PATIENT INFORMATION LEAFLET

BRONCHOSTOP Cough Suppressor and Expectorant, oral solution

Extract ofThymus vulgaris/ Extract ofAlthaea officinalis

Read this leaflet carefully before you start taking the 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.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed inthisleaflet. See section4.
• You should consult a doctor if you get worse or do not improve after 5 days of treatment.

You will find the following information in this leaflet:

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

BRONCHOSTOP Antitusivo y Expectorante, oral solution is a traditional herbal medicine for productive cough associated with the common cold, and to relieve dry cough in throat irritation. Based exclusively on its traditional use. BRONCHOSTOP Antitusivo y Expectorante is a medication for adults, adolescents, and children older than 6 years.adolescents and children older than 6 years.

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

Do not take BRONCHOSTOP Antitusivo y Expectorante, oral solution

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

Warnings and precautions

Consult your doctor before taking Bronchostop medication:

• if you observe purulent secretions,
• if you experience 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 medication may trigger allergic reactions, including anaphylaxis, including anaphylactic shock, in patients who are prone to allergic reactions.

Children under 6 years:

Administration of the medication is not recommended for children under 6 years of age, as there is insufficient clinical information available.

BRONCHOSTOP Antitusivo y Expectorante 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 product should not be taken 30 minutes to 1 hour before or after the ingestion of other medications.

Pregnancy, lactation, and fertility

There is no information on the effects of this medication on fertility, during pregnancy, and lactation. In the absence of clinical information, the use of this medication during pregnancy and lactation is not recommended.

If you are pregnant, breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

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

BRONCHOSTOP Antitusivo y Expectorante, oral solution contains concentrated raspberry juice, which contains sucrose, glucose, and fructose. This medication contains 66 mg of fructose in each 15 ml.

If your doctor has indicated that you (or your child) suffer from 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 or administering this medication to you (or your child).

BRONCHOSTOP Antitusivo y Expectorante, oral solution contains propylene glycol. This medication contains 38.9 mg of propylene glycol in each 15 ml.

BRONCHOSTOP Antitusivo y Expectorante oral solution contains sodium. This medication contains less than 23 mg (1 mmol) of sodium per 15 ml; it is essentially "sodium-free".

If you have difficulty breathing, a high fever, greenish-yellow or brown mucus (purulent sputum), you should consult your doctor.

Follow exactly the 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 old

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 between6 and 12 years old:

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 6years

BRONCHOSTOP Cough and Expectorant, oral solutionis not recommended for patients under 6 years old.

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

Administration form:

Oral solution

Take BRONCHOSTOP Cough and Expectorant, oral solutionundiluted, measuring the recommended dose according to age, in the measuring cupwhose scale ranges from 2.5 ml to 20 ml.

If necessary, the medication can be administered withwater or warm tea.

If you take more than the recommended amount of BRONCHOSTOP Cough and Expectorant, oral solution:

If you have accidentally taken more than the recommended dosefor this medication, the adverse effects (listed in section 4) may intensify. If any of these adverse effects are severe, inform your doctor. They will decide on the necessary measures.

If you have forgotten to take BRONCHOSTOP Cough and Expectorant, oral solution

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

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.

The frequency of occurrence of the following side effects is unknown.

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:

• symptoms that may include dizziness or fainting, difficulty breathing or wheezing, rapid heartbeats, 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus; Skin allergic reactions that include urticaria (red bumps on the skin) and itching. Gastrointestinal disorders such as abdominal pain or discomfort, diarrhea, vomiting, and nausea.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es

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

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

Store the bottle in the original box to protect its contents from light.

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.

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

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

Composition of BRONCHOSTOP Antitussive and Expectorant, oral solution

The active principles are:

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

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

0.83 g of liquid extract of marshmallow root (extract-to-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 flavoring (synthetic and natural flavorings, propylene glycol E1520)), maltodextrin, gum arabic, glycerol (E422), sodium saccharin (E954), neohesperidin-dihydrochalcone, purified water.

Appearance of the product and content of the container

BRONCHOSTOP Antitussive and Expectorant oral solution is a brownish-red viscous solution with a thyme and raspberry odor and taste. It is presented in amber glass bottles with a screw-top seal in sizes of 120 ml, 200 ml, and 240 ml. Not all container sizes may be marketed.

The dosing cup attached to the container, with a scale of 2.5 ml to 20 ml, facilitates taking the recommended dose with precision.

Holder of the marketing authorization, manufacturer, and distributor

Holder of the marketing authorization:

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 review of this leaflet:March 2023

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