Bronhipret Forte

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: Information for the patient

Bronchipret Forte
(490 mg + 49 mg)/ml
oral solution
Thymi herbae extractum fluidum + Hederae helicis folii extractum fluidum

It is necessary to carefully read the contents of the leaflet before starting the use of the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See: section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Bronchipret Forte and what is it used for
• 2. Important information before using Bronchipret Forte
• 3. How to use Bronchipret Forte
• 4. Possible side effects
• 5. How to store Bronchipret Forte
• 6. Contents of the pack and other information

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

Bronchipret Forte is a herbal medicine used as an expectorant in the case of productive (wet) cough.
Bronchipret Forte is indicated for use in adults and adolescents from 12 years of age.
If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

2. Important information before using Bronchipret Forte

When not to use Bronchipret Forte:

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

Warnings and precautions

Before starting the use of Bronchipret Forte, the patient should discuss it with their doctor or pharmacist, and if:

• symptoms persist for more than 7 days
• symptoms worsen during the use of the medicine
• shortness of breath, fever, or purulent or bloody sputum occurs
• the patient has been diagnosed with gastric mucosa inflammation or stomach and duodenal ulcer disease.

Children and adolescents

The medicine is not intended for children from 2 to 12 years of age, as other pharmaceutical forms and/or strengths may be more suitable for this group of patients.
This medicine should not be used in children under 2 years of age.

Bronchipret Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The effects of concomitant use with other medicines have not been studied. So far, no interactions with other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The safety of using the medicine during pregnancy and breastfeeding has not been established. Due to the lack of sufficient data, the use of Bronchipret Forte during pregnancy is not recommended.
It is not known whether the active substances or metabolites of Bronchipret Forte pass into breast milk. The risk to the newborn and/or breastfed infant cannot be excluded.
Bronchipret Forte should not be used during breastfeeding.

Driving and using machines

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

Bronchipret Forte contains a maximum of 15% m/m, which corresponds to a maximum of 21% v/v ethanol (alcohol)

This medicine contains approximately 310 mg of alcohol (ethanol) in each 1.85 ml (single dose), which is equivalent to 168 mg/ml (15% m/m). The amount contained in 1.85 ml of this medicine corresponds to less than 8 ml of beer or 4 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

Bronchipret Forte contains liquid maltitol (contains sorbitol (E420))

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. This medicine contains 34.20 mg of sorbitol in 1.85 ml (single dose), which corresponds to 18.5 mg/ml.

3. How to use Bronchipret Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose:

Adults and adolescents from 12 years of age: 1.85 ml three times a day.
Maximum daily dose is 5.55 ml.
Using the attached measuring cup, Bronchipret Forte should be taken 3 times a day. Bronchipret Forte should be swallowed undiluted. After taking the medicine, the patient should drink a small amount of liquid (preferably water). Before each use, the bottle should be shaken well.
If symptoms persist for more than 7 days of using the medicine, the patient should consult their doctor or pharmacist.
Due to the lack of sufficient data, the recommended dose for patients with renal or hepatic impairment has not been determined.
The medicine is not intended for use in children from 2 to 12 years of age, as other pharmaceutical forms and/or strengths may be more suitable for this group of patients.
This medicine should not be used in children under 2 years of age.

Taking a higher dose of Bronchipret Forte than recommended

In case of overdose, gastrointestinal disorders, such as nausea, vomiting, and diarrhea, may occur.
In case of taking a higher dose of Bronchipret Forte than recommended, the patient should inform their doctor. The doctor may decide on any necessary measures.

Missing a dose of Bronchipret Forte

A double dose should not be taken to make up for a missed dose, but the patient should continue taking Bronchipret Forte as prescribed by their doctor or according to the leaflet.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bronchipret Forte can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data):
Hypersensitivity and/or allergic reactions, such as shortness of breath, hives, swelling of the face, mouth, and/or throat, anaphylactic reaction.
In case of the first symptoms of hypersensitivity and/or allergic reactions, the patient should immediately stop using the medicine and urgently consult their doctor.
Uncommon side effects (may affect up to 1 in 100 people):
Gastrointestinal disorders, such as cramps, nausea, vomiting, diarrhea.
Rare side effects (may affect up to 1 in 1,000 people):
Hypersensitivity and/or allergic reactions with rash.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to:
Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bronchipret Forte

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the carton and bottle after "EXP".
The expiry date refers to the last day of that month.
The factory-sealed product does not require special storage conditions.
Shelf life after first opening: 6 months.
After first opening: Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bronchipret Forte contains

The active substances in 1 ml (corresponding to 1.09 g) of the solution are:
490 mg of liquid extract from Thymus vulgarisL. and/or Thymus zygisL., herba or their mixture (thyme) (1:2-2.5);
extract solvent: 10% m/m ammonia solution / glycerol 85% m/m / ethanol 90% v/v / purified water (1/20/70/109).
49 mg of liquid extract from Hedera helixL., folium (ivy leaf) (1:1);
extract solvent: ethanol 70% v/v.
Other ingredients: ethanol 96%; hydroxypropylbetadex; levomenthol; liquid maltitol (contains sorbitol (E420)); purified water.
The medicine contains a maximum of 15% m/m, which corresponds to a maximum of 21% v/v ethanol.

What Bronchipret Forte looks like and what the pack contains

Bronchipret Forte is a brown, transparent liquid. During storage, a slight turbidity and/or sediment may occur, which can be redissolved.
Bronchipret Forte is available in brown glass bottles with a dosing device (LDPE), a cap (PP) with a tamper-evident closure (HDPE), and a measuring cup (PP) with a scale for a single dose: 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
Phone: +49 (0)9181 231-90
Fax: +49 (0)9181 231-265
Email: [email protected]

For more detailed information on this medicine, please contact the representative of the marketing authorization holder:

Bionorica Polska Sp z o.o.
ul. Hrubieszowska 6B
01-209 Warsaw
Poland
Phone / Fax: +48 22 886 46 06
email: [email protected]

This medicine is authorized in the EEA member states under the following names:

AUSTRIA:
Bronchipret Duo Hustenlöser Lösung zum Einnehmen
BULGARIA:
Bronchipret oral solution
CROATIA:
Bronchipret forte oral solution
ESTONIA:
Bronchipret Comp
FRANCE:
Brolion
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

Date of last revision of the leaflet: