Bronchiclear cough mucolytic
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: information for the patient
Bronchiclear cough expectorant oral solution
Liquid extract of thyme
Liquid extract of ivy leaves
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.
Contents of this leaflet
- What Bronchiclear cough expectorant is and what it is used for
- What you need to know before taking Bronchiclear cough expectorant
- How to take Bronchiclear cough expectorant
- Possible side effects
- How to store Bronchiclear cough expectorant
- Package contents and other information
1. What Bronchiclear mucolytic cough is and what it is used for
A herbal medicinal product used as an expectorant in productive cough.
Bronchiclear Bronchiclear mucolytic cough is indicated for adults and adolescents aged 12 years and older.
Consult a doctor if you do not feel better or if you feel worse after 7 days.
2. What you need to know before taking Bronchiclear expectorant mucolytic
Do not take Bronchiclear expectorant mucolytic:
- If you are allergic (hypersensitive) to thyme or ivy leaves, to other plants of the Lamiaceae (Labiatae) or Araliaceae families, or to any of the other ingredients of this medicine (listed in section 6).
- Bronchiclear expectorant mucolytic must not be used in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bronchiclear expectorant mucolytic if:
- Symptoms persist for more than 7 days
- Symptoms worsen during treatment with this medicine
- You suffer from shortness of breath, fever, or produce purulent or blood-streaked sputum
- You suffer from gastritis or gastric ulcer.
Children
Bronchiclear expectorant mucolytic is not intended for children aged between 2 and 12 years.
This medicine must not be used in children under 2 years of age.
Other medicines and Bronchiclear expectorant mucolytic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of using this medicine together with other medicines have not been studied. No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of using this medicine during pregnancy and breastfeeding has not been established. Due to lack of sufficient data, the use of Bronchiclear expectorant mucolytic during pregnancy is not recommended.
It is unknown whether the active substances or metabolites of Bronchiclear expectorant mucolytic are excreted in breast milk. A risk to breastfed infants/children cannot be excluded. For this reason, Bronchiclear expectorant mucolytic must not be used during breastfeeding.
Driving and using machines
No studies on the ability to drive vehicles and use machines have been conducted.
Bronchiclear expectorant mucolytic contains up to 15% m/m, equivalent to up to 21% v/v of ethanol (alcohol).
This medicine contains approximately 310 mg of alcohol (ethanol) per 1.85 mL dose, equivalent to 168 mg/mL (15% m/m). The amount contained in 1.85 mL of this medicine is equivalent to less than 8 mL of beer or 4 mL of wine.
The small amount of alcohol contained in this medicine has no significant effects.
Bronchiclear expectorant mucolytic contains liquid maltitol (containing sorbitol).
If your doctor has informed you of an intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains 34.20 mg of sorbitol per 1.85 mL dose, equivalent to 18.5 mg/mL.
3. How to take Bronchiclear cough mucolytic
Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents aged 12 years and older: 1.85 mL three times daily.
The maximum daily dose is 5.55 mL.
Use the provided dosing cup to take Bronchiclear cough mucolytic three times a day.
Swallow Bronchiclear cough mucolytic without diluting it. Drink additional fluids (preferably water) after taking the medicine. Shake well before each use.
Consult your doctor or pharmacist if symptoms persist for more than 7 days or worsen during treatment with this medicine.
There are insufficient data available to provide specific dosage recommendations for patients with impaired renal or hepatic function.
Use in children
This medicine is not intended for children aged between 2 and 12 years.
The medicine must not be used in children under 2 years of age.
If you take more Bronchiclear cough mucolytic than you should
In case of overdose, gastrointestinal disturbances such as nausea, vomiting, and diarrhoea may occur.
Inform your doctor if you take more Bronchiclear cough mucolytic than you should. The doctor may decide on any necessary countermeasures.
If you forget to take Bronchiclear cough mucolytic
Do not take a double dose to make up for the missed dose. Continue taking Bronchiclear cough mucolytic as prescribed by your doctor or as directed in this leaflet.
Contact your doctor or pharmacist if you have any further questions about the use of this medicine.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Frequency not known (frequency cannot be estimated from the available data):
hypersensitivity/allergic reactions, such as shortness of breath, urticaria, swelling of the face, mouth
and/or throat, anaphylactic reaction.
At the first signs of hypersensitivity/allergic reaction, stop taking this medicine and
contact your doctor immediately.
Uncommon adverse reactions (may affect up to 1 in 100 people):
gastrointestinal disturbances, such as cramps, nausea, vomiting and diarrhoea.
Rare adverse reactions (may affect up to 1 in 1,000 people):
hypersensitivity/allergic reactions with skin rashes.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor,
pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to store Bronchiclear mucolytic cough syrup
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
The medicine, kept in its original packaging, does not require special storage conditions.
Validity period after first opening: 6 months.
After first opening: store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Bronchiclear mucolytic cough contains
-
The active substances in 1 mL (equivalent to 1.09 g) of Bronchiclear mucolytic cough are:
490 mg of liquid extract of Thymus Vulgaris L. or Thymus Zygis L., herba or a mixture of both species (thyme herb) (1:2-2.5); extraction agent: 10% m/m ammonia solution / 85% m/m glycerol / 90% v/v ethanol / water (1/20/70/109).
49 mg of liquid extract of Hedera Helix L., folium (ivy leaves) (1:1); extraction solvent: 70% v/v ethanol. -
The other components are: ethanol 96%; hydroxypropylbetadex; levomenthol; liquid maltitol (containing sorbitol (E420)); purified water.
The medicine contains up to 15% m/m ethanol, equivalent to up to 21% v/v.
Description of the appearance of Bronchiclear mucolytic cough and package contents
Bronchiclear mucolytic cough is a brownish, transparent liquid. During storage, slight cloudiness and/or a resuspendable precipitate may occur.
Bronchiclear mucolytic cough is available in brown glass bottles equipped with a pouring spout (LDPE), screw cap (PP) with tamper-evident closure (HDPE), and a dosing cup (PP) graduated at 1.85 mL.
The following pack sizes are available:
50 mL oral solution
100 mL oral solution
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany
Tel: 09181 / 231-90
Fax: 09181 / 231-265
E-Mail: [email protected]
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Bronchipret Duo Hustenlöser Lösung zum Einnehmen
Bulgaria Bronchipret oral solution
Croatia Bronchipret forte oralna otopina
Estonia Bronchipret Comp
France Brolion
Germany, Luxembourg Bronchipret Tropfen TE
Greece Bronchipret forte
Italy Bronchiclear tosse mucolitico
Latvia Bronchipret šķīdums iekšķīgai lietošanai
Lithuania Bronchipret TI intens geriamasis tirpalas
Poland Bronchipret Forte
Czech Republic Bronchipret tymián a břečťan
Romania Bronchipret forte soluție orală
Slovakia Bronchipret s tymianom a brečtanom perorálny roztok
Spain Bronchiclear solucion oral
Sweden Mucofyl forte
Hungary Bronchipret belsőleges oldat