BRONCHOSTOP COUGH SUPPRESSANT AND EXPECTORANT SOFT PASTILLES

Introduction

Patient Information Leaflet

BRONCHOSTOP®Cough Suppressant and Expectorant, soft tablets

Extract of Thymus vulgarisL. / Extract of Althaea officinalisL.

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 it worsens or does not improve after 5 days of treatment.

Contents of the leaflet

1. What is BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets and what is it used for
2. What you need to know before taking BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets
3. How to take BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets
4. Possible side effects
5. Storage of BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets
6. Package contents and additional information

1. What is BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets and what is it used for

BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets is a traditional herbal medicinal product for productive cough associated with colds, to relieve dry cough and soothe irritated throat.

Based exclusively on its traditional use.

BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets is a medicine for adults, adolescents, and children over 6 years of age.

How it worksBRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

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

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

You should consult a doctor if it worsens or does not improve after 5 days of treatment.

2. What you need to know before taking BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

Do not takeBRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

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

Warnings and precautions

Consult your doctor or pharmacist before taking BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets.

If you have asthma or are prone to developing allergic reactions, there is a possible risk that this medicine may trigger allergic reactions in patients who have a tendency to develop allergic reactions or asthma. Treatment should be stopped at the first symptom of an allergic reaction (see section 4. Possible side effects).

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

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

Children

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

TakingBRONCHOSTOP Cough Suppressant and Expectorant, soft tabletswith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including medicines without a prescription.

The absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the medicine should not be taken ½ to 1 hour before or after the ingestion of other medicines.

No interactions with other medicines are known.

Pregnancy, breastfeeding, and fertility

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

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

No fertility studies have been conducted.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machinery. It does not contain ingredients known to cause drowsiness.

BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets contains sorbitol (E420) and maltitol (E965), propylene glycol (E1520), benzyl alcohol (E1519), and sodium.

This medicine 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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Consult your doctor before taking this medicine 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.

The medicine contains 6.42 mg of propylene glycol in each tablet.

This medicine 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 can accumulate in your body and cause side effects (so-called "metabolic acidosis"). Do not use it for more than one week in small children, except if recommended by your doctor or pharmacist.

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

3. How to take BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 (4-6 times a day). The maximum daily dose is 12 tablets.

Children between 6-12 years:

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

Children under 6 years:

The use of this medicine is not recommended in children under 6 years of age due to the lack of available data, and medical advice should be sought.

Method of administration:

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 during this period, consult a doctor, as there may be a more serious illness.

If you take moreBRONCHOSTOP Cough Suppressant and Expectorant, soft tablets than you should

If you have accidentally taken more than the recommended dose for this medicine, the side effects may be intensified. In this case, inform your doctor. He will decide on the measures to be taken.

If you forget to takeBRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

Do not take a double dose to make up for the forgotten dose.

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

If you stop takingBRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

No special precautions are required.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Sudden and severe allergic reactions, with difficulty breathing, swelling, dizziness, tachycardia, sweating, and loss of consciousness.
• Rapid swelling under the skin in areas such as the face, throat, arms, and legs.
• Difficulty breathing or shortness of breath.

Other possible side effects:

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

• Skin allergic reactions including rash, itching, and itchy rash.
• Stomach and intestine disorders such as abdominal pain or discomfort, diarrhea, vomiting, and nausea.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

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

Do not store above 25°C.

Do not use this medicine after the expiry date, which is stated on the carton after "EXP". The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition ofBRONCHOSTOP®Cough Suppressant and Expectorant, soft tablets

The active ingredients are:

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

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

The other ingredients are:

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

Appearance of the product and package contents

BRONCHOSTOP®Cough Suppressant and Expectorant, soft tablets are round, brown, soft tablets.

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kwizda Pharma GmbH

Effingergasse 21, 1160 Vienna, Austria

Manufacturer:

Kwizda Pharma GmbH

Effingergasse 21, 1160 Vienna, Austria

Distributed by: Perrigo España S.A.

Date of the last revision of this leaflet:May 2024

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