FLUIDIN MUCOLYTIC 50 MG/ML ORAL SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluidín Mucolytic 50 mg/ml oral solution

Carbocysteine

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

• Follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor or pharmacist.
• Keep this leaflet, as you may need to read 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.
• You must consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Contents of the leaflet:

1. What Fluidín Mucolytic is and what it is used for.
2. What you need to know before taking Fluidín Mucolytic.
3. How to take Fluidín Mucolytic.
4. Possible adverse effects.
5. How to store Fluidín Mucolytic.
6. Contents of the pack and other information.

1. What Fluidín Mucolítico is and what it is used for

Carbocisteine, the active ingredient in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it less thick and facilitating its elimination.

Fluidín Mucolítico is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults and adolescents aged 12 years and older.

2. What you need to know before starting to take Fluidín Mucolytic

Do not take Fluidín Mucolytic:

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

Warnings and precautions

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

• If you have asthma or any other serious respiratory disease, as it may increase obstruction of the airways.
• During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.

Taking Fluidín Mucolytic with other medicines

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

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

Taking Fluidín Mucolytic with food and drinks

Take this medicine preferably before meals.

Use in children

This medicine must not be given to children under 12 years of age.

Pregnancy and breastfeeding

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

This medicine should not be used during pregnancy unless specifically advised by your doctor.

Driving and using machines

The effect of Fluidín Mucolytic on the ability to drive and operate machinery is none or negligible.

Fluidín Mucolytic contains sucrose, methylparaben sodium salt (E-219), propylparaben sodium salt (E-217), and sulfites

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 2 g of sucrose per 5 ml.

It may cause allergic reactions (possibly delayed) because it contains methylparaben sodium salt (E-219) and propylparaben sodium salt (E-217).

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

3. How to take Fluidín Mucolítico

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents from 12 years of age: Initially 15 ml (750 mg of carbocisteine) three times daily. Once improvement is observed, the dose may be reduced to 10 ml (500 mg of carbocisteine) three times daily.

Use in children

Children under 12 years of age must not take this medicine.

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

Instructions for correct administration of the preparation

Take the required amount of medicine using the dosing cup provided in the package, which is marked with the following measurements: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml.

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

After use, wash the dosing cup with water.

It is recommended to drink a glass of water after each dose and to maintain abundant fluid intake throughout the day.

If your symptoms worsen, if there is no improvement after 5 days of treatment, or if fever, skin rash, persistent headache, or sore throat occur, 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 rashes.

If you have taken more Fluidín Mucolítico than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 0420, stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Fluidín Mucolítico can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed during the period of use of carbocisteine, although their frequency cannot be accurately determined.

Occasionally, nausea, gastric discomfort or diarrhoea may occur, which usually disappear when the dose is reduced.

Rarely, other reactions such as bleeding in the stomach or intestine, headache, itching and skin rashes have been observed, and very rarely difficulty in breathing.

In these cases, it is advisable to stop treatment and consult a doctor.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluidín Mucolytic

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the label of the bottle or the carton, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluidín Mucolítico:

• The active substance is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.
• The other components are: sucrose, methylparahydroxybenzoate, sodium salt (E-219), propylparahydroxybenzoate, sodium salt (E-217), raspberry and orange flavorings, carameline, hydrochloric acid for pH adjustment, sodium hydroxide for pH adjustment, demineralized water. See section 2, “Fluidin Mucolítico contains sucrose, methylparahydroxybenzoate sodium salt (E-219), propylparahydroxybenzoate sodium salt (E-217) and sulfites”.

Appearance of the product and contents of the pack:

Fluidín Mucolítico is an oral solution presented in a glass bottle with a polypropylene/high-density polyethylene (PP/HDPE) cap equipped with a child-resistant closure (Child-Proof), containing 200 ml of oral solution and a dosing cup.

The dosing cup is marked with the following measurements: 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml.

Marketing Authorization Holder

Laboratorios Veris, S.A.

Parque Empresarial Cristalia

Vía de los Poblados, 3 – Edif. 2 – 2ºizda.

28033 Madrid (Madrid)

Spain

Manufacturer

Faes Farma, S.A.

Scientific and Technological Park of Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/