SOLEDUM

SOLEDUM 100 mg gastro-resistant capsules

Important notes (mandatory information)

Soledum Capsules 100 mg, enteric-coated soft capsules. Active ingredient: Cineole. Areas of application: for the treatment of symptoms in bronchitis and colds of the respiratory tract, for additional treatment in chronic and inflammatory diseases of the respiratory tract (e.g. of the paranasal sinuses).

For risks and side effects, read the package insert and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Soledum Capsules 100 mg, enteric-coated soft capsules
Active ingredient: Cineole

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Soledum Capsules must be used as directed to ensure the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet includes

1. WHAT ARE SOLEDUM CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SOLEDUM CAPSULES?
3. HOW SHOULD SOLEDUM CAPSULES BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SOLEDUM CAPSULES BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE SOLEDUM CAPSULES AND WHAT ARE THEY USED FOR?

Soledum Capsules are an anti-inflammatory and expectorant medicine for additional treatment in diseases of the respiratory tract. For the treatment of symptoms in bronchitis and colds of the respiratory tract, for additional treatment in chronic and inflammatory diseases of the respiratory tract (e.g. of the paranasal sinuses).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SOLEDUM CAPSULES?

Soledum Capsules must not be taken:

• if you are known to be hypersensitive to the active ingredient cineole or to any of the other ingredients,
• in whooping cough and croup,
• by infants and toddlers up to the age of 2.

Special care must be taken when taking:

• Diseases that are associated with pronounced hypersensitivity of the respiratory tract.
• In bronchial asthma, therapy with Soledum Capsules should only be carried out under medical supervision.
• If symptoms persist for more than a week, in case of shortness of breath, fever or purulent or bloody sputum, a doctor should be consulted.

Children

Due to the limited scientific evidence, Soledum Capsules should only be used in children under 8 years of age under medical supervision.

When taking Soledum Capsules with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription 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

breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy

There are no scientific studies on the use of Soledum Capsules in pregnant women. If you are pregnant, you should only use Soledum Capsules after consulting your doctor. In animal experiments on rats, cineole, the active ingredient in Soledum Capsules, passes through the placenta and reaches the foetus, but the animal experimental data available to date have not provided any evidence of malformations.

Breastfeeding

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. Soledum Capsules should only be used during breastfeeding after consulting your doctor.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Soledum Capsules

This medicine contains sorbitol. Please only take Soledum Capsules after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW SHOULD SOLEDUM CAPSULES BE TAKEN?

Always take Soledum Capsules exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

Age	Single dose	Total daily dose
Adults and adolescents aged 12 and over	2 capsules (equivalent to 200 mg cineole)	4 – 8 capsules (equivalent to 400 – 800 mg cineole)
Children aged 8 – under 12 years (approx. 25 – 43 kg)	1 capsule (equivalent to 100 mg cineole)	3 capsules (equivalent to 300 mg cineole)
Children aged 2 – under 8 years (approx. 13 – 24 kg)	1 capsule (equivalent to 100 mg cineole)	3 capsules (equivalent to 300 mg cineole)

Adults and adolescents aged 12 and over take 2 capsules 3 times a day. In particularly stubborn cases, 2 capsules 4 times a day. For further and long-term treatment, 2 capsules 2 times a day are generally sufficient. Children from 2 to 12 years of age take 1 capsule 3 times a day. Soledum Capsules are also suitable for diabetics. Take Soledum Capsules whole with plenty of not too hot liquid (preferably a glass of drinking water [200 ml]) if possible half an hour before eating. If you have a sensitive stomach, it is advisable to take Soledum Capsules during meals. The duration of use depends on the type, severity and course of the disease. If symptoms persist for more than a week, in case of shortness of breath, fever or purulent or bloody sputum, a doctor should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Soledum Capsules is too strong or too weak.

If you have taken more Soledum Capsules than you should

Poisoning with Soledum Capsules has not been reported to date. If you suspect an overdose of Soledum Capsules, please notify your doctor. Depending on the severity of the poisoning symptoms, he/she can decide on the measures that may be necessary. Possible symptoms of an overdose of Soledum Capsules include central nervous disorders such as clouding of consciousness, fatigue, weakness of the extremities, miosis and, in severe cases, coma and respiratory disorders.

If you forget to take Soledum Capsules

Do not take double the dose if you have forgotten to take the previous dose.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Soledum Capsules can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Gastrointestinal complaints (nausea, diarrhoea) may occur occasionally. Hypersensitivity reactions (facial oedema, itching, shortness of breath, coughing) and difficulty swallowing are rarely described. At the first signs of a hypersensitivity reaction, Soledum Capsules must not be taken again.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD SOLEDUM CAPSULES BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton/container after "Use by". The expiry date refers to the last day of the month. Do not store above 30 °C.

6. FURTHER INFORMATION

What Soledum Capsules contain

The active ingredient is: Cineole. 1 enteric-coated soft capsule contains 100 mg cineole. The other ingredients are: Medium-chain triglycerides, sorbitol solution 70% (non-crystallising) (Ph. Eur.), gelatine, glycerol 85%, ethylcellulose, ammonium hydroxide 28%, oleic acid, sodium alginate, stearic acid, candelilla wax. One Soledum capsule corresponds to 0.0013 BE.

What Soledum Capsules look like and contents of the pack

Soledum Capsules are oval and colourless. Original pack with 50 enteric-coated soft capsules, original pack with 100 enteric-coated soft capsules.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne
Tel.: 0800/1652-200
Fax: 0800/1652-700
E-mail: dialog@cassella-med.eu
(Please contact Cassella-med for any questions.)

Divapharma GmbH
Motzener Str. 41
12277 Berlin

Manufacturer

Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin

This package leaflet was last revised in September 2016.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Cineole. Areas of application: for the treatment of symptoms in bronchitis and colds of the respiratory tract, for additional treatment in chronic and inflammatory diseases of the respiratory tract (e.g. of the paranasal sinuses).