FLUIMUCIL 200 mg ORAL SOLUTION GRANULES

Introduction

Leaflet: Information for the user

Fluimucil 200 mg granules for oral solution

Acetylcysteine

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

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

• Keep this 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 not listed in this leaflet. See section 4.
• You should consult a doctor if you do not improve after 5 days.

Contents of the leaflet:

1. What is Fluimucil and what is it used for
2. What you need to know before taking Fluimucil
3. How to take Fluimucil
4. Possible side effects
5. Storage of Fluimucil
6. Package contents and additional information

1. What is Fluimucil and what is it used for

Acetylcysteine, the active ingredient of this medicine, belongs to a 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 a doctor if it worsens or if it does not improve after 5 days.

2. What you need to know before taking Fluimucil

Do not take Fluimucil:

• If you are allergic to acetylcysteine and its derivatives, or to any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluimucil.

If you are asthmatic or have a severe respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active ingredient, but it does not indicate that the medicine is in poor condition.

If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will decrease throughout the treatment.

Children

Children between 2 and 12 years old should not take this medicine.

There are other presentations more suitable for this population.

Taking Fluimucil with other medicines

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

Concomitant therapy with nitroglycerin may cause headache and hypotension should be monitored, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may decrease the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medicines (for cough) or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidized mucus.

When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of Fluimucil from the intake of the other medicine by at least 2 hours.

It is not recommended to dissolve Fluimucil with other medicines.

Taking Fluimucil with food and drinks

The intake of food and drinks does not affect the efficacy of this medicine.

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.

As a precaution, it is preferable to avoid its use during pregnancy.

Its intake should be avoided during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive and use machines.

Fluimucil contains Aspartame, Sorbitol, Glucose, and Lactose

This medicine contains 25 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains 675 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

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

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

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3. How to take Fluimucil

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

The recommended dose is:

For adults and adolescents from 12 years old: 1 sachet of granules every 8 hours. Do not exceed the dose of 3 sachets per day.

How to take:

Fluimucil is taken orally.

Dissolve the contents of the sachet in a glass of water. It is recommended to drink plenty of liquid throughout the day.

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

Use in children

Children under 12 years old should not take this medicine.

There are other presentations more suitable for this population.

If you take more Fluimucil than you should

If you take more Fluimucil than you should, you may notice: nausea, vomiting, burning and stomach pain, diarrhea, or any other side effect described in section 4. Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount taken.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another drug.

Frequency not known (cannot be estimated from available data): facial swelling.

If any skin or mucous membrane disorder occurs, the administration of acetylcysteine should be discontinued immediately and medical assistance should be sought.

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is 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 contribute to providing more information on the safety of this medicine.

5. Storage of Fluimucil

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Fluimucil

The active ingredient is acetylcysteine. Each sachet of granules contains 200 mg of acetylcysteine.

The other ingredients are: aspartame (E951), sorbitol (E420), and orange flavor.

Appearance of the product and package contents

Fluimucil is presented in the form of sachets with white granules.

Each package contains 30 sachets of granules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Zambon S.A.U.

Maresme 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda-Barcelona

Manufacturer:

Zambon, S.p.A.

Via della Chimica, 9,

36100 Vicenza (Italy)

Zambon S.A.U.

Maresme, 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda – Barcelona

Date of the last revision of this leaflet: November 2021

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/.