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MUCODYNE 375MG CAPSULES

Active substance(s): CARBOCISTEINE

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Package Leaflet: Information for the user

Mucodyne® 375mg Capsules
(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 Capsules are and what they are used for
2) Before you take Mucodyne Capsules
3) How to take Mucodyne Capsules
4) Possible side effects
5) How to store Mucodyne Capsules
6) Further information
1) 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.
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).
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’
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 last 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 CAPSULES





Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package in order to protect from light.
Do not use Mucodyne Capsules after the expiry date which is stated
on the carton. The expiry date refers to the last day of that month.
• If your capsules become discoloured or show any signs of
deterioration, return them to your pharmacist.
• 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 Capsules contain
Each capsule contains 375mg of carbocisteine.
The other ingredients are lactose, sodium laurilsulfate, aerosil 200
(E551) and magnesium stearate E572.
The capsule shell contains quinoline yellow (E104), sunset yellow
(E110), titanium dioxide (E171) and gelatin.
Printing ink contains iron oxide black.
What Mucodyne Capsules look like and contents of the pack
Mucodyne Capsules are size No. 1 opaque, yellow, hard capsules,
having an identification mark printed “Mucodyne 375” in black ink and
containing a white to almost white powder.
Mucodyne Capsules come in blister packs of 120 capsules.
Manufacturer:
Sanofi-Aventis S.A., Avenida de Leganés, Alcorcon, Madrid, Spain.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0594 Mucodyne® 375mg Capsules

POM

th

Leaflet date 28 August 2015
Leaflet code xxxxxxxx
Mucodyne® is a registered trademark of Sanofi-Aventis Netherlands B.V.
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.

Package Leaflet: Information for the user

Carbocisteine 375mg Capsules
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 Capsules are and what they are used for
2) Before you take Carbocisteine Capsules
3) How to take Carbocisteine Capsules
4) Possible side effects
5) How to store Carbocisteine Capsules
6) Further information
1) 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.
2) 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.
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
3) 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).
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.
4) 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’
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 last 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 CAPSULES





Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package in order to protect from light.
Do not use Carbocisteine Capsules after the expiry date which is
stated on the carton. The expiry date refers to the last day of that
month.
• If your capsules become discoloured or show any signs of
deterioration, return them to your pharmacist.
• 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 Capsules contain
Each capsule contains 375mg of carbocisteine.
The other ingredients are lactose, sodium laurilsulfate, aerosil 200
(E551) and magnesium stearate E572.
The capsule shell contains quinoline yellow (E104), sunset yellow
(E110), titanium dioxide (E171) and gelatin.
Printing ink contains iron oxide black.
What Carbocisteine Capsules look like and contents of the pack
Carbocisteine Capsules are size No. 1 opaque, yellow, hard capsules,
having an identification mark printed “Mucodyne 375” in black ink and
containing a white to almost white powder.
Carbocisteine Capsules come in blister packs of 120 capsules.
Manufacturer:
Sanofi-Aventis S.A., Avenida de Leganés, Alcorcon, Madrid, Spain.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0594 Carbocisteine 375mg Capsules

POM

th

Leaflet date 28 August 2015
Leaflet code xxxxxxxx
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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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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