BRONCHICUM

BRONCHICUM drops

Important notes (mandatory information)

Bronchicum drops.. Areas of application: for the treatment of symptoms of acute bronchitis and colds of the respiratory tract with viscous mucus. Warning: Contains 27.7% alcohol by volume! Warning: Contains sucrose and invert sugar.

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Bronchicum drops, for use in children aged 6 and over, adolescents and adults
Active ingredients: 43.4 g thyme herb fluid extract and 21.7 g primrose root tincture/100 ml liquid

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take 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, 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 even worse after one week, contact your doctor.

What this package leaflet contains

1. WHAT ARE BRONCHICUM DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BRONCHICUM DROPS?
3. HOW TO TAKE BRONCHICUM DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BRONCHICUM DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE BRONCHICUM DROPS AND WHAT ARE THEY USED FOR?

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

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BRONCHICUM DROPS?

Bronchicum drops must not be taken if you are allergic to primrose, thyme and other Lamiaceae (Labiatae), levomenthol, eucalyptus oil or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Bronchicum drops. If symptoms persist for more than one week or if shortness of breath, fever over 39°C, or purulent or bloody sputum occur, a doctor should be consulted immediately.

Taking Bronchicum drops with other medicines

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

Pregnancy and breast-feeding

There is no evidence from the widespread use of thyme as a medicine and food and the use of primrose root as a medicine to suggest any risks during pregnancy and breast-feeding. However, results of adequate studies on the use of this medicine during pregnancy and breast-feeding are not available. The use of Bronchicum drops during pregnancy and breast-feeding is therefore not recommended.

Driving and using machines

No special precautions are required.

Bronchicum drops contain alcohol, sucrose and invert sugar

This medicine contains 27.7% alcohol by volume, sucrose and invert sugar. Invert sugar is a mixture of glucose and fructose. Please take Bronchicum drops only after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE BRONCHICUM DROPS?

Always take 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
Children aged 6 - 12 years (approx. 20 - 43 kg)	30 drops 3 to 5 times a day	90 - 150 drops (equivalent to 1.8 g thyme fluid extract and 0.9 g primrose tincture per day)
Adolescents aged 12 years and over and adults	35 drops 5 times a day	175 drops (equivalent to 2.2 g thyme fluid extract and 1.1 g primrose tincture per day)

There are no adequate studies on the use in children under 6 years of age, therefore the medicine is not intended for use in children under 6 years of age.

Take Bronchicum drops on sugar or in hot tea evenly distributed throughout the day. Shake before use! Hold the bottle upright when dripping. To drip, tap the bottom of the bottle lightly. The application is not limited in time. However, please always observe the information under point 2 and under point 4.

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

If you have taken more Bronchicum drops 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 take Bronchicum drops

Do not take twice the amount if you have forgotten to take the previous dose. If you have taken too little Bronchicum drops or have forgotten to take a dose, you should take it as soon as possible and then continue with the prescribed or prescribed dosage. However, if you have forgotten to take Bronchicum drops for a whole day, do not take the missing amount, but continue taking 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. The list includes all known side effects under treatment with primrose root and thyme herb preparations, including those under higher dosage or long-term therapy.

Possible side effects

Very rare (may affect up to 1 in 10,000 people)

Hypersensitivity reactions such as shortness of breath, skin rashes, hives and swelling of the face, mouth and/or throat (Quincke's edema) may occur. Stomach upset such as cramps, nausea, vomiting may also occur. In appropriately sensitized patients, hypersensitivity reactions (including shortness of breath) can be triggered by levomenthol and eucalyptus oil.

Special notes

If you experience any of the above side effects, especially swelling of the face, mouth and/or throat, discontinue Bronchicum drops and seek medical attention immediately so that the doctor can decide on the severity and any necessary measures. Bronchicum drops must not be taken 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 DROPS?

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

No special storage conditions are required for this medicine.

Note on shelf life after opening or preparation

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bronchicum drops contain

The active ingredients are: Fluid extract of thyme herb, primrose root tincture. 100 ml liquid contains: Fluid extract of thyme herb (1:2- 2.5), extractant: 10% ammonia solution (m/m), glycerol 85%, ethanol 90% (V/V), water (1:20:70: 109) 43.4 g, tincture of primrose root (1 : 5), extractant: Ethanol 50% (V/V) 21.7 g. The other ingredients are: Sucrose-invert sugar mixture, eucalyptus oil, levomenthol, purified water. 1 ml of liquid corresponds to 35 drops.

What Bronchicum drops look like and contents of the pack

Bronchicum drops are available in packs of 30 ml liquid, 50 ml liquid and 100 ml liquid. Bronchicum drops contain plant extracts; the occasional flocculation or deposits have no effect on the efficacy. When Bronchicum drops are dripped into liquids, streaks and cloudiness may form; this does not affect the efficacy or tolerability of the preparation.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne
Telephone: 0800/1652-200
Telefax: 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: Information from the package leaflet
Status: 06/2023
Areas of application: for the treatment of symptoms of acute bronchitis and colds of the respiratory tract with viscous mucus. Warning: Contains 27.7% alcohol by volume! Warning: Contains sucrose and invert sugar.