Mucoactiol 50 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
MucoActiol 50 mg/ml Oral solution
Carbocysteine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for taking this medicine contained in this leaflet or those provided 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.4.
- You should consult your doctor if you worsen or do not improve after 5 days of treatment.
Contents of the leaflet:
- What MucoActiol is and what it is used for.
- What you need to know before taking MucoActiol.
- How to take MucoActiol.
- Possible side effects.
- How to store MucoActiol.
- Contents of the pack and other information.
1. What MucoActiol is and what it is used for
Carbocysteine, the active substance of this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, thereby liquefying it and facilitating its elimination.
This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults and adolescents aged 12 years and older.
You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.
2. Before taking MucoActiol
Do not take MucoActiol
If you are allergic to carbocisteine, to a related compound, or to any of the other components of this medicine (listed in section 6).
This medicine is contraindicated in children under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to take MucoActiol:
- If you have a stomach or duodenal ulcer, or if you have any thyroid disease.
- If you have asthma or any severe respiratory disease, as it may increase airway obstruction.
- During the first few days, you may notice an increase in mucus and phlegm, which will gradually decrease during treatment.
Children
Children under 12 years of age must not take this medicine.
Taking MucoActiol with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take this medicine with medications used to suppress non-productive cough (antitussives) or with medications used to inhibit bronchial secretions, as this may cause accumulation of liquefied mucus.
Taking MucoActiol with food and drink
Take this medicine preferably before meals.
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.
This medicine should not be used during pregnancy or breastfeeding unless your doctor has instructed you to do so.
Driving and using machines
The effect of MucoActiol on the ability to drive and use machines is none or negligible.
MucoActiol contains tartrazine (E-102), sodium methyl parahydroxybenzoate (E-219), and sodium.
This medicine may cause allergic reactions because it contains tartrazine (E-102). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.
This medicine may cause allergic reactions (possibly delayed) because it contains sodium methyl parahydroxybenzoate (E-219).
This medicine contains 121 mg of sodium (main component of table/cooking salt) in each 15 ml. This corresponds to 6% of the maximum daily recommended sodium intake for an adult.
3. How to take MucoActiol
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.
Recommended dose:
Adults and adolescents over 12 years of age:
1 dose of 15 ml measured with the dosing cup 3 times daily.
Once improvement is observed, the dose may be reduced to 10 ml, 3 times daily.
Use in children:
Children under 12 years of age must not take this medicine.
Take this medicine orally, preferably before meals.
Measure the amount of medicine to be taken using the dosing cup provided in the package.
It is recommended to drink a glass of water after each dose and plenty of fluids throughout the day.
If your condition worsens or does not improve after 5 days of treatment, or if fever, skin rashes, persistent headache or sore throat occur, you should consult your doctor.
If you take more MucoActiol than you should
If you have taken more MucoActiol than you should, you may experience stomach pain, nausea and diarrhea, itching and skin rashes.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, stating the medicine and the amount taken.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
During the period of carbocysteine use, the following adverse effects have been observed, whose frequency cannot be accurately determined. Allergic reactions may occur, such as skin rash, urticaria, itching, and erythema multiforme (a severe allergic skin reaction causing raised red spots that may form blisters).
Gastrointestinal disorders (diarrhea, nausea, vomiting, upper abdominal pain, gastrointestinal bleeding), headache, dizziness, difficulty breathing with or without whistling sounds (bronchospasm), may also occur.
In such cases, it is recommended to discontinue treatment and consult your doctor.
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 Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of MucoActiol
Keep this medicine out of the sight and reach of children.
Store below 25°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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of MucoActiol 50 mg/ml Oral Solution
The active substance in MucoActiol 50 mg/ml Oral Solution is carbocisteine. Each ml of oral solution contains 50 mg of carbocisteine.
The other components are: sodium hydroxide, sodium carmellose, sucralose, disodium phosphate, tartrazine (E-102), sodium methyl parahydroxybenzoate (E-219), vanilla flavouring, and purified water.
Appearance of the medicinal product and contents of the pack
MucoActiol is a yellow-coloured solution with a vanilla odour, supplied in 200 ml bottles, with a dosing cup marked to allow doses of 10 and 15 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall, S.A. General Mitre, 151 08022 Barcelona (Spain)
Manufacturer
Industrias Farmacéuticas Almirall, S.A., Ctra. de Martorell, 41-61, 08740 - Sant Andreu de la Barca – Barcelona (Spain).
Date of the most recent revision of this leaflet:
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es