Package Insert: Information for the User

Fluimucil Forte 600 mg Effervescent Tablets

Acetylecysteine

Read this 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.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4
• You should consult a doctor if you do not improve after 5 days.

Acetilcisteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it, 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 does not improve after 5 days.

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 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 must consult with your doctor before taking this medication.

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is spoiled.

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor or pharmacist. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers.

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

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 used recently, or may need to use any other medication.

Concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

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

Do not take concurrently with cough suppressants or with medications that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or antibiotics like amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your Fluimucil intake from the medication intake by at least 2 hours.

Do not 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is recommended to avoid taking this medication during breastfeeding.

Driving and operating machinery

There is no evidence of effects on the ability to drive and operate machinery.

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 cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

This medication contains glucose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) due to the presence of sulfites.

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

The recommended dose is:

Adults: 1 tablet, once a day. Do not exceed a 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 ceased. It is recommended to drink an abundant amount of liquid during the day.

You should consult a doctor if you worsen or do not improve after 5 days of treatment.

Use in children and adolescents

Children and adolescents cannot 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, heartburn, and stomach pain, diarrhea, or any other adverse effect described in section 4. Possible adverse effects.

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

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

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

The following adverse effects may occur:

Rare (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.

Uncommon (may affect up to 1 in 1,000 patients): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

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 simultaneous use of another medication.

Unknown frequency (cannot be estimated from available data): facial swelling.

In the event of any skin or mucous membrane alteration, discontinue acetaminophen administration immediately and seek medical assistance.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 aroma (contains glucose and sulfites).

Appearance of the product and contents of the packaging

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

Each package contains 10 or 20 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Zambon S.A.U.

Maresme 5. Polígono Can Bernades-Subirà

08130 Sta. Perpètua de Mogoda-Barcelona

Responsible for manufacturing:

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

Last review date of this leaflet: November 2021

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/.