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CARBOCISTEINE 250MG/5ML SYRUP

Active substance(s): CARBOCISTEINE / CARBOCISTEINE / CARBOCISTEINE

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5. How to store Mucodyne
syrup








KEEP OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not store above 25ºC.
Do not take the Mucodyne
syrup after the expiry date
which is stated on the carton
and bottle label 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.
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 syrup contains 250mg
of the active substance,
carbocisteine. The other
ingredients are methyl
parahydroxybenzoate (E218),
caramel colour, cinnamon oil,
Aromatic Elixir (containing ethyl
alcohol, rum and aromatic rum
flavour), sodium hydroxide, purified
water and sucrose.

What Mucodyne syrup looks like
and contents of the pack
Mucodyne syrup is clear, amber
coloured syrup with an odour of
cinnamon and rum.
Mucodyne syrup is available in
250ml and 300ml bottles and
comes with a measuring beaker.
Manufactured by:
Sanofi Winthrop Industrie, 1-3
allée de la Neste - Z.I. d'en Sigal,
31770, Colomiers, France.
OR
A. NATTERMANN & Cie GmbH,
Cologne, Germany.
Procured from within the EU and
repackaged by the Product
Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Mucodyne® 250mg/5ml syrup
PL 18799/2592
POM
Leaflet date: 23.02.2017

Blind or partially
sighted?
Is this leaflet hard
to see or read?
Call 0208 515 3763
to obtain the leaflet
in a format suitable
for you.

PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Mucodyne
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
The name your medicine is
Mucodyne syrup 250mg/5ml but
will be referred as Mucodyne syrup
throughout this leaflet.
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
at it is and
usedwhat
for\ it is used
for
Mucodyne Syrup 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
2. Before you take Mucodyne
syrup
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
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 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.

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 breastfeeding.
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 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.
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
A new strength pack
presentation of 125 ml
Mucodyne 250mg/5ml
Paediatric Syrup is available
for 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).
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.
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:
 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
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 25ºC.
Do not take the Carbocisteine
syrup after the expiry date
which is stated on the carton
and bottle label 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.
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 syrup contains 250mg
of the active substance,
carbocisteine. The other
ingredients are methyl
parahydroxybenzoate (E218),
caramel colour, cinnamon oil,
Aromatic Elixir (containing ethyl
alcohol, rum and aromatic rum
flavour), sodium hydroxide, purified
water and sucrose.

What Carbocisteine syrup looks
like and contents of the pack
Carbocisteine syrup is clear,
amber coloured syrup with an
odour of cinnamon and rum.
Carbocisteine syrup is available in
250ml and 300ml bottles and
comes with a measuring beaker.
Manufactured by:
Sanofi Winthrop Industrie, 1-3
allée de la Neste - Z.I. d'en Sigal,
31770, Colomiers, France.
OR
A. NATTERMANN & Cie GmbH,
Cologne, Germany.
Procured from within the EU and
repackaged by the Product
Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Carbocisteine 250mg/5ml syrup
PL 18799/2592
POM
Leaflet date: 23.02.2017

Blind or partially
sighted?
Is this leaflet hard
to see or read?
Call 0208 515 3763
to obtain the leaflet
in a format suitable
for you.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Carbocisteine
250mg/5ml syrup
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
The name your medicine is
Carbocisteine syrup 250mg/5ml
but will be referred as
Carbocisteine syrup throughout
this leaflet.
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
at it syrup
is used
\ what it is
isfor
and
used for
Carbocisteine Syrup 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
2. Before you take Carbocisteine
Carbocisteine syrup
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 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 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.

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 breastfeeding.
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 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.

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
A new strength pack
presentation of 125 ml
Carbocisteine 250mg/5ml
Paediatric Syrup is available
for use in children.

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
product, 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:
 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
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.

Expand Transcript

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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