BABIX

BABIX Inhalat N

Important notes (mandatory information)

Babix-Inhalat N. Areas of application: for improving 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.


INSTRUCTIONS FOR USE: INFORMATION FOR USERS

Babix-Inhalat N for infants, children and adults
Active ingredients: Eucalyptus oil and spruce needle oil
Herbal medicinal product for colds of the respiratory tract

Dear patients! Please read the entire package leaflet carefully, as it contains important information for you. This medicinal product is available without a prescription. However, to achieve the best possible treatment success, Babix-Inhalat N must be used as prescribed.

• 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 leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS BABIX-INHALAT N AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BABIX-INHALAT N?
3. HOW IS BABIX-INHALAT N USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BABIX-INHALAT N BE STORED?
6. FURTHER INFORMATION

1. WHAT IS BABIX-INHALAT N AND WHAT IS IT USED FOR?

Babix-Inhalat N is a herbal medicinal product for colds of the respiratory tract. Babix-Inhalat N is used to improve symptoms of colds of the respiratory tract with viscous mucus.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BABIX-INHALAT N?

Babix-Inhalat N must not be used:

• in patients with bronchial asthma or other respiratory diseases that are associated with pronounced hypersensitivity of the respiratory tract. Inhalation of Babix-Inhalat N can lead to shortness of breath or trigger an asthma attack.
• if you are hypersensitive (allergic) to eucalyptus oil or spruce needle oil.

Special care should be taken when using Babix-Inhalat N

If symptoms worsen or if there is no improvement after 7 days, a doctor should be consulted.

In children

Do not let children inhale unsupervised, as there is a risk of scalding. In infants and toddlers under 2 years of age, do not apply near the respiratory tract, but on clothing or bedding.

When using Babix-Inhalat N with other medicinal products

There are no studies on the risk of interaction with Babix-Inhalat N. Eucalyptus oil activates the foreign substance-degrading liver enzyme system in the liver. The effects of other medicinal products can therefore be weakened and/or shortened. Before treatment with Babix-Inhalat N, a doctor should be consulted if other medicinal products are already being used, as interactions are possible.

Pregnancy and breastfeeding

Babix-Inhalat N should not be used during pregnancy and breastfeeding due to insufficient studies. It should be noted that use in women of childbearing age who are not using contraception must also be carefully considered due to the risk of early pregnancy. Due to the fat-soluble properties of the active ingredients, it is to be expected that they will pass into breast milk, but no studies have been conducted on this. Essential oils can alter the taste of milk and lead to drinking problems.

Driving and operating machinery

No special precautions are required.

3. HOW IS BABIX-INHALAT N USED?

Always use Babix-Inhalat N exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Type of application

For inhalation by adults and children.

Unless otherwise prescribed by your doctor, Babix-Inhalat N should be used as follows:

• Adults and adolescents aged 12 and over: Inhalation with hot water: Pour 7 drops into hot water 3 - 4 times a day and inhale the vapours.
• Children aged 6 -11: Inhalation with hot water: Pour 4 drops into hot water 3 - 4 times a day and inhale the vapours.
• Children aged 2-5: Inhalation by dripping onto clothing: Apply 3 drops to clothing near the respiratory organs 3 - 5 times a day.
• Infants and children up to 2 years: Inhalation by dripping onto clothing: Apply 1-3 drops of the essential oil mixture to the surroundings (e.g. bedding) 3 - 5 times a day and not near the respiratory organs.

Duration of use

Babix-Inhalat N can be used until the symptoms subside. If your symptoms worsen or if there is no improvement after 7 days, you must see a doctor in any case. Please note the information under "Special care should be taken when using Babix-Inhalat N". Please talk to your doctor or pharmacist if you have the impression that the effect of Babix-Inhalat N is too strong or too weak.

If you have used more Babix-Inhalat N than you should

The side effects listed below may be more pronounced. In this case, please notify a doctor. He/she can decide on any necessary measures.

If you forget to use Babix-Inhalat N

Do not use double the amount the next time, but continue using it as prescribed by your doctor or as described in the instructions for use.

If you interrupt or stop using Babix-Inhalat N prematurely, this is harmless.

If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicinal products, Babix-Inhalat N 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.

Rarely contact eczema, allergic reactions, coughing. Increased irritation of the skin and mucous membranes may occur. A spasm of the respiratory muscles (bronchospasm) can be aggravated. Hypersensitivity reactions with rapid heart rate (tachycardia), reduced respiratory drive (respiratory depression) and a tendency to convulsions have been reported very rarely, especially in infants and toddlers. In rare cases, inhalation of concentrated vapours of essential oils in infants and toddlers leads to respiratory arrest, presumably due to spasms of the glottis. Note: If not used as intended (swallowed), nausea, vomiting and diarrhoea may occur.

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 SHOULD BABIX-INHALAT N BE STORED?

Keep medicinal products out of the reach of children. Shelf life after opening: 3 months. Do not use the medicinal product after the expiry date which is stated on the label and carton. Storage conditions: Do not store above 25°C.

6. FURTHER INFORMATION

What Babix-Inhalat N contains

10 g of liquid (= 11 ml) contain as active ingredients: 2.86 g eucalyptus oil, 7.14 g spruce needle oil. Active ingredients: Eucalyptus oil, spruce needle oil. Other ingredients: None.

What Babix-Inhalat N looks like and contents of the pack

Babix-Inhalat N is a liquid and is available in original packs of 5 ml, 10 ml and 20 ml.

Pharmaceutical entrepreneur and manufacturer

MICKAN Arzneimittel GmbH
Postfach 21 09 40
76159 Karlsruhe
Telephone: 07 21 - 9 50 93-0
Telefax: 07 21 - 9 50 93-10

This leaflet was last revised in April 2013.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for improving symptoms of colds of the respiratory tract with viscous mucus.