Carbocisteine 375mg Capsules
Ref: LTT171/070716/1/F
Mucodyne ® 375mg Capsules
(carbocisteine)
Patient Information 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Mucodyne 375mg Capsules but will be called Mucodyne Capsules throughout this leaflet.
In this leaflet:
^ What Mucodyne Capsules are and what they are used for Before you take Mucodyne Capsules ^3) How to take Mucodyne Capsules ^ Possible side effects
How to store Mucodyne Capsules ^2 Further information
What Mucodyne Capsules are and what they are used for
Mucodyne 375mg Capsules (called Mucodyne Capsules in this leaflet) contain 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 Capsules are 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 Capsules
Do not take this medicine and tell your doctor if:
* You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne Capsules (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.
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 Capsules.
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
Capsules
Mucodyne Capsules contain:
* Lactose. This medicine contains lactose. This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Mucodyne Capsules.
* Sunset yellow (E110): May cause allergic reactions. 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 Capsules
Always take Mucodyne Capsules 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
* 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 two capsules, 3 times each day
* If your symptoms improve, your dose should be lowered to one capsule, 4 times, each day
Children
* Mucodyne Capsules are not recommended for children. A syrup form of this medicine called 'Mucodyne Paediatric 125mg/5ml Syrup' is available for use in children.
If you take more Mucodyne Capsules than you should
If you take more Mucodyne Capsules 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 many Mucodyne Capsules, it is likely that you will get an upset stomach (gastrointestinal disturbance).
Mucodyne ® 375mg Capsules
(carbocisteine)
Patient Information Leaflet (continued)
If you forget to take Mucodyne Capsules
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 Capsules can cause side effects, although not everybody gets them.
Stop taking Mucodyne Capsules 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'
* 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.
[m How to store Mucodyne Capsules
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store this medicine above 25°C.
* Store in the original package in order to protect from light.
* Do not use after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
* If your capsules becomes discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
Further information
What this medicine contains:
Each capsule contains 375 mg of the active substance carbocisteine The other ingredients are lactose, sodium laurilsulfate, aerosil 200 (E551) and magnesium stearate (E572).
The capsule shell also includes quinoline yellow (E104),
sunset yellow (E110), titanium dioxide and gelatin. The printing ink contains
iron oxide black.
What this medicine looks like and contents of the pack
Mucodyne Capsules are yellow hard capsules printed ‘MUCODYNE' on the body and ‘375' on the cap in black ink.
They are available in blister packs containing 120 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Sanofi-Aventis S.A., Avenida de Leganes, Alcorcon, Madrid, Spain and is procured from within the EU. Product licence holder: LTT Pharma Ltd, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Ltd,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
pOMI PL 33723/0171 Mucodyne 375mg Capsules
Mucodyne is a registered trademark of Aventis Pharma B.V Revision date: 07/07/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Carbocisteine 375mg Capsules
Patient Information 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Carbocisteine 375mg Capsules but will be called Carbocisteine Capsules throughout this leaflet.
In this leaflet:
[ft What Carbocisteine Capsules are and what they are used for (4 Before you take Carbocisteine Capsules How to take Carbocisteine Capsules ,4 Possible side effects
How to store Carbocisteine Capsules Further information
^ What Carbocisteine Capsules are and what they are used for
Carbocisteine 375mg Capsules (called Carbocisteine Capsules in this leaflet) contain 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 Capsules are used for problems with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky.
Before you take Carbocisteine Capsules
Do not take this medicine and tell your doctor if:
* You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Carbocisteine Capsules (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
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 Capsules.
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 Carbocisteine
Capsules
Carbocisteine Capsules contain:
* Lactose. This medicine contains lactose. This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Carbocisteine Capsules.
* Sunset yellow (E110): May cause allergic reactions. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
[4 How to take Carbocisteine Capsules
Always take Carbocisteine Capsules 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
* 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 two capsules, 3 times each day
* If your symptoms improve, your dose should be lowered to one capsule, 4 times, each day
Children
* Carbocisteine Capsules are not recommended for children. A syrup form of this medicine called 'Mucodyne Paediatric 125mg/5ml Syrup' is available for use in children.
If you take more Carbocisteine Capsules than you should
If you take more Carbocisteine Capsules 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 many Carbocisteine Capsules, it is likely that you will get an upset stomach (gastrointestinal disturbance).
Carbocisteine 375mg Capsules
Patient Information Leaflet (continued)
If you forget to take Carbocisteine Capsules
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.
3 Possible side effects
Like all medicines, Carbocisteine Capsules can cause side effects, although not everybody gets them.
Stop taking Carbocisteine Capsules 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'
* 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.
Further information
What this medicine contains:
Each capsule contains 375 mg of the active substance carbocisteine The other ingredients are lactose, sodium laurilsulfate, aerosil 200 (E551) and magnesium stearate (E572).
The capsule shell also includes quinoline yellow (E104),
sunset yellow (E110), titanium dioxide and gelatin. The printing ink contains
iron oxide black.
What this medicine looks like and contents of the pack
Carbocisteine are yellow hard capsules printed ‘MUCODYNE' on the body and ‘375' on the cap in black ink.
They are available in blister packs containing 120 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Sanofi-Aventis S.A., Avenida de Leganes, Alcorcon, Madrid, Spain and is procured from within the EU. Product licence holder: LTT Pharma Ltd, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Ltd,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 33723/0171 Carbocisteine 375mg Capsules
Revision date: 07/07/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
[5 How to store Carbocisteine Capsules
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* Do not store this medicine above 25°C.
* Store in the original package in order to protect from light.
* Do not use after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
* If your capsules becomes discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.