Mucosan Retard 75 mg prolonged-release capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mucosan Retard 75 mg prolonged-release capsules

Ambroxol hydrochloride

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

Always follow exactly the instructions for administration of the medicine as described in this leaflet or as given 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.
• You should consult a doctor if you worsen or do not improve after 5 days.

Contents of the leaflet

1. What Mucosan is and what it is used for
2. What you need to know before taking Mucosan
3. How to take Mucosan
4. Possible adverse effects
5. How to store Mucosan
6. 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, making it less thick and helping its removal.

This medicine is indicated to help eliminate 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 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).

Warnings and precautions

Talk to 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.

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 genitals), stop using Mucosan and consult your doctor immediately.

Children

Its use is not indicated in children.

Other medicines and Mucosan

Use of 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 might 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 in the breastfed infant are not expected, its use should be avoided during breastfeeding.

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

There are no clinical data available on fertility for ambroxol hydrochloride.

Driving and using machines

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

3. How to take Mucosan

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults: 1 capsule (75 mg of ambroxol hydrochloride) daily.

How to take:

Mucosan is taken orally.

The capsule must be swallowed whole with a small amount of liquid, without opening or chewing it. It is recommended to drink a glass of water after administration and plenty of fluids throughout the day.

In exceptional cases, remnants of excipient particles may be found in the stools. These no longer contain the active substance and are therefore of no significance.

Consult a doctor if your condition worsens or does not improve after 5 days of treatment.

If you take more Mucosan than you should

If you have taken more Mucosan than you should, you may experience nausea 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 Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount ingested.

In the event of accidental massive administration, symptomatic treatment is recommended.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

The following adverse effects may occur:

• Common (may affect up to 1 in 10 people): nausea.

• Uncommon (may affect up to 1 in 100 people): vomiting, diarrhoea, indigestion, abdominal pain.

• Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria.

• Frequency not known (cannot be estimated from available data): anaphylactic reactions, anaphylactic shock, angioedema (rapidly developing 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 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 via the Spanish System for Pharmacovigilance of Human Medicinal Products: 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.

Do not store at temperatures above 30°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 must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 prolonged-release capsule contains 75 mg of ambroxol hydrochloride in the form of pellets.
• The other components are crospovidone, carnauba wax, stearyl alcohol and magnesium stearate. The capsule shell contains gelatin, purified water, titanium dioxide (E 171), iron oxide red (E 172) and iron oxide yellow (E 172). The white printing ink contains shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Mucosan is available in boxes containing 10 or 30 prolonged-release hard capsules.

These are hard gelatin capsules, elongated in shape, with the upper part red and the lower part orange.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

Manufacturer:

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims

France

Date of the most recent revision of this leaflet: November 2025

You can access detailed and up-to-date information about this medication 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/60102/Prospecto_60102.html

Detailed 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/.