MUCODYNE-CLEAR 250 MG/5 ML SYRUP

Active substance: CARBOCISTEINE

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CCDS Update- Global labelling update (GLU) Version 3

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Mucodyne-Clear 250mg/5ml Syrup
Carbocisteine
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours
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-Clear Syrup is and what it is used for
2.
Before you take Mucodyne-Clear Syrup
3.
How to take Mucodyne-Clear Syrup
4.
Possible side effects
5.
How to store Mucodyne-Clear Syrup
6.
Further information

1. WHAT MUCODYNE–CLEAR SYRUP IS AND WHAT IT IS USED FOR
Mucodyne-Clear 250mg/5ml Syrup (called Mucodyne-Clear Syrup 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-Clear Syrup 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.

2. BEFORE YOU TAKE MUCODYNE–CLEAR SYRUP
Do not take this medicine and tell your doctor if:
You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne-Clear
Syrup (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
You have an ulcer in your stomach or gut (small intestine)
Do not give this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before giving Mucodyne-Clear Syrup.

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if:
You are pregnant, might become pregnant or think you may be pregnant. This medicine should 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 breast-feeding.

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Important information about some of the ingredients of Mucodyne-Clear Syrup
Mucodyne-Clear Syrup contains:
Sucrose: If you have been told by the doctor that you cannot tolerate some sugars , talk to your doctor
before taking Mucodyne-Clear Syrup
Ethanol: Mucodyne-Clear Syrup contains 1-34% ethanol (alcohol). A 15ml dose of this medicine
contains up to 200mg of ethanol; this is about the same amount of alcohol as 4ml of beer or 1.76ml of
wine per dose. This can be harmful for those suffering from alcoholism. It should also be taken into
account in pregnant or breast-feeding women and high risk groups such as patients with liver disease or
fits (epilepsy).
Sodium:This medicine contains 97mg of sodium in each 5ml dose. Take this into consideration if you
are on a controlled sodium diet
Methyl parahydroxybenzoate: 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.

3. HOW TO TAKE MUCODYNE –CLEAR SYRUP
Always take Mucodyne-Clear Syrup exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Taking this medicine
Take this medicine by mouth
Mucodyne-Clear Syrup 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
doctor
How much to take
Adults (including the elderly)
Usual dose is 15ml three times each day
If your symptoms improve, your dose may be lowered to 10ml, three times, each day
Children
Mucodyne-Clear Syrup is not recommended for children. A lower strength syrup called ‘Mucodyne
Paediatric 125mg/5ml Syrup’ is available for use in children

If you take more Mucodyne-Clear Syrup than you should
If you take more Mucodyne-Clear Syrup than you should, tell a doctor or go to a hospital casualty
department straight away. Take the medicine pack with you. This is so that the doctor knows what has been
taken. If you take too much Mucodyne-Clear Syrup, it is likely that you will get an upset stomach
(gastrointestinal disturbance).
If you forget to take Mucodyne-Clear Syrup
If you forget a dose, do not worry. Just wait until the next dose is due. Do not take 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-Clear Syrup can cause side effects, although not everybody gets them.
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Stop taking Mucodyne-Clear Syrup and see a doctor or go to a hospital straight away if:
You have 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 your vomit or black tarry stools
Talk to your doctor or pharmacist if you notice any side effects not listed in this leaflet.

5. HOW TO STORE MUCODYNE–CLEAR SYRUP
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Mucodyne-Clear Syrup after the expiry date which is stated on the label and carton after EXP.
The expiry date 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 take this medicine, 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-Clear Syrup contains
-

Each 5ml of syrup contains 250mg of active substance, carbocisteine
The other ingredients are methyl parahydroxybenzoate (E218), sucrose, caramel (E150), aromatic
elixir flavour (contains rum flavour and ethanol), cinnamon flavour, sodium hydroxide and water.

What Mucodyne-Clear Syrup looks like and contents of the pack
Mucodyne-Clear Syrup is a clear amber coloured syrupy liquid.
Mucodyne-Clear Syrup is available in 300ml bottles and comes with a measuring beaker.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer
Sanofi Winthrop Industrie, 1-3 Allée de la Neste, Z.I 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.
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This leaflet was last revised in April 2013.

Zentiva 2013

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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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