Bronchostop antitussive and expectorant oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

BRONCHOSTOP Antitussive and Expectorant, oral solution

Extract of Thymus vulgaris / Extract of Althaea officinalis

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

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

This leaflet contains the following information:

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 adverse effects
5. How to store BRONCHOSTOP Antitussive and Expectorant, oral solution
6. Contents of the pack and other information

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

BRONCHOSTOP Cough Suppressant and Expectorant, oral solution is a traditional herbal medicine used for productive cough associated with the common cold, and to relieve dry cough due to throat irritation. Its use is based solely on long-standing traditional practice. BRONCHOSTOP Cough Suppressant and Expectorant is a medicine for adults, adolescents, and children over 6 years of age.

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 Antitussive and Expectorant, oral solution

Do not take BRONCHOSTOP Antitussive and Expectorant, oral solution

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 Lamiaceae family.

Warnings and precautions

Consult your doctor before taking Bronchostop if you:

• observe purulent secretions,
• experience fever,
• have difficulty breathing,
• 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, and in very rare cases, anaphylaxis including anaphylactic shock, in patients predisposed to allergic reactions.

Children under 6 years of age:

Administration of this medicine is not recommended in children under 6 years of age, as sufficient clinical data are not available.

Taking BRONCHOSTOP Antitussive and Expectorant with other medicines

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

The absorption of concomitantly administered medicines may be delayed. As a precaution, this product should not be taken within half an hour to one hour before or after taking other medicines.

Pregnancy, breast-feeding and fertility

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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). These 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 diagnosed you (or your child) with intolerance to certain sugars or with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be properly broken down, consult your doctor before you (or your child) take or receive 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; hence, 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 phlegm is yellow-green or brown in color (purulent sputum), you should consult your doctor.

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

The recommended dose is:

Adults and adolescents over 12 years of age:

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

Children between 6 and 12 years of age:

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

Use in children under 6 years of age:

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

The recommended duration of treatment is 5 days. Do not continue treatment without first consulting your doctor regarding the appropriateness of continuing. Take into account the warnings and precautions listed 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 dosing cup, which has a scale ranging from 2.5 ml to 20 ml.

If necessary, the medicine may be taken with water or hot tea.

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

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

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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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 which may include feeling dizzy or faint, 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 trouble breathing).

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet; skin allergic reactions including hives (red, raised bumps on the skin) and itching. Gastrointestinal disorders such as abdominal pain or discomfort, diarrhea, vomiting and nausea.

Reporting of adverse effects

If you experience any 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 Antitussive and Expectorant, oral solution

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

Store the bottle in the original carton to protect the contents from light.

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

Close the bottle tightly. After opening, use the contents within 4 weeks. Write the date of opening in the white box on the carton.

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

6. Contents of the pack and other information

Composition of BRONCHOSTOP Cough Suppressant and Expectorant, oral solution

The active substances are:

15 ml (= 15.45 g) of oral solution contains:

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

0.83 g of liquid extract from marshmallow root (extract to crude drug ratio, (DER) = 1:12-14; extraction solvent: water).

The other components are:

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

Nature of the product and pack contents

BRONCHOSTOP Cough Suppressant and Expectorant oral solution is a viscous reddish-brown solution with the odour and taste of thyme and raspberry. It is supplied in amber glass bottles with screw caps sealed in sizes of 120 ml, 200 ml and 240 ml. Not all pack sizes may be marketed.

The dosing cup provided in the package, with graduations from 2.5 ml to 20 ml, facilitates accurate administration of the recommended dose.

Marketing Authorisation Holder, Manufacturer and Distributor

Marketing Authorisation 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 most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/