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MUCODYNE PAEDIATRIC 125MG/5ML SYRUP

Active substance(s): CARBOCISTEINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mucodyne Paediatric 125mg/5ml Syrup
Carbocisteine
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
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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Reference: 117013 1.3.2.1 - Mock-up Leaflet - PIL - 125mg/5ml - 2016-02-15 - Glu v.5 (Clean) 0.1

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

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



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

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

Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email:uk-medicalinformation@sanofi.com
Manufacturer
Unither Liquid Manufacturing
1-3 Allée 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

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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