Klosterfrau

KLOSTERFRAU Cold Balm

Important notes (mandatory information)

Klosterfrau Cold Balm.

Indications

For external use in colds of the respiratory tract such as runny nose, cough, hoarseness, congestion and bronchitis.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Klosterfrau Cold Balm for use in children from 2 years and adults
Active ingredients in 100 g ointment: Eucalyptus oil 0.8 g, levomenthol 4.0 g, D-camphor 8.0 g

Read the entire package leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, Klosterfrau Cold Balm 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 after 3-5 days, you must see a doctor.
• If any of the side effects listed become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS KLOSTERFRAU COLD BALM AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING KLOSTERFRAU COLD BALM?
3. HOW TO USE KLOSTERFRAU COLD BALM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE KLOSTERFRAU COLD BALM?
6. FURTHER INFORMATION

1. WHAT IS KLOSTERFRAU COLD BALM AND WHAT IS IT USED FOR?

Klosterfrau Cold Balm is a herbal medicine for use in colds of the respiratory tract.

Indications

For external use in colds of the respiratory tract such as runny nose, cough, hoarseness, congestion and bronchitis.

2. WHAT YOU NEED TO KNOW BEFORE USING KLOSTERFRAU COLD BALM?

When should you not use Klosterfrau Cold Balm?
Do not use in:

• Hypersensitivity to any of the ingredients.
• Infants and toddlers under 2 years of age.
• Asthma and whooping cough, as well as pseudocroup and other respiratory diseases that are associated with a pronounced hypersensitivity of the respiratory tract; here, inhalation can lead to constriction of the bronchial muscles.
• inhalation therapy for acute inflammation of the respiratory tract and for acute pneumonia.

Do not use for external rubbing in skin and childhood diseases with exanthema as well as on damaged skin, e.g. in burns.

Precautions and warnings

In case of external large-scale application, poisoning symptoms may occur, e.g. kidney damage and damage to the central nervous system (CNS), e.g. due to camphor. Camphor-containing ointments should not be used in children with an increased risk of seizures. Do not apply to mucous membranes (including the nose) or in the eye area. Do not apply to the face. Wash hands thoroughly after use. Klosterfrau Cold Balm may only be used externally and for inhalation treatment.

Children

In infants and toddlers, camphor or eucalyptus oil-containing preparations should not be applied or accidentally smeared in the area of the neck and face, especially the nose.

When using Klosterfrau Cold Balm with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Eucalyptus oil induces the foreign substance-degrading enzyme system in the liver. The effects of other medicines can therefore be weakened and/or shortened. This cannot be ruled out in case of large-scale and/or long-term use due to absorption of larger amounts of active ingredients through the skin.

Pregnancy and

Breastfeeding

Pregnancy

Since the safety of using Klosterfrau Cold Balm during pregnancy has not been proven, you should only use Klosterfrau Cold Balm on the advice of your doctor and only if your doctor considers the use to be clearly necessary.

Breastfeeding

It is not known whether the active ingredients from Klosterfrau Cold Balm pass into breast milk and lead to undesirable effects in the breastfed child. Therefore, you should not use Klosterfrau Cold Balm during breastfeeding. However, if use is necessary on the advice of your doctor, this should not be done in the breast area.

3. HOW TO USE KLOSTERFRAU COLD BALM?

Always use Klosterfrau Cold Balm exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

Massage the patient's throat, chest and back areas lightly with Klosterfrau Cold Balm in the morning, at noon and in the evening. Then keep warm.

Type and duration of use

For external use. If symptoms persist for longer than 3 - 5 days, if you have shortness of breath, headache, fever or purulent/bloody sputum or nasal discharge, you must see a doctor urgently. Care should be taken to ensure that children cannot come into contact with the rubbed skin areas with their hands.

If you have used more Klosterfrau Cold Balm than you should

With proper use for external application or inhalation, overdose symptoms are not to be expected. In case of accidental ingestion (swallowing), nausea and vomiting usually occur due to the mucous membrane-irritating properties, and diarrhoea may also occur. Symptoms such as palpitations, hot flushes, weakness and dry mouth, diarrhoea and fever have also occurred in rare cases with external use and overdose. In case of external, large-scale application, poisoning symptoms may occur, e.g. kidney damage and damage to the central nervous system (CNS).

Treatment of intoxications

In mild cases, it is sufficient to discontinue the medication. Otherwise, treatment is symptomatic. In the case of large amounts (over 100 mg essential oils/kg body weight or over 50 mg camphor or cineole/kg body weight), primary detoxification may be necessary, especially in children.

If you forget to use Klosterfrau Cold Balm

Continue using as directed.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Klosterfrau Cold Balm 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.

Possible side effects

Irritation and contact eczema on the skin and mucous membranes are possible with inhalation (also after external rubbing): Cough irritation and increased bronchospasm (bronchial spasm) are possible. Inhalation (also inhalation of vapours after external rubbing) can itself trigger respiratory problems. Bronchospasm (bronchial spasm) can reflexively lead to asthma-like conditions. Not known (frequency cannot be estimated from the available data): Burns at the site of application.

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 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 about the safety of this medicine.

5. HOW TO STORE KLOSTERFRAU COLD BALM?

Keep out of reach of children. The expiry date of this pack is printed on the outer packaging and the container. Do not use this pack after this date! Shelf life after opening: 3 months.

6. FURTHER INFORMATION

What Klosterfrau Cold Balm contains

The active ingredients are: 100 g ointment contains eucalyptus oil 0.8 g, levomenthol 4.0 g, D-camphor 8.0 g. The other ingredients are: hard paraffin and white petrolatum.

Contents of the pack

20 g ointment.

Pharmaceutical entrepreneur and manufacturer

Divapharma GmbH
Motzener Straße 41
D-12277 Berlin
Phone: +49(0)30 72007-266
Fax: +49(0)30 72007-326

Co-distributor

Klosterfrau Vertriebs GmbH
Gereonsmühlengasse 1-11
D-50670 Cologne
Phone: +49(0)221 1652-0
Fax: +49(0)221 1652-575

This leaflet was last revised in April 2018.

Source: Information from the package leaflet
Status: 04/2022
Indications: For external use in colds of the respiratory tract such as runny nose, cough, hoarseness, congestion and bronchitis.