Bronchostop antitussive and expectorant soft lozenges

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

BRONCHOSTOP® Cough Suppressant and Expectorant, soft lozenges**

Extract of Thymus vulgaris L. / Extract of Althaea officinalis L.

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Contents of the leaflet

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

1. What BRONCHOSTOP Cough Suppressant and Expectorant Soft Lozenges is and what it is used for

BRONCHOSTOP Cough Suppressant and Expectorant Soft Lozenges is a traditional herbal medicinal product for productive cough associated with the common cold, to relieve dry cough and soothe an irritated throat.

Based solely on its traditional use.

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

How BRONCHOSTOP Cough Suppressant and Expectorant Soft Lozenges works

Based on evidence from long-standing traditional use, the components of thyme help loosen thick and persistent mucus and promote its expectoration, while also relaxing spasms during bronchial episodes, thereby clearing the airways.

Based on evidence from long-standing traditional use, the mucilaginous substances contained in marshmallow root soothe the irritated throat and reduce the urge to cough.

You should consult a doctor if your condition 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 take BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets

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

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 allergic reactions, there is a potential risk that this medicine may trigger allergic reactions in patients who tend to develop allergies or asthma. Treatment must be discontinued at the first sign of an allergic reaction (see section 4. Possible side effects).

Consult your doctor if you develop fever, difficulty breathing, or purulent secretions.

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

Children

Use is not recommended in children under 6 years of age, as there is no clinical data available for this age group.

Taking BRONCHOSTOP Cough Suppressant and Expectorant, soft tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not prescribed.

The absorption of concomitantly administered medicines may be delayed. As a precaution, this medicine should not be taken within ½ to 1 hour before or after 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 are planning to become pregnant, consult a doctor or pharmacist before using this medicine.

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

Fertility studies have not been conducted.

Driving and use of machinery

No studies on the effects on the ability to drive and use machines have been performed. 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 (containing glucose) per tablet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you 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 this medicine.

Talk to your doctor before taking this medicine if you have been diagnosed with an intolerance to certain sugars.

One tablet corresponds to approximately 0.1 carbohydrate exchange units. This should be taken into account in patients with diabetes mellitus.

The medicine contains 6.42 mg of propylene glycol per tablet.

This medicine contains 0.005 mg of benzyl alcohol (E1519) per 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 the body and cause side effects (referred to as "metabolic acidosis"). Do not use for longer than one week in young children, unless otherwise advised by your doctor or pharmacist.

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

3. How to take BRONCHOSTOP Antitussive and Expectorant, soft tablets

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and adolescents over 12 years of age:

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

Children between 6 – 12 years of age:

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

Children under 6 years of age:

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

Administration method:

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

Duration of treatment:

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

If you take more BRONCHOSTOP Antitussive and Expectorant, soft tablets than you should

If you have accidentally taken more than the recommended dose of this medicine, adverse effects may become more pronounced. In such a case, inform your doctor. He or she will decide on the necessary measures.

If you forget to take BRONCHOSTOP Antitussive and Expectorant, soft tablets

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

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

If you stop treatment with BRONCHOSTOP Antitussive and Expectorant, soft tablets

No special precautions are required.

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 cause adverse effects, although not everybody will experience 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, rapid heartbeat, 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 adverse effects:

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

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

The frequency of occurrence of these adverse effects is unknown (frequency cannot be estimated from the available data).

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

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

5. Storage of BRONCHOSTOP Cough Suppressant and Expectorant, Soft Lozenges

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the carton under “Expiry date”, following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of BRONCHOSTOP® Cough Suppressant and Expectorant, soft lozenges**

The active substances are:

51.1 mg of dry extract of thyme (Thymus vulgaris or 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 components are:

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

Nature of the product and contents of the container

BRONCHOSTOP***®*** Cough Suppressant and Expectorant, soft lozenges are round, soft, brown-coloured lozenges.

They are presented in blisters and available in pack sizes of 10, 20, 30 or 40 soft lozenges. 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 most recent revision of this package leaflet: May 2024

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