CORDARONE X 150MG/3ML SOLUTION FOR INJECTION

Active substance: AMIODARONE HYDROCHLORIDE

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Transcript
How much will be given to you
Your doctor will decide how much to give you
depending on your illness
Adults
• The usual dose is 5 mg for every
kilogram of your weight given over a
period of 20 minutes to 2 hours
• You may be given another infusion of
approximately 15 mg for every kilogram
of your weight every 24 hours
depending on your illness
• In an emergency, your doctor may
decide to give you a dose of 150 mg to
300 mg as a slow injection over 3
minutes
Children and adolescents
• There are only limited data on the
efficacy and safety in children. The
doctor will carefully calculate the
amount of Cordarone X depending on
the child's or adolescent's body weight.
Elderly
• The doctor may give you a lower dose
of Cordarone X and monitor your heart
rate and thyroid function more closely
If you have more Cordarone X than you
should
Your doctor will carefully calculate how much
Cordarone X you should get. Therefore it is
unlikely your doctor, nurse or pharmacist will
give you too much of this medicine. But, if you
think that you have been given too much or
too little Cordarone X, tell your doctor, nurse
or pharmacist.
The following effects may happen: feeling
dizzy, faint, sick, tired or confused. Having an
abnormally slow or fast heartbeat. Too much
amiodarone can damage the heart and liver.
If you forget to have Cordarone X
Your doctor or nurse will have instructions on
when to give you this medicine. It is unlikely
that you will not be given the medicine as it
has been prescribed. However, if you think
you may have missed a dose, then talk to
your doctor or nurse.
If you stop having Cordarone X
It is important for you to keep having
Cordarone X injections until your doctor
decides to stop them. If you stop having this
medicine the uneven heartbeats may come
back. This could be dangerous.
Tests
Your doctor will take regular tests to check
how your liver is working. Cordarone X can
affect how your liver works. If this happens,
your doctor will decide whether you should
keep having this medicine.
Your doctor may do regular thyroid tests
while you are taking this medicine. This is
because Cordarone X contains iodine which
can cause problems to your thyroid.
Your doctor may also do other regular tests
such as blood tests, chest X-rays, ECG (electrical
test of your heartbeat) and eye tests both
before and while you are having Cordarone X.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Cordarone X can cause
side effects, although not everybody gets
them. Cordarone X may stay in your blood for
up to a month after stopping treatment. You
may still get side effects in this time.
Stop having Cordarone X and tell a doctor,
nurse or pharmacist or go to a hospital
straight away if:
Very rare (affects less than 1 in 10,000 people)
• You have an allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
• Your heartbeat becomes very slow or
stops beating. You may also feel dizzy,
unusually tired and short of breath. This
may occur especially in people over 65
years old or to people with other heart
beat problems
• Your heartbeat becomes even more
uneven or erratic. This can lead to a
heart attack, so you should go to
hospital straight away
• You get yellowing of the skin or eyes
(jaundice), feel tired or sick, loss of
appetite, stomach pain or high
temperature. These can be signs of liver
problems or damage which can be very
dangerous
• Difficulty breathing or tightness in the
chest, coughing which will not go away,
wheezing, weight loss and fever. This
could be due to inflammation of your
lungs which can be very dangerous
Stop having Cordarone X and see a doctor
straight away if you notice any of the
following serious side effects - you may
need urgent medical treatment:
Very rare (affects less than 1 in 10,000 people)
• Headache (which is usually worse in the
morning or happens after coughing or
straining), feeling sick (nausea), fits,
fainting, eyesight problems or
confusion can occur. These could be a
signs of problems with your brain
Tell your doctor as soon as possible if you
have any of the following side effects:
Common (affects less than 1 in 10 people)
• Dizziness, lightheadedness, fainting.
This may occur temporarily and is due
to lowering of blood pressure
Frequency not known (Cannot be estimated
from the available data)
• Feeling extremely restless or agitated,
weight loss, increased sweating and
being unable to stand the heat. These
could be signs of an illness called
'hyperthyroidism'.
Tell your doctor, nurse or pharmacist if
any of the following side effects get
serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
• Slightly slower heart beat
• You have pain, swelling, irritation,
reddening or skin discolouration in the
area you have been injected with
Turn
Cordarone X
Over

3

PACKAGE LEAFLET:
INFORMATION FOR THE USER

2. Before you have Cordarone X

Cordarone® X 150mg/3ml,
solution for injection

Do not have this medicine and tell
your doctor, pharmacist or nurse if:
× You are allergic (hypersensitive) to:
- iodine
- amiodarone
- any of the other ingredients of
Cordarone X (listed in Section 6 below)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
× You have a slower than usual heartbeat
(called ‘sinus bradycardia’) or an illness
called ‘sino-atrial’ heart block
× You have any other problems with your
heartbeat and do not have a pacemaker
fitted
× You have ever had thyroid problems. Your
doctor should test your thyroid before
giving you this medicine
× You have severe breathing problems
× You have serious blood circulation problems
× You have very low blood pressure
× You are taking certain other medicines
which could affect your heartbeat (see
‘Taking other medicines’ below)
× The person having the medicine is a child
under the age of 3 years, a premature or
new born baby
× You are pregnant or breast-feeding (see
‘Pregnancy and breast-feeding’ below)
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Cordarone X.

amiodarone hydrochloride
Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you
start having this medicine
• Keep this leaflet. You may need to read it
again
• If you have any further questions, ask your
doctor, nurse 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 Cordarone X is and what it is used for
2. Before you have Cordarone X
3. How Cordarone X is given
4. Possible side effects
5. How to store Cordarone X
6. Further information
1. What Cordarone X is and
what it is used for
Cordarone X 150mg/3ml, solution for
injection (called Cordarone X in this leaflet)
contains a medicine called amiodarone
hydrochloride. This belongs to a group of
medicines called anti-arrhythmics.
It works by controlling the uneven beating of
your heart (called ‘arrhythmias’). Having the
injection helps your heartbeat to return to
normal.
Cordarone X is normally only given in a
hospital when a quick response is needed or
when tablets cannot be given. Cordarone X
can be used to:
• Treat uneven heartbeats where other
medicines either have not worked or
cannot be used
• Treat an illness called
Wolff-Parkinson-White Syndrome. This is
where your heart beats unusually fast
• Treat other types of fast or uneven
heartbeats known as ‘atrial flutter’ or
‘atrial fibrillation. Cordarone X is used
only when other medicines cannot be
used
• Treat fast heartbeats which may happen
suddenly and may be uneven. Cordarone X
is used only when other medicines cannot
be used

Take special care with Cordarone X
Check with your doctor, pharmacist or
nurse before having this medicine if:
▲ You have a weak heart (‘cardiomyopathy’)
or heart failure
▲ You have low blood pressure
▲ You have liver problems
▲ You have any problems with your lungs
including asthma
▲ You have a problems with your thyroid gland
▲ You are taking amiodarone tablets
▲ You are about to have an operation
▲ The person having the medicine is an
infant or child under 3 years old
If you are not sure if any of the above apply
to you, talk to your doctor, nurse or
pharmacist before having Cordarone X.
Taking other medicines
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any
other medicines. This includes medicines you
buy without a prescription, including herbal
medicines. This is because Cordarone X can
affect the way some other medicines work.
Also some medicines can affect the way
Cordarone X works.
In particular, do not take this medicine
and tell your doctor, if you are taking:
• Other medicines for an uneven heartbeat
(such as quinidine, procainamide,
Turn
disopyramide, sotalol or bretylium) Over 1

Tell your doctor if you are taking any of
the following medicines:
• Medicines for infection (such as
ciprofloxacin, ofloxacin or levofloxacin)
• Medicines for heart problems called
beta-blockers (such as propranolol)
• Medicines called calcium channel blockers
for chest pain (angina) or high blood
pressure (such as diltiazem or verapamil)
• Medicines for constipation (laxatives) such
as bisacodyl or senna
• Medicines for high cholesterol (statins)
such as simvastatin or atorvastatin
The following medicines can increase the
chance of you getting side effects, when
taken with Cordarone X:
• Amphotericin (when given directly into a
vein) used for fungal infections
• Corticosteroids used for inflammation
such as hydrocortisone, betamethasone or
prednisolone
• Water tablets (diuretics) such as furosemide
• General anaesthetics or high dose oxygen used during surgery
• Tetracosactide - used to test some
hormone problems
• Amiodarone tablets - used to control the
uneven beating of the heart called
‘arrhythmias’.
Cordarone X may increase the effect of
the following medicines:
• Warfarin – used for thinning the blood. Your
doctor should reduce your dose of warfarin
and monitor your treatment closely.
• Digoxin – used for heart problems. Your
doctor should monitor your treatment
closely and may halve your dose of digoxin.
• Phenytoin – used to treat fits.
• Flecainide - another medicine used for
uneven heartbeats. Your doctor should
monitor your treatment closely and may
halve your dose of flecainide.
• Ciclosporin and tacrolimus - used to help
prevent rejection of transplants.
• Medicines for impotence such as sildenafil,
tadalafil or vardenafil
• Fentanyl - used for pain relief
• Ergotamine - used for migraines
• Midalozam - used to relieve anxiety or to
help you relax before surgery
• Lidocaine – used as an anaesthetic
If you are not sure if any of the above apply
to you, talk to your doctor, nurse or
pharmacist before taking Cordarone X.

Taking Cordarone X with food and drink
Do not drink grapefruit juice while taking this
medicine. This is because drinking grapefruit
juice while taking Cordarone X can increase
your chance of getting side effects.
Protect your skin from sunlight
Keep out of direct sunlight while taking this
medicine and for a few months after you
have finished taking it. This is because your
skin will become much more sensitive to the
sun and may burn, tingle or severely blister if
you do not take the following precautions:
• Make sure you use high factor sun cream
• Always wear a hat and clothes which cover
your arms and legs
Pregnancy and breast-feeding
Do not take this medicine if
• You are pregnant, might become pregnant
or think you may be pregnant
• 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 Cordarone X
This medicine contains:
• Iodine: Cordarone X contains
approximately 56 mg of iodine in a 3 ml
ampoule. Iodine is present in amiodarone
hydrochloride, the medicine your infusion
contains. Iodine can cause problems to
your thyroid (see ‘Tests’ below)
• Benzyl Alcohol: Cordarone X contains
benzyl alcohol (20 mg/ml) as a preservative.
It must not be given to children, premature
or newborn babies. Benzyl alcohol may
cause toxic reactions and allergic reactions
in infants and children up to 3 years old.
3. How Cordarone X is given
Your doctor or nurse will normally give you
Cordarone X. This is because it needs to be
given as an infusion into your vein in the
hospital where the doctor can monitor your
progress.
Having this medicine
• This medicine will be diluted before it is
given to you
• Your doctor will change you over to
Cordarone X tablets as soon as possible
• If you feel the effect of your medicine is
too weak or too strong, tell your doctor,
nurse or pharmacist
If you are not sure why you are receiving
Cordarone X or have any questions about how
much Cordarone X is being given to you, speak
to your doctor, pharmacist or nurse.

Turn
Over

Very rare (affects less than 1 in 10,000 people)
• Changes in the amount of liver
enzymes at the beginning of treatment.
This can be seen in blood tests
• Feeling sick (nausea)
• Headache
• Sweating
• Hot flushes
Frequency not known (frequency cannot be
estimated from the available data)
• Hives (itchy, lumpy rash)
• Back pain
Talk to your doctor, nurse or pharmacist if
any of the side effects gets serious or lasts
longer than a few days or if you notice any
side effects not listed in this leaflet.

Manufacturer
Sanofi Winthrop Industrie
1 Rue de la Vierge
Ambares et Lagrave,
33565 Carbon Blanc Cedex,
France
Sanofi Winthrop Industrie
6 boulevard de l'Europe
21800 Quetigny
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 03/2012
© Sanofi-aventis, 2001−2012

5. How to store Cordarone X
This medicine will be kept by your doctor or
pharmacist in a safe place where children
cannot see or reach it.
Do not use Cordarone X after the expiry date
which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
Do not store above 25oC. Store in the original
container. Only clear solutions free of
particles should be used.
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 Cordarone X contains
• Each 3ml ampoule contains 150mg of the
active substance, amiodarone
hydrochloride
• The other ingredients are benzyl alcohol,
polysorbate and water for injections
What Cordarone X looks like and contents
of the pack
• Cordarone X is a pale yellow solution and
is available as 3ml glass ampoules in
cartons of 6 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi-aventis, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email:
uk-medicalinformation@sanofi-aventis.com
478535
157 x 315

• Medicines for infections (such as
intravenous erythromycin, co-trimoxazole,
moxifloxacin or pentamidine injection)
• Medicines for schizophrenia (such as
chlorpromazine, thioridazine,
fluphenazine, pimozide, haloperidol,
amisulpiride or sertindole)
• Medicines for other mental illnesses (such
as lithium, doxepin, maprotiline or
amitriptyline)
• Medicines for malaria (such as quinine,
mefloquine, chloroquine or halofantrine)
• Medicines used for hay fever, rashes or
other allergies called antihistamines (such
as terfenadine, astemizole or mizolastine)

2

4

PACKAGE LEAFLET:
INFORMATION FOR THE USER

2. Before you have Cordarone X

Cordarone® X 150mg/3ml,
solution for injection

Do not have this medicine and tell
your doctor, pharmacist or nurse if:
× You are allergic (hypersensitive) to:
- iodine
- amiodarone
- any of the other ingredients of
Cordarone X (listed in Section 6 below)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
× You have a slower than usual heartbeat
(called ‘sinus bradycardia’) or an illness
called ‘sino-atrial’ heart block
× You have any other problems with your
heartbeat and do not have a pacemaker
fitted
× You have ever had thyroid problems.
Your doctor should test your thyroid
before giving you this medicine
× You have severe breathing problems
× You have serious blood circulation problems
× You have very low blood pressure
× You are taking certain other medicines
which could affect your heartbeat (see
‘Taking other medicines’ below)
× The person having the medicine is a child
under the age of 3 years, premature or new
born baby
× You are pregnant or breast-feeding (see
‘Pregnancy and breast-feeding’ below)
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Cordarone X.

amiodarone
hydrochloride

i

Cordarone X 150mg/3ml, solution for
injection (called Cordarone X in this leaflet)
contains a medicine called amiodarone
hydrochloride. This belongs to a group of
medicines called anti-arrhythmics.
It works by controlling the uneven beating
of your heart (called ‘arrhythmias’). Having
the injection helps your heartbeat to
return to normal.
Cordarone X is normally only given in a
hospital when a quick response is needed
or when tablets cannot be given. Cordarone
X can be used to:
• Treat uneven heartbeats where other
medicines either have not worked or
cannot be used
• Treat an illness called
Wolff-Parkinson-White Syndrome. This is
where your heart beats unusually fast
• Treat other types of fast or uneven
heartbeats known as ‘atrial flutter’ or
‘atrial fibrillation'. Cordarone X is used
only when other medicines cannot be
used
• Treat fast heartbeats which may happen
suddenly and may be uneven.
Cordarone X is used only when other
medicines cannot be used

Take special care with Cordarone X
Check with your doctor, pharmacist or
nurse before having this medicine if:
▲ You
have
a
weak
heart
(‘cardiomyopathy’) or heart failure
▲ You have low blood pressure
▲ You have liver problems
▲ You have any problems with your
lungs including asthma
▲ You have a problems with your
thyroid gland
▲ You are taking amiodarone tablets
▲ You are about to have an operation
▲ The person having the medicine is an
infant or child under 3 years old
If you are not sure if any of the above
apply to you, talk to your doctor, nurse or
pharmacist before having Cordarone X.

246064

1.What Cordarone X is and what
it is used for

*246064*

Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before
you start having this medicine
• Keep this leaflet. You may need to read
it again
• If you have any further questions, ask
your doctor, nurse 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 Cordarone X is and what it is used for
2. Before you have Cordarone X
3. How Cordarone X is given
4. Possible side effects
5. How to store Cordarone X
6. Further information

1

Taking other medicines
Please tell your doctor, pharmacist or
nurse if you are taking or have recently
taken any other medicines. This includes
medicines you buy without a prescription,
including herbal medicines. This is
because Cordarone X can affect the way
some other medicines work.
Also some medicines can affect the way Turn
Over

SENS DE DEROULEMENT
RECTO
(Intérieur bobine)
Zone de collage côté
spot

• Flecainide - another medicine used for
uneven heartbeats. Your doctor should
monitor your treatment closely and may
halve your dose of flecainide.
• Ciclosporin and tacrolimus - used to help
prevent rejection of transplants.
• Medicines for impotence such as
sildenafil, tadalafil or vardenafil
• Fentanyl - used for pain relief
• Ergotamine - used for migraines
• Midalozam - used to relieve anxiety or to
help you relax before surgery
• Lidocaine – used as an anaesthetic
If you are not sure if any of the above
apply to you, talk to your doctor, nurse or
pharmacist before taking Cordarone X.
Taking Cordarone X with food and drink
Do not drink grapefruit juice while taking
this medicine. This is because drinking
grapefruit juice while taking Cordarone X
can increase your chance of getting side
effects.
Protect your skin from sunlight
Keep out of direct sunlight while taking
this medicine and for a few months after
you have finished taking it. This is because
your skin will become much more sensitive
to the sun and may burn, tingle or severely
blister if you do not take the following
precautions:
• Make sure you use high factor sun cream
• Always wear a hat and clothes which
cover your arms and legs
Pregnancy and breast-feeding
Do not take this medicine if
• You are pregnant, might become
pregnant or think you may be pregnant
• 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 Cordarone X
This medicine contains:
• Iodine:
Cordarone
X
contains
approximately 56 mg of iodine in a 3 ml
ampoule. Iodine is present in amiodarone
hydrochloride, the medicine your infusion
contains. Iodine can cause problems to
your thyroid (see ‘Tests’ below)
• Benzyl Alcohol: Cordarone X contains
benzyl alcohol (20 mg/ml) as a
preservative. It must not be given to
children, premature or newborn babies.
Benzyl alcohol may cause toxic reactions
and allergic reactions in infants and
children up to 3 years old.
246064

Cordarone X works.
In particular, do not take this medicine
and tell your doctor, if you are taking:
• Other medicines for an uneven heartbeat
(such as quinidine, procainamide,
disopyramide, sotalol or bretylium)
• Medicines for infections (such as
intravenous erythromycin, co-trimoxazole,
moxifloxacin or pentamidine injection)
• Medicines for schizophrenia (such as
chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpiride or sertindole)
• Medicines for other mental illnesses
(such as lithium, doxepin, maprotiline or
amitriptyline)
• Medicines for malaria (such as quinine,
mefloquine, chloroquine or halofantrine)
• Medicines used for hay fever, rashes or
other allergies called antihistamines
(such as terfenadine, astemizole or
mizolastine)
Tell your doctor if you are taking any of
the following medicines:
• Medicines for infection (such as
ciprofloxacin, ofloxacin or levofloxacin)
• Medicines for heart problems called
beta-blockers (such as propranolol)
• Medicines called calcium channel
blockers for chest pain (angina) or high
blood pressure (such as diltiazem or
verapamil)
• Medicines for constipation (laxatives)
such as bisacodyl or senna
• Medicines for high cholesterol (statins)
such as simvastatin or atorvastatin
The following medicines can increase
the chance of you getting side effects,
when taken with Cordarone X:
• Amphotericin (when given directly into a
vein) used for fungal infections
• Corticosteroids used for inflammation
such as hydrocortisone, betamethasone
or prednisolone
• Water tablets (diuretics) such as furosemide
• General anaesthetics or high dose
oxygen - used during surgery
• Tetracosactide - used to test some
hormone problems
• Amiodarone tablets - used to control the
uneven beating of the heart called
‘arrhythmias’.
Cordarone X may increase the effect of
the following medicines:
• Warfarin – used for thinning the blood.
Your doctor should reduce your dose of
warfarin and monitor your treatment
closely.
• Digoxin – used for heart problems. Your
doctor should monitor your treatment
closely and may halve your dose of
digoxin.
• Phenytoin – used to treat fits.

2

3. How Cordarone X is given
Your doctor or nurse will normally give
you Cordarone X. This is because it

Turn
Over

If you stop having Cordarone X
It is important for you to keep having
Cordarone X injections until your doctor
decides to stop them. If you stop having
this medicine the uneven heartbeats may
come back. This could be dangerous.
Tests
Your doctor will take regular tests to check
how your liver is working. Cordarone X can
affect how your liver works. If this
happens, your doctor will decide whether
you should keep having this medicine.
Your doctor may do regular thyroid tests
while you are taking this medicine. This is
because Cordarone X contains iodine
which can cause problems to your thyroid.
Your doctor may also do other regular tests
such as blood tests, chest X-rays, ECG
(electrical test of your heartbeat) and eye
tests both before and while you are having
Cordarone X.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

246064

needs to be given as an infusion into your
vein in the hospital where the doctor can
monitor your progress.
Having this medicine
• This medicine will be diluted before it is
given to you
• Your doctor will change you over to
Cordarone X tablets as soon as possible
• If you feel the effect of your medicine is
too weak or too strong, tell your doctor,
nurse or pharmacist
If you are not sure why you are receiving
Cordarone X or have any questions about
how much Cordarone X is being given to
you, speak to your doctor, pharmacist or
nurse.
How much will be given to you
Your doctor will decide how much to give
you depending on your illness
Adults
• The usual dose is 5 mg for every
kilogram of your weight given over a
period of 20 minutes to 2 hours
• You may be given another infusion of
approximately 15 mg for every kilogram of
your weight every 24 hours depending on
your illness
• In an emergency, your doctor may
decide to give you a dose of 150 mg to
300 mg as a slow injection over 3
minutes
Children and adolescents
• There are only limited data on the efficacy
and safety in children. The doctor will
carefully calculate the amount of
Cordarone X depending on the child's or
adolescent's body weight.
Elderly
• The doctor may give you a lower dose of
Cordarone X and monitor your heart rate
and thyroid function more closely
If you have more Cordarone X than you
should
Your doctor will carefully calculate how
much Cordarone X you should get.
Therefore it is unlikely your doctor, nurse
or pharmacist will give you too much of
this medicine. But, if you think that you
have been given too much or
too little Cordarone X, tell your doctor,
nurse or pharmacist.
The following effects may happen: feeling
dizzy, faint, sick, tired or confused. Having
an abnormally slow or fast heartbeat. Too
much amiodarone can damage the heart
and liver.
If you forget to have Cordarone X
Your doctor or nurse will have instructions
on when to give you this medicine. It is
unlikely that you will not be given the
medicine as it has been prescribed.
However, if you think you may have missed
a dose, then talk to your doctor or nurse.

3

4. Possible side effects
Like all medicines, Cordarone X can cause
side effects, although not everybody gets
them. Cordarone X may stay in your blood
for up to a month after stopping
treatment. You may still get side effects in
this time.
Stop having Cordarone X and tell a doctor, nurse or pharmacist or go to a hospital straight away if:
Very rare (affects less than 1 in 10,000
people)
• You have an allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
• Your heartbeat becomes very slow or
stops beating. You may also feel dizzy,
unusually tired and short of breath. This
may occur especially in people over 65
years old or to people with other
heartbeat problems
• Your heartbeat becomes even more
uneven or erratic. This can lead to a
heart attack, so you should go to
hospital straight away
• You get yellowing of the skin or eyes
(jaundice), feel tired or sick, loss of
appetite, stomach pain or high
temperature. These can be signs of liver
problems or damage which can be very
dangerous
• Difficulty breathing or tightness in the
chest, coughing which will not go away,
wheezing, weight loss and fever. This
could be due to inflammation of your
lungs which can be very dangerous Turn
Over

EXP. The expiry date refers to the last day
of that month.
Do not store above 25°C. Store in the
original container. Only clear solutions free
of particles should be used.
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.

Stop having Cordarone X and see a doc-

tor straight away if you notice any of
the following serious side effects - you
may need urgent medical treatment:
Very rare (affects less than 1 in 10,000
people)
• Headache (which is usually worse in
the morning or happens after
coughing or straining), feeling sick
(nausea), fits, fainting, eyesight
problems or confusion can occur.
These could be a signs of problems
with your brain
Tell your doctor as soon as possible if
you have any of the following side effects:
Common (affects less than 1 in 10
people)
• Dizziness, lightheadedness, fainting.
This may occur temporarily and is due
to lowering of blood pressure.
Frequency not known (Cannot be
estimated from the available data)
• Feeling extremely restless or agitated,
weight loss, increased sweating and
being unable to stand the heat. These
could be signs of an illness called
'hyperthyroidism'.
Tell your doctor, nurse or pharmacist if
any of the following side effects get
serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
• Slightly slower heart beat
• You have pain, swelling, irritation,
reddening or skin discolouration in
the area you have been injected with
Cordarone X
Very rare (affects less than 1 in 10,000
people)
• Changes in the amount of liver
enzymes at the beginning of
treatment.
This can be seen in blood tests
• Feeling sick (nausea)
• Headache
• Sweating
• Hot flushes
Frequency not known (frequency cannot be
estimated from the available data)
• Hives (itchy, lumpy rash)
• Back pain
Talk to your doctor, nurse or pharmacist
if any of the side effects gets serious or
lasts longer than a few days or if you
notice any side effects not listed in this
leaflet.

246064

5. How to store Cordarone X
This medicine will be kept by your doctor
or pharmacist in a safe place where
children cannot see or reach it.
Do not use Cordarone X after the expiry
date which is stated on the carton after

6. Further Information
What Cordarone X contains
• Each 3ml ampoule contains 150mg of
the active substance, amiodarone
hydrochloride
• The other ingredients are benzyl alcohol,
polysorbate and water for injections
What Cordarone X looks like and contents of the pack
• Cordarone X is a pale yellow solution
and is available as 3ml glass ampoules in
cartons of 6 or 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email:
uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie
6 boulevard de l’Europe
21800 Quetigny,
France
Sanofi Winthrop Industrie
1 Rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc Cedex,
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 03/2012
© Sanofi, 2001−2012

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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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