tract.

In bronchial asthma and COPD (chronic obstructive pulmonary disease), additional treatment with Soledum 200 mg capsules is possible, but must only be carried out under medical supervision, as an individual benefit/risk assessment is required.

The decision to treat with Soledum 200 mg capsules should be reviewed every six months.

If symptoms persist for more than one week, in case of shortness of breath, fever, purulent or bloody sputum, a doctor must be consulted.

Children
Soledum 200 mg capsules are not suitable for children under 12 years of age due to the high active ingredient content. Soledum 100 mg capsules are available for use in children aged 6 to 11.

Taking Soledum 200 mg capsules together with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Cineole leads to the induction of metabolising enzymes in the liver in animal experiments. It is therefore not impossible that high doses of cineole will weaken and/or shorten the effect of other medicines. However, such an effect has not yet been observed in humans when cineole is used as intended.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
There are no scientific studies on the use of Soledum 200 mg capsules in pregnant women. In animal experiments on rats, cineole, the active ingredient of Soledum 200 mg capsules, passed through the placenta (placenta) and reached the foetuses, however, the animal experimental data available to date have not provided any evidence of the occurrence of malformations. As there is insufficient data, the use of this medicine is not recommended during pregnancy.

Breast-feeding:
Due to the fat-soluble properties of the active ingredient, it cannot be ruled out that it will pass into breast milk. However, there are no systematic studies on this, particularly with regard to the possible occurrence of undesirable medicinal effects. Essential oils can change the taste of milk and lead to drinking problems. As there is insufficient data, the use of this medicine is not recommended during breast-feeding.

Driving and using machines
No studies have been carried out on the effects on driving and using machines.

Soledum 200 mg capsules contain sorbitol as sorbitol solution 70% and sodium (sodium alginate)
Soledum 200 mg capsules contain 17 mg sorbitol per capsule.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is virtually "sodium-free".

How should the medicine be taken?

How should Soledum 200 mg capsules be taken?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents aged 12 and over:
1 capsule 3 times a day
In particularly stubborn cases: 1 capsule 4 times a day
For further treatment in general: 1 capsule 2 times a day

Type of use

For oral use.
Please take Soledum 200 mg capsules unchewed with plenty of not too hot liquid (preferably 1 glass of drinking water [200 ml]) if possible 1/2 hour before eating.
If you have a sensitive stomach, it is advisable to take Soledum 200 mg capsules during meals.

Duration of use

The duration of use depends on the type, severity and course of the disease.

If you do not feel better or even worse after 7 days, contact your doctor.

Use in children
Soledum 200 mg capsules are not suitable for children under 12 years of age due to the high active ingredient content (see section Warnings and precautions).

If you have taken more Soledum 200 mg capsules than you should Poisoning with Soledum 200 mg capsules has not been reported to date.

If you suspect an overdose of Soledum 200 mg capsules, please notify a doctor. Depending on the severity of the poisoning symptoms, the doctor can decide on the measures that may be necessary.
Possible symptoms of an overdose with Soledum 200 mg capsules include central nervous disorders such as clouding of consciousness, tiredness, weakness in the arms and legs, constriction of the pupil in the eye (miosis) and, in severe cases, coma and respiratory disorders.

Note for medical professionals
Information on the treatment of an overdose can be found at the end of the package leaflet.

If you forget to take Soledum 200 mg capsules
Do not take double the amount if you have forgotten the previous dose, but continue as usual with the next dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What side effects are possible?

How should Soledum 200 mg capsules be stored?

Do not store above 30 ºC.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/blister pack after "Use by". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

Special storage instructions

How should® 200 mg capsules be stored?

Do not store above 30 ºC.
Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton/container after ,,Use by" has passed. The expiry date refers to the last day of the month indicated.

Special information on the content

Contents of the pack and further information

What Soledum 200 mg capsules contain
The active ingredient is: 1,8-cineole
1 gastro-resistant soft capsule contains 200 mg 1,8-cineole.

The other ingredients are:
Medium-chain triglycerides,
Sorbitol solution 70 % (non-crystallising), gelatine, glycerol 85 %, ethylcellulose, concentrated ammonium hydroxide solution, oleic acid, sodium alginate, stearic acid, candelilla wax, purified water

What Soledum 200 mg capsules look like and contents of the pack
Soledum 200 mg capsules are oval and colourless.
Original pack with 20 gastro-resistant soft capsules
Original pack with 25 gastro-resistant soft capsules
Original pack with 50 gastro-resistant soft capsules
Original pack with 100 gastro-resistant soft capsules