Carbocisteine 250mg/5ml Syrup
MUCODYNE® 250MG/5ML SYRUP
(carbocisteine)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Mucodyne 250mg/5ml Syrup, but will be referred to as Mucodyne Syrup throughout this leaflet.
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
1. What Mucodyne Syrup is and what it is used for
Mucodyne 250mg/5ml 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.
2. Before you take Mucodyne 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 Syrup (listed in Section 6 overleaf). 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 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.
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 breastfeeding 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 hydroxybenzoate (E218): 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 Syrup
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
■ Do not take this medicine if your child is under 2 years of age.
■ This product is also available as 'Mucodyne 250mg/5ml Paediatric Syrup' only for use in children aged 2-12 years of age. Mucodyne 250mg/5ml Paediatric Syrup is only available as a 125ml bottle presentation and comes with a graduated oral dosing syringe for accurate dosing.
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).
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
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:
■ 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.
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.
5. How to store Mucodyne Syrup
■ Keep out of the sight and reach of children.
■ Do not store above 25°C.
■ 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.
■ If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise further.
■ If your doctor tells you to stop taking the syrup, please take it back to the pharmacist for safe disposal. Only keep the syrup if your doctor tells you to.
■ 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 Syrup contains
Each 5ml of oral solution contains 250mg of carbocisteine.
The other ingredients are methyl hydroxybenzoate (E218), sucrose, caramel (E150), aromatic elixir, cinnamon oil, sodium hydroxide and purified water.
What Mucodyne Syrup looks like and contents of the pack
Mucodyne Syrup is a clear, amber coloured solution with an odour of cinnamon and rum.
Mucodyne Syrup is available in 300ml bottles and comes with a measuring beaker.
Manufacturer
Aventis Pharma (Waterford) Ltd., Unit 19-21 Industrial Park, Waterford, Ireland.
Or
Sanofi Winthrop Industrie., 1-3 Allee de la Neste,
Z.I d'En Sigal, 31770, Colomiers, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
POM
PL No: 21828/0375
Leaflet issue and revision date (Ref): 16.06.16 Mucodyne® is a registered trademark of Aventis Pharma B.V.
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name: Mucodyne 250mg/5ml Syrup Reference number: 21828/0375
CARBOCISTEINE 250MG/5ML SYRUP
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Carbocisteine 250mg/5ml Syrup, but will be referred to as Carbocisteine Syrup throughout this leaflet.
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 Carbocisteine Syrup is and what it is used for
2. Before you take Carbocisteine Syrup
3. How to take Carbocisteine Syrup
4. Possible side effects
5. How to store Carbocisteine Syrup
6. Further information
1. What Carbocisteine Syrup is and what it is used for
Carbocisteine 250mg/5ml Syrup (called Carbocisteine 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.
Carbocisteine 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 Carbocisteine Syrup
Do not take this medicine and tell your doctor if:
■ You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Carbocisteine Syrup (listed in Section 6 overleaf). 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 take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carbocisteine 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.
Important information about some of the ingredients of Carbocisteine Syrup
Carbocisteine Syrup contains:
■ Sucrose: If you have been told by the doctor that you cannot tolerate some sugars, talk to your doctor before taking Carbocisteine Syrup.
■ Ethanol: Carbocisteine 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 breastfeeding 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 hydroxybenzoate (E218): 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 Carbocisteine Syrup
Always take Carbocisteine 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.
■ Carbocisteine 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
■ Do not take this medicine if your child is under 2 years of age.
■ This product is also available as 'Carbocisteine 250mg/5ml Paediatric Syrup' only for use in children aged 2-12 years of age. Carbocisteine 250mg/5ml Paediatric Syrup is only available as a 125ml bottle presentation and comes with a graduated oral dosing syringe for accurate dosing.
If you take more Carbocisteine Syrup than you should
If you take more Carbocisteine 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 Carbocisteine Syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).
If you forget to take Carbocisteine 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Carbocisteine Syrup can cause side effects, although not everybody gets them.
Stop taking Carbocisteine 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.
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 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.
5. How to store Carbocisteine Syrup
■ Keep out of the sight and reach of children.
■ Do not store above 25°C.
■ Do not use Carbocisteine 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.
■ If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise further.
■ If your doctor tells you to stop taking the syrup, please take it back to the pharmacist for safe disposal. Only keep the syrup if your doctor tells you to.
■ 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 Carbocisteine Syrup contains
Each 5ml of oral solution contains 250mg of carbocisteine.
The other ingredients are methyl hydroxybenzoate (E218), sucrose, caramel (E150), aromatic elixir, cinnamon oil, sodium hydroxide and purified water.
What Carbocisteine Syrup looks like and contents of the pack
Carbocisteine Syrup is a clear, amber coloured solution with an odour of cinnamon and rum.
Carbocisteine Syrup is available in 300ml bottles and comes with a measuring beaker.
Manufacturer
Aventis Pharma (Waterford) Ltd.,
Unit 19-21 Industrial Park, Waterford, Ireland.
Or
Sanofi Winthrop Industrie.,
1-3 Allee de la Neste, Z.I d'En Sigal, 31770, Colomiers, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
POM
PL No: 21828/0375
Leaflet issue and revision date (Ref): 16.06.16
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name: Carbocisteine 250mg/5ml Syrup Reference number: 21828/0375
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