BRONCHOFORTON

BRONCHOFORTON Ointment

Important notes (mandatory information)

Bronchoforton Ointment. Areas of application: for inhalation and external use to alleviate symptoms of colds of the respiratory tract with viscous mucus.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bronchoforton Ointment 10 %/10 %/5 % for use in children aged 4 years and older and adults
Active ingredients: eucalyptus oil, spruce needle oil, peppermint oil

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 4–5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS BRONCHOFORTON OINTMENT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BRONCHOFORTON OINTMENT?
3. HOW IS BRONCHOFORTON OINTMENT USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BRONCHOFORTON OINTMENT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BRONCHOFORTON OINTMENT AND WHAT IS IT USED FOR?

Bronchoforton Ointment is a herbal medicine for colds of the respiratory tract. Bronchoforton Ointment is used for inhalation and external use to alleviate symptoms of colds of the respiratory tract with viscous mucus.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BRONCHOFORTON OINTMENT?

Bronchoforton Ointment must not be used:

• if you are allergic to any of the active ingredients eucalyptus oil, spruce needle oil or peppermint oil, to cineole (the main component of eucalyptus oil), menthol (the main component of peppermint oil) or any of the other ingredients of this medicine listed in section 6,
• in infants and toddlers under 30 months (risk of laryngospasm),
• on damaged skin, e.g. in the case of burns and injuries,
• in bronchial asthma,
• in whooping cough,
• in croup,
• during breastfeeding,
• in children who have previously suffered a seizure or febrile convulsion.

Warnings and precautions

If symptoms persist for more than one week, worsen or if shortness of breath, fever or bloody or purulent sputum occur, a doctor should be consulted. Bronchoforton Ointment must not be applied/rubbed into the face. When using Bronchoforton Ointment, avoid contact of the medicine with the eyes, as this can irritate the eyes. Bronchoforton Ointment should not be used on mucous membranes or irritated skin. After using Bronchoforton Ointment, wash your hands thoroughly.

Children

Use is not recommended in children aged 30 months to 4 years, as there is insufficient experience. For general safety reasons, only children aged 6 years and older and adults should use Bronchoforton Ointment as steam inhalation. Do not allow children to inhale without supervision! In rare cases, inhalation of concentrated vapours of essential oils leads to respiratory arrest in infants and toddlers, probably as a result of spasms of the glottis. Care should be taken to ensure that children cannot come into contact with the rubbed-in areas of skin with their hands.

Use of Bronchoforton Ointment together with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Eucalyptus oil activates 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 the case of large-scale use due to the absorption of larger amounts of active ingredients through the skin. Therefore, consult your doctor if you are using or intend to use other medicines, in particular certain anaesthetics or medicines for the treatment of epilepsy (barbiturates), certain painkillers (pyrazolones) or certain stimulants (amphetamines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There are no adequate studies on the use of Bronchoforton Ointment during pregnancy. Therefore, this medicine should not be used during this time. If you are breastfeeding, you must not use Bronchoforton Ointment.

Driving and operating machinery

The effects on the ability to drive and operate machinery have not been studied.

Bronchoforton Ointment contains stearyl alcohol

Stearyl alcohol can cause localised skin irritation (e.g. contact dermatitis).

3. HOW IS BRONCHOFORTON OINTMENT USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is

Application to the skin (rubbing in)

Adults and adolescents aged 12 years and older rub 3-5 cm of Bronchoforton Ointment onto the chest or back 2 to 4 times a day. In children aged 6-12 years, 1-3 cm of Bronchoforton Ointment is rubbed in 2 to 4 times a day, in children aged 4-6 years, 1-2 cm of ointment is rubbed in 2 to 4 times a day.

Inhalation with water vapour

For inhalation, pour a 3-5 cm long strip of ointment for adults and adolescents aged 12 years and older, a 1-3 cm long strip of ointment for children aged 6 to 12 years over 0.6 litres of hot water 2 to 4 times a day and inhale the rising vapours through the mouth and nose for about 10 minutes (be careful, the vapours are hot at first!). Do not allow children to inhale without supervision! Be careful when handling hot water! When inhaling with the Bronchoforton Inhaler, please follow the instructions for use! Children under 6 years of age should not inhale for safety reasons.

The duration of treatment depends on the course of the disease and will be adjusted by the attending physician if necessary. Do not use Bronchoforton Ointment for more than 5 days without medical advice. For the duration of use, please also note the information in section 2. "What should you consider before using Bronchoforton Ointment?".

Children

Use is not recommended in children aged 30 months to 4 years, as there is insufficient experience. Bronchoforton Ointment must not be used in infants and children under 30 months (see section 2. "Bronchoforton Ointment must not be used").

If you have used more Bronchoforton Ointment than you should

Excessive inhalation can cause coughing and shortness of breath. These symptoms subside after inhalation is stopped. Excessive use on the skin can cause skin irritation. Inhalation or accidental ingestion of larger amounts of Bronchoforton Ointment can cause significant discomfort (e.g. nausea, vomiting, abdominal pain, diarrhoea, headache, drowsiness, dizziness, drowsiness with speech disorders, confusion, double vision, muscle weakness, shortness of breath, seizures). In this case, even if no symptoms have yet occurred, you should contact your doctor. This applies in particular if a small child has swallowed larger amounts of Bronchoforton Ointment. Milk or alcohol should not be drunk in the event of an overdose, as these can promote the absorption of the active ingredients of Bronchoforton Ointment into the blood. In severe cases of poisoning, shallow, irregular breathing, circulatory collapse and coma are possible. Isolated cases of transient cardiac arrhythmias and kidney damage have also been reported.

If you forget to use Bronchoforton Ointment

Do not use twice the amount to make up for a forgotten application, but continue to use as prescribed by your doctor or as described in the dosage instructions.

If you stop using Bronchoforton Ointment

Use can be discontinued at any time. Discontinuing Bronchoforton Ointment is generally harmless.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The list includes all known side effects under treatment with eucalyptus oil preparations, including those under higher dosage or long-term therapy.

Rarely (may affect up to 1 in 1,000 people), contact eczema, allergic reactions or coughing may occur, mainly after application to the skin. Increased irritation may occur on the skin and mucous membranes. Mainly after inhalation, a spasm of the respiratory muscles (bronchospasm, laryngospasm) may occur or be exacerbated. Hypersensitivity reactions with tachycardia, reduced respiratory drive (respiratory depression) and a tendency to seizures have become known, especially in infants and toddlers (see section 2. "Bronchoforton Ointment must not be used"). Note: In case of improper use (swallowing), nausea, vomiting and diarrhoea may occur. In appropriately sensitised patients, Bronchoforton Ointment can trigger hypersensitivity reactions (including shortness of breath, respiratory arrest).

Countermeasures

If side effects or hypersensitivity reactions occur, the medicine should be discontinued and a doctor consulted.

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, 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 on the safety of this medicine.

5. HOW SHOULD BRONCHOFORTON OINTMENT BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container after "Use by". The expiry date refers to the last day of the month indicated. After opening the tube, Bronchoforton Ointment can be stored for 8 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bronchoforton Ointment contains

The active ingredients are eucalyptus oil, spruce needle oil and peppermint oil. 100 g of ointment contain 10 g of eucalyptus oil, 10 g of spruce needle oil and 5 g of peppermint oil. The other ingredients are: glycerol monostearate 40 - 55, macrogol-1000-glycerol monostearate, stearyl alcohol (Ph. Eur.), liquid paraffin, isopropyl (palmitate/stearate) (10 : 90), glycerol 85 %, purified water.

What Bronchoforton Ointment looks like and contents of the pack

Bronchoforton Ointment is a white ointment in a tube. Bronchoforton Ointment is available in packs of 40 g, 100 g, 400 g or 1,000 g of ointment as well as Bronchoforton Combi in packs of 100 g of ointment + inhaler + VaPor. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur:
Winthrop Arzneimittel GmbH
65927 Frankfurt am Main

Co-distribution

Zentiva Pharma GmbH
65927 Frankfurt am Main
Telephone: (01 80)2 02 00 10*
Telefax: (01 80)2 02 00 11*

*0.06 EUR/call (German landline); max. 0.42 EUR/min (mobile).

Manufacturer

Sanofi Winthrop Industrie
196 rue du Maréchal Juin
45200 Amilly
France

This package leaflet was last revised in May 2016.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for inhalation and external use to alleviate symptoms of colds of the respiratory tract with viscous mucus.