SOLEDUM

SOLEDUM capsules forte 200 mg

Important notes (mandatory information)

Soledum Capsules forte 200 mg, gastro-resistant soft capsules. Active ingredient: Cineole. Areas of application: anti-inflammatory and expectorant medicine for additional treatment of respiratory diseases, for treatment of 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).

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


PACKAGE INSERT: INFORMATION FOR THE USER

Soledum Capsules forte 200 mg, gastro-resistant soft capsules
Active ingredient: Cineole

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

• Keep the package insert. 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 insert, please inform your doctor or pharmacist.

This package insert contains

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

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

Soledum Capsules forte are an anti-inflammatory and expectorant medicine for additional treatment of respiratory diseases, for treatment of 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).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SOLEDUM CAPSULES FORTE?

Soledum Capsules forte must not be taken:

• if you are known to be hypersensitive to the active ingredient cineole or to any of the other ingredients,
• in cases of whooping cough and pseudocroup,
• by children under 12 years of age.

Special caution is required when taking:

• Diseases that are associated with pronounced hypersensitivity of the respiratory tract.
• In cases of bronchial asthma, therapy with Soledum Capsules forte should only be carried out under medical supervision.
• In cases of complaints that last longer than one week, in cases of shortness of breath, fever or purulent or bloody sputum, a doctor should be consulted.

When taking Soledum Capsules forte with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if these are non-prescription medicines. In animal experiments, cineole leads to the induction of metabolising enzymes in the liver. It is therefore not impossible that high doses of cineole could 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 forte in pregnant women. If you are pregnant, you should only use Soledum Capsules forte after consulting your doctor. In animal experiments on rats, cineole, the active ingredient in Soledum Capsules forte, 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 forte should only be used during breastfeeding after consulting your doctor.

Driving ability and operating machinery

No special precautions are required.

Important information about certain other ingredients of Soledum Capsules forte

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

3. HOW SHOULD SOLEDUM CAPSULES FORTE BE TAKEN?

Always take Soledum Capsules forte exactly as described in this package insert. 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	1 capsule (equivalent to 200 mg cineole)	2 – 4 capsules (equivalent to 400 – 800 mg cineole)

Adults and adolescents aged 12 and over take 1 capsule 3 times a day. In particularly stubborn cases, 1 capsule 4 times a day. For continued and long-term treatment, 1 capsule 2 times a day is generally sufficient. Soledum Capsules forte are also suitable for diabetics. Take Soledum Capsules forte 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 forte during meals. The duration of use depends on the type, severity and course of the disease. In cases of complaints that last longer than one week, in cases 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 forte is too strong or too weak.

If you have taken a larger amount of Soledum Capsules forte than you should

Poisoning with Soledum Capsules forte has not been reported to date. If you suspect an overdose of Soledum Capsules forte, please notify your doctor. Depending on the severity of the poisoning symptoms, your doctor can decide on the measures that may be necessary. Possible symptoms of an overdose of Soledum Capsules forte 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 forte

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 forte 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 patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
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 forte 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 insert. 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 to provide more information on the safety of this medicine.

5. HOW SHOULD SOLEDUM CAPSULES FORTE BE STORED?

Keep medicine out of 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 forte contain

The active ingredient is: Cineole. 1 gastro-resistant soft capsule contains 200 mg cineole. The other ingredients are: Medium-chain triglycerides, gelatine, glycerol 85%, sorbitol solution 70% (non-crystallising) (Ph. Eur.), ethylcellulose, ammonium hydroxide 28%, oleic acid, sodium alginate, stearic acid, candelilla wax. One Soledum Capsule forte corresponds to 0.0015 BE.

What Soledum Capsules forte look like and contents of the pack

Soledum Capsules forte are oval and colourless. Original packs of 20, 50 and 100 gastro-resistant 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 insert was last revised in September 2016.

Source: Information from the package insert
Status: 10/2017
Active ingredient: Cineole. Areas of application: anti-inflammatory and expectorant medicine for additional treatment of respiratory diseases, for treatment of 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).