FLUMILEXA 600 mg EFFERVSCENT TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Flumilexa 600 mg Effervescent Tablets EFG

Acetylcysteine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

1. What Flumilexa is and what it is used for

Flumilexa belongs to a group of medications called mucolytics and is used to liquefy excessive and/or thick bronchial secretions.

Flumilexa is indicated to facilitate the elimination of excess mucus and phlegm in respiratory processes with excessive or thick mucous secretion, such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of fibrosis, and other related pathologies.

2. What you need to know before taking Flumilexa

Do not take Flumilexa:

• If you are allergic to the active ingredient or 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 Flumilexa.

If you have asthma or a severe respiratory disease, you should consult 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, stop treatment and consult your doctor. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

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

It should be administered with caution in long-term treatment in patients with histamine intolerance.

Children

It is contraindicated in children under 2 years of age.

Taking Flumilexa 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 cause 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 those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of liquefied mucus.

When taking any medication containing 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 Flumilexa by at least 2 hours.

It is not recommended to dissolve Flumilexa with other medications.

Taking Flumilexa with food and beverages

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

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 medication.

Its use should be avoided during breastfeeding.

Driving and using machines

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

Flumilexa 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 disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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 told you 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.

3. How to take Flumilexa

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

The effervescent tablets should be dissolved in a glass of water and ingested when they have dissolved completely. It is recommended to drink plenty of liquid throughout the day.

The recommended daily dose for adults and children over 7 years is 600 mg of acetylcysteine, 1 tablet of Flumilexa 600 mg once a day (600 mg of acetylcysteine once a day), or 3 doses of 200 mg every 8 hours (for this last option, there are other more suitable formulations) without exceeding the daily dose of 600 mg.

Use in children

Children between 2 and 7 years

The 600 mg dose is not recommended.

There are other formulations more suitable for administering to this population.

It is contraindicated in children under 2 years of age.

If you take more Flumilexa than you should

If you take more Flumilexa 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 medication and the amount ingested.

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

4. Possible side effects

Like all medications, Flumilexa can cause side effects, although not everyone will 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.

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

Reporting of side effects

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

5. Storage of Flumilexa

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

Do not use this medication after the expiration date stated 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 Flumilexa 600 mg Effervescent Tablets

• The active ingredient is Acetylcysteine.
• The other components are: aspartame (E951), sodium hydrogen carbonate, citric acid (E330), and lemon flavor (contains glucose and sulfites).

Appearance of the product and package contents

Flumilexa 600 mg are effervescent tablets.

Each package contains 30 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:June 2018

“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/”