PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucodyne Paediatric 125mg/5ml Syrup

Carbocisteine

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Read all of this leaflet carefully before giving your child this medicine

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, ask your child's doctor or pharmacist

•    This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What Mucodyne Paediatric is and what it is used for

2.    Before you give Mucodyne Paediatric to your child

3.    How to give Mucodyne Paediatric to your child

4.    Possible side effects

5.    How to store Mucodyne Paediatric

6.    Further information

1.    What Mucodyne Paediatric is and what it is used for

Mucodyne Paediatric 125mg/5ml Syrup (called Mucodyne Paediatric in this leaflet) contains a medicine called carbocisteine. This belongs to a group of medicines called 'mucolytics'. It works by making mucus (phlegm) less sticky. This makes the mucus easier to cough up.

Mucodyne Paediatric is used for problems with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky.

Mucodyne Paediatric is specially made for children.

2.    Before you give Mucodyne Paediatric to your child

Do not give this medicine to your child and tell your doctor if:

•    Your child is under 2 years of age

•    Your child is allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne Paediatric (listed in Section 6 below)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue

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Do not give this medicine if any of the above apply. If you are not sure, talk to your doctor or pharmacist before giving Mucodyne Paediatric.

Warnings and precautions

Talk to your doctor before taking this medicine if:

•    You are elderly.

•    Have had an ulcer in your stomach or gut.

•    You are taking other medicines known to cause bleeding in the stomach.

Pregnancy and breast-feeding

This medicine is normally only given to children. If you are an adult using this medicine, it is important to talk to your doctor before taking this medicine if:

•    You are pregnant, might become pregnant or think you may be pregnant. This medicine must not be taken during the first three months of your pregnancy

•    You are breast-feeding or planning to breast-feed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Important information about some of the ingredients of Mucodyne Paediatric

Mucodyne Paediatric contains:

•    Sucrose: If you have been told by the doctor that your child cannot tolerate some sugars, talk to your child's doctor before giving your child Mucodyne Paediatric

•    Sodium methyl parahydroxybenzoate and a colouring agent - Red Ponceau 4R: Both of these ingredients may cause allergic reactions (these may not happen straight away). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue

•    Sodium: This medicine contains 16mg of sodium in each 5ml dose. Take this into consideration if your child is on a controlled sodium diet

•    Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose

3. How to give Mucodyne Paediatric to your child

Always use Mucodyne Paediatric exactly as your child's doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Giving this medicine

•    Give this medicine to your child by mouth 301810

The amount of medicine given will depend on the age of your child

•    Mucodyne Paediatric comes with a measuring beaker

•    If you feel that this medicine is too weak or too strong, do not change the dose yourself, but ask your child's doctor

How much to give

Children 2 - 5 years

•    Usual dose is 2.5 - 5ml four times each day

Children 5 -12 years

•    Usual dose is 10ml three times each day

If your child has taken more Mucodyne Paediatric than they should

If your child has too much of this medicine, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what has been taken. If too much Mucodyne Paediatric is taken, it is likely that your child will get an upset stomach (gastrointestinal disturbance).

If you forget to give Mucodyne Paediatric to your child

If a dose is missed, do not worry. Just wait until the next dose is due. Do not give your child a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Mucodyne Paediatric can cause side effects, although not everybody gets them.

Stop giving your child Mucodyne Paediatric and see a doctor or go to a hospital straight away if:

•    Your child has an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue

•    You have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called 'Stevens-Johnson syndrome'

Tell a doctor straight away if you notice any of the following serious side effects:

•    blood in vomit or black tarry stools

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

•    Vomiting

•    Talk to your doctor or a pharmacist if you notice any side effects not listed in this leaflet.

Reporting of side effects

If your child gets any side effects, talk to your child's doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Mucodyne Paediatric

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Mucodyne Paediatric after the expiry date which is stated on the label and carton after EXP. The expiry refers to the last day of that month.

After use, wipe the neck of the bottle with a clean, damp cloth. This will remove any medicine left on the bottle, so you can put the cap back on tight. If you use the measuring beaker to give this medicine to your child, make sure the beaker is clean and dry before you use it.

Store below 25°C

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

What Mucodyne Paediatric contains

•    Each 1ml of syrup contains 25mg of the active substance, carbocisteine

•    The other ingredients are sucrose, sodium methyl parahydroxybenzoate (E219), vanillin, raspberry flavour, cherry flavor, red ponceau 4R (E214), sodium hydroxide, hydrochloric acid and water

What Mucodyne Paediatric looks like and contents of the pack

Mucodyne Paediatric is a rosy brown to red brown mobile liquid.

Mucodyne Paediatric is available in 200 or 300ml bottles and comes with a measuring beaker.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi

One Onslow Street 301810

Guildford Surrey GU1 4YS UK

Tel: 0845 372 7101

email:uk-medicalinformation@sanofi.com

Manufacturer

Unither Liquid Manufacturing

1-3 Allee de la Neste

Z.l en Sigal, 31770

Colomiers

France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 02/2016

© Sanofi, 1981 - 2016 301810

Reference: 117013 1.3.2.1 - Mock-up Leaflet - PIL - 125mg/5ml - 2016-02-15 - Glu v.5 (Clean) 0.1