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CORDARONE X 150MG/3ML SOLUTION FOR INJECTION

Active substance(s): AMIODARONE HYDROCHLORIDE

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Accord CQL

Code actuel / Current code : 700688
Couleur (s) / Color(s) : 1

Noir
Plan N° :

N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

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

i

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 any problems with your eyesight.
This includes an illness called ‘optic
neuropathy’ or 'neuritis’
▲ You have a problem 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.
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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

1

Taking other medicines
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any

SENS DE DEROULEMENT
RECTO
(Intérieur bobine)

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

- Cedric Blanchet’s modifications requested on the 27/04/16.

2. Before you have Cordarone X

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

*700898*

Accord Spécification

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Polices / Fonts : Ocean Sans Pro
Texte corps mini / Text size mini : 10pt

Delpharm

Code AC / Item : 700898
Description AC : Notice Cordarone 150 mg
Destination :
Grande Bretagne
Date / Version : 04/05/16 v2
Dimension :
210x148 mm
Type :
Roul. double

Turn
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Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans Pro
Texte corps mini / Text size mini : 10pt

Delpharm

Code AC / Item : 700898
Description AC : Notice Cordarone 150 mg
Destination :
Grande Bretagne
Date / Version : 04/05/16 v2
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700688
Couleur (s) / Color(s) : 1

Noir
Plan N° :

N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

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)
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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, disopyramide,
sotalol or bretylium)
• Medicines for infections (such as intravenous
erythromycin, co-trimoxazole, moxifloxacin or
pentamidine injection)
• Medicines for schizophrenia (such as
chlorpromazine, thioridazine, fluphena-zine,
pimozide, haloperidol, ami-sulpiride 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)
• Medicines for hepatitis C treatment (such as
sofosbuvir, daclatasvir, simeprevir or
ledispasvir)
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’.

- Cedric Blanchet’s modifications requested on the 27/04/16.

2

Turn
Over

Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans Pro
Texte corps mini / Text size mini : 10pt

Delpharm

Code AC / Item : 700898
Description AC : Notice Cordarone 150 mg
Destination :
Grande Bretagne
Date / Version : 04/05/16 v2
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700688
Couleur (s) / Color(s) : 1

Noir
Plan N° :

N 84

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

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 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
700898

• 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.
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.

- Cedric Blanchet’s modifications requested on the 27/04/16.

3

• Difficulty breathing or tightness in the
chest, coughing which will not go away,

Turn
Over

Accord Spécification

Accord CQL
Site de Dijon

Polices / Fonts : Ocean Sans Pro
Texte corps mini / Text size mini : 10pt

Delpharm

Code AC / Item : 700898
Description AC : Notice Cordarone 150 mg
Destination :
Grande Bretagne
Date / Version : 04/05/16 v2
Dimension :
210x148 mm
Type :
Roul. double

Code actuel / Current code : 700688
Couleur (s) / Color(s) : 1

Noir
Plan N° :

N 84

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)
• You get loss of eyesight in one eye or your
eyesight becomes dim and colourless. Your eyes
may feel sore or tender and feel painful to
move. This could be an illness called ‘optic
neuropathy’ or ‘neuritis’
• 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
• Feeling unwell, confused or weak, feeling sick
(nausea), loss of appetite, feeling irritable. This
could be an illness called ‘syndrome of
inappropriate anti-diuretic hormone secretion’
(SIADH)
Frequency not known (frequency cannot be
estimated from the available data)
• Hives (itchy, lumpy rash)
• Back pain
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

700898

Modification(s) apportée(s) à cette version / Modification(s) brought to this version :

4

- Cedric Blanchet’s modifications requested on the 27/04/16.

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 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 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.
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: 0845 372 7101
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 04/2016
© Sanofi, 2001-2016

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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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