Package leaflet: Information for the patient

Bronchitabs
60 mg + 160 mg
coated tablets
Primulae radicis extractum siccum + Thymi herbae extractum siccum
Please read the entire leaflet carefully before starting to take the medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet for possible future reference.
If you have any doubts, consult your pharmacist.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See: section 4.
If there is no improvement after 7 days, or if the patient's condition worsens, consult a doctor.

Table of contents

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

1. What Bronchitabs is and what it is used for

Bronchitabs is a herbal medicinal product used for productive (wet) cough, facilitating the expectoration of thick mucus.

2. Important information before using Bronchitabs

When not to use Bronchitabs:

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

Warnings and precautions
Consult a doctor or pharmacist if:

shortness of breath, fever, or purulent sputum occur
the patient has been diagnosed with gastric mucosal inflammation or peptic ulcer disease of the stomach or duodenum
symptoms worsen during use of the medicinal product

Children and adolescents
Use in children and adolescents under 18 years of age has not been established due to insufficient data on efficacy.

Bronchitabs and other medicines
Clinical studies on interactions have not been conducted.
Inform 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 insufficient data, the use of this medicine is not recommended during pregnancy.
It is unknown whether the active substances or metabolites of Bronchitabs pass into human milk.
Therefore, Bronchitabs 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.

Bronchitabs contains glucose and lactose.
If a doctor has previously diagnosed the patient with intolerance to certain sugars, the patient should consult a doctor before starting use of the medicinal product.
Bronchitabs contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which essentially means it is "sodium-free".

3. How to use Bronchitabs

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:
Adults: 1 coated tablet 3 times daily (maximum 3 coated tablets per day).
Bronchitabs tablets should be swallowed whole without chewing, before meals, with a large amount of fluid (preferably a glass of water).

If symptoms persist for longer than 1 week of treatment, consult your doctor or another qualified healthcare professional.

Due to lack of sufficient data, a recommended dose has not been established for patients with renal or hepatic impairment.

Use in children and adolescents
Not recommended for children and adolescents under 18 years of age (see section 2).

Taking more Bronchitabs than recommended
No cases of overdose have been reported. Overdose may cause stomach upset, vomiting or diarrhoea. If more than the recommended dose of Bronchitabs has been taken, inform your doctor. The doctor will decide on further actions.

Missed dose of Bronchitabs
Do not take a double dose to make up for a missed tablet. Continue taking Bronchitabs as prescribed by your doctor or according to the instructions in the package leaflet.

Stopping Bronchitabs
Stopping treatment with Bronchitabs is usually harmless.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Uncommon adverse effects (may occur in 1 out of 100 people)
Gastrointestinal disorders such as: cramps, nausea, vomiting and diarrhoea.
Very rare adverse effects (may occur in 1 out of 10,000 people)
Allergic reactions such as breathlessness, rash, urticaria, facial swelling, and/or swelling of the mouth and/or throat.
If the first symptoms of an allergic reaction occur, do not take Bronchitabs again.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring of 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bronchitabs

Do not store above 25°C.
Keep the blisters in the outer carton to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Bronchitabs contains

Active substances:
60 mg of extract (as dry extract) from Primula veris L./ Primula elatior (L.) Hill, radix (primrose root) (DER 6 - 7 : 1; extraction solvent: ethanol 47.4% [V/V])
160 mg of extract (as dry extract) from Thymus vulgaris L./ Thymus zygis L., herba (thyme herb) (DER 6 - 10 : 1; extraction solvent: ethanol 70% [V/V])
Excipients:
Simethicone
Glucose syrup, spray-dried
Tablet core 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 flavour (containing flavouring preparations, gum arabic, maltodextrin, lactose)
Riboflavin (E101)
Chlorophyllin 25% (containing copper chlorophyllin complex (E141), glucose syrup)
Sodium saccharin
Dimethicone

What Bronchitabs looks like and contents of the pack
Bronchitabs are green, round, biconvex coated tablets with a semi-matte surface.
The coated tablet has a diameter of 10.1–10.3 mm.
Bronchitabs are available in PVC/PVDC/Aluminium blisters.
The following pack sizes are available:
20 coated tablets
50 coated tablets
100 coated tablets
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]

The medicinal product is authorised 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