Patient Information Leaflet

BRONCHOSTOP®Cough Suppressant and Expectorant, Soft Tablets

Extract ofThymus vulgarisL. / Extract ofAlthaea officinalisL.

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, contact your pharmacist.
• Report any side effects you may get to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
• You must see a doctor if your symptoms worsen or do not improve after 5 days of treatment.

1. What isBRONCHOSTOP Cough Suppressant and Expectorant, Soft Tabletsand what it is used for

2. What you need to know before takingBRONCHOSTOP Cough Suppressant and Expectorant, Soft Tablets

3. How to takeBRONCHOSTOP Cough Suppressant and Expectorant, Soft Tablets

4. Possible side effects

5. Storage ofBRONCHOSTOP Cough Suppressant and Expectorant, Soft Tablets

6. Contents of the pack and additional information

BRONCHOSTOP Antitusivo y expectorante, soft tabletsis a traditional herbal medicine for productive cough associated with cold, to relieve dry cough and soothe an irritated throat.

Based exclusively on its traditional use.

BRONCHOSTOP Antitusivo y expectorante, soft tabletsis a medication for adults, adolescents, and children over 6 years of age.

How it worksBRONCHOSTOP Antitusivo y expectorante, soft tablets

Based on the evidence of a long tradition of use, the thyme components help in the expectoration of thick and persistent mucus and relax bronchial spasms, thus releasing the airways.

Based on the evidence of a long tradition of use, the mucilaginous substances contained in the marshmallow root calm an irritated throat and reduce the need to cough.

Consult a doctor if it worsens or does not improve after 5 days of treatment.

Do not takeBRONCHOSTOP Expectorant and Antitussive, Soft Tablets

If you are hypersensitive (allergic) to the active ingredients, to any of the other components of this medication (listed in section 6), or to any other plants in the Lamiaceae family.

Warnings and Precautions

Consult your doctor or pharmacist before taking BRONCHOSTOP Expectorant and Antitussive, Soft Tablets.

If you have asthma or are prone to allergic reactions, there is a possible risk that this medication may trigger allergic reactions in patients who are prone to allergic reactions or asthma. Treatment should be stopped at the first sign of an allergic reaction (see section 4. Possible Adverse Effects).

You should consult a doctor in case of fever, difficulty breathing, or purulent secretions.

If symptoms persist or worsen, you should consult a doctor or healthcare professional.

Children

This product is not recommended for use in children under 6 years of age, as there is no clinical information available.

Taking BRONCHOSTOP Expectorant and Antitussive, Soft Tablets with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

The absorption of concomitantly administered medications may be delayed. As a precaution, the medication should not be taken ½ to 1 hour before or after the ingestion of other medications.

No interactions with other medications are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult a doctor or pharmacist before using this medication.

Due to the lack of clinical information, this medication should not be taken during pregnancy or breastfeeding.

No studies have been conducted on fertility.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. It does not contain ingredients identified as causing drowsiness.

BRONCHOSTOP Expectorant and Antitussive, Soft Tablets contain sorbitol (E420) and maltitol (E965), propylene glycol (E1520), benzyl alcohol (E1519), and sodium.

This medication contains 615 mg of maltitol (E965), 210 mg of sorbitol (E420), and maltodextrin (which contains glucose) in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, speak with your doctor before you (or your child) take or receive this medication.

Consult with your doctor before taking this medication if you have been told that you have an intolerance to certain sugars.

One tablet corresponds to approximately 0.1 units of carbohydrates. This should be considered in patients with diabetes mellitus.

This medication contains 6.42 mg of propylene glycol in each tablet.

This medication contains 0.005 mg of benzyl alcohol (E1519) in each tablet. Benzyl alcohol (E1519) may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease, if you are pregnant, or if you are breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause secondary effects (known as "metabolic acidosis"). Do not use it for more than a week in young children, except if recommended by your doctor or pharmacist.

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

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

The recommended dose is:

Adults and adolescents over 12 years:

1 – 2 tablets every 4 hours (4 to 6 times a day). The maximum daily dose is 12 tablets.

Children between 6 – 12 years:

1 tablet every 3-4 hours (4 to 6 times a day). The maximum daily dose is 6 tablets.

Children under 6 years:

This medication is not recommended for use in children under 6 years of age due to insufficient available data, and medical advice should be sought.

Administration form:

For oral use (suck the tablet until it dissolves in the mouth).

Duration of administration:

The recommended treatment duration is 5 days. If there is no significant improvement within this period, consult a doctor as there may be a more serious underlying condition.

If you take more BRONCHOSTOP Expectorant and Antitussive, Soft Tablets than you should

If you have accidentally taken more than the recommended dose for this medication, the adverse effects may intensify. In this case, inform your doctor. They will decide on the necessary measures.

If you forget to take BRONCHOSTOP Expectorant and Antitussive, Soft Tablets

Do not take a double dose to compensate for the missed dose.

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

If you interrupt treatment with BRONCHOSTOP Expectorant and Antitussive, Soft Tablets

No special precautions are required.

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 may experience them.

This medication may cause the following severe allergic reactions. If you experience any of the following effects, stop taking the medication and seek urgent medical attention:

- Sudden and severe allergic reactions, with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness.

- Rapid swelling under the skin in areas such as the face, neck, arms, and legs.

- Difficulty breathing or shortness of breath.

Other possible adverse effects:

If any of the following adverse effects worsen or concern you, or if you notice any other adverse effect, stop taking this medication and seek medical attention as soon as possible:

- Skin allergic reactions that include hives, itching, and hives with itching.

- Gastrointestinal disorders such as abdominal pain or discomfort, diarrhea, vomiting, and nausea.

The frequency of these adverse effects is unknown (the frequency cannot be established based on the available data).

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 Medicines for Human Use: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date, written on the box in the caption “Expiration Date”, after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition ofBRONCHOSTOP®Antitussive and expectorant, soft tablets

Theactive principles are:

51.1 mg of dry extract of thyme (Thymus vulgarisorThymus zygis, leaves and flowers, drug-extract ratio = 7-13:1; solvent of extraction: water).

4.5 mg of dry extract of marshmallow root (Althaea officinalis, root, drug-extract ratio = 7-9:1; solvent of extraction: water).

The other components are:

Acacia (E414), liquid sorbitol (non-crystallizable, E420), liquid maltitol (E965), maltodextrin, anhydrous citric acid (E330), sodium saccharin, aronia flavoring (which contains propylene glycol (E1520)), berry flavoring (which contains propylene glycol (E1520) and benzyl alcohol (E1519)), light liquid paraffin, purified water.

Appearance of the product and contents of the packaging

BRONCHOSTOP®Antitussive and expectorant, soft tabletsare round, soft, brown tablets.

They are presented in blisters and can be found in packaging of 10, 20, 30 or 40 soft tablets. Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kwizda Pharma GmbH

Effingergasse 21, 1160 Vienna, Austria

Responsible for manufacturing:

Kwizda Pharma GmbH

Effingergasse 21, 1160 Vienna, Austria

Distributed by: Perrigo España S.A.

Last review date of this leaflet:May 2024

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