Bionorica Bronchipret TE Syrup 100 ml
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Description
Bionorica Bronchipret TE Syrup 100 ml.
Key features of the product
Inhibits inflammation (1), Facilitates expectoration (2), Reduces coughing fits (2,3), 1) Jan Seibel, Carlo Pergola, Oliver Werz, Kirill Kryshen, Katja Wosikowski, Martin D. Lehner, Jutta Haunschild, Bronchipret® syrup containing thyme and ivy extracts suppresses bronchoalveolar inflammation and goblet cell hyperplasia in experimental bronchoalveolitis, Phytomedicine 22 (2015) 1172-1177. 2) Kemmerich B, Eberhardt R, Stammer H.: Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung, 2006; 56: 652-660. 3) Marzian O.: Treatment of acute bronchitis in children and adolescents. Noninterventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves. MMW Fortschr Med, 2006; 149: 69-74.
Description
A tingling cough? Bronchitis?
Bronchipret® is a herbal medicine in the form of syrup for children over 2 years of age, for use in infections accompanied by cough (4). It is a drug that inhibits the inflammatory process, dilutes secretions, facilitates expectoration , and as a result reduces coughing attacks (1,2.3).
Bronchipret® is a broad-spectrum drug with a high safety profile (2,3).
It shows efficacy at the level of synthetic drugs (5), can be used after 5 pm (4); reduces sleep disturbances caused by cough attacks (6).
In addition, it contains no sugar and is safe for teeth (4).
1)Jan Seibel, Carlo Pergola, Oliver Werz, Kirill Kryshen, Katja Wosikowski, Martin D. Lehner, Jutta Haunschild, Bronchipret® syrup containing thyme and ivy extracts suppresses bronchoalveolar inflammation and goblet cell hyperplasia in experimental bronchoalveolitis, Phytomedicine 22 (2015) 1172-1177.
2)Kemmerich B, Eberhardt R, Stammer H.: Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung, 2006; 56: 652-660.
3)Marzian O.: Treatment of acute bronchitis in children and adolescents. Noninterventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves. MMW Fortschr Med, 2006; 149: 69-74.
4)CHPL of the medicinal product Bronchipret®TE.
5)Ismail Ch et al. 2003, Schweizerische Zeitschrift fur Ganzheits Medizin. Bronchipret in cases of acute bronchitis 2003; 15(4):171-175
6)L.S. Namazova-Baranova et al, "Comparative analysis of effectiveness and safety of phyto- and antibiotic therapy of acute bronchitis in children: results of a multicenter double blind randomized clinical trial",Pediatric pharmacology. 2014; 11 (5): 22-29)
Bronchipret® is a herbal medicine in the form of syrup for children over 2 years of age, for use in infections accompanied by cough (4). It is a drug that inhibits the inflammatory process, dilutes secretions, facilitates expectoration , and as a result reduces coughing attacks (1,2.3).
Bronchipret® is a broad-spectrum drug with a high safety profile (2,3).
It shows efficacy at the level of synthetic drugs (5), can be used after 5 pm (4); reduces sleep disturbances caused by cough attacks (6).
In addition, it contains no sugar and is safe for teeth (4).
1)Jan Seibel, Carlo Pergola, Oliver Werz, Kirill Kryshen, Katja Wosikowski, Martin D. Lehner, Jutta Haunschild, Bronchipret® syrup containing thyme and ivy extracts suppresses bronchoalveolar inflammation and goblet cell hyperplasia in experimental bronchoalveolitis, Phytomedicine 22 (2015) 1172-1177.
2)Kemmerich B, Eberhardt R, Stammer H.: Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung, 2006; 56: 652-660.
3)Marzian O.: Treatment of acute bronchitis in children and adolescents. Noninterventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves. MMW Fortschr Med, 2006; 149: 69-74.
4)CHPL of the medicinal product Bronchipret®TE.
5)Ismail Ch et al. 2003, Schweizerische Zeitschrift fur Ganzheits Medizin. Bronchipret in cases of acute bronchitis 2003; 15(4):171-175
6)L.S. Namazova-Baranova et al, "Comparative analysis of effectiveness and safety of phyto- and antibiotic therapy of acute bronchitis in children: results of a multicenter double blind randomized clinical trial",Pediatric pharmacology. 2014; 11 (5): 22-29)
Storage and use
Dosage and method of administration
Orally, usually 3 times daily, according to the dosage recommended in the drug leaflet.
Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 132 mm. Width: 49 mm. Depth: 48 mm.
Packaging: Box
Orally, usually 3 times daily, according to the dosage recommended in the drug leaflet.
Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 132 mm. Width: 49 mm. Depth: 48 mm.
Packaging: Box
Composition
100 g of syrup contains: Liquid extract of thyme herb 15.0 g (DER: 1:2-2.5; extractant: ammonia solution 10 % [m/m]: glycerol 85 % [m/m]: ethanol 90 % [V/V]: purified water (1:20:70:109)) Liquid extract of ivy leaves 1.5 g (DER: 1:1; extractant: ethanol 70 % [V/V]), Medicinal product contains 7 % (V/V) alcohol and liquid maltitol
Manufacturer
BIONORICA SE
Manufacturer address
Entity Responsible
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Safety warning
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Keep out of reach and sight of children.
General information
Read the leaflet carefully before taking this medication, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet, or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 7 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet
Always take this medication exactly as described in the patient leaflet, or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 7 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet:
1 What is Bronchipret TE drug and for what purpose it is used.
2. important information before using Bronchipret TE
3. how to use Bronchipret TE drug
4 Possible side effects
5. how to store Bronchipret TE
6. package contents and other information
Description and application
1 What is Bronchipret TE drug and for what purpose it is used.
2. important information before using Bronchipret TE
3. how to use Bronchipret TE drug
4 Possible side effects
5. how to store Bronchipret TE
6. package contents and other information
1. WHAT IS THE DRUG BRONCHIPRET TE SYRUP AND FOR WHAT PURPOSE IS IT USED?
Herbal medicinal product used in symptoms of cough with persistent secretions, in mild to moderate infections and inflammation of the respiratory tract, such as acute bronchitis.
How to use the drug
Herbal medicinal product used in symptoms of cough with persistent secretions, in mild to moderate infections and inflammation of the respiratory tract, such as acute bronchitis.
3. HOW TO USE THE DRUG BRONCHIPRET TE, SYRUP?
Bronchipret TE should be taken exactly as described in the leaflet for patients, or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Unless otherwise prescribed by your doctor, Bronchipret TE, syrup should be taken 3 times daily:
Dosage:
Children aged 2 to 5 years 3.2 ml 3 times a day, total daily dose 9.6 ml.
Children aged 6 to 11 years 4.3 ml 3 times a day, total daily dose 12.9 ml.
Adults and adolescents over 12 years of age 5.4 ml 3 times a day, total daily dose 16.2 ml.
Method of administration:
Orally. Use the provided measuring cup and take Bronchipret TE, syrup 3 times a day, according to the patient's age, as instructed in the table above.
The syrup should be swallowed without dilution. You can sip the drug with a small amount of liquid (preferably water).
Mix before use!
Duration of treatment:
In case of complaints persisting for more than 10 days or the appearance of difficulty in breathing, fever or purulent or bloody discharge, contact your doctor immediately (see information given under: "Warnings and Precautions" and "Possible side effects").
Use of a higher than recommended dose of Bronchipret TE, syrup.
In case of overdose, stomach upset, vomiting and diarrhea may occur.
In this case, contact your doctor, who will decide on further treatment.
Omission of use of Bronchipret TE, syrup:
If you miss another dose of the drug at the appointed time, do not take a
double dose to make up for the missed dose, but rather continue taking the
the drug according to your doctor's instructions or as described in the leaflet.
Discontinuation of Bronchipret TE, syrup:
Discontinuation of Bronchipret TE, syrup is usually harmless.
If you have any doubts or questions, consult your doctor or pharmacist.
How to store the drug
Bronchipret TE should be taken exactly as described in the leaflet for patients, or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Unless otherwise prescribed by your doctor, Bronchipret TE, syrup should be taken 3 times daily:
Dosage:
Children aged 2 to 5 years 3.2 ml 3 times a day, total daily dose 9.6 ml.
Children aged 6 to 11 years 4.3 ml 3 times a day, total daily dose 12.9 ml.
Adults and adolescents over 12 years of age 5.4 ml 3 times a day, total daily dose 16.2 ml.
Method of administration:
Orally. Use the provided measuring cup and take Bronchipret TE, syrup 3 times a day, according to the patient's age, as instructed in the table above.
The syrup should be swallowed without dilution. You can sip the drug with a small amount of liquid (preferably water).
Mix before use!
Duration of treatment:
In case of complaints persisting for more than 10 days or the appearance of difficulty in breathing, fever or purulent or bloody discharge, contact your doctor immediately (see information given under: "Warnings and Precautions" and "Possible side effects").
Use of a higher than recommended dose of Bronchipret TE, syrup.
In case of overdose, stomach upset, vomiting and diarrhea may occur.
In this case, contact your doctor, who will decide on further treatment.
Omission of use of Bronchipret TE, syrup:
If you miss another dose of the drug at the appointed time, do not take a
double dose to make up for the missed dose, but rather continue taking the
the drug according to your doctor's instructions or as described in the leaflet.
Discontinuation of Bronchipret TE, syrup:
Discontinuation of Bronchipret TE, syrup is usually harmless.
If you have any doubts or questions, consult your doctor or pharmacist.
5. HOW TO STORE THE DRUG BRONCHIPRET TE, SYRUP?
No special recommendations for storing the drug.
Store out of reach and sight of children.
Do not use Bronchipret TE, syrup after the expiration date (EXP) on the package.
The expiration date means the last day of the given month.
After opening the bottle, the shelf life is 6 months.
Additional information:
Store in the original package.
Possible side effects
No special recommendations for storing the drug.
Store out of reach and sight of children.
Do not use Bronchipret TE, syrup after the expiration date (EXP) on the package.
The expiration date means the last day of the given month.
After opening the bottle, the shelf life is 6 months.
Additional information:
Store in the original package.
4. POSSIBLE SIDE EFFECTS:
Like any drug, Bronchipret TE, syrup may cause adverse reactions, although they will not occur in everyone.
The incidence of adverse reactions is divided into the following categories:
Very common: in more than 1 in 10 patients;
Frequent: in more than 1 in 100, patients, but less than 1 in 10 patients;
Uncommon: in more than 1 in 1,000 patients, but less than 1 in 100 patients;
Rare: in more than 1 in 10,000 patients, but less than 1 in 1,000 patients;
Very rare: in less than 1 in 10,000 patients,
Frequency unknown cannot be determined from available data.
Gastrointestinal disorders: gastrointestinal disorders such as cramps, nausea, vomiting, diarrhea (not very common).
Immune system disorders: skin hypersensitivity reactions with rash (rare).
Hypersensitivity reactions such as exertional dyspnea, urticaria
and swelling of the face, mouth and/or throat area (frequency unknown).
If a hypersensitivity reaction occurs, Bronchipret TE, syrup should be discontinued immediately.
Reporting of side effects:
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
Package contents and other information
Like any drug, Bronchipret TE, syrup may cause adverse reactions, although they will not occur in everyone.
The incidence of adverse reactions is divided into the following categories:
Very common: in more than 1 in 10 patients;
Frequent: in more than 1 in 100, patients, but less than 1 in 10 patients;
Uncommon: in more than 1 in 1,000 patients, but less than 1 in 100 patients;
Rare: in more than 1 in 10,000 patients, but less than 1 in 1,000 patients;
Very rare: in less than 1 in 10,000 patients,
Frequency unknown cannot be determined from available data.
Gastrointestinal disorders: gastrointestinal disorders such as cramps, nausea, vomiting, diarrhea (not very common).
Immune system disorders: skin hypersensitivity reactions with rash (rare).
Hypersensitivity reactions such as exertional dyspnea, urticaria
and swelling of the face, mouth and/or throat area (frequency unknown).
If a hypersensitivity reaction occurs, Bronchipret TE, syrup should be discontinued immediately.
Reporting of side effects:
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
6. PACKAGE CONTENTS AND OTHER INFORMATION:
What does the drug Bronchipret TE, syrup contain?
The active substances of the drug are: liquid extract of thyme herb, liquid extract of common ivy leaves.
Other ingredients of the drug are: citric acid monohydrate, purified water, hydroxypropyl betadex, potassium sorbate, liquid maltitol (15.6 g maltitol/100 g Bronchipret TE syrup).
What does the drug Bronchipret TE, syrup look like and what does the package contain?
Clear brown syrup, available in colored glass bottles with a polyethylene discharge stopper, a polypropylene cap and an attached polypropylene measuring cup,
In a cardboard box.
The printed unit carton contains 1 bottle along with an information leaflet.
Package sizes:
1 bottle of 100 ml.
Responsible party and manufacturer:
BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Germany
Phone: +49918123190
Fax: +499181231265
E-mail: info@bionorica.de
Phone: +49918123190
Fax: +499181231265
E-mail: info@bionorica.de
For more detailed information, please contact the representative of the responsible party:
Bionorica Polska Sp. z o.o.
6B Hrubieszowska St.
01-209 Warsaw
Poland
Tel /Fax +(48) 22 886 46 06
e-mail: bionorica@bionorica.pl
Important before use
What does the drug Bronchipret TE, syrup contain?
The active substances of the drug are: liquid extract of thyme herb, liquid extract of common ivy leaves.
Other ingredients of the drug are: citric acid monohydrate, purified water, hydroxypropyl betadex, potassium sorbate, liquid maltitol (15.6 g maltitol/100 g Bronchipret TE syrup).
What does the drug Bronchipret TE, syrup look like and what does the package contain?
Clear brown syrup, available in colored glass bottles with a polyethylene discharge stopper, a polypropylene cap and an attached polypropylene measuring cup,
In a cardboard box.
The printed unit carton contains 1 bottle along with an information leaflet.
Package sizes:
1 bottle of 100 ml.
Responsible party and manufacturer:
BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Germany
Phone: +49918123190
Fax: +499181231265
E-mail: info@bionorica.de
Phone: +49918123190
Fax: +499181231265
E-mail: info@bionorica.de
For more detailed information, please contact the representative of the responsible party:
Bionorica Polska Sp. z o.o.
6B Hrubieszowska St.
01-209 Warsaw
Poland
Tel /Fax +(48) 22 886 46 06
e-mail: bionorica@bionorica.pl
2. INFORMATION IMPORTANT BEFORE USING BRONCHIPRET TE, SYRUP:
When not to use Bronchipret TE, syrup:
In case of hypersensitivity to the active substances and to other plants of the light family (Lamiaceae) and araliaceae (Araliacae), birch, common mugwort, celery, or to any of the excipients listed in section 6.
Warnings and precautions:
If symptoms do not resolve after about 10 days, or if you experience difficulty breathing, fever, purulent or bloody discharge, contact your doctor.
Do not use Bronchipret TE without consulting your doctor if you suffer from inflammation or ulceration of the gastric mucosa.
Children:
The drug should not be administered to children under 2 years of age. In case of persistent
or recurrent cough in children between 2 and 4 years of age, consult a doctor, as such symptoms may be a sign of severe disease.
Bronchipret TE drug and other drugs:
To date, there are no known interactions with any other drugs.
There are no studies on the interaction of the drug Bronchipret TE, syrup
with other drugs when administered simultaneously.
Inform your doctor about all recently taken medications, including those,
which are issued without a prescription.
Pregnancy, breastfeeding and effects on fertility:
Due to the lack of data on the use of the medicinal product during pregnancy and lactation, the medicinal product should not be used in pregnant or lactating women.
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before using this drug.
Driving and operating machinery:
Special precautions are not required.
The drug Bronchipret TE, syrup contains 7% alcohol by volume,
this means that 5.4 ml contains up to 0.30 g of alcohol, which is equivalent to 8 ml of beer or 3 ml of wine.
It may be harmful to alcohol addicts.
The presence of alcohol should also be taken into account and consulted with a doctor when wishing to use the product in children in doses higher than recommended and in high-risk groups, such as those with liver disease or epilepsy.
The drug Bronchipret TE, syrup contains maltitol.
If the patient has been diagnosed with intolerance to certain sugars, before taking the drug
Bronchipret TE, syrup you should consult your doctor.
Information for diabetics:
One dose of Bronchipret TE, syrup (5.4 ml) contains about 1.9 g of easily digestible carbohydrates.
Product identification
When not to use Bronchipret TE, syrup:
In case of hypersensitivity to the active substances and to other plants of the light family (Lamiaceae) and araliaceae (Araliacae), birch, common mugwort, celery, or to any of the excipients listed in section 6.
Warnings and precautions:
If symptoms do not resolve after about 10 days, or if you experience difficulty breathing, fever, purulent or bloody discharge, contact your doctor.
Do not use Bronchipret TE without consulting your doctor if you suffer from inflammation or ulceration of the gastric mucosa.
Children:
The drug should not be administered to children under 2 years of age. In case of persistent
or recurrent cough in children between 2 and 4 years of age, consult a doctor, as such symptoms may be a sign of severe disease.
Bronchipret TE drug and other drugs:
To date, there are no known interactions with any other drugs.
There are no studies on the interaction of the drug Bronchipret TE, syrup
with other drugs when administered simultaneously.
Inform your doctor about all recently taken medications, including those,
which are issued without a prescription.
Pregnancy, breastfeeding and effects on fertility:
Due to the lack of data on the use of the medicinal product during pregnancy and lactation, the medicinal product should not be used in pregnant or lactating women.
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before using this drug.
Driving and operating machinery:
Special precautions are not required.
The drug Bronchipret TE, syrup contains 7% alcohol by volume,
this means that 5.4 ml contains up to 0.30 g of alcohol, which is equivalent to 8 ml of beer or 3 ml of wine.
It may be harmful to alcohol addicts.
The presence of alcohol should also be taken into account and consulted with a doctor when wishing to use the product in children in doses higher than recommended and in high-risk groups, such as those with liver disease or epilepsy.
The drug Bronchipret TE, syrup contains maltitol.
If the patient has been diagnosed with intolerance to certain sugars, before taking the drug
Bronchipret TE, syrup you should consult your doctor.
Information for diabetics:
One dose of Bronchipret TE, syrup (5.4 ml) contains about 1.9 g of easily digestible carbohydrates.
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