Bronchipret
Italy
Table of Contents
Package leaflet: Information for the patient
Bronchipret
Film-coated tablets
Active substances:
Dry extract of primula root
Dry extract of thyme
Read this entire 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.
- 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 any improvement or if your symptoms worsen after 7 days.
Contents of this leaflet
- What Bronchipret is and what it is used for
- What you need to know before taking Bronchipret
- How to take Bronchipret
- Possible side effects
- How to store Bronchipret
- Contents of the pack and other information
1. What Bronchipret is and what it is used for
Bronchipret is a herbal medicinal product used for productive cough to help loosen and expel thick mucus.
2. What you need to know before taking Bronchipret
Do not take Bronchipret:
- if you are allergic (hypersensitive) to the active substances, to other plants of the Lamiaceae family, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist:
- if you suffer from shortness of breath, fever, or purulent sputum
- if you suffer from gastritis or gastric ulcer
- if your symptoms worsen during treatment with this medicine.
Children and adolescents
Due to the lack of adequate data on efficacy, use is not recommended in children and adolescents under 18 years of age.
Other medicines and Bronchipret
No clinical interaction studies have been conducted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
The safety of the product during pregnancy has not been established. Due to insufficient data, the use of this medicine during pregnancy is not recommended.
It is not known whether the active substances or metabolites of Bronchipret are excreted in breast milk.
Therefore, the use of Bronchipret is not recommended during breastfeeding.
Driving and using machines
No studies have been conducted regarding the effects on the ability to drive vehicles or operate machinery.
Bronchipret contains glucose and lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, please consult him before taking this medicine.
Bronchipret contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.
3. How to take Bronchipret
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.
The recommended dose is:
Adults: 1 film-coated tablet 3 times daily (maximum 3 film-coated tablets per day).
Bronchipret should be taken before meals, without chewing, and with sufficient liquid (preferably a glass of water).
If symptoms persist for more than 1 week during treatment, consult a doctor or qualified healthcare professional.
There are insufficient data to establish a recommended specific dose in patients with impaired renal or hepatic function.
Use in children and adolescents
The use of this medicinal product is not recommended in children and adolescents under 18 years of age (see section 2).
If you take more Bronchipret than you should
Cases of overdose have not been reported. Overdose may cause stomach disturbances, vomiting or diarrhoea. If you take more Bronchipret than you should, consult your doctor, who will decide on the appropriate course of action.
If you forget to take Bronchipret
Do not take a double dose to make up for the missed tablet; continue taking Bronchipret as prescribed by your doctor or as indicated in this patient information leaflet.
If you stop taking Bronchipret
Stopping treatment with Bronchipret does not normally cause any problems.
For further information on the use of this product, please consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects (may affect up to 1 in 100 people):
Gastrointestinal disorders such as cramps, nausea, vomiting, and diarrhoea.
Very rare side effects (may affect up to 1 in 10,000 people):
Hypersensitivity reactions such as shortness of breath, skin rash, urticaria, swelling of the face, mouth and/or throat.
If the first signs of hypersensitivity occur, stop taking Bronchipret.
Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This applies also to any side effects not listed in this leaflet. You can also report side effects directly via the reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Bronchipret
Store below 25°C.
Keep the blisters in the outer packaging to protect the medicine from light and
moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
6. Package contents and other information
What Bronchipret contains
- The active substances are 60 mg of extract (in the form of dry extract) of Primula veris L./ Primula elatior (L.) Hill, radix (primula root) (6 - 7 : 1). Extraction solvent: ethanol 47.4% (V/V). 160 mg of extract (in the form of dry extract) of Thymus vulgaris L./ Thymus zygis L., herba (thyme) (6 - 10 : 1). Extraction solvent: ethanol 70% (V/V).
The other components are: Microcrystalline cellulose, Lactose monohydrate, Spray-dried glucose syrup, Anhydrous colloidal silica, Polycrylate dispersion 30%, Crospovidone, Hypromellose, Talc, Povidone K 25, Magnesium stearate, Titanium dioxide (E171), Propylene glycol, Peppermint flavour (Contains Arabic gum, Maltodextrin, Lactose), Copper chlorophyllin E 141 (Contains Glucose syrup), Sodium saccharin, Simethicone, Dimethicone, Riboflavin (E101).
Description of the appearance of Bronchipret and pack contents
The film-coated tablets are green, round, biconvex, with a semi-opaque surface.
The film-coated tablets have a diameter of 10.1–10.3 mm.
Bronchipret is available in PVC/PVDC/aluminium blisters.
The following pack sizes are available:
20 film-coated tablets
50 film-coated tablets
100 film-coated tablets.
It is possible that not all pack sizes are 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]
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Bronchithym Filmtabletten
Bulgaria, Italy Bronchipret
Croatia, Germany, Luxembourg, Netherlands Bronchipret TP
Denmark, France, Sweden Mucopret
Estonia Bronchipret thyme & primula
Hungary Bronchipret filmtabletta
Latvia Mucopret apvalkotās tabletes
Lithuania Bronchipret plėvele dengtos tabletės
Poland Bronchitabs
Romania Bronchipret TP comprimate filmate
Slovakia Bronchipret tymian a prvosienka filmom obalené tablety
Slovenia Tussipret
Spain Bronchipret Comprimidos recubiertos con película