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CORDARONE X 200

Active substance(s): AMIODARONE HYDROCHLORIDE

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148 mm

Amiodarone hydrochloride

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 Cordarone X Tablets are and what they are used for
2. Before you take Cordarone X Tablets
3. How to take Cordarone X Tablets
4. Possible side effects
5. How to store Cordarone X Tablets
6. Further information

1. What Cordarone X Tablets are and
what they are used for
Cordarone X 100mg or 200mg Tablets (called Cordarone
X Tablets in this leaflet) contain 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’). Taking the tablets helps your
heartbeat to return to normal.
Cordarone X Tablets 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 Tablets
are used only when other medicines cannot be used.
•• Treat fast heartbeats which may happen suddenly
and may be uneven. Cordarone X Tablets are used
only when other medicines cannot be used.

2. Before you take Cordarone X Tablets
Do not take this medicine and tell your doctor if:

××You are allergic (hypersensitive) to:

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3. How to take Cordarone X Tablets
Always take Cordarone X Tablets 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
•• Swallow the tablets whole. Do not crush or chew
your tablets
•• If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor
How much to take
Adults
•• The usual starting dose is 200mg (one 200mg or
two 100mg Cordarone X Tablets) three times each
day for one week
•• The dose will then be lowered to 200mg twice
each day for one week
•• The dose will then be lowered to 200mg once each
day, until you are told otherwise
•• In some cases, your doctor may then decide to either
increase or lower the amount you take each day. This
will depend on how you react to this medicine
Children and adolescents
•• Cordarone X Tablets should not be given to
children and adolescents.
Elderly
•• The doctor may give you a lower dose of
Cordarone X Tablets. Also, the doctor
should check your blood pressure and
Turn
thyroid function regularly

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Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken any other medicines. This
includes medicines you buy without prescription,
including herbal medicines. This is because Cordarone
X Tablets can affect the way some other medicines work.
Also, some medicines can affect the way Cordarone X
Tablets works.
In particular, do not take this medicine and tell
your doctor, if you are taking:
•• Other medicines for an uneven heartbeat (such as solatol,
quinidine, procainamide, disopyramide or bretylium)
•• Medicines for infections (such as intra-venous
erythromycin, co-trimoxazole, moxifloxacin or
pentamidine)
•• Medicines for schizophrenia (such as chlorpromazine,
thioridazine, fluphenazine, pimozide, haloperidol,
amisulpride 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)

Driving and using machines
You may have blurred eyesight after taking this
medicine. If this happens, do not drive or use any tools
or machines.
Important information about some of the
ingredients of Cordarone X Tablets
This medicine contains:
•• Lactose (a type of sugar): If you have been told by
your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to
your doctor before taking this medicine
•• Iodine: Cordarone X Tablets contain 37.5mg of iodine
in a 100mg tablet and 75mg of iodine in a 200mg
tablet. Iodine is present in Amiodarone hydrochloride,
the medicine your tablets contain. Iodine can cause
problems to your thyroid (see ‘Tests’’ below)

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Take special care with Cordarone X Tablets.
Check with your doctor or pharmacist before taking
your medicine if:
SSYou have heart failure
SSYou have liver problems
SSYou have any problems with your lungs or have asthma
SSYou have any problems with your eyesight. This
includes an illness called ‘optic neuritis’
SSYou are about to have an operation
SSYou are elderly (over 65 years of age). The doctor
will need to monitor you more carefully
SSYou have a pacemaker or implantable cardioverter
defibrillator (ICD). Your doctor will check that your
device is working properly shortly after you start
taking the tablets or if your dose is changed
SSYou have blistering or peeling of the skin around
the lips, eyes, mouth, nose and genitals, flu-like
symptoms and fever. This could be a condition called
Steven-Johnsons syndrome
SSYou have a severe blistering rash in which layers
of the skin may peel off to leave large areas of
raw exposed skin over the body. You may also feel
generally unwell, have a fever, chills and aching
muscles (Toxic Epidermal Necrolysis)
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Cordarone
X Tablets.

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− iodine
− amiodarone
− any of the other ingredients of Cordarone X Tablets
(listed in Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing difficulties, 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 are taking certain other medicines which could affect
your heartbeat (see ‘Taking other medicines’ below)
××You are pregnant or breast-feeding (see ‘Pregnancy
and breast-feeding’ below)
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 Cordarone X Tablets.

sofosbuvir, daclatasvir, simeprevir or ledispasvir)
Tell your doctor if you are taking any of the
following medicines:
•• Medicines that lengthen your heart beat (the QT
interval) such as medicines for infection (such as
clarithromycin, 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 Tablets:
•• Amphotericin (when given directly into a vein) – used
for fungal infections
•• Medicines for inflammation (corticosteroids) such as
hydrocortisone, betamethasone or prednisolone
•• Water tablets (diuretics)
•• General anaesthetics or high dose oxygen – used
during surgery
•• Tetracosactide – used to test some hormone problems
Cordarone X Tablets may increase the effect of the
following medicines:
•• 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
•• Midazolam – used to relieve anxiety or to help you
relax before surgery
•• Colchicine – used for the treatment of gout
•• Flecainide – another medicine used for uneven
heartbeats. Your doctor should monitor your
treatment and may half your dose of Flecainide
•• Lidocaine – used as an anaesthetic
•• Warfarin – used to stop your blood from clotting
•• Digitalis – used for some heart conditions
•• Dabigatran- used to thin the blood
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Cordarone
X Tablets.
Taking Cordarone X Tablets with food and drink
Do not drink grapefruit juice while taking this medicine.
This is because drinking grapefruit juice while taking
Cordarone X Tablets can increase your chance of getting
side effects.
Limit the amount of alcohol you drink whilst taking
this medicine. This is because drinking alcohol while
taking this medicine will increase the chance of you
having problems with your liver. Talk to your doctor or
pharmacist about the amount of alcohol you can drink.
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
•• Tell your doctor before taking this medicine if you are
pregnant, might become pregnant or think you may
be pregnant. Cordarone X Tablets are not normally
given during pregnancy
•• Do not take if you are breast-feeding or plan to
breast-feed. This is because small amounts of this
medicine may pass into the mothers’ milk
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.

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Cordarone® X 100mg and 200mg
Tablets

•• Medicines for hepatitis C treatment (such as

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

If you take more Cordarone X Tablets than you
should
If you take more Cordarone X Tablets 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. The
following effects may happen: feeling dizzy, faint or
tired, confusion, slow heartbeat, damage to the liver or
being sick.
If you forget to take Cordarone X Tablets
If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the
missed dose.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Cordarone X Tablets
Keep taking Cordarone X Tablets until your doctor tells
you to stop. Do not stop taking Cordarone X Tablets just
because you feel better. If you stop taking 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 Tablets can affect how
your liver works. If this happens, your doctor will
decide whether you should keep taking these tablets.
Your doctor may do regular thyroid tests while you
are taking this medicine. This is because Cordarone X
Tablets contain 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
taking Cordarone X Tablets.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

5. How to store Cordarone X Tablets
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Cordarone X Tablets after the expiry date
which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Keep the blister strip in the outer carton in order to
protect from light. Do not store above 25°C.
Do not use Cordarone X Tablets if you notice your
tablets are crumbling, broken or discoloured
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 Tablets contain
•• Each Cordarone X 100mg Tablet contains 100mg of
the active substance, amiodarone hydrochloride
•• Each Cordarone X 200mg Tablet contains 200mg of
the active substance, amiodarone hydrochloride
•• The other ingredients are lactose monohydrate,
maize starch, povidone, colloidal anhydrous silica
and magnesium stearate
What Cordarone X Tablets looks like and contents
of the pack
100mg Tablets: The tablets are round and white in
colour. One side has a break-line and the other side is
imprinted with ‘100’.
200mg Tablets: The tablets are round and white in
colour. One side has a break-line and the other side is
imprinted with ‘200’.
The tablets are available in blister-packs of 28 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Manufacturer
Fawdon Manufacturing Centre, Edgefield Avenue,
Fawdon, Newcastle-upon-Tyne, NE3 3YY, UK
or
S.C. Zentiva S.A., 50, Theodor Pallady Blvd., 032266,
Bucharest, Romania.
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 September 2015.
‘Zentiva’ is a registered trademark © 2015
Zentiva.
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4. Possible side effects
Like all medicines, Cordarone X Tablets can cause side
effects, although not everybody gets them. Cordarone X
Tablets may stay in your blood for up to a month after
stopping treatment. You may still get side effects in this
time.
Stop taking Cordarone X Tablets 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,
swollen eyelids, face, lips, throat or tongue
•• You have blistering or peeling of the skin around
the lips, eyes, mouth, nose and genitals, flu-like
symptoms and fever. This could be a condition
called Steven-Johnsons syndrome.
•• You have a severe blistering rash in which layers
of the skin may peel off to leave large areas of
raw exposed skin over the body. You may also feel
generally unwell, have a fever, chills and aching
muscles (Toxic Epidermal Necrolysis)
•• You have inflammation of the skin characterised
by fluid filled blisters (bullous dermatitis)
•• You have flu like symptoms and a rash on the
face followed by an extended rash with a high
temperature, increased levels of liver enzymes
seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph
nodes (DRESS)
Common (affects less than 1 in 10 people)
•• 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
Uncommon (affects less than 1 in 100 people)
•• Your heartbeat becomes even more uneven or
erratic. This can lead to a heart attack, so you
should go to hospital straight away
Very rare (affects less than 1 in 10,000 people)
•• 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’
•• Your heartbeat becomes very slow or stops beating.
If this happens go to hospital straight away
Stop taking Cordarone X Tablets and see a doctor
straight away if you notice any of the following
serious side effects – you may need urgent medical
treatment:
Uncommon (affects less than 1 in 100 people)
•• Feeling numb or weak, tingling or burning feelings
in any part of your body
Very rare (affects less than 1 in 10,000 people)
•• Skin rash caused by narrow or blocked blood
vessels (called ‘vasculitis’)
•• 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 signs of
problems with your brain.
•• Moving unsteadily or staggering, slurred or slow
speech
•• Feeling faint, dizzy, unusually tired and short
of breath. These could be signs of a very slow
heartbeat (especially in people over 65 years old)
or other problems with your heart’s natural beat
Some cases of bleeding in the lungs have been reported
in patients taking Cordarone X Tablets. You should tell
your doctor straight away if you cough up any blood.
Not known (frequency cannot be estimated from
the available data)
•• Chest pain and shortness of breath and irregular
heartbeat. These could be signs of a condition
called “Torsade de pointes”
Tell your doctor as soon as possible if you have any
of the following side effects:
Very common (affects more than 1 in 10 people)
•• Blurred eyesight or seeing a coloured halo in
dazzling light
Common (affects less than 1 in 10 people)
•• Feeling extremely restless or agitated, weight loss,
increased sweating and being unable to stand the
heat. These could be signs of an illness called
‘hyper-thyroidism’
•• Feeling extremely tired, weak or ‘run-down’,
weight gain, being unable to stand the cold,

constipation and aching muscles. These could be
signs of an illness called ‘hypo-thyroidism’.
•• Trembling when you move your arms or legs
•• Blue or grey marks on parts of your skin exposed
to sunlight, especially the face
Uncommon (affects less than 1 in 100 people)
•• Muscle cramps, stiffness or spasm
Very rare (affects less than 1 in 10,000 people)
•• Swelling of the testicles
•• Red, scaly patches of skin, loss of hair or loosening
of nails (called ‘exfoliative dermatitis’)
•• Feeling tired, faint, dizzy or having pale skin.
These could be signs of anaemia
•• You may bleed or bruise more easily than usual.
This could be because of a blood disorder (called
‘thrombocytopenia’)
•• 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)
Not Known (frequency cannot be estimated from the
available data)
•• Severe stomach pain which may reach through to
your back. This could be a sign of pancreatitis
•• You may get more infections than usual. This could
be caused by a decrease in the number of white
blood cells (neutropenia)
•• You may get infections more easily than usual.
This could be because of a blood disorder
(agranulocytosis)
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer than
a few days:
Very common (affects more than 1 in 10 people)
•• Feeling sick (nausea) or being sick (vomiting)
•• Change in the way things taste
•• Changes in the amount of liver enzymes at the
beginning of treatment. This can be seen in blood tests
•• Burning more easily in the sun (see ‘Protect your
skin from sunlight’ in Section 2)
Common (affects less than 1 in 10 people)
•• Slightly slower heartbeat
•• Nightmares
•• Problems sleeping
•• Scaly and itchy rash (eczema)
Very rare (affects less than 1 in 10,000 people)
•• Headache
•• Balance problems, feeling dizzy (vertigo)
•• Difficulty in getting or maintaining an erection or
in ejaculating
•• Hair loss, balding
•• Skin rash
•• Skin redness during radio-therapy
Not known (frequency cannot be estimated from the
available data)
•• Hives (itchy, lumpy rash)
•• Granulomas, small red lumps on the skin or inside
the body which are seen by X-ray
•• Feeling less hungry
•• Movements that you cannot control, mainly of the
tongue, mouth, jaw, arms and legs (Parkinsonism)
•• Feeling confused or seeing or hearing things that
are not there (hallucination)
•• Decreased sex drive
•• A distorted sense of smell (parosmia)
•• Dry mouth
•• Constipation
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.

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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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