Package leaflet: Information for the patient

Bronchipret Forte
(490 mg + 49 mg)/ml
oral solution
Thymi herbae extractum fluidum + Hederae helicis folii extractum fluidum
Please read all of this leaflet carefully before you start taking this medicine, because it
contains important information for you.
This medicine should always be taken exactly as described in this 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 further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See: section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Bronchipret Forte is and what it is used for
Important information before taking Bronchipret Forte
How to take Bronchipret Forte
Possible side effects
How to store Bronchipret Forte
Contents of the pack and other information

1. What Bronchipret Forte is and what it is used for

A herbal medicinal product used as an expectorant in productive (wet) cough.
Bronchipret Forte is indicated for use in adults and adolescents aged 12 years and older.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

2. Important information before using Bronchipret Forte

When not to use Bronchipret Forte:

if the patient is allergic (hypersensitive) to the active substances, to other species of plants from the mint family (Lamiaceae) and/or the aralia family (Araliaceae), or to any of the other ingredients of this medicine (listed in section 6).
Bronchipret Forte must not be used in children under 2 years of age.

Warnings and precautions
Before starting treatment with Bronchipret Forte, consult a doctor or pharmacist
if:

symptoms persist for more than 7 days
symptoms worsen during treatment
shortness of breath, fever, or purulent or bloody sputum occur
the patient has been diagnosed with gastric mucosal inflammation or peptic ulcer disease of the stomach or duodenum.

Children and adolescents
This medicine is not intended for children aged 2 to 12 years, as other pharmaceutical forms and/or strengths may be more suitable for this patient group.
Bronchipret Forte must not be used in children under 2 years of age.

Bronchipret Forte and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The effects of concomitant use with other medicines have not been studied. No interactions with other medicines are currently known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The safety of using this medicine during pregnancy and breastfeeding has not been established. Due to insufficient data, the use of Bronchipret Forte during pregnancy is not recommended.
It is unknown whether the active substances or metabolites of Bronchipret Forte pass into human milk. Risk to the newborn and/or breastfed infant cannot be excluded.
Bronchipret Forte should not be used during breastfeeding.

Driving and operating machinery
Studies on the influence on the ability to drive vehicles and operate machinery have not been conducted.

Bronchipret Forte contains up to 15% m/m, equivalent to up to 21% v/v ethanol (alcohol)
This medicine contains approximately 310 mg of alcohol (ethanol) in each 1.85 ml (single dose), which corresponds 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 will not cause noticeable effects.

Bronchipret Forte contains liquid maltitol (contains sorbitol (E420))
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. This medicine contains 34.20 mg of sorbitol in 1.85 ml (single dose), corresponding to 18.5 mg/ml.

3. How to use Bronchipret Forte

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, 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.
Using the provided measuring device, take Bronchipret Forte three times daily. Bronchipret Forte should be swallowed undiluted. After taking the medicine, drink a small amount of liquid (preferably water). Shake the bottle well before each use.
If symptoms persist for more than 7 days of treatment, consult your doctor or pharmacist.
Due to insufficient data, a recommended dose has not been established for patients with renal or hepatic impairment.
This medicine is not intended for use in children aged 2 to 12 years, as other pharmaceutical forms and/or strengths may be more suitable for this patient group.
Bronchipret Forte must not be used in children under 2 years of age.
Taking more Bronchipret Forte than recommended
In case of overdose, gastrointestinal disturbances such as nausea, vomiting, and diarrhoea may occur.
If you have taken more Bronchipret Forte than recommended, inform your doctor. The doctor will decide on any necessary measures.
Missing a dose of Bronchipret Forte
Do not take a double dose to make up for a missed dose. Continue taking Bronchipret Forte as prescribed by your doctor or as described in the package leaflet.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Frequency unknown (frequency cannot be determined from the available data):
Hypersensitivity and (or) allergic reactions, such as dyspnea, urticaria, facial swelling,
oral cavity and (or) throat swelling, anaphylactic reaction.
If symptoms of hypersensitivity and (or) allergic reactions occur, administration of the medicine must be discontinued immediately and urgent medical advice must be sought.
Uncommon adverse reactions (may occur in up to 1 in 100 people):
Gastrointestinal disorders such as: cramps, nausea, vomiting, diarrhea.
Rare adverse reactions (may occur in up to 1 in 1,000 people):
Hypersensitivity and (or) allergic reactions with rash.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bronchipret Forte

Keep this medicine out of 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 the stated month.
The factory-sealed medicinal product does not require special storage conditions.
Shelf life after first opening: 6 months.
After first opening: Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice helps protect the environment.

6. Contents of the package and other information

What Bronchipret Forte contains
The active substances in 1 ml (corresponding to 1.09 g) of solution are:
490 mg of liquid extract from Thymus vulgaris L. and/or Thymus zygis L., herba or their mixture
(common thyme herb) (1:2-2.5);
extraction solvent: 10% m/m ammonia solution / 85% m/m glycerol / 90% v/v ethanol / purified water
(1/20/70/109).
49 mg of liquid extract from Hedera helix L., folium (ivy leaf) (1:1);
extraction solvent: 70% v/v ethanol.
Other components: ethanol 96%; hydroxypropylbetadex; levomenthol; liquid maltitol (contains
sorbitol (E420)); purified water.
The medicine contains up to 15% m/m, corresponding to up to 21% v/v ethanol.

What Bronchipret Forte looks like and contents of the pack
Bronchipret Forte is a brown, clear liquid. During storage, slight opalescence and/or sediment may occur, which readily re-suspends.
Bronchipret Forte is available in brown glass bottles equipped with a dosing dispenser for easy pouring (LDPE), a closure cap (PP) with tamper-evident seal (HDPE), and a measuring spoon (PP) with appropriate graduations for a single dose of 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 Authorisation Holder and Manufacturer
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany
Tel.: +49 (0)9181 231-90
Fax: +49 (0)9181 231-265
E-mail: [email protected]

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Bionorica Polska Sp. z o.o.
ul. Hrubieszowska 6B
01-209 Warsaw
Poland
Tel/Fax: +48 22 886 46 06
e-mail: [email protected]

This medicine is authorised for marketing in the EEA Member States 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
GREECE: Bronchipret forte
SPAIN: Bronchiclear solucion oral
GERMANY: Bronchipret Tropfen TE
LUXEMBOURG: Bronchipret Tropfen TE
LATVIA: Bronchipret šķīdums iekšķīgai lietošanai
LITHUANIA: Bronchipret TI intens geriamasis tirpalas
POLAND: Bronchipret Forte
CZECH REPUBLIC: Bronchipret tymián a břečťan
ROMANIA: Bronchipret forte solutie orala
SLOVAKIA: Bronchipret s tymianom a brečtanom perorálny roztok
SWEDEN: Mucofyl forte
HUNGARY: Bronchipret belsőleges oldat
ITALY: Bronchiclear