Mucosan retard 75 mg capsulas de liberacion prolongada

Package Leaflet:Information for the User

Mucosan Retard 75 mg prolonged-release capsules

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 symptoms worsen or do not improve after 5 days.

1. What Mucosan is and what it is used for

2. What you need to know before you start taking 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 adults.

Consult a doctor if symptoms worsen or do not improve after 5 days.

Do not take Mucosan

-If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medication (listed in section 6).

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 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

This medication is not indicated for use in children.

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 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 medication.

No adverse effects have been observed during pregnancy. However, usual precautions should be taken regarding the use of medications during pregnancy. Mucosan is not recommended for use, 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.

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:

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

How to take:

Mucosan is taken orally.

The capsule must be swallowed whole with a little liquid, without opening and without chewing.It is recommended to drink a glass of water after administration and abundant liquid throughout the day.

In exceptional cases, remnants of excipient particles may be found in the feces, which no longer contain the active principle and are therefore of no importance.

You should consult a doctor if you worsen or do 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 experiencenauseaor 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 accidental massive 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::

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.

Do not store at a temperature above 30°C.

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

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

Composition of Mucosan

• The active ingredient 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, stearic alcohol, and magnesium stearate. The capsule coating 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 packaging

Mucosan is presented in boxes of 10 or 30 hard prolonged-release capsules.

It is a hard, elongated gelatin capsule with a red top and an orange bottom.

Holder of the marketing authorization

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims

France

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 at the following internet address:

https://cima.aemps.es/cima/dochtml/p/60102/Prospecto_60102.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/.