MUCOACTIOL 50 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

MucoActiol 50 mg/ml Oral Solution

Carbocisteine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.4.
• You should consult your doctor if your condition worsens or does not improve after 5 days of treatment.

Contents of the Package Leaflet:

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

1. What is MucoActiol and what is it used for

Carbocisteine, the active substance of this medicine, belongs to the group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults and adolescents from 12 years old.

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

2. Before taking MucoActiol

Do not takeMucoActiol

If you are allergic to carbocisteine, to any related compound or to any of the other components of this medicine (listed in section 6).

This medicine is contraindicated in children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MucoActiol:

• If you have stomach ulcers, duodenal ulcers or any thyroid disease.
• If you have asthma or any severe respiratory disease, as it may increase respiratory tract obstruction.
• During the first days, you may observe an increase in mucus and phlegm that will decrease throughout the treatment.

Children

Children under 12 years old should not take this medicine.

Taking MucoActiol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take this medicine with medicines used to reduce non-productive cough (antitussives) or with medicines used to inhibit bronchial secretions, as it may cause an accumulation of fluidified mucus.

Taking MucoActiol with food and drinks

Take this medicine preferably before meals.

Pregnancy and breastfeeding

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

This medicine should not be used during pregnancy or breastfeeding, unless your doctor advises you to do so.

Driving and using machines

MucoActiol has no or negligible influence on the ability to drive and use machines.

MucoActiol contains tartrazine (E-102), methyl parahydroxybenzoate (E-219) and sodium.

This medicine may cause allergic reactions because it contains tartrazine (E-102). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-219).

This medicine contains 121 mg of sodium (main component of table/cooking salt) in each 15 ml. This is equivalent to 6% of the maximum recommended daily intake of sodium for an adult.

3. How to take MucoActiol

Follow exactly the administration instructions of the medicine contained in this leaflet or the instructions given by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years old:

1 dose of 15 ml measured with the dosing cup 3 times a day.

Once improvement is observed, the dose can be reduced to 10 ml, 3 times a day.

Use in children:

Children under 12 years old should not take this medicine.

Take this medicine orally and preferably before meals.

Measure with the dosing cup included in the pack the amount of medicine to take.

It is recommended to drink a glass of water after each dose and a large amount of liquid throughout the day.

If your condition worsens or does not improve after 5 days of treatment, or if you develop fever, skin rash, persistent headache or sore throat, you should consult your doctor.

If you take more MucoActiol than you should

If you have taken more MucoActiol than you should, you may experience stomach pain, nausea and diarrhea, itching and skin rash.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

4. Possible side effects

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

During the use of carbocisteine, the following side effects have been observed, whose frequency could not be established with precision. Allergic reactions such as skin rash, urticaria, itching, erythema multiforme (severe allergic reaction of the skin that causes red patches that can form blisters) may occur.

Gastrointestinal disorders (diarrhea, nausea, vomiting, pain in the upper abdominal area, gastrointestinal bleeding), headache, dizziness, difficulty breathing, with or without wheezing (bronchospasm) may also appear.

In these cases, it is recommended to interrupt the treatment and consult a doctor.

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: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MucoActiol

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

Store below 25°C.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of MucoActiol 50 mg/ml Oral Solution

The active substance of MucoActiol 50 mg/ml Oral Solution is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.

The other components are: sodium hydroxide, sodium carmellose, sucralose, disodium phosphate, tartrazine (E-102), methyl parahydroxybenzoate (E-219), vanilla flavor and purified water.

Appearance and pack contents

MucoActiol is a yellow solution with a vanilla odor, presented in 200 ml bottles, with a dosing cup with marks that allow for 10 and 15 ml doses.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A. General Mitre, 151 08022 Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A., Ctra. de Martorell, 41-61, 08740 - Sant Andreu de la Barca – Barcelona (Spain).

Date of the last revision of this leaflet:

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