Bronchipret film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bronchipret film-coated tablets

Dry extract of Primrose

Dry extract of Thyme

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine contained in this leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 1 week.

Contents of the leaflet

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

1. What Bronchipret is and what it is used for

Bronchipret is a herbal medicine used for productive cough to help loosen and expel mucus.

2. What you need to know before starting to take Bronchipret

Do not take Bronchipret:

• if you are allergic to the active substances, to other plants of the family Lamiaceae, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bronchipret:

• if you have 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

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

Taking Bronchipret with other medicines

No clinical interaction studies have been conducted.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Safety during pregnancy has not been established.

Due to insufficient data, use during pregnancy is not recommended.

It is unknown whether the active substances or metabolites of Bronchipret are excreted in breast milk. Therefore, Bronchipret should not be used during breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been performed regarding the ability to drive or use machinery.

Bronchipret contains glucose and lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Bronchipret contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Bronchipret

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults: 1 tablet 3 times daily (maximum, 3 tablets per day).

Take Bronchipret without chewing before meals and with sufficient liquid (preferably a glass of water).

If symptoms persist for more than 1 week during treatment with this medicine, consult a doctor or qualified healthcare professional.

There are insufficient data available to make dosage recommendations for patients with impaired renal or hepatic function.

Use in children and adolescents

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

If you take more Bronchipret than you should

No cases of overdose have been reported.

An overdose could cause discomfort, vomiting, or diarrhea.

Inform your doctor if you have taken more Bronchipret than you should. Your doctor will decide on the necessary measures.

If you forget to take Bronchipret

Do not take a double dose to make up for the missed dose, but continue taking Bronchipret as prescribed by your doctor or as described in this leaflet.

If you stop taking Bronchipret

Generally, stopping treatment with Bronchipret is harmless.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Uncommon adverse effects (may affect up to 1 in 100 people):

Gastrointestinal disorders such as cramps, nausea, vomiting, and diarrhoea.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Hypersensitivity reactions, such as shortness of breath, rashes, urticaria, and swelling of the face, mouth, or throat.

If the first symptoms of a hypersensitivity reaction occur, Bronchipret must not be taken again.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bronchipret

Do not store above 25°C.

Keep the blisters in the original packaging to protect 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Brochipret

• The active substances are 60 mg of extract (as dry extract) from Primula veris L./Primula elatior (L.) Hill, radix (Primula root) (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) (6 - 10: 1). Extraction solvent: Ethanol 70% (V/V).

• The other components are: microcrystalline cellulose, lactose monohydrate, spray-dried liquid glucose, colloidal anhydrous silica, 30% polyacrylate dispersion, crospovidone, hypromellose, talc, povidone K 25, magnesium stearate, titanium dioxide (E171), propylene glycol, mint flavour (contains arabic gum, maltodextrin, lactose), copper chlorophyllin E141 (contains glucose syrup), sodium saccharin, simeticone, dimethicone, riboflavin (E101).

Appearance of the product and contents of the pack

The film-coated tablets are green, round, biconvex and have a semi-opaque surface. The film-coated tablet has a diameter of 10.1 to 10.3 mm.

Bronchipret is available in PVC/PVDC/aluminum blisters.

Pack sizes available:

20 tablets

50 tablets

100 tablets

Only some pack sizes may be marketed.

Marketing Authorization 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 authorized in the EEA Member States under the following names:

Date of the most recent review of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)