Fluimucil Forte 600 mg effervescent tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fluimucil Forte 600 mg effervescent tablets
Acetylcysteine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if you do not feel better after 5 days.
Contents of the leaflet
- What Fluimucil is and what it is used for
- What you need to know before taking Fluimucil
- How to take Fluimucil
- Possible adverse effects
- How to store Fluimucil
- Contents of the pack and other information
1. What Fluimucil is and what it is used for
Acetylcysteine, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it less thick and easier to expel.
This medicine is indicated to help remove excess mucus and phlegm in colds and flu, for adults.
You should consult a doctor if you get worse or do not improve after 5 days.
2. What you need to know before starting to take Fluimucil
Do not take Fluimucil:
- If you are allergic to acetylcysteine or to any of the other ingredients 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 have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.
The possible sulphurous smell (like rotten eggs) of the medicine is due to the active substance and does not indicate that the medicine is spoiled.
If you experience stomach discomfort while taking the medicine, stop treatment and consult your doctor or pharmacist. Caution is advised in patients with peptic ulcer or a 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.
Children and adolescents
Children and adolescents should not take this medicine. There are other formulations more suitable for this population.
Taking Fluimucil 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 medicines containing minerals such as iron or calcium, or medicines with antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), separate their administration from that of Fluimucil by at least 2 hours.
Dissolving Fluimucil together with other medicines is not recommended.
Taking Fluimucil with food and drinks
Taking this medicine is not affected by food or drink.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might 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.
Fluimucil contains aspartame, sodium hydrogen carbonate, glucose and sulphites
This medicine contains 20 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful if you suffer from 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 (a main component of table/cooking salt) per tablet. This corresponds to 7.9% of the maximum daily recommended sodium intake for an adult.
This medicine contains glucose (as part of the lemon flavour). If your doctor has diagnosed you with 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 sulphites (as part of the lemon flavour).
3. How to take Fluimucil
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Recommended dose:
Adults: 1 tablet, once daily. Do not exceed the dose of 1 tablet per day.
How to take:
Fluimucil is taken orally.
Dissolve in a glass of water; do not drink until effervescence has completely stopped. It is recommended to drink plenty of fluids throughout the day.
You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.
Use in children and adolescents
This medicine must not be used in children and adolescents. There are other formulations 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, burning sensation and stomach pain, diarrhoea, or any other adverse effect described in section 4. Possible side effects.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91.562.04.20, indicating the medicine and the amount taken.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Fluimucil 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, sometimes identified with the concomitant intake of another medicinal product.
Frequency not known (cannot be estimated from available data): facial swelling.
If any skin or mucous membrane changes occur, administration of acetylcysteine must be stopped immediately and medical advice should be sought.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may 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. Storage of Fluimucil
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
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 medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fluimucil
The active substance is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
The other components (excipients) are: aspartame (E951), sodium hydrogen carbonate, citric acid (E330) and lemon flavour (contains glucose and sulphites).
Nature and contents of the product and pack
Fluimucil is available in blisters containing effervescent tablets, flat and white in colour.
Each pack contains 10 or 20 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 patient information leaflet: November 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.