Flumilexa 600 mg effervescent tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Flumilexa 600 mg effervescent tablets EFG
Acetylcysteine
Read the entire 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Flumilexa is and what it is used for.
- What you need to know before taking Flumilexa.
- How to take Flumilexa.
- Possible side effects.
- How to store Flumilexa.
- Contents of the pack and other information.
1. What Flumilexa is and what it is used for
Flumilexa belongs to a group of medicines called mucolytics and is used to liquefy excessive and/or thick bronchial secretions.
Flumilexa is indicated to facilitate the removal of excess mucus and phlegm in respiratory conditions associated with excessive or thick mucus 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 starting to take Flumilexa
Do not take Flumilexa:
- If you are allergic to the active substance 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 Flumilexa
If you have asthma or suffer from a serious 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 substance and does not indicate that the medicine is in poor condition.
If you experience stomach discomfort when taking the medicine, discontinue 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 gradually decrease over the course of treatment.
Should be administered with caution in long-term treatment of patients with histamine intolerance.
Children
Use in children under 2 years of age is contraindicated.
Taking Flumilexa with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.
Concomitant therapy with nitroglycerin may cause headache and the occurrence of hypotension, which may be severe, should be monitored.
Concomitant administration with the antiepileptic carbamazepine may lead to reduced efficacy of carbamazepine.
Do not take together with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.
When taking any medicine containing minerals such as iron or calcium, or medicines with antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), separate the administration from that of Flumilexa by at least 2 hours.
Dissolving Flumilexa with other medicines is not recommended.
Taking Flumilexa with food and drink
Taking food and drink does not affect the effectiveness of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Its use should be avoided during breastfeeding.
Driving and using machines
There is no evidence of effects on the ability to drive or operate machinery.
Flumilexa contains aspartame, sodium hydrogen carbonate, glucose, and sulfites
This medicine contains 20 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
This medicine contains approximately 157 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 7.9% of the maximum recommended daily sodium intake for an adult.
This medicine contains glucose (as part of the lemon flavor). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sulfites (as part of the lemon flavor).
3. How to take Flumilexa
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The effervescent tablets must be dissolved in a glass of water and should be taken once completely dissolved. It is recommended to drink plenty of fluids throughout the day.
The recommended daily dose for adults and children over 7 years of age is 600 mg of acetylcysteine: 1 tablet of Flumilexa 600 mg once daily (600 mg acetylcysteine once daily), or 3 doses of 200 mg every 8 hours (for this latter option, other formulations are more suitable), without exceeding the daily dose of 600 mg.
Use in children
Children between 2 and 7 years of age
The 600 mg dose is not recommended.
Other formulations more suitable for this population are available.
Flumilexa 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 experience: nausea, vomiting, stomach burning and 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Flumilexa may cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:
Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, 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, breathing difficulty, gastrointestinal discomfort.
Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome, occasionally identified in association with the concomitant use of another medicinal product.
Frequency not known (cannot be estimated from available data): facial swelling.
If any changes occur in the skin or mucous membranes, administration of acetylcysteine must be stopped immediately and medical advice sought.
Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Flumilexa Storage
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Flumilexa 600 mg effervescent tablets
- The active substance is Acetylcysteine.
- The other components are: aspartame (E951), sodium hydrogen carbonate, citric acid (E330), and lemon flavour (contains glucose and sulphites).
Appearance of the medicinal product and contents of the pack
Flumilexa 600 mg are effervescent tablets.
Each pack contains 30 effervescent tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 most recent revision of this package leaflet: June 2018
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”