Mucodyne 250mg/5 Ml Syrup
Si o _3 u
Mucodyne 250mg/5 ml Paediatric Syrup
Carbocisteine
SANOFI
Q Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
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 Paediatric Syrup is and what it is used for
2. Before you take Mucodyne Paediatric Syrup
3. How to take Mucodyne Paediatric Syrup
4. Possible side effects
5. How to store Mucodyne Paediatric Syrup
6. Further information
or any of the other ingredients of Mucodyne Paediatric Syrup (listed in Section 6 below).
X Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
X You have an ulcer in your stomach or gut (small intestine)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mucodyne Paediatric Syrup.
Important information about some of the ingredients of Mucodyne Paediatric Syrup
Mucodyne Paediatric Syrup contains:
For use in children
Sucrose: This medicine contains 2g of sucrose in each 5 ml dose. May be harmful to teeth. If you have been told by your doctor or pharmacist that you have intolerance to some sugars, contact your doctor before taking this medicinal product. Ethanol: This medicine contains a small amount of ethanol (alcohol), less than 100mg per dose contained in the aromatic elixir flavouring as an ingredient necessary for the medicine to work properly.
Sodium: This medicine contains 32.33 mg of sodium in each 5ml dose.
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.
Mucodyne 250 mg/5 ml Paediatric Syrup (called Mucodyne Paediatric 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.
Always take Mucodyne Paediatric 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 Paediatric Syrup (only for use in children) comes with a graduated oral dosing syringe for accurate dosing.
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
Mucodyne Paediatric 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.
Do not take this medicine and tell doctor if:
X Your child is under 2 years of age.
X You are allergic (hypersensitive) to carbocisteine
How much to take Mucodyne Paediatric Syrup For children
• Give this medicine to your child by mouth.
• The amount of medicine will depend on the age of the child.
Mucodyne Paediatric Syrup 125ml pack size comes with a graduated oral dosing syringe for measuring the correct dose. The syringe for oral administration is graduated per 0.25ml. One graduation, 0.25ml. corresponds to 12.5mg/ml of carbocisteine.
Packaging code : /
Old packaging code : /
Update : 18/04/2016 - V6
Product : MUCODYNE AD 125ML
Packaging type : Leaflet
Country : UK Languages : EN
Graphic designer : EH Plant : ULM - Colomiers
Format : 157x210 - DCRL Plant barcode : /
Colors :
Pantone Reflex Blue C Decoupe
Fonts : Ocean sans Pro SAN Min font size used :9pts Logo version :
Children 2 - 5 years: 1.25 - 2.5 ml four times a day Children 5 - 12 years: Usual dose is 5ml three times a day
How to use the syringe - using the 5ml easy dosing syringe
Step 1: The syringe end should be placed into the neck of the bottle below the liquid fill line.
Step 2: To fill the syringe whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. The dose for children is given above based on age.
Step 3: Remove the syringe from the bottle neck carefully.
Step 4: Place the end of the syringe into the child’s mouth against the cheek and carefully press the plunger down slowly to gently release the medicine. After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of children.
If you take more Mucodyne Paediatric Syrup than you should. If you take more Mucodyne Paediatric 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 the doctor knows what you have taken. If you take too much Mucodyne Paediatric Syrup it is likely that you will get an upset stomach (gastrointestinal disturbance).
If you forget to take Mucodyne Paediatric 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.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
• Vomiting
Reporting of side effects
If your child gets any side effects, talk to your 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.
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Mucodyne Paediatric 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 oral dosing measuring syringe for Mucodyne Paediatric Syrup to take this medicine, make sure the measuring device is clean and dry before use.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Like all medicines, Mucodyne Paediatric Syrup can cause side effects, although not everybody gets them.
Stop taking Mucodyne Paediatric 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 something called ‘Stephens-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
What Mucodyne Paediatric Syrup contains
• Each 5ml of Syrup contains 250mg of the active substance, carbocisteine
• The other ingredients are methyl parahydroxybenzoate (E218), sucrose, caramel (E150), aromatic elixir flavour (contains ethanol), cinnamon flavour, sodium hydroxide and purified water.
What Mucodyne Paediatric Syrup looks like and contents of the pack
Mucodyne Paediatric Syrup is a clear amber coloured syrupy liquid.
Mucodyne Paediatric Syrup for children is available in 125ml bottles and comes with a graduated dosing syringe.
Marketing Authorisation Holder and Manufacturer g
Marketing Authorisation Holder *
Sanofi
One Onslow Street Guildford
Packaging code : /
Old packaging code : /
Update : 18/04/2016 - V6
Product : MUCODYNE AD 125ML
Packaging type : Leaflet
Country : UK Languages : EN
Graphic designer : EH Plant : ULM - Colomiers
Format : 157x210 - DCRL Plant barcode : /
Colors :
Pantone Reflex Blue C Decoupe
Fonts : Ocean sans Pro SAN Min font size used :9pts Logo version :
GU1 4YS UK
Tel: 0845 372 7 101
Email: uk-medicalinformation@sanofi.com Manufacturer
Unither Liquid Manufacturing
1-3 Allee de la Neste
Z.I. d’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 03/2016
© Sanofi, 1972 - 2016
Packaging code : /
Old packaging code : /
Update : 18/04/2016 - V6
Product : MUCODYNE AD 125ML
Packaging type : Leaflet
Country : UK Languages : EN
Graphic designer : EH Plant : ULM - Colomiers
Format : 157x210 - DCRL Plant barcode : /
Colors :
Pantone Reflex Blue C Decoupe
Fonts : Ocean sans Pro SAN Min font size used :9pts Logo version :
o
4
Packaging code : /
Old packaging code : /
Update : 18/04/2016 - V6
Product : MUCODYNE AD 125ML
Packaging type : Leaflet
Country : UK Languages : EN
Graphic designer : EH Plant : ULM - Colomiers
Format : 157x210 - DCRL Plant barcode : /
Colors :
Pantone Reflex Blue C Decoupe
Fonts : Ocean sans Pro SAN Min font size used :9pts Logo version :
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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.
What Mucodyne Syrup contains
• Each 5ml of syrup contains 250mg of the 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 Syrup looks like and contents of the pack
Mucodyne Syrup is a clear amber coloured syrupy liquid.
Mucodyne Syrup is available in 300ml bottles and comes with a measuring beaker.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sanofi
One Onslow Street 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.I. d’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 06/2016
© Sanofi, 1972 - 2016
Mucodyne 250 mg/5 ml Syrup
Carbocisteine
SANOFI
Q Is this leaflet hard to see or read? Phone 0845 372 7101 for help
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 Syrup is and what it is used for
2. Before you take Mucodyne Syrup
3. How to take Mucodyne Syrup
4. Possible side effects
5. How to store Mucodyne Syrup
6. Further information
Mucodyne 250 mg/5 ml Syrup (called Mucodyne 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 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.
XDo not take this medicine and tell your doctor if:
X You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne 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 X You have an ulcer in your £ stomach or gut (small intestine) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mucodyne Syrup.
Packaging code : 302645 Old packaging code : 302231
Update : 29/06/2016 - V3 Product :
MUCODYNEAD 300ML Packaging type : Leaflet
Country : UK Languages : EN
Graphic designer : C.R. - EH Plant : Colomiers_
Format : 157 x 210 -RL Plant barcode : 645 Colors :
Pantone Reflex Blue C
Fonts : Ocean sans Pro SAN Min font size used : 9 pts Logo version :
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
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.
Important information about some of the ingredients of Mucodyne Syrup
Mucodyne Syrup contains:
• Sucrose: If you have been told by the doctor that you cannot tolerate some sugars, talk to your doctor before taking Mucodyne Syrup
• Ethanol: Mucodyne 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 1.67ml of wine per dose. This can be harmful for those suffering from alcoholism. It should also be taken into account in pregnant or
llllllll
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 15ml 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.
use in children.
If you take more Mucodyne Syrup than you should
If you take more Mucodyne 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 the doctor knows what you have taken. If you take too much Mucodyne Syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).
Always take Mucodyne 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 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
• A new strength pack presentation of 125 ml Mucodyne 250mg/5ml Paediatric Syrup is available for 2
I
If you forget to take Mucodyne 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.
Like all medicines, Mucodyne Syrup can cause side effects, although not everybody gets them.
Stop taking Mucodyne 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:
• You have blood in your 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 you get any side effects, talk to your 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.
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Mucodyne 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, 3
Packaging code : 302645 Old packaging code : 302231
Update : 29/06/2016 - V3 Product :
MUCODYNEAD 300ML Packaging type : Leaflet
Country : UK Languages : EN
Graphic designer : C.R. - EH Plant : Colomiers_
Format : 157 x 210 -RL Plant barcode : 645 Colors :
Pantone Reflex Blue C
Fonts : Ocean sans Pro SAN Min font size used : 9 pts Logo version :