Package Insert: Information for the User

MucoActiol 50 mg/ml Oral Solution

Carbocisteine

Read this entire package insert carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this package insert or the instructions given by your pharmacist.

• Keep this package insert, 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 in this package insert. See section 4.4.
• You should consult your doctor if your condition worsens or does not improve after 5 days of treatment.

Carbocisteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it, and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults and adolescents aged 12 years and above.

Consult a doctor if symptoms worsen or do not improve after 5 days of treatment.

Do not takeMucoActiol

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

This medication is contraindicated in children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MucoActiol:

• If you have a stomach ulcer, duodenum, or any thyroid disease.
• If you have asthma or any severe respiratory disease, as it may increase airway obstruction.
• You may observe an increase in mucus and phlegm during the first few days, which will decrease throughout the treatment.

Children

Children under 12 years should not take this medication.

Taking MucoActiol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take this medication with cough suppressants or with medications used to inhibit bronchial secretions, as it may cause an accumulation of fluidified mucus.

Taking MucoActiol with food and drinks

Take this medication preferably before meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding, unless your doctor advises otherwise.

Driving and operating machinery

MucoActiol has no or insignificant influence on the ability to drive and operate machinery.

MucoActiol contains tartrazine (E-102), sodium p-hydroxybenzoate (E-219), and sodium.

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

This medication may cause delayed allergic reactions because it contains sodium p-hydroxybenzoate (E-219).

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

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

The recommended doseis:

For adults and adolescents over 12 years:

1dose of 15mlmeasured with the dosing cup3 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 cannot take this medication.

Take this medication orally and preferably before meals.

Measure the amount of medication to be taken with the dosing cup included in the package.

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

If it worsens or does not improve after5 daysof treatment, or fever, skin eruptions, persistent headache or sore throat occur, consult your doctor.

If you take moreMucoActiolthan you should

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

During the period of use of carbocisteine, the following adverse effects have been observed, whose frequency has not been established with precision. Allergic reactions such as skin rash, urticaria, itching, and erythema multiforme (a severe skin allergy that causes raised red patches that may form blisters) may occur.

Gastrointestinal disorders (diarrhea, nausea, vomiting, upper abdominal pain, gastrointestinal bleeding) may also appear, as well as headaches, dizziness, difficulty breathing, accompanied or not by wheezing (bronchospasm).

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.esBy reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout ofsight and out ofreach of children.

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofMucoActiol50 mg/ml Oral Solution

The active ingredient 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 caramelose, sucralose, disodium phosphate, tartrazine (E-102), methyl parahydroxybenzoate sodium (E-219), vanilla flavor, and purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder

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

Responsible for manufacturing

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

Date of the last review of this leaflet:

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