BRONCHIPRET

BRONCHIPRET Syrup TE

Important notes (mandatory information)

Bionorica Bronchipret Saft TE. Indications: for the relief of symptoms in acute bronchitis with cough and colds with viscous mucus. Warning: Contains 7% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bionorica Bronchipret Saft TE, oral liquid for use in children from one year of age and adults
Active ingredients: thyme herb fluid extract, ivy leaf fluid extract
Herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Bronchipret Saft TE 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 any of the side effects gets 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 BRONCHIPRET SAFT TE AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING BRONCHIPRET SAFT TE?
3. HOW TO TAKE BRONCHIPRET SAFT TE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BRONCHIPRET SAFT TE?
6. FURTHER INFORMATION

1. WHAT IS BRONCHIPRET SAFT TE AND WHAT IS IT USED FOR?

Herbal medicinal product for colds of the respiratory tract. For the relief of symptoms in acute bronchitis with cough and colds with viscous mucus.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING BRONCHIPRET SAFT TE?

Bronchipret Saft TE must not be used in case of known hypersensitivity to ivy, plants of the Araliaceae family, thyme or other Lamiaceae (Labiatae), birch, mugwort, celery or any of the other ingredients of the medicinal product listed in section 6.

Special care must be taken when taking Bronchipret Saft TE

If symptoms persist for more than one week or if shortness of breath, fever, purulent or bloody sputum occur, a doctor should be consulted immediately.

Children

Bronchipret Saft TE should not be used in children under one year of age.

When taking Bronchipret Saft TE 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.

When taking Bronchipret Saft TE with food and drink

Not applicable.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Bronchipret Saft TE should not be used during pregnancy and breast-feeding due to insufficient research.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Bronchipret Saft TE

The medicinal product contains 7% alcohol by volume.

This medicine contains maltitol solution

Do not take Bronchipret Saft TE until you have consulted your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE BRONCHIPRET SAFT TE?

Always take Bronchipret SaftTE exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

Age	Single dose in ml (3 times daily)	Total daily dose
Children from 1 to 5 years	3.2 ml	9.6 ml
Children from 6 to 11 years	4.3 ml	12.9 ml
Adults and adolescents from 12 years	5.4 ml	16.2 ml

Method of administration

Dose with the enclosed measuring cup and take Bronchipret Saft TE 3 times daily (morning, noon and evening) undiluted or in a little water. If necessary, you can rinse with liquid (no alcohol), preferably a glass of drinking water. Bronchipret Saft TE can be taken with food, with drinks or independently of meals. If you have a sensitive stomach, it is best to take Bronchipret SaftTE after meals. Shake before use!

Duration of use

The duration of treatment depends on the course of the disease. If symptoms persist for more than one week, a doctor should be consulted immediately.

If you have taken more Bronchipret Saft TE than you should

Overdosage may cause stomach upset, vomiting and possibly diarrhoea. In this case, please notify a doctor. He/she can decide on any necessary measures.

If you forget to take Bronchipret Saft TE

If you have taken too little Bronchipret Saft TE or have forgotten to take it, do not take twice the amount the next time, but continue taking it as prescribed by your doctor or as described in the dosage instructions.

If you stop taking Bronchipret Saft TE

Discontinuing Bronchipret Saft TE 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, Bronchipret SaftTE can have side effects, although not everybody gets them.

The following frequency information is used to evaluate 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.

Important side effects or signs to watch out for, and measures to be taken if you are affected

If you are affected by any of the following side effects, do not take Bronchipret Saft TE any more and see your doctor as soon as possible. He/she can decide on the severity and any further measures that may be necessary. Occasionally, gastrointestinal complaints such as cramps, nausea, vomiting may occur. Rarely, hypersensitivity reactions (allergic reactions) with skin rashes may occur. Hypersensitivity reactions with e.g. shortness of breath, hives and swelling of the face, mouth and/or throat may also occur. At the first signs of a hypersensitivity reaction, Bronchipret Saft TE must not be taken again.

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 on the safety of this medicine.

5. HOW TO STORE BRONCHIPRET SAFT TE?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton or container. The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C. Store the medicinal product in the original container in order to protect the contents from light. Note on shelf life after opening: Shelf life after opening: 6 months.

6. FURTHER INFORMATION

What Bronchipret Saft TE contains

The active ingredients are: 100 ml (equivalent to 112 g) oral liquid contain: 16.8 g fluid extract of thyme herb (1 : 2-2.5); extraction solvent: 10% ammonia solution (m/m): 85% glycerol (m/m): 90% ethanol (V/V): water (1:20:70:109); 1.68 g fluid extract of ivy leaves (1:1); extraction solvent: 70% ethanol (V/V). The medicinal product contains 7% alcohol by volume. The other ingredients are: citric acid monohydrate, purified water, hydroxypropyl betadex, potassium sorbate, maltitol solution.

Note for diabetics

A single dose of Bronchipret Saft TE (5.4 ml) contains an average of 0.18 bread units (BU).

What Bronchipret Saft TE looks like and contents of the pack

Bronchipret Saft TE is available in packs of 50 ml (N1) and 100 ml (N2). Bronchipret SaftTE is a light brown, clear liquid.

Pharmaceutical entrepreneur and manufacturer

Bionorica SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Phone: 09181/231-90
Fax: 09181/231-265
Internet: www.bionorica.de
E-mail: info(5)bionoNca.de

Co-distributor

Plantamed Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Phone: 09181/231-0
Fax: 09181/21850

This package leaflet was last revised in December 2014.

Source: Package leaflet information
Status: 11/2017
Indications: for the relief of symptoms in acute bronchitis with cough and colds with viscous mucus. Warning: Contains 7% alcohol by volume!