FLUIMUCIL 40mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Fluimucil 40 mg/ml Oral Solution

Acetylcysteine

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

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

• Keep this package leaflet, 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 package 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. Storage of the Package 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.

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 medicine (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 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 and Adolescents

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

Taking Fluimucil with Other Medicines

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

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 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 fluidified 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, 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 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 sodium, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sorbitol, and propylene glycol

This medicine contains 32.77 mg of sodium (main component of table salt/cooking salt) in each 5 ml dose. 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 methyl p-hydroxybenzoate and propyl p-hydroxybenzoate.

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

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 56 mg of propylene glycol in each 5 ml dose.

3. How to Take Fluimucil

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

The recommended dose is:

In adults: 15 ml of oral solution 1 time a day. Do not exceed the dose of 15 ml per day.

How to take:

Fluimucil is taken orally.

Measure the amount of medicine to take with the measuring cup included in the box and swallow it directly. It is recommended to drink a glass of water after each dose and a large amount 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 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, heartburn, 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 everybody 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 at least with the simultaneous intake of another medicine.

Frequency not known (cannot be estimated from the 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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluimucil

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Discard the package 15 days after opening.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines 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 ml contains 40 mg of acetylcysteine.

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Zambon S.A.U.

Maresme 5, Can Bernades-Subirà Industrial Estate

08130 Sta. Perpètua de Mogoda, Barcelona

Spain

Manufacturer:

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza (Italy)

Date of the Last Revision of this Package Leaflet: November 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/.