Package Leaflet:Information for the User

Mucosan Pediatric 3 mg/mlSyrup

Ambroxol Hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

1. What Mucosan is and what it is used for

2. What you need to know before starting to take Mucosan

3. How to take Mucosan

4. Possible side effects

5. Storage of Mucosan

6. Contents of the pack and additional information

Ambroxol, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it, and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for children aged 2 to 12 years.

Consult a doctor if it worsens or does not improve after 5 days.

Do not take Mucosan

• If you are allergic to ambroxol hydrochloride or any of the other components of this medication (listed in section 6).
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mucosan.

If you have kidney or liver function problems, consult your doctor before using this medication.

Severe skin reactions have been reported associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using Mucosan and consult 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 medications and Mucosan

Use of Mucosan with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Mucosan with food and drinks

Mucosan can be taken with or without meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

No adverse effects have been observed during pregnancy. However, usual precautions should be taken regarding the use of medications during pregnancy.

The use of Mucosan is not recommended, especially in the first trimester of pregnancy.

Studies in animals have shown that the active ingredient of this medication, ambroxol hydrochloride, passes into breast milk, and although no adverse effects are expected in the infant, its use should be avoided during breastfeeding.

Animal studies do not indicate direct or indirect adverse effects on fertility.

No clinical data are available on fertility for ambroxol hydrochloride.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

Mucosan contains benzoic acid

This medication contains 0.5 mg of benzoic acid in each ml.

Benzoic acid may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks).

Mucosan contains propylene glycol

This medication contains 5.2 mg of propylene glycol in each ml.

If the baby is under 4 weeks of age, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Children aged 6 to 12 years:1 dose of 5 ml, 2-3 times a day, (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosing regimen can be reduced to 2 times a day every 12 hours.

Children aged 2 to 5 years: 1 dose of 2.5 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosing regimen can be reduced to 2 times a day every 12 hours.

How to take:

Mucosan is taken orally.

Measure the amount of medication to be taken with the measuring device included in the box.

It is recommended to drink a glass of water after each dose and plenty of liquid throughout the day.

You should consult a doctor if you worsen or do not improve after 5 days of treatment (3 days in children under 6 years).

If you take more Mucosan than you should

If you have taken more Mucosan than you should, you may noticenausea, alteration of taste,numbness of the pharynx, numbness of the mouth or any other adverse effect described in section 4 Possible adverse effects. In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

In case of massive accidental administration, symptomatic treatment is recommended.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

-Unknown frequency (cannot be estimated from available data):anaphylactic reactions, anaphylactic shock, angioedema (rapid progression of skin, subcutaneous tissues, mucous membranes, or submucosal tissues swelling) and pruritus. Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute exanthematous pustulosis).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mucosan

• The active ingredient is ambroxol hydrochloride. Each milliliter of syrup contains 3 mg of ambroxol hydrochloride.
• The other components are: hydroxyethylcellulose, sucralose, benzoic acid (E 210), wild berry aroma (contains propylene glycol), vanilla aroma (contains propylene glycol), and purified water.

Appearance of the product and contents of the packaging

Mucosan is presented in 125 ml or 200 ml bottles of syrup with a plastic cap with a child safety system. Its appearance is slightly viscous, clear, and practically colorless. It has a fruity, aromatic odor.

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

A. Nattermann & Cie. GmbH

Nattermannallee 1

50829 Cologne

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

Last review date of this leaflet: May 2022

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information on the following internet address:

https://cima.aemps.es/cima/dochtml/p/56156/P_56156.html

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.