BRONCHOSTOP COUGH SUPPRESSANT AND EXPECTORANT ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THEPATIENT

BRONCHOSTOP Antitussive and Expectorant, oral solution

Extract of Thymus vulgaris/ Extract of Althaea officinalis

Read the entire package leaflet carefully before starting totake the medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment.

In this package leaflet, you will find:

1. What BRONCHOSTOP Antitussive and Expectorant, oral solution is and what it is used for.
2. What you need to know before taking BRONCHOSTOP Antitussive and Expectorant, oral solution
3. How to take BRONCHOSTOP Antitussive and Expectorant, oral solution
4. Possible side effects
5. Storage of BRONCHOSTOP Antitussive and Expectorant, oral solution
6. Contents of the pack and further information

1. What is BRONCHOSTOP Antitussive and Expectorant, oral solution and what is it used for

BRONCHOSTOP Antitussive and Expectorant, oral solution is a traditional herbal medicinal product for productive cough associated with colds and to relieve dry cough in throat irritation. Based exclusively on its traditional use. BRONCHOSTOP Antitussive and Expectorant is a medicine for adults, adolescents, and children over 6 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment.

2. What you need to know before taking BRONCHOSTOP Antitussive and Expectorant, oral solution

Do not take BRONCHOSTOP Antitussive and Expectorant, oral solution

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

Warnings and precautions

Consult your doctor before taking BRONCHOSTOP Antitussive and Expectorant, oral solution:

• if you have purulent secretions,
• if you have a fever,
• if you have difficulty breathing,
• if you have asthma or are prone to allergic reactions, as BRONCHOSTOP may worsen asthma symptoms. There is a possible risk that this medicine may trigger allergic reactions, in very rare cases, anaphylaxis, including anaphylactic shock, in patients who are prone to allergic reactions.

Children under 6 years:

The administration of the medicine is not recommended for children under 6 years of age, as there is not sufficient clinical information available.

Taking BRONCHOSTOP Antitussive and Expectorant with other medicines

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

The absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken half an hour to 1 hour before or after the intake of other medicines.

Pregnancy, breastfeeding, and fertility

There are no data on the effects of this medicine on fertility, during pregnancy, and breastfeeding. In the absence of clinical data, the use of this medicine is not recommended during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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 Antitussive and Expectorant, oral solution contains the preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). They may cause allergic reactions (possibly delayed).

BRONCHOSTOP Antitussive and Expectorant, oral solution contains concentrated raspberry juice, which contains sucrose, glucose, and fructose. This medicine contains 66 mg of fructose in each 15 ml.

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 fructose cannot be broken down, consult your doctor before taking this medicine.

BRONCHOSTOP Antitussive and Expectorant, oral solution contains propylene glycol. This medicine contains 38.9 mg of propylene glycol in each 15 ml.

BRONCHOSTOP Antitussive and Expectorant oral solution contains sodium. This medicine contains less than 23 mg (1 mmol) of sodium per 15 ml; i.e., it is essentially "sodium-free".

3. How to take BRONCHOSTOP Antitussive and Expectorant, oral solution

If you have difficulty breathing, have a high fever, or your sputum is yellowish-green or brown (purulent sputum), you should consult your doctor.

Follow exactly the administration instructions of the medicine contained in this package 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

Using the measuring cup, 15 ml every 4 hours (4 times a day). If necessary, up to a maximum of 6 doses per day (90 ml) can be taken.

Children between 6 and 12 years of age:

Using the measuring cup, 7.5 ml every 3 to 4 hours (4 times a day). If necessary, up to a maximum of 6 doses per day (45 ml) can be taken.

Use in children under 6 years

BRONCHOSTOP Antitussive and Expectorant, oral solution is not recommended for patients under 6 years of age.

The recommended treatment duration is 5 days. Do not continue treatment without consulting your doctor about the convenience of continuing it. Take into account the warnings and precautions in section 2.

Method of administration:

Oral solution

Take BRONCHOSTOP Antitussive and Expectorant, oral solution undiluted, measuring the recommended dose according to age, using the measuring cup with a scale from 2.5 ml to 20 ml.

If necessary, the medicine can be administered with water or hot tea.

If you take more BRONCHOSTOP Antitussive and Expectorant, oral solutionthan you should:

If you have accidentally taken more than the recommended dose of this medicine, the side effects (listed in section 4) may be intensified. If any of these side effects are severe, inform your doctor. He/she will decide on the measures to be taken.

If you forget to take BRONCHOSTOP Antitussive and Expectorant, oral solution

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

If you have any further questions on 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.

The frequency of the following side effects is not known.

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:

• symptoms that may include dizziness or fainting, difficulty breathing or wheezing, rapid heartbeat, skin rash, confusion, and anxiety, or loss of consciousness (anaphylactic reaction)
• swelling of the face, lips, tongue, mouth, or throat (angioedema),
• blisters in the mouth and throat
• worsening of asthma symptoms
• difficulty breathing (including difficulty breathing).

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet; allergic skin reactions, including urticaria (red patches on the skin) and itching. Gastrointestinal disorders such as abdominal pain or discomfort, diarrhea, vomiting, and nausea.

Reporting of side effects

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

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

5. Storage of BRONCHOSTOP Antitussive and Expectorant, oral solution

Keep this medicine out of the sight and reach of children. No special storage conditions are required.

Keep the bottle in the original package to protect its contents from light.

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

Close the bottle tightly. Once the bottle is opened, use its contents within 4 weeks. Write the date of opening on the white box on the carton.

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. Contents of the pack and further information

Composition of BRONCHOSTOP Antitussive and Expectorant, oral solution

The active substances are:

15 ml (= 15.45 g) of the oral solution contain:

0.12 g of dry extract of thyme leaves and flowers (extract-drug ratio (DER) = 7-13:1; extraction agent: water).

0.83 g of liquid extract of marshmallow root (extract-drug ratio (DER) = 1:12-14; extraction agent: water).

The other components are:

Maltodextrin, acacia (gum arabic), xylitol (E967), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), concentrated raspberry juice (containing sucrose, glucose, and fructose), xanthan gum, citric acid monohydrate (E330), raspberry flavor (synthetic and natural flavorings, propylene glycol E1520)), maltodextrin, gum arabic, glycerol (E422), sodium saccharin (E954), neohesperidin dihydrochalcone, purified water.

Appearance and pack contents

BRONCHOSTOP Antitussive and Expectorant oral solution is a viscous reddish-brown solution with a thyme and raspberry odor and flavor. It is available in amber glass bottles with a screw cap, in sizes of 120 ml, 200 ml, and 240 ml. Not all pack sizes may be marketed.

The measuring cup provided with the pack, with a scale from 2.5 ml to 20 ml, facilitates accurate measurement of the recommended dose.

Marketing authorization holder, manufacturer, and distributor

Marketing authorization holder:

KWIZDA PHARMA GMBH.

Effingergasse 21

A-1160 Vienna

Austria

Manufacturer:

Kwizda Pharma GmbH,

A-1160 Vienna,

Effingergasse 21

Distributed by:

Perrigo España S.A

Date of the last revision of this package leaflet:March 2023

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/