Fluimucil 40 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Fluimucil 40 mg/ml 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 administration contained in this leaflet or those indicated 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 improve 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
- Disposal of the container and additional 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 thinner and easier to eliminate.
This medicine is indicated to help remove excess mucus and phlegm in colds and flu, for adults.
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 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 Fluimucil.
If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.
The possible sulphurous (rotten egg) odour of the medicine is characteristic of the active ingredient and does not indicate that the medicine is in poor condition.
If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor. Caution is advised in patients with peptic ulcer or a history of peptic ulcer.
During the first few days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.
Children and adolescents
Children and adolescents should not take this medicine. There are other more suitable formulations available 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 should be monitored for the development of hypotension, which could be severe.
Concomitant administration with the antiepileptic carbamazepine may lead to a reduction in carbamazepine efficacy.
Do not administer simultaneously with antitussive (cough-suppressant) medicines or with 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 containing antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), separate their administration from Fluimucil by at least 2 hours.
Dissolving Fluimucil together with other medicines is not recommended.
Taking Fluimucil with food and drinks
Taking food and drinks does not affect the effectiveness of this medicine.
Pregnancy, breastfeeding, and fertility
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.
As a precautionary measure, it is preferable to avoid use during pregnancy.
You should avoid taking this medicine during breastfeeding.
Driving and using machines
There is no evidence of effects on the ability to drive or operate machinery.
Fluimucil contains sodium, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sorbitol, and propylene glycol
This medicine contains 32.77 mg of sodium (the main component of table/cooking salt) in each 5 ml dose. This corresponds to 1.64% of the maximum daily recommended sodium intake for an adult.
It may cause allergic reactions (possibly delayed) because it contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate.
This medicine contains 420 mg of sorbitol in each 5 ml dose.
Sorbitol is a source of fructose. If your doctor has informed 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 before taking this medicine.
This medicine contains 56 mg of propylene glycol in each 5 ml dose.
3. How to take Fluimucil
Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
In adults: 15 ml of oral solution once daily. Do not exceed the dose of 15 ml per day.
How to take it:
Fluimucil is taken orally.
Measure the amount of medicine to be taken using the dosing cup provided in the package, and take it directly. It is recommended to drink a glass of water after each dose and to consume abundant 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, stomach burning and pain, diarrhoea, or any other adverse effect described in section 4. Possible adverse effects.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, 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 produce 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 identified at least with the concomitant use of another medicinal product.
Frequency not known (cannot be estimated from the available data): Facial swelling.
If any skin changes or mucosal membrane alterations 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 such adverse effects are 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.
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.
Discard the container 15 days after opening.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, 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 Fluimucil
The active substance is acetylcysteine. Each ml contains 40 mg of acetylcysteine.
The other components are: methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), disodium edetate, sodium carmellose, sodium saccharin, sorbitol (E420), strawberry flavour, grenadine flavour, sodium hydroxide, and purified water.
Nature of the product and contents of the container
Fluimucil is supplied in amber glass bottles containing 100 or 200 ml of oral solution. It is a clear, colourless solution with a fruity strawberry-grenadine odour. A plastic graduated dosing cup is included for accurate administration of the medicine.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zambon S.A.U.
Maresme 5. Polígono Can Bernades-Subirà
08130 Sta. Perpètua de Mogoda-Barcelona
Spain
Manufacturer:
Zambon, S.p.A.
Via della Chimica, 9
36100-Vicenza (Italy)
Date of the most recent review of this leaflet: November 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.