MUXIMED SYRUP

Introduction

Package Leaflet: Information for the User

MUXIMED SYRUP EFG

Ambroxol

In this package leaflet:

1. What MUXIMED syrupis and what it is used for.
2. Before taking MUXIMED syrup.
3. How to take MUXIMED syrup.
4. Possible side effects.
5. Storage of MUXIMED syrup.
6. Additional information

1. What is MUXIMED syrup and what is it used for

Muximed belongs to the group of medicines called mucolytics. It acts by decreasing the viscosity of bronchial secretions and facilitating expectoration.

Muximed is indicated in acute and chronic conditions of the respiratory tract where it is necessary to facilitate the elimination of secretions.

2. BEFORE TAKING MUXIMED syrup

Do not take MUXIMED syrup:

• If you are allergic (hypersensitive) to ambroxol or any of the other components of Muximed.
• This medicine should not be used in children under 2 years of age.

Warnings and precautions

Reports of serious skin reactions associated with the administration of ambroxol have been received. If you experience a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using MUXIMED syrup and consult your doctor immediately.

Be especially careful with MUXIMED syrup:

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine. Treatment with Muximed has not been shown to be harmful during pregnancy. However, your doctor will assess the benefit/risk of its administration.

Treatment with Muximed has not been shown to be harmful to the child. However, your doctor will assess the benefit/risk of its administration.

Children

Muximed is contraindicated in children under 2 years of age.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Important information about some of the components of Muximed

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may produce a slight laxative effect because it contains 2.25 g of sorbitol per 5 ml. Caloric value: 2.6 kcal/g of sorbitol.

This medicine may produce headache, stomach upset, and diarrhea because it contains glycerol.

3. HOW TO TAKE MUXIMED syrup

Follow exactly the administration instructions of Muximed indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the appropriate dose and duration of treatment.

The normal dose is:

Adults:1 measure of 10 ml, 3 times a day.

Children over 5 years:1 measure of 5 ml, 2-3 times a day.

Children from 2 to 5 years:1 measure of 2.5 ml, 3 times a day.

If you take more MUXIMED syrup than you should

If you have taken more MUXIMED syrupthan you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Muximed

Do not take a double dose to make up for forgotten doses.

Take your dose as soon as possible. If it is almost time for your next dose, wait until then to take your dose.

If you stop treatment with Muximed

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Muximed can have side effects, although not everyone gets them.

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Disorders of the stomach and intestine:

• Frequent (at least one in 100 patients): diarrhea
• Uncommon: nausea, vomiting, and gastrointestinal discomfort.
  • Rare (at least 1 in 10,000 patients): heartburn

Immune system disorders

• Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions.
• Frequency not known (cannot be estimated from the available data): anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus.

Skin disorders:

• Uncommon (at least 1 in 1,000 patients): allergic reactions.
• Rare (may affect up to 1 in 1,000 people): exanthema, urticaria
• Frequency not known (cannot be estimated from the available data): serious cutaneous adverse 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, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the National Pharmacovigilance System for Human Use Medicines, web: www.notificaRAM.es

5. Storage of MUXIMED syrup

Do not store above 30°C.

Do not use Muximed syrup after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Muximed syrup:

• The active ingredient is ambroxol hydrochloride.
• The other ingredients are: raspberry flavor, citric acid monohydrate (E 330), glycerol (E 422), hydroxyethylcellulose, benzoic acid (E 210), propylene glycol, sorbitol (E 420), sodium saccharin, and purified water.

Appearance of the product and packaging content:

Muximed syrup is presented in packaging containing 200 ml.

Each 5 ml of syrup contains 15 mg of Ambroxol.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Amneal Pharma Spain, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte – Pamplona (Navarra) Spain.

O

LABORATORIO BASI – INDUSTRIA FARMACEUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira

Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This package leaflet was approved in May 2016

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”