Fluimucil 200 mg granules for oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Fluimucil 200 mg effervescent granules for oral solution
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 of this medicine 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 further 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.
Leaflet contents:
- What Fluimucil is and what it is used for
- What you need to know before taking Fluimucil
- How to take Fluimucil
- Possible side 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 helping its removal.
This medicine is indicated to help remove excess mucus and phlegm in colds and flu, for adults and adolescents from 12 years of age.
You should consult a doctor if you worsen 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 and its derivatives, 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 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 after taking the medicine, you should stop treatment and consult your doctor. Caution is advised 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 during the course of treatment.
Children
Children between 2 and 12 years of age 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 medicines.
Concomitant therapy with nitroglycerin may cause headache, and hypotension—which can be severe—should be monitored.
Concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.
Do not administer simultaneously with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may lead to 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.
It is not recommended to dissolve Fluimucil together with other medicines.
Taking Fluimucil with food and drink
Taking this medicine is not affected by food or drink.
Pregnancy and breastfeeding
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.
As a precautionary measure, it is preferable to avoid use during pregnancy.
Fluimucil 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, sorbitol, glucose, and lactose
This medicine contains 25 mg of aspartame per sachet.
Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains 675 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.
This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Fluimucil
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The recommended dose is:
For adults and adolescents aged 12 years and older: 1 sachet of granules every 8 hours. Do not exceed a dose of 3 sachets per day.
How to take:
Fluimucil is taken orally.
Dissolve the contents of the sachet in a glass of water. 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
Children under 12 years of age must not take this medicine.
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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 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 syndrome, sometimes reported with at least concomitant use of another medicinal product.
Frequency not known (cannot be estimated from available data): swelling of the face.
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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via 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 the sight and reach of children.
Do not store above 30°C.
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 Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly 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 sachet of granules contains 200 mg of acetylcysteine.
The other components are: aspartame (E951), sorbitol (E420) and orange flavouring.
Appearance of the product and contents of the pack
Fluimucil is presented as sachets containing white granules.
Each pack contains 30 sachets of granules.
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 leaflet: November 2021
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/.