Patient Information Leaflet

Flumilexa 600 mg Effervescent Tablets EFG

Acetylecysteine

Read this leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 that involve 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.

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 in children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Flumilexa

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 after taking the medication, discontinue treatment and consult your doctor. Caution is recommended in patients with peptic ulcers or a history of peptic ulcers.

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

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

Children

It is contraindicated in children under 2 years old.

Flumilexa 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 effectiveness of carbamazepine.

Do not take concomitantly with cough medications or those that decrease 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 such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake from Flumilexa by at least 2 hours.

Do not dissolve Flumilexa with other medications.

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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It should be avoided during lactation.

Driving and operating machines

There is no evidence of effects on the ability to drive and operate 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 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 an intolerance to certain sugars, 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.

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

The effervescent tablets must be dissolved in a glass of water, and must be ingested when they have completely dissolved. It is recommended to drink an abundant amount of liquid during the day.

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

Use in children

Children between 2 and 7 years old

The 600 mg dose is not recommended.

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

It is contraindicated in children under 2 years old.

If you take more Flumilexathan you should

If you take more Flumilexa 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 ingested.

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

Like all medications, Flumilexa may produce adverse effects, although not all people 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, identified in cases where at least one other medication is taken simultaneously.

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

In the event of any skin or mucous membrane alteration, discontinue acetilcisteína 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 a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat 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 Flumilexa 600 mg effervescent tablets

- The active ingredient is Acetilcisteína.

- The other components are: aspartamo (E951), sodium hydrogen carbonate, citric acid (E330) and lemon aroma (contains glucose and sulfites).

Appearance of the product and contents of the packaging

Flumilexa600 mg are effervescent tablets.

Each package contains30effervescent tablets.

Holder of the marketing authorizationand manufacturer

Holder of the marketing authorization

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

Last review date of this leaflet:June 2018

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