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MUCODYNE 250 MG/5 ML PAEDIATRIC SYRUP

Active substance(s): CARBOCISTEINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Mucodyne 250mg/5 ml Paediatric
Syrup
Carbocisteine

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
Read all of this leaflet carefully before you start have been told by your doctor or pharmacist that
taking this medicine
you have intolerance to some sugars, contact your
doctor before taking this medicinal product.
• Keep this leaflet. You may need to read it again. Ethanol: This medicine contains a small amount of
• If you have any further questions, ask your doctor ethanol (alcohol), less than 100mg per dose
or pharmacist.
contained in the aromatic elixir flavouring as an
• This medicine has been prescribed for you. Do
ingredient necessary for the medicine to work
not pass it on to others. It may harm them, even properly.
if their symptoms are the same as yours.
Sodium: This medicine contains 32.33 mg of
• If any of the side effects gets serious, or if you
sodium in each 5ml dose.
notice any side effects not listed in this leaflet,
Methyl parahydroxybenzoate: May cause allergic
please tell your doctor or pharmacist.
reactions (these may not happen straight away).
Signs of an allergic reaction include: a rash,
In this leaflet:
swallowing or breathing problems, swelling of the
1. What Mucodyne Paediatric Syrup is and what it is lips, face, throat or tongue.
used for
2. Before you take Mucodyne Paediatric Syrup
3. How to take Mucodyne Paediatric Syrup
3. How to take Mucodyne Paediatric Syrup
4. Possible side effects
5. How to store Mucodyne Paediatric Syrup
Always take Mucodyne Paediatric Syrup exactly as
6. Further information
your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
1. What Mucodyne Paediatric Syrup is
and what it is used for
Taking this medicine
• Take this medicine by mouth
Mucodyne 250 mg/5 ml Paediatric Syrup (called
• Mucodyne Paediatric Syrup (only for use in
Mucodyne Paediatric Syrup in this leaflet) contains
children) comes with a graduated oral dosing
a medicine called carbocisteine. This belongs to a
syringe for accurate dosing.
group of medicines called ‘mucolytics’.
• If you feel the effect of your medicine is too weak
or too strong, do not change the dose yourself, but
It works by making mucus (phlegm) less sticky. This
ask your doctor
makes the mucus easier to cough up.
How much to take
Mucodyne Paediatric Syrup is used for problems
Mucodyne Paediatric Syrup
with the breathing passages (respiratory tract).
For children
These problems happen when too much mucus is
• Give this medicine to your child by mouth.
made or the mucus is too sticky.
• The amount of medicine will depend on the age
of the child.
Mucodyne Paediatric Syrup 125ml pack size
2. Before you take Mucodyne Paediatric Syrup
comes with a graduated oral dosing syringe for
Do not take this medicine and tell your
measuring the correct dose. The syringe for oral
doctor if:
administration is graduated per 0.25ml. One
graduation, 0.25ml. corresponds to 12.5mg/ml of
✕ Your child is under 2 years of age.
✕ You are allergic (hypersensitive) to carbocisteine carbocisteine.
1
30XXXX - XXX

Laetus
Code

Is this leaflet hard
to see or read?
Phone 0845 372 7101 for
help

or any of the other ingredients of Mucodyne
Paediatric 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 Paediatric
Syrup.

LIQUID MANUFACTURING

Packaging code : /
Old packaging code : /

Format : 157x210 - DCRL
Plant barcode : /

Update : 18/04/2016 - V6

Colors :

Product : MUCODYNE AD 125ML

Pantone Reflex Blue C
Découpe

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9pts

Graphic designer : EH
Plant : ULM - Colomiers

Logo version :

Children 2 – 5 years: 1.25 – 2.5 ml four times a day Tell your doctor or pharmacist if any of the
Children 5 – 12 years: Usual dose is 5ml three times following side effects get serious or lasts longer
a day
than a few days:
• Vomiting
How to use the syringe – using the 5ml easy
Reporting of side effects
dosing syringe
If your child gets any side effects, talk to your
Step 1: The syringe end should be placed into the
doctor, pharmacist or nurse. This includes any
neck of the bottle below the liquid fill line.
possible side effects not listed in this leaflet. You
Step 2: To fill the syringe whilst holding the syringe can also report side effects directly via the Yellow
in place, gently pull the plunger down drawing the Card Scheme at:
medicine to the correct mark on the syringe. The
www.mhra.gov.uk/yellowcard
dose for children is given above based on age.
By reporting side effects you can help provide more
Step 3: Remove the syringe from the bottle neck
information on the safety of this medicine.
carefully.
Step 4: Place the end of the syringe into the child’s
5. How to store Mucodyne Paediatric Syrup
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 Keep this medicine in a safe place where children
warm water and allow to dry. Store out of the reach cannot see or reach it.
of children.
Do not use Mucodyne Paediatric Syrup after the
expiry date which is stated on the label and carton
If you take more Mucodyne Paediatric Syrup
after EXP. The expiry date refers to the last day of
than you should. If you take more Mucodyne
that month.
Paediatric Syrup than you should, tell a doctor or
go to a hospital casualty department straight away. After use, wipe the neck of the bottle with a clean,
damp cloth. This will remove any medicine left on
Take the medicine pack with you. This is so the
doctor knows what you have taken. If you take too the bottle, so you can put the cap back on tight.
If you use the oral dosing measuring syringe for
much Mucodyne Paediatric Syrup it is likely that
Mucodyne Paediatric Syrup to take this medicine,
you will get an upset stomach (gastrointestinal
make sure the measuring device is clean and dry
disturbance).
before use.
If you forget to take Mucodyne Paediatric Syrup Store below 25°C
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
If you forget a dose, do not worry. Just wait until
the next dose is due. Do not take a double dose to dispose of medicines no longer required. These
measures will help to protect the environment.
make up for a forgotten dose.
6. Further information

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 Paediatric Syrup can
cause side effects, although not everybody gets
them.

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 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
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
2

30XXXX - XXX

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 ‘StephensJohnson Syndrome’

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.

LIQUID MANUFACTURING

Packaging code : /
Old packaging code : /

Format : 157x210 - DCRL
Plant barcode : /

Update : 18/04/2016 - V6

Colors :

Product : MUCODYNE AD 125ML

Pantone Reflex Blue C
Découpe

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9pts

Graphic designer : EH
Plant : ULM - Colomiers

Logo version :

GU1 4YS
UK
Tel: 0845 372 7 101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Unither Liquid Manufacturing
1-3 Allée 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

30XXXX - XXX

© Sanofi, 1972 - 2016

3

LIQUID MANUFACTURING

Packaging code : /
Old packaging code : /

Format : 157x210 - DCRL
Plant barcode : /

Update : 18/04/2016 - V6

Colors :

Product : MUCODYNE AD 125ML

Pantone Reflex Blue C
Découpe

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9pts

Graphic designer : EH
Plant : ULM - Colomiers

Logo version :

30XXXX - XXX

Laetus
Code
4

LIQUID MANUFACTURING

Packaging code : /
Old packaging code : /

Format : 157x210 - DCRL
Plant barcode : /

Update : 18/04/2016 - V6

Colors :

Product : MUCODYNE AD 125ML

Pantone Reflex Blue C
Découpe

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9pts

Graphic designer : EH
Plant : ULM - Colomiers

Logo version :

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),
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
100ml or 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 Allée 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
02/2015
© Sanofi, 1972 - 2015

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Mucodyne 250 mg/5 ml
Syrup
Carbocisteine

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

4

1. What Mucodyne Syrup is
and what it is used for
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.

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.
1

LIQUID MANUFACTURING

Packaging code : 302231
Old packaging code : 301703
Update : 17/02/2015 - V2
Product :

MUCODYNE AD 300ML

Packaging type : Leaflet
Country : UK
Languages : EN

2. Before you take Mucodyne
Syrup

302231 - 231

or household waste. Ask your
pharmacist how to dispose of
medicines no longer required.
These measures will help to protect
the environment.

Graphic designer : C.R.
Plant : Colomiers
Format : 157 x 210 -RL
Plant barcode : 231
Colors :

Pantone Reflex Blue C

Fonts : Ocean sans Pro SAN
Min font size used : 9 pts
Logo version :

• 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
• Mucodyne Syrup is not
recommended for children.
A lower strength syrup
called ‘Mucodyne Paediatric
125mg/5ml 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 2

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 ‘StevensJohnson 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 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, 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 3

302231 - 231

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
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

LIQUID MANUFACTURING

Packaging code : 302231
Old packaging code : 301703
Update : 17/02/2015 - V2
Product :

MUCODYNE AD 300ML

Packaging type : Leaflet
Country : UK
Languages : EN
Graphic designer : C.R.
Plant : Colomiers
Format : 157 x 210 -RL
Plant barcode : 231
Colors :

Pantone Reflex Blue C

Fonts : Ocean sans Pro SAN
Min font size used : 9 pts
Logo version :

Expand view ⇕

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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