Muximed syrup EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MUXIMED JARABE EFG

Ambroxol

In this leaflet:

1. What MUXIMED syrup is and what it is used for.
2. Before you take MUXIMED syrup.
3. How to take MUXIMED syrup.
4. Possible side effects.
5. How to store MUXIMED syrup.
6. Further information

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

Muximed belongs to a group of medicines called mucolytics. It works by reducing the viscosity of bronchial secretions and facilitating expectoration.

Muximed is indicated in acute and chronic respiratory tract disorders where enhanced elimination of secretions is required.

2. BEFORE TAKING MUXIMED syrup

Do not take MUXIMED syrup:

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

Warnings and precautions

Serious skin reactions have been reported in association with ambroxol administration. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genital area), stop using MUXIMED syrup and consult your doctor immediately.

Take special care with MUXIMED syrup:

Pregnancy and breastfeeding:

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

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

Children

Muximed is contraindicated in children under 2 years of age.

Use of other medicines:

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

Important information about some components of Muximed

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

It may cause a mild laxative effect because it contains 2.25 g of sorbitol per 5 ml. Calorific value: 2.6 kcal/g of sorbitol.

This medicine may cause headache, stomach discomfort, and diarrhea because it contains glycerol.

3. How to TAKE MUXIMED syrup

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

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

The normal dose is:

Adults: 10 ml measuring spoonful, 3 times daily.

Children over 5 years: 5 ml measuring spoonful, 2–3 times daily.

Children from 2 to 5 years: 2.5 ml measuring spoonful, 3 times daily.

If you take more Muximed syrup than you should

If you have taken more MUXIMED syrup than you should, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 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 missed doses.

Take your dose as soon as possible. If it is almost time for your next dose, wait and take your dose at the scheduled time.

If you stop treatment with Muximed

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

4. Possible adverse effects

Like all medicines, Muximed may have adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Disorders of the stomach and intestine:

• Common (affects at least 1 in 100 patients): diarrhoea
• Uncommon: nausea, vomiting, and gastrointestinal discomfort
• Rare (affects at least 1 in 10,000 patients): gastric burning sensation

Immune system disorders:

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

Skin disorders:

• Uncommon (affects at least 1 in 1,000 patients): allergic reactions
• Rare (may affect up to 1 in 1,000 people): rash, urticaria
• Frequency not known (cannot be estimated from available data): serious cutaneous adverse 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the National Pharmacovigilance System for Human Medicinal Products, website: 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 EXP. The expiry date is 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 packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Muximed syrup:

• The active substance is ambroxol hydrochloride.
• The other components 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 medicinal product and contents of the pack:

Muximed syrup is presented in containers containing 200 ml.

Each 5 ml of syrup contains 15 mg of ambroxol.

Marketing Authorization Holder and Manufacturing Responsible Party:

Marketing Authorization Holder

Amneal Pharma Spain, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturing Responsible Party

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte – Pamplona (Navarra), Spain.

Or

LABORATORIO BASI – INDUSTRIA FARMACEUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira

Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This leaflet was approved in May 2016

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”