MUCOSAN 6 mg/mL SYRUP

Introduction

Leaflet:information for the user

Mucosan 6 mg/ml syrup

Ambroxol hydrochloride

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as 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 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 it worsens or does not improve after 5 days.

Contents of the leaflet

1. What is Mucosan and what is it used for
2. What you need to know before taking Mucosan
3. How to take Mucosan
4. Possible side effects
5. Storage of Mucosan
6. Package contents and additional information

1. What is Mucosan and what is it used for

Ambroxol, the active ingredient of this medicine, belongs to a group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults and children from 2 years old.

You should consult a doctor if it worsens or does 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 components of this medicine (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 problems related to kidney or liver function, consult your doctor before using this medicine.

There have been reports of serious skin reactions associated with the administration of ambroxol hydrochloride. If you experience a skin rash (including lesions of the mucous membranes, such as 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 from 2 to 6 years old, consult a doctor.

Other medicines and Mucosan

Use of Mucosan with other medicines

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

TakingMucosan 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

No harmful effects have been observed during pregnancy. However, the usual precautions related to 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 ingredient of this medicine, ambroxol hydrochloride, passes into breast milk, and although no harmful effects are expected in the breastfed infant, its use should be avoided during breastfeeding.

No clinical data are available on fertility for ambroxol hydrochloride.

Studies conducted in animals do not indicate direct or indirect harmful effects on fertility.

Driving and using machines

No effects on the ability to drive and use machines 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, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

3. How to take Mucosan

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: 10 ml, 2 times a day (every 12 hours), which means a maximum daily dose of 120 mg of ambroxol hydrochloride.

Once the patient starts to improve, the dose can be reduced to half.

Adolescents over 12 years old: 5 ml to 7.5 ml, as needed (30 mg to 45 mg of ambroxol hydrochloride), 2 times a day (every 12 hours), which means a maximum daily dose of 60 to 90 mg of ambroxol hydrochloride.

Use in children

Children from 6 to 12 years old: 1 dose of 2.5 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 dosage can be reduced to 2 times a day every 12 hours.

Children from 2 to 5 years old: 1 dose of 1.25 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 dosage can be reduced to 2 times a day every 12 hours.

How to take:

Mucosan is taken orally.

Measure the amount of medicine to take 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 it worsens or does not improve after 5 days of treatment (3 days in children under 6 years old).

If you take more Mucosan than you should

If you have taken more Mucosan than you should, you may experience nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth, or any other side effect 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, phone 915 620 420, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects may occur:

• Frequent (may affect up to 1 in 10 people): nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth.
• Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, 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 reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http;//www.notificaram.es. By reporting side 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Mucosan

• The active ingredient is ambroxol hydrochloride. Each ml of syrup contains 6 mg of ambroxol hydrochloride.
• The other ingredients are: hydroxyethylcellulose, sucralose, benzoic acid (E-210), strawberry flavor (contains propylene glycol), vanilla flavor (contains propylene glycol), and purified water.

Appearance of the product and package contents

Mucosan is presented in bottles of 100 ml or 250 ml of syrup with a child-resistant plastic cap. Its appearance is slightly viscous, clear, and practically colorless. It has a fruity, aromatic smell of strawberry cream.

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

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 last revision 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 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.