Bronchipret comprimidos recubiertos con pelicula

Package Leaflet: Information for the Patient

Bronchipret Film-Coated Tablets

Dried Primula Extract

Dried Thyme Extract

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 1 week.

1. What is Bronchipret and what it is used for

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

3. How to take Bronchipret

4. Possible side effects

5. Storage of Bronchipret

6. Contents of the pack and additional information

Bronchipret is a plant-based medication used in cases of productive cough to facilitate the expectoration of mucus.

Do not take Bronchipret:

-if you are allergic to the active ingredients, to other plants of the Lamiaceae family or to any of the other components of this medication(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 have gastritis or gastric ulcer;
• if your symptoms worsen during use of the medication.

Childrenand adolescents

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

Use ofBronchipretwithother medications

No clinical interaction studies have been conducted.

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

Pregnancy and lactation

The safety during pregnancy has not been established.

Due to the lack of sufficient data, use during pregnancy is not recommended.

The active ingredients or metabolites of Bronchipret are unknown to be excreted in breast milk. Therefore, Bronchipret should not be used during lactation.

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted regarding the ability to drive and operate machinery.

Bronchipret contains glucose and lactose

If your doctor has told you that you have intolerance to some sugars, contact him before taking this medication.

Bronchipret contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medicationcontained in this leafletor those indicated by your doctor or pharmacist. In case of doubt,consult againyour doctor or pharmacist.

The recommended dose is:

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

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

If symptoms persist for more than 1 week during use of the medication, you should consult a doctor or a qualified healthcare professional.

No sufficient data is available for dosage recommendations in patients with decreased renal or hepatic function.

Use in children and adolescents

Do not recommend use in children and adolescents under 18 years (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 forgot to take Bronchipret

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

If you interrupt treatment with Bronchipret

Generally, interrupting treatment with Bronchipret is harmless.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

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.

In the case of observing the first symptoms of a hypersensitivity reaction, do not take Bronchipret again.

Reporting 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 prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Do not storeat a temperature above25ºC.

Store the blister packs in theoriginal packaging to protect from light and moisture.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears onthe packaging after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or inthe trash.Depositthe packaging and medications you no longer need at the SIGREcollection pointat the pharmacy.Askyour pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Brochipret

-The active principles are60 mg of extract (as dry extract) ofPrimula verisL./Primula elatior(L.) Hill, radix (root of Primula) (6 - 7: 1). Solvent for extraction: Ethanol 47.4% (V/V).

160 mg of extract (as dry extract) ofThymus vulgarisL./Thymus zygisL., herba (thyme) (6 - 10: 1). Solvent for extraction: Ethanol 70% (V/V).

-The other components are:microcrystalline cellulose, lactose monohydrate, dehydrated liquid glucose by atomization, anhydrous colloidal silica, dispersion of polyacrylate 30%, crospovidone, hypromellose, talc, povidone K 25, magnesium stearate, titanium dioxide (E171), propylene glycol, peppermint flavor (contains gum arabic, maltodextrin, lactose), copper chlorophyllin E141 (contains glucose syrup), sodium saccharin, simethicone, dimethicone, riboflavin (E101).

Appearance of the product and contents of the package

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 10.3mm.

Bronchipret is presented in PVC/PVDC/aluminum blisters.

It is available in the following package sizes:

20 tablets

50 tablets

100 tablets

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

BIONORICA SE

Kerschensteinerstraße 11-15

92318 Neumarkt

Germany

Phone: +49 (0)9181 231-90

Fax: +49 (0)9181 231-265

Email: [email protected]

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

Last review date of this leaflet: October 2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)