DOPPELHERZ

DOPPELHERZ Cold Capsules Eucalyptus Oil

Important notes (mandatory information)

Cold capsules eucalyptus oil.

Indications

For the relief of symptoms of colds of the respiratory tract with viscous mucus.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cold capsules eucalyptus oil
Active ingredient: eucalyptus oil
Soft capsule
For use in adults and adolescents aged 12 years and over.

Read the entire package leaflet carefully as it contains important information for you. This medicine is available without a prescription. However, in order to achieve the best possible treatment results, cold capsules eucalyptus oil must be used as directed.

• 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 4-5 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 ARE COLD CAPSULES EUCALYPTUS OIL AND WHAT ARE THEY USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING COLD CAPSULES EUCALYPTUS OIL?
3. HOW TO TAKE COLD CAPSULES EUCALYPTUS OIL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE COLD CAPSULES EUCALYPTUS OIL?
6. FURTHER INFORMATION

1. WHAT ARE COLD CAPSULES EUCALYPTUS OIL AND WHAT ARE THEY USED FOR?

Cold capsules eucalyptus oil is a herbal medicine for colds of the respiratory tract.

Indications

For the relief of symptoms of colds of the respiratory tract with viscous mucus.

2. WHAT YOU NEED TO KNOW BEFORE TAKING COLD CAPSULES EUCALYPTUS OIL?

Cold capsules with eucalyptus oil must not be taken:

• in inflammatory diseases of the gastrointestinal tract and the biliary tract as well as in severe liver diseases,
• in case of hypersensitivity to eucalyptus oil, cineole as the main component of eucalyptus oil, soya, peanut or any of the other ingredients,
• in infants and children under 2 years of age,
• in patients with bronchial asthma, whooping cough or other respiratory diseases associated with pronounced hypersensitivity of the respiratory tract.

Special care should be taken when taking cold capsules eucalyptus oil

If symptoms do not improve or worsen within 4-5 days, if you have shortness of breath, fever, purulent or bloody sputum, you must see a doctor.

The following should be noted when taking cold capsules eucalyptus oil with other medicines

When taken together, medicines can influence each other's effects. Eucalyptus oil affects the foreign substance-degrading enzyme system in the liver. The effect of other medicines can therefore be weakened and/or shortened. Such effects on antiepileptic drugs as well as on sleeping and pain relievers are known from cineole, the main component of eucalyptus oil. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

When taking cold capsules eucalyptus oil with food and drink

No interactions with food and beverages are known.

Pregnancy and breast-feeding

There are no adequate studies on the use of cold capsules eucalyptus oil during pregnancy and breast-feeding. Therefore, this medicine should not be used during this time.

Children

There are no adequate studies on the use of cold capsules eucalyptus oil in children between 2 and 12 years of age. Therefore, cold capsules eucalyptus oil should not be used in children of this age group.

Driving and using machines

No impairments are known.

Important information about certain other ingredients of cold capsules eucalyptus oil

This medicine contains sorbitol. Please only take cold capsules eucalyptus oil after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE COLD CAPSULES EUCALYPTUS OIL?

Always take cold capsules eucalyptus oil 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

For adults and adolescents over 12 years: 1 - 2 soft capsules 3 times a day

Method of administration

Please take the capsules unchewed with sufficient liquid, preferably a glass of water, preferably 1/2 hour before meals.

Duration of use

The duration of use is not limited for cold capsules eucalyptus oil. However, please note the information in section 2. "Special care should be taken when taking cold capsules eucalyptus oil". Please talk to your doctor or pharmacist if you have the impression that the effect of cold capsules eucalyptus oil is too strong or too weak.

If you have taken more cold capsules eucalyptus oil than you should

No more cold capsules eucalyptus oil should be taken per day than stated in the dosage instructions or prescribed by your doctor. If you accidentally take 1 or 2 single doses more than intended, this will usually have no adverse consequences. If significantly higher amounts are taken, abdominal pain, nausea, vomiting and diarrhoea may occur, as well as drowsiness, dizziness, headache and speech disorders; in severe cases, shortness of breath, life-threatening circulatory reactions and unconsciousness may occur. However, since it cannot be ruled out that, especially in sensitive individuals, even about 4 - 5 ml (corresponding to about 35 - 40 soft capsules) can lead to fatal poisoning, a doctor should be notified immediately in the event of any possible poisoning with eucalyptus oil, who will initiate the necessary measures; in children, the contents of about 5 soft capsules can already lead to severe poisoning. Specific antidotes are not known; under no circumstances should milk or alcoholic beverages be drunk, as this can promote the absorption of essential oils.

If you forget to take cold capsules eucalyptus oil

Do not take a double dose, but continue taking as directed in this leaflet or as directed by your doctor.

If you stop taking cold capsules eucalyptus oil

An interruption or premature termination of treatment is usually harmless. If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, cold capsules eucalyptus oil 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
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

In rare cases, nausea, vomiting and diarrhoea may occur after taking eucalyptus preparations. Soya oil can very rarely cause allergic reactions.

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, 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 about the safety of this medicine.

5. HOW TO STORE COLD CAPSULES EUCALYPTUS OIL?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton or blister after "use by". The expiry date refers to the last day of the month.

Storage conditions

Do not store above 25 °C.

6. FURTHER INFORMATION

What cold capsules eucalyptus oil contains

The active ingredient is: eucalyptus oil
1 soft capsule contains: 100 mg eucalyptus oil

The other ingredients are

Soya oil, milk fat, gelatine, glycerol, sorbitol solution 70% (non-crystallising), purified water.

Available pack sizes

Original packs of 40 soft capsules for oral administration.

Pharmaceutical entrepreneur and manufacturer

Queisser Pharma GmbH & Co. KG
Schleswiger Str. 74
24941 Flensburg
Phone 04 61 / 99 96 0
Fax 04 61 / 99 96 110
E-mail: info@queisser.de

Marketing Authorisation Holder

Swiss Caps GmbH
Grassingerstrasse 9
D-83043 Bad Aibling

This leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 02/2017
Indications: For the relief of symptoms of colds of the respiratory tract with viscous mucus.