Bronchostop

BRONCHOSTOP Sine Cough Syrup

Important notes (mandatory information)

Bronchostop Sine Cough Syrup, liquid for oral use. Areas of application: for the relief of mucous membrane irritation in the mouth and throat and associated dry, irritating cough as well as for promoting coughing up of productive cough in connection with a cold. Warning: Contains xylitol and propylene glycol. Contains raspberry juice concentrate, which contains sucrose, glucose and fructose.

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Bronchostop Sine Cough Syrup, liquid for oral use for use in adults, adolescents and children aged 3 years and over
Active ingredients: 0.129 g/15 ml thyme herb dry extract, 0.830 g/15 ml marshmallow root extract

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 experience 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 after 5 days or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS BRONCHOSTOP SINE COUGH SYRUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BRONCHOSTOP SINE COUGH SYRUP?
3. HOW TO TAKE BRONCHOSTOP SINE COUGH SYRUP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BRONCHOSTOP SINE COUGH SYRUP?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BRONCHOSTOP SINE COUGH SYRUP AND WHAT IS IT USED FOR?

Bronchostop Sine Cough Syrup is a traditional herbal medicinal product used to relieve mucous membrane irritation in the mouth and throat and associated dry, irritating cough as well as to promote coughing up of productive cough in connection with a cold. The medicinal product is a traditional medicinal product that is registered for the area of application exclusively on the basis of long-standing use.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BRONCHOSTOP SINE COUGH SYRUP?

Bronchostop Sine Cough Syrup must not be taken if you are allergic to thyme dry extract, marshmallow root liquid extract, another member of the Lamiaceae family, methyl 4-hydroxybenzoate (E 218), propyl 4-hydroxybenzoate (E 216), or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Special care should be taken when taking Bronchostop Sine Cough Syrup in the following cases

Talk to your doctor or pharmacist before taking Bronchostop Sine Cough Syrup if you have asthma or are prone to allergic reactions, as BRONCHOSTOP' Sine Cough Syrup can worsen asthma symptoms. There is a possibility that this medicine may trigger allergic reactions, in very rare cases anaphylaxis including anaphylactic shock, in patients who are prone to allergic reactions. If you have a fever, shortness of breath or purulent sputum, you should see a doctor.

Children

Use in children under 3 years of age is not recommended as there is insufficient data and medical advice should be sought. The user should consult a doctor or other qualified person in the healthcare profession if symptoms of the illness persist or if side effects other than those mentioned in the package leaflet occur.

Taking Bronchostop Sine Cough Syrup with other medicines

No interactions of Bronchostop Sine Cough Syrup with other medicines are known. Studies on possible interactions of Bronchostop Sine Cough Syrup with other medicines have not been conducted. The absorption of concomitantly administered medicines may be delayed. As a precaution, the product should not be taken 1/2 to 1 hour before or after taking other medicines. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Pregnancy, breastfeeding and fertility

Ask your doctor or pharmacist for advice before using any medicine. As there is insufficient data, use during pregnancy and breastfeeding is not recommended. There are no data on the effects on fertility.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Bronchostop Sine Cough Syrup contains xylitol

15 ml of this medicine contains 4.61 g of xylitol. The calorific value is 2.4 kcal/g xylitol. Xylitol may have a mild laxative effect.

Bronchostop Sine Cough Syrup contains raspberry juice concentrate, which contains sucrose, glucose and fructose

This medicine contains 66 mg of fructose per 15 ml of solution corresponding to 440 mg/100 ml. Talk to your doctor before you (or your child) take (or receive) this medicine if your doctor has told you (or your child) that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which fructose cannot be broken down.

Bronchostop Sine Cough Syrup contains propylene glycol

This medicine contains 33.3 mg of propylene glycol per 15 ml.

3. HOW TO TAKE BRONCHOSTOP SINE COUGH SYRUP?

Always take Bronchostop Sine Cough Syrup 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:

• Adults and adolescents aged 12 years and over: 15 ml every 3 to 4 hours, 4 times a day, if necessary up to 6 times a day; total daily dose up to 90 ml.
• Children aged 6 to 11 years: 7.5 ml every 3 to 4 hours, 4 times a day, if necessary up to 6 times a day; total daily dose up to 45 ml.
• Children aged 3-5 years: 7.5 ml every 3 to 4 hours, 4 times a day; total daily dose up to 30 ml.

Patients with impaired liver and/or kidney function

There are insufficient data for specific dosage recommendations in the case of impaired renal or hepatic function.

Take Bronchostop Sine Cough Syrup undiluted by pouring the dose indicated above into the enclosed measuring cup. The measuring cup has a scale between 2.5 ml and 20 ml. You can also drink Bronchostop Sine Cough Syrup diluted in water if necessary. Self-treatment with Bronchostop Sine Cough Syrup should be limited to 5 days. If there is no significant improvement by then, you should see a doctor as a more serious illness may be present. If you are short of breath, have a high temperature (fever), your mucus is yellow-green or brown (purulent sputum), you must see your doctor or other qualified person in the healthcare profession.

If you have taken more Bronchostop Sine Cough Syrup than you should

If you have significantly overdosed on this medicine, symptoms known as side effects may be more pronounced. In this case, please notify your doctor. He/she can decide on any necessary measures.

If you forget to take Bronchostop Sine Cough Syrup

Do not take a double dose to make up for a forgotten dose.

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, Bronchostop Sine Cough Syrup can have side effects, although not everybody gets them. Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice any side effects not listed in this leaflet. The frequency of occurrence of the following side effects is not known. This medicine can cause the following serious allergic reactions. If you notice any of the following effects, stop taking the medicine and seek urgent medical attention:

• Symptoms such as dizziness or fainting, difficulty breathing or wheezing, rapid heartbeat, rash, confusion and anxiety or unconsciousness (anaphylactic reaction).
• Swelling of the face, lips, tongue, mouth or throat (angioedema).
• Blistering in the mouth and throat.
• Worsening of asthma symptoms.
• Difficulty breathing (including shortness of breath).

Other possible side effects

If any of the following side effects are severe or if they concern you, or if you notice any other side effect, stop taking the medicine and see a doctor as soon as possible: Allergic skin reactions including urticaria (red bumps on the skin) and itching. Gastrointestinal complaints such as abdominal pain or discomfort, diarrhoea, vomiting and nausea.

Bronchostop Sine Cough Syrup contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate

Methyl 4-hydroxybenzoate (E 218) and propyl 4-hydroxybenzoate (E 216) can cause hypersensitivity reactions, also with a time delay.

Reporting of side effects

If you experience 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 TO STORE BRONCHOSTOP SINE COUGH SYRUP?

Do not store above 25°C. Store the bottle in the original packaging to protect the contents from light. Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Use by:". The expiry date refers to the last day of the month indicated. Close the bottle tightly after use, use the contents within 4 weeks after opening. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bronchostop Sine Cough Syrup contains

The active ingredients are: 15 ml (= 16.7 g) of solution contain: 0.129 g dry extract of thyme herb (7 -13 :1), extraction solvent: water, 0.830 g extract of marshmallow roots (1 : 12 -14), extraction solvent: water. The other ingredients are: Xylitol (E 967), methyl 4-hydroxybenzoate (Ph. Eur.) (E 218), propyl 4-hydroxybenzoate (E 216) (Ph. Eur.), raspberry juice concentrate (contains sucrose (sugar), glucose and fructose), raspberry flavour (contains propylene glycol (E1520)), xanthan gum, citric acid monohydrate, maltodextrin, gum arabic, purified water.

What Bronchostop Sine Cough Syrup looks like and contents of the pack

Bronchostop Sine Cough Syrup is a brownish-red, viscous solution for oral use with the smell and taste of thyme and raspberries. It is filled in brown glass bottles with original sealed screw caps of 120 ml and 200 ml. Not all pack sizes may be marketed. The enclosed measuring cup with a scale between 2.5 ml and 20 ml facilitates accurate dosing of the recommended amount.

Pharmaceutical entrepreneur

Kwizda Pharma GmbH
Effingergasse 21
1160 Vienna
Austria

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

Manufacturer

Kwizda Pharma GmbH
Effingergasse 21
1160 Vienna
Austria

This package leaflet was last revised in July 2022.

Source: Information from the package leaflet
Status: 06/2023
Areas of application: for the relief of mucous membrane irritation in the mouth and throat and associated dry, irritating cough as well as for promoting coughing up of productive cough in connection with a cold. Warning: Contains xylitol and propylene glycol. Contains raspberry juice concentrate, which contains sucrose, glucose and fructose.