BRONCHIPRET FILM-COATED TABLETS

2. What you need to know before taking Bronchipret

Do not take Bronchipret:

• if you are allergic to the active substances, 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 suffer from gastritis or gastric ulcer;
• if symptoms worsen during medication use.

Children and Adolescents

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

Taking Bronchipret with Other Medications

No clinical interaction studies have been conducted.

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

Pregnancy and Breastfeeding

Safety during pregnancy has not been established.

Due to a lack of sufficient data, the use of Bronchipret 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 the breastfeeding period.

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

Driving and Using Machines

No studies have been conducted on the ability to drive and use machinery.

Bronchipret Contains Glucose and Lactose

If your doctor has told you that you have an intolerance to some sugars, contact them 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".

3. How to Take Bronchipret

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The Recommended Dose is:

Adults: 1 tablet 3 times a day (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 medication use, you should consult a doctor or a qualified healthcare professional.

There is not enough data to recommend dosage in patients with reduced renal or hepatic function.

Use in Children and Adolescents

The use of Bronchipret in children and adolescents under 18 years of age is not recommended (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 forgotten dose, but continue taking Bronchipret as prescribed by your doctor or as described in this package leaflet.

If You Stop Taking Bronchipret

Generally, stopping treatment with Bronchipret is harmless.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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)

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

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bronchipret

Do not store above 25°C.

Keep the blisters in the original package to protect from light and moisture.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bronchipret

• The active substances are 60 mg of extract (as 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 (as dry extract) of Thymus vulgarisL./Thymus zygisL., herba (thyme) (6-10:1). Extraction solvent: Ethanol 70% (V/V).

• The other components are: microcrystalline cellulose, lactose monohydrate, spray-dried glucose liquid, colloidal anhydrous silica, 30% polyacrylate dispersion, 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 Package Contents

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

Bronchipret is presented in PVC/PVDC/aluminum blisters.

It is available in the following package sizes:

20 tablets

50 tablets

100 tablets

Not all package 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 medication is authorized in EEA member states under the following names:

Date of the Last Revision of this Package Leaflet: October 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)