Bronhitabs

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: Information for the patient

Bronchitabs
60 mg + 160 mg
coated tablets
Primulae radicis extractum siccum + Thymi herbae extractum siccum

You should carefully read the contents of the leaflet before starting to use 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See: section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Bronchitabs and what is it used for

Bronchitabs is a herbal medicinal product used for wet cough, making it easier to cough up thick mucus.

2. Important information before taking Bronchitabs

When not to take Bronchitabs:

• if the patient is allergic (hypersensitive) to the active substances, to other species of the Lamiaceae family, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You should consult a doctor or pharmacist if:

• shortness of breath, fever, or purulent sputum occur
• the patient has been diagnosed with gastric mucosa inflammation or stomach and duodenal ulcer disease
• symptoms worsen during the use of the medicinal product

Children and adolescents

The use in children and adolescents under 18 years of age has not been established due to the lack of sufficient data on efficacy.

Bronchitabs and other medicines

No clinical trials have been conducted on interactions. You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

The safety of use during pregnancy has not been established. Due to the lack of sufficient data, it is not recommended to use this medicine during pregnancy.
It is not known whether the active substances or metabolites of Bronchitabs pass into human milk.
Therefore, Bronchitabs 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.

Bronchitabs contains glucose and lactose.

If the doctor has previously determined that the patient has an intolerance to some sugars, they should consult their doctor before starting to use the medicinal product.
Bronchitabs contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means it is essentially "sodium-free".

3. How to take Bronchitabs

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.

Recommended dose:

Adults: 1 coated tablet 3 times a day (maximum 3 coated tablets per day).
Bronchitabs should be swallowed without chewing, before meals, with a large amount of liquid (preferably a glass of water).
If symptoms persist for more than 1 week of using the medicinal product, you should consult a doctor or a qualified healthcare professional.
Due to the lack of sufficient data, the recommended dose for patients with renal or hepatic impairment has not been determined.

Use in children and adolescents

The use in children and adolescents under 18 years of age is not recommended (see: section 2).

Taking a higher dose of Bronchitabs than recommended

No cases of overdose have been reported. Overdose may cause stomach upset, vomiting, or diarrhea. If a higher dose of Bronchitabs than recommended is taken, you should inform your doctor. The doctor will decide on further actions.

Missing a dose of Bronchitabs

You should not take a double dose to make up for a missed tablet, just continue taking Bronchitabs as prescribed by your doctor or according to the leaflet included in the packaging.

Stopping the use of Bronchitabs

Stopping the use of Bronchitabs is usually harmless.
If you have any further doubts about the use of this medicine, you should consult a 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 diarrhea.
Very rare side effects (may affect up to 1 in 10,000 people)
Allergic reactions such as shortness of breath, rash, urticaria, swelling of the face, mouth, and/or throat.
If the first symptoms of an allergic reaction occur, you should not take Bronchitabs anymore.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products
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 .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bronchitabs

Do not store above 25°C.
The blisters should be stored in the outer carton to protect from light and moisture.
The medicine should be stored 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 the month stated.

6. Contents of the pack and other information

What Bronchitabs contains

• Active substances: 60 mg extract (as dry extract) of Primula verisL./ Primula elatior(L.) Hill, radix (primrose root) (DER 6 - 7 : 1; extraction solvent: ethanol 47.4% [V/V]) 160 mg extract (as dry extract) of Thymus vulgarisL./ Thymus zygisL., herba (thyme) (DER 6 - 10 : 1; extraction solvent: ethanol 70% [V/V])
• Excipients: Simethicone Glucose liquid spray-dried Core tablet ingredients:Microcrystalline cellulose Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Povidone K 25

Talc
Magnesium stearate
Coating ingredients:
Hypromellose type 2910
Polyacrylate dispersion 30%
Talc
Titanium dioxide (E171)
Propylene glycol
Peppermint flavor (containing flavoring preparations, gum arabic, maltodextrin, lactose)
Riboflavin (E101)
Chlorophyllin 25% (containing copper complex of chlorophyllin (E141), glucose syrup)
Saccharin sodium
Dimethicone

What Bronchitabs looks like and contents of the pack

Green, round, biconvex, coated tablets with a matt finish.
The coated tablet has a diameter of 10.1–10.3 mm.
Bronchitabs is available in PVC/PVDC/Aluminum blisters.
The following pack sizes are available:
20 coated tablets
50 coated tablets
100 coated tablets
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]

The medicinal product is authorized in the EEA member states 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

Date of last revision of the leaflet: