FLUIMUCIL FORTE 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Fluimucil Forte 600 mg Effervescent Tablets

Acetylcysteine

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

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

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

Contents of the Package 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 medication, belongs to a group of medications called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

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

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 or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years of age.

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 with your doctor before taking this medication.

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

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

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

Children and Adolescents

Children and adolescents should not take this medication. There are other presentations more suitable for this population.

Taking Fluimucil with Other Medications

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

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

Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

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

When taking any medication that contains minerals such as iron or calcium, or any medication 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 these medications by at least 2 hours.

It is not recommended to dissolve Fluimucil with other medications.

Taking Fluimucil with Food and Beverages

The intake of food and beverages does not affect the efficacy of this medication.

Pregnancy, Breastfeeding, and Fertility

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

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, Sodium, Glucose, and Sulfites

This medication contains 20 mg of aspartame in each tablet.

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 correctly.

This medication contains 157.9 mg of sodium (main component of table salt) in each tablet. This is equivalent to 7.9% of the maximum daily sodium intake recommended for an adult.

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

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

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3. How to Take Fluimucil

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

The recommended dose is:

Adults: 1 tablet, 1 time a day. Do not exceed the dose of 1 tablet per day.

How to take:

Fluimucil is taken orally.

Dissolve in a glass of water, do not drink until the effervescence has completely stopped. 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 and Adolescents

Children and adolescents should not take this medication. 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, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount taken.

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

4. Possible Side Effects

Like all medications, Fluimucil can cause side effects, although not all people experience 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 medication.

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

In case of any alteration in the skin or mucous membranes, the administration of acetylcysteine should be interrupted immediately and medical assistance should be sought.

Reporting of Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fluimucil

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluimucil

The active ingredient is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.

The other components (excipients) are: aspartame (E951), sodium hydrogen carbonate, anhydrous citric acid (E330), and lemon flavor (contains glucose and sulfites).

Appearance of the Product and Package Contents

Fluimucil is presented in blisters with effervescent tablets, flat and white in color.

Each package contains 10 or 20 effervescent tablets.

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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.