Mucosan 6 mg/ml syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mucosan 6 mg/ml syrup
Ambroxol hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for taking this medicine as described 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 5 days.
Contents of the leaflet
- What Mucosan is and what it is used for
- What you need to know before taking Mucosan
- How to take Mucosan
- Possible side effects
- How to store Mucosan
- Contents of the pack and other information
1. What Mucosan is and what it is used for
Ambroxol, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, liquefying it and facilitating its elimination.
This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults and children from 2 years of age.
You should consult a doctor if you get worse or do not improve after 5 days.
2. What you need to know before taking Mucosan
Do not take Mucosan
If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
In children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Mucosan.
If you have kidney or liver function problems, consult your doctor before using this medicine.
Serious skin reactions have been reported in association with ambroxol hydrochloride administration. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genital area), stop using Mucosan and contact your doctor immediately.
Children
Mucosan is contraindicated in children under 2 years of age.
In children aged 2 to 6 years, consult a doctor.
Other medicines and Mucosan
Using Mucosan with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Mucosan with food and drinks
Mucosan can be taken with or without food.
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.
No harmful effects have been observed during pregnancy. However, usual precautions regarding the use of medicines during pregnancy should be followed.
The use of Mucosan is not recommended, especially during the first trimester of pregnancy.
Animal studies have shown that the active substance of this medicine, ambroxol hydrochloride, passes into breast milk. Although harmful effects on the infant are not expected, its use should be avoided during breastfeeding.
There are no clinical data available on fertility with ambroxol hydrochloride.
Animal studies have not indicated any direct or indirect adverse effects on fertility.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Mucosan contains benzoic acid
This medicine contains 0.5 mg of benzoic acid per ml. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns.
Mucosan contains propylene glycol
This medicine contains 5.75 mg of propylene glycol per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been administered other medicines containing propylene glycol or alcohol.
3. How to take Mucosan
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults: 10 ml, twice daily (every 12 hours), corresponding to a maximum daily dose of 120 mg of ambroxol hydrochloride.
Once the patient's condition improves, the dose may be reduced by half.
Adolescents over 12 years: 5 ml to 7.5 ml, according to need (30 mg to 45 mg of ambroxol hydrochloride), twice daily (every 12 hours), corresponding to a maximum daily dose of 60 to 90 mg of ambroxol hydrochloride.
Use in children
Children aged 6 to 12 years: 1 measure of 2.5 ml, 2–3 times daily (every 8–12 hours, as needed), corresponding to a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2–3 days, once the patient improves, the dosing regimen may be reduced to twice daily (every 12 hours).
Children aged 2 to 5 years: 1 measure of 1.25 ml, 3 times daily (every 8 hours), corresponding to a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2–3 days, once the patient improves, the dosing regimen may be reduced to twice daily (every 12 hours).
How to take:
Mucosan is taken orally.
Measure the amount of medicine to be taken using the measuring device provided in the package.
It is recommended to drink a glass of water after each dose and to maintain abundant fluid intake throughout the day.
You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment (3 days in children under 6 years of age).
If you take more Mucosan than you should
If you have taken more Mucosan than you should, you may experience nausea, altered taste sensation, numbness of the pharynx, numbness of the mouth, or any other adverse reaction 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 915 620 420, indicating the medicine and the amount ingested.
In case of accidental massive administration, symptomatic treatment is recommended.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:
- Frequent (may affect up to 1 in 10 people): nausea, altered taste sensation, numbness of the pharynx, numbness of the mouth.
- Uncommon (may affect up to 1 in 100 people): vomiting, diarrhoea, indigestion, abdominal pain, dry mouth.
- Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria, dry throat.
- Frequency not known (cannot be estimated from available data): anaphylactic reactions, anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes or submucosal tissues), and pruritus. Serious skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
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 may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mucosan
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 is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mucosan
- The active substance is ambroxol hydrochloride. Each ml of syrup contains 6 mg of ambroxol hydrochloride.
- The other components are: hydroxyethylcellulose, sucralose, benzoic acid (E-210), strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), and purified water.
Appearance of the product and contents of the container
Mucosan is available in 100 ml or 250 ml bottles of syrup with a plastic child-resistant safety cap. The product is slightly viscous, clear and almost colourless. It has a fruity, aromatic strawberry cream odour.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Opella Healthcare Spain, S.L.
C/ Rosselló i Porcel, 21
08016 Barcelona,
Spain
Manufacturer:
- Nattermann & Cie. GmbH
Nattermannallee 1
50829 Köln
Germany
or
Delpharm Reims, S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims
France
or
Opella Healthcare Italy, S.r.l.
viale Europa 11, 21040
Origgio (Va)
Italy
Date of the most recent review of this leaflet: November 2025
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/68110/P_68110.html
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.