BRONCHICUM Elixir

Important notes (mandatory information)

Bronchicum Elixir, liquid for oral use.. Indications: for the treatment of symptoms of acute bronchitis and colds of the respiratory tract with viscous mucus. Warning: Contains 4.9% alcohol by volume! Warning: Contains sucrose, invert sugar and sodium benzoate.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bronchicum Elixir, liquid for oral use for use in infants from 6 months, children, adolescents and adults
Active ingredients: 6.635 g thyme herb fluid extract and 3.318 g primrose root fluid extract/100 ml liquid

Read the entire package leaflet carefully before you start using this medicine, because 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 need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to 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 1 week, contact your doctor.

What this package leaflet contains

1. WHAT IS BRONCHICUM ELIXIR AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BRONCHICUM ELIXIR?
3. HOW TO USE BRONCHICUM ELIXIR?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BRONCHICUM ELIXIR?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BRONCHICUM ELIXIR AND WHAT IS IT USED FOR?

Bronchicum Elixir is a herbal medicine for colds of the respiratory tract. Bronchicum Elixir is used to treat the symptoms of acute bronchitis and colds of the respiratory tract with viscous mucus. If you do not feel better or if you feel worse after 1 week, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BRONCHICUM ELIXIR?

Bronchicum Elixir must not be used if you are allergic to primrose, thyme or other Lamiaceae (Labiatae) or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Bronchicum Elixir. If you have shortness of breath, fever over 39°C or purulent or bloody sputum, you should see a doctor immediately.

Children

There are no adequate studies on the use in children under 6 months. Bronchicum Elixir should therefore not be used in children under 6 months.

Use of Bronchicum Elixir with other medicines

No interactions are known. Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or plan to take/use any other medicines.

Use of Bronchicum Elixir with food and drink

No restrictions known to date.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 studies on thyme and primrose preparations for use during pregnancy and breast-feeding. Therefore, use is not recommended. There are no data on the effect on fertility.

Driving and using machines

No special precautions are required.

Bronchicum Elixir contains alcohol, sucrose, invert sugar and sodium benzoate

This medicine contains 4.9% alcohol by volume, sucrose and invert sugar. Invert sugar is a mixture of glucose and fructose. Please take Bronchicum Elixir only after consulting your doctor if you are known to suffer from an intolerance to certain sugars. 1 ml contains 1.1 g of a mixture of sucrose, glucose and fructose. This should be taken into account in patients with diabetes mellitus. This medicine contains 2.4 mg sodium benzoate per 1 ml of liquid.

3. HOW TO USE BRONCHICUM ELIXIR?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Age or (body weight)	Single dose	Total daily dose
Infants from 6 to under 12 months (approx. 6 - 10 kg)	1.0 ml 6 times daily	6.0 ml
Toddlers from 1 - 4 years (approx. 8 - 16 kg)	2.5 ml 6 times daily	15 ml
Children from 5 years, adolescents and adults	7.5 ml 4 times daily	30 ml

Bronchicum Elixir should be taken evenly throughout the day. It is taken using the enclosed dosing aid. 5 ml corresponds to a fully filled measuring spoon. 2.5 ml or 1 ml: See corresponding markings! To pour out, tap the bottom of the bottle lightly. The duration of use is not limited in time. However, if symptoms persist for more than 1 week, a doctor should be consulted. In any case, please observe the information under section 2 and under section 4.

Please talk to your doctor or pharmacist if you have the impression that the effect of Bronchicum Elixir is too strong or too weak.

There are no sufficient data for specific dosage recommendations in case of impaired renal or hepatic function.

If you have used more Bronchicum Elixir 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 Bronchicum Elixir

If you have used too little Bronchicum Elixir or have forgotten to use it, you should take it as soon as possible and then continue with the prescribed or prescribed dosage. However, if you have forgotten to use Bronchicum Elixir for a whole day, do not use double the amount, but continue using it the next day as stated in the package leaflet or as prescribed by your doctor.

If you have any further questions about 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.

Possible side effects

Hypersensitivity reactions such as skin rashes, hives and swelling of the face, mouth and/or throat (Quincke's oedema) associated with shortness of breath may occur. Gastrointestinal symptoms such as cramps, nausea, vomiting and diarrhoea may also occur. The frequency is not known (frequency cannot be estimated from the available data).

Additional side effects in children

Vomiting may occur frequently (1 to 10 out of 100 treated) in infants under 12 months.

Special notes

If you experience any of the above side effects, especially swelling of the face, mouth and/or throat, discontinue Bronchicum Elixir and seek medical attention immediately so that the doctor can decide on the severity and any necessary measures. Bronchicum Elixir must not be used again at the first signs of a hypersensitivity reaction.

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 about the safety of this medicine.

5. HOW TO STORE BRONCHICUM ELIXIR?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "Use by:". The expiry date refers to the last day of the month indicated.

Storage conditions

Do not store above 30°C.

Note on shelf life after opening

After opening the bottle, Bronchicum Elixir can be stored at room temperature for 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bronchicum Elixir contains

The active ingredients are: thyme herb fluid extract and primrose root fluid extract. 100 ml (= 132.7 g) liquid contain: Fluid extract of thyme herb (1:2- 2.5) Extraction agent: 10% (m/m) ammonia solution, 85% glycerol, 90% (V/V) ethanol, water (1 : 20 : 70 : 109) 6.635 g, Fluid extract of primrose root (1:2- 2.5) Extraction agent: 70% (m/m) ethanol 3.318 g. The other ingredients are: invert sugar syrup, caramel syrup, sodium benzoate, purified water.

What Bronchicum Elixir looks like and contents of the pack

Bronchicum Elixir is available in packs of 100 ml liquid and 250 ml liquid. Bronchicum Elixir contains plant extracts; the occasional flocculation or deposits have no effect on the efficacy.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne
Telephone: 0800/1652-200
Fax: 0800/1652-700
E-mail: dialog@cassella-med.eu

Manufacturer

Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin

This package leaflet was last revised in August 2020.

Source: Package leaflet information
Status: 06/2023
Indications: for the treatment of symptoms of acute bronchitis and colds of the respiratory tract with viscous mucus. Warning: Contains 4.9% alcohol by volume! Warning: Contains sucrose, invert sugar and sodium benzoate.