Package Insert: Information for the User

Fluidín Mucolítico 50 mg/ml Oral Solution

Carbocisteine

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

• Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this package insert.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

The active ingredient, Carbocisteina, belongs to the group of medications called mucolítics, which act by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

Fluidín Mucolítico is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults and adolescents 12 years of age and older.

Do not take Fluidín Mucolítico:

• If you are allergic (hypersensitive) to carbocisteína and its derivatives, or to any of the other componentsof this medication (listed in section 6).
• If you have a stomach or duodenal ulcer.
• This medication is contraindicated in children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluidín Mucolítico.

• If you have asthma or any severe respiratory disease, as it may increase the obstructionof the respiratory passages.
• During the first days of treatment, you may observe an increase in mucus and phlegm that willdecrease over the course of treatment.

Taking Fluidín Mucolítico with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take this medication with medications used to reduce non-productive cough (antitusives) or with medications used to inhibit bronchial secretions, as it may cause a buildup of fluidified mucus.

Taking Fluidín Mucolítico with food and drinks

Take this medication preferably before meals.

Use in children

This medication should not be administered to children under 12 years.

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 unless your doctor advises it.

Driving and operating machines

The influence of Fluidin Mucolitico on the ability to drive and operate machines is negligible or insignificant.

Fluidín Mucolítico contains sacarosa, parahidroxibenzoate of methanol, sodium salt (E-219), parahidroxibenzoate of propyl, sodium salt (E-217), and sulfites

This medication contains sacarosa. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 2 g of sacarosa per 5 ml.

This medication may cause allergic reactions (possibly delayed) because it contains parahidroxibenzoate of methanol, sodium salt (E-219) and parahidroxibenzoate of propyl, sodium salt (E-217).

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sulfites.

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

The recommended dose is:

• Adults and adolescents 12 years and older: Initially 15 ml (750 mg of carbocisteine) 3 times a day.Once you observe improvement, you can reduce to10 ml (500 mg of carbocisteine) 3 times a day.

Use in children

Children under 12 years cannot take this medication.

This medication is administered orally, either alone or diluted in water or another liquid and preferably before meals.

Instructions for correct administration of the preparation

Take the amount of medication to be taken using the dosing cup included in the box thathas marked the following measurements:2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Place the dosing cup on a flat surface and at eye level. Fill it with the solution up to the line that indicates your dose.

After use, wash the dosing cup with water.

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

If it worsens, or if it does not improve after 5 days of treatment, or if fever, skin eruptions, persistent headache, or sore throat occurs, you must consult your doctor.

If you take more Fluidín Mucolítico than you should

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

If you have taken more Fluidín Mucolítico than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 0420, indicating the medication and the amount ingested.

Like all medications, Fluidín Mucolítico may produce adverse effects, although not everyone will experience them.

During the period of use of carbocisteína, the following adverse effects have been observed, whose frequency has not been established with precision.

Nausea, stomach discomfort, or diarrhea may appear, which usually disappear when the dose is reduced.

Rarely, other reactions such as stomach or intestinal bleeding, headache, itching, and skin eruptions have been observed, and very rarely, difficulty breathing.

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 of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not usethis medicationafter the expiration date shown on the bottle label or on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Fluidín Mucolítico:

• The active ingredient is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.
• The other components are:sucrose, methyl parahydroxybenzoate, sodium chloride (E-219), propyl parahydroxybenzoate, sodium chloride (E-217), raspberry and orange essence, caramel, hydrochloric acid for pH adjustment, sodium hydroxide for pH adjustment, demineralized water. See section 2, “Fluidin Mucolítico contains sucrose, methyl parahydroxybenzoate sodium chloride (E-219), propyl parahydroxybenzoate sodium chloride (E-217) and sulfites”.

Appearance of the product and contents of the packaging:

Fluidín Mucolítico is an oral solution for administration that is presented in a glass bottle with a polipropylene/poliethylene high-density (PP/HDPE) cap with a child-resistant closure, which contains 200 ml of oral solution and a dosing cup.

The dosing cup has the following markings: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Holder of the marketing authorization:

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing:

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this prospectus:April 2025

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