SOLEDUM

SOLEDUM liquid balm

Important notes (mandatory information)

Soledum Balsam. Active ingredient: Cineole. Area of application: for improving well-being in the case of colds of the upper respiratory tract (such as uncomplicated runny nose, hoarseness, uncomplicated bronchitis, uncomplicated sinusitis).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Soledum Balsam 15% solution
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 Balsam must be used as directed in order to achieve 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 contains

1. WHAT IS SOLEDUM BALSAM AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING SOLEDUM BALSAM?
3. HOW IS SOLEDUM BALSAM USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SOLEDUM BALSAM BE STORED?
6. FURTHER INFORMATION

1. WHAT IS SOLEDUM BALSAM AND WHAT IS IT USED FOR?

Soledum Balsam is a medicine that is used to support respiratory tract conditions. Soledum Balsam is used to improve well-being in the case of colds of the upper respiratory tract (such as uncomplicated runny nose, hoarseness, uncomplicated bronchitis, uncomplicated sinusitis). Soledum Balsam is intended exclusively for external use (inhalation, rubbing). Do not ingest!

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING SOLEDUM BALSAM?

Soledum Balsam must not be used if:

• You or your child are hypersensitive (allergic) to the active ingredient cineole or any of the other ingredients of Soledum Balsam.
• You want to treat your infant or toddler under 2 years of age.
• You or your child suffer from acute pneumonia.
• You or your child have skin conditions or injured skin, e.g. after skin burns.
• Your child has a childhood illness with exanthema.
• You or your child have pseudocroup or whooping cough.

Special care must be taken when using Soledum Balsam:

• In the case of conditions that are associated with pronounced hypersensitivity of the respiratory tract, Soledum Balsam should only be used under medical supervision of the overall treatment regimen for the condition.
• If fever, shortness of breath, purulent or bloody sputum occur, a doctor must be consulted immediately, as treatment with cineole as a balsam is not sufficient in these cases. If the symptoms persist for more than seven days in the other treatment cases (without fever, without shortness of breath, without purulent or bloody sputum), a doctor must also be consulted.
• Do not use in the eye area.

When using Soledum Balsam 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. In animal studies, cineole has been found to accelerate certain metabolic processes in the liver. In humans, such an effect of Soledum Balsam has not yet been observed when used as intended.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy

There are no scientific studies on the use of Soledum Balsam in pregnant women. If you are pregnant, you should only use Soledum Balsam after consulting your doctor. In animal studies on rats, cineole, the active ingredient in Soledum Balsam, crosses the placenta and reaches the fetus, but the animal studies conducted to date have not provided any evidence of malformations.

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 alter the taste of milk and lead to drinking problems. Soledum Balsam should not be applied to the breast area during breast-feeding in order to avoid contact between the infant or toddler and Soledum Balsam. Soledum Balsam should only be used during breast-feeding after consulting your doctor.

Driving and operating machinery

No special precautions are required.

3. HOW IS SOLEDUM BALSAM USED?

Always use Soledum Balsam 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:

• Rubbing: Apply 5 – 15 drops of Soledum Balsam to the chest and back 2– to 4–times daily. For toddlers over 2 years of age, 5 – 10 drops 1 – to 2–times daily are sufficient.
• Inhalation: 15 – 20 drops of Soledum Balsam are poured into the designated inhaler (Soledum) with 1/2 l of hot water.
• Bedroom/climate room: In the patient's room, mainly in the evenings and also during the day, cloth rags or cotton balls are attached, preferably at the head of the bed, which are soaked with 15 – 20 drops of Soledum Balsam, so that continuous inhalation is ensured.
• Bath: 10 – 20 drops of Soledum Balsam are sufficient as a bath additive in approx. 20 l of water.

Type of use

For use on the skin. For inhalation. Do not ingest! The application is carried out regardless of the time of day during the duration of the illness. If possible, carry out the inhalation treatment 2 - 3 times a day for about 3 - 5 minutes.

Duration of use

Soledum Balsam should be used for the duration of the illness.

If fever, shortness of breath, purulent or bloody sputum occur, a doctor must be consulted immediately, as treatment with cineole as a balsam is not sufficient in these cases. If the symptoms persist for more than seven days in the other treatment cases (without fever, without shortness of breath, without purulent or bloody sputum), a doctor must also be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Soledum Balsam is too strong or too weak.

If you have used more Soledum Balsam than you should

There have been no cases of overdose specifically with cineole to date. Poisoning with high doses of eucalyptus oil of undefined purity led to central nervous disorders such as clouding of consciousness, fatigue, weakness of the extremities, miosis and, in severe cases, to coma and respiratory disorders. Due to the rapid excretion of the substance, the symptoms are expected to subside quickly and recovery to be complete. The further possibilities for treating poisoning with cineole depend on the extent and course as well as the symptoms of the disease.

If you forget to use Soledum Balsam

Do not use a double dose to make up for a forgotten 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 Balsam can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of 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.

Hypersensitivity reactions such as coughing and irritation of the skin and mucous membranes can occur. As with other inhalation treatments, bronchospasms (paradoxical bronchospasms) can occur independently of the active ingredient. In this very rare case, you should stop treatment immediately and consult your doctor without delay.

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, Department 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 BALSAM BE STORED?

Keep medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the label/carton after "Use by". The expiry date refers to the last day of the month. No special storage conditions are required for this medicine. The shelf life after opening the container is 6 months.

6. FURTHER INFORMATION

What Soledum Balsam contains

The active ingredient is cineole. 100 g solution contains 15 g cineole. The other ingredient is: Medium-chain triglycerides.

What Soledum Balsam looks like and contents of the pack

Clear, colourless liquid with a characteristic eucalyptus odour. Brown dropper bottle with screw cap. Pack of 20, 50 and 100 ml solution, combination pack: pack of 20 ml solution + inhaler.

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.)

Manufacturer

Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Cineole. Area of application: for improving well-being in the case of colds of the upper respiratory tract (such as uncomplicated runny nose, hoarseness, uncomplicated bronchitis, uncomplicated sinusitis).