FLUIDIN MUCOLITIC 50 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Fluidin Mucolytic 50 mg/ml Oral Solution

Carbocisteine

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

• Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.
• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.
• You should consult a doctor if you worsen or do not improve after 5 days of treatment.

Contents of the Package Leaflet:

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

1. What Fluidin Mucolytic is and what it is used for

Carbocisteine, the active ingredient 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.

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

2. What you need to know before taking Fluidin Mucolytic

Do not take Fluidin Mucolytic:

• If you are allergic (hypersensitive) to carbocisteine and its derivatives, or to any of the other components of this medicine (listed in section 6).
• If you have stomach or duodenal ulcers.
• This medicine is contraindicated in children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluidin Mucolytic.

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

Taking Fluidin Mucolytic with other medicines

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

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 accumulation of fluidified mucus.

Taking Fluidin Mucolytic with food and drinks

Take this medicine preferably before meals.

Use in children

This medicine should not be administered to children under 12 years old.

Pregnancy and lactation

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

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

Driving and using machines

The influence of Fluidin Mucolytic on the ability to drive and use machines is nil or insignificant.

Fluidin Mucolytic contains saccharose, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), and sulfites

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217).

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfites.

3. How to take Fluidin Mucolytic

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

The recommended dose is:

• Adults and adolescents from 12 years old: Initially 15 ml (750 mg of carbocisteine) 3 times a day. Once you observe improvement, you can reduce to 10 ml (500 mg of carbocisteine) 3 times a day.

Use in children

Children under 12 years old cannot take this medicine.

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

Instructions for the correct administration of the preparation

Take the amount of medicine to be taken using the measuring cup included in the box, which has the following measures marked: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Place the measuring 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 measuring cup with water.

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

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

If you take more Fluidin Mucolytic than you should

If you have taken more Fluidin Mucolytic than you should, you may notice stomach pain, nausea, and diarrhea, itching, and skin rash.

If you have taken more Fluidin Mucolytic than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 0420, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Fluidin Mucolytic can cause side effects, although not everyone gets them.

During the period of use of carbocisteine, the following side effects have been observed, whose frequency cannot be established with precision.

Occasionally, nausea, gastric 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 rash, and very rarely, difficulty breathing, have been observed.

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package 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 contribute to providing more information on the safety of this medicine.

5. Storage of Fluidin Mucolytic

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

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the label of the bottle or on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Fluidin Mucolytic:

• The active ingredient is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.
• The other components are: saccharose, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), wild raspberry and orange flavorings, caramel coloring, hydrochloric acid for pH adjustment, sodium hydroxide for pH adjustment, demineralized water. See section 2, "Fluidin Mucolytic contains saccharose, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), and sulfites".

Appearance of the product and contents of the pack:

Fluidin Mucolytic is an oral solution that comes in a glass bottle with a polypropylene/polyethylene high-density (PP/HDPE) cap with a child-proof closure, which contains 200 ml of oral solution and a measuring cup.

The measuring cup has the following measures marked: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this package leaflet:April 2025

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/