Package Leaflet: Information for the user

Fluimucil 40 mg/ml oral solution

Acetylcysteine

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any 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.

Acetylecysteine, the active ingredient of thismedication, 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.

Consult a doctor if it worsens or does not improve after 5 days.

Do not take Fluimucil:

• If you are allergic to acetylcysteine or 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 in poor condition.

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

During the first few days of treatment, you may observe 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.

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

The concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not administer concomitantly with cough suppressants or with medications that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or medications with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate your intake of Fluimucil 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, lactation, 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.

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

Its use should be avoided during lactation.

Driving and operating machinery

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

Fluimucil contains sodium, p-hydroxybenzoate of methyl, p-hydroxybenzoate of propyl, sorbitol, and propylene glycol

This medication contains 32.77 mg of sodium (main component of table salt/for cooking) in each dose of 5 ml. This is equivalent to 1.64% of the maximum daily sodium intake recommended for an adult.

It may cause allergic reactions (possibly delayed) because it contains p-hydroxybenzoate of methyl and p-hydroxybenzoate of propyl.

This medication contains 420 mg of sorbitol in each dose of 5 ml.

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

This medication contains 56 mg of propylene glycol in each dose of 5 ml.

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:

For adults: 15 ml of oral solution once a day. Do not exceed a dose of 15 ml per day.

How to take:

Fluimucil is taken orally.

Measure the amount of medication to take with the dosing cup provided in the box, and ingest it directly. It is recommended to drink a glass of water after each dose and abundant amounts of liquid throughout 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 experience: 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 immediately, 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 all people may 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, which may be identified in some cases 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.

Dispose of the packaging within 15 days of opening.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fluimucil

The active ingredient is acetylcysteine. Each ml contains 40 mg of acetylcysteine.

The other components are: methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), sodium edetate, sodium saccharin, sodium saccharinate, sorbitol (E420), strawberry flavor, orange blossom flavor, sodium hydroxide, and purified water.

Appearance of the product and content of the packaging

Fluimucil is presented in amber glass bottles with 100 or 200 ml of oral solution. Its appearance is that of a transparent and colorless solution. It has a fruity strawberry-orange blossom odor. A plastic and graduated dosing cup is included for the correct dosing of the medication.

Holder of the marketing authorization and manufacturer responsible Holder of the marketing authorization

Zambon S.A.U.

Maresme 5. Can Bernades-Subirà Industrial Estate

08130 Sta. Perpètua de Mogoda-Barcelona

Spain

Manufacturer responsible:

Zambon, S.p.A.

Via della Chimica, 9

36100-Vicenza (Italy)

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/.