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AMIODARONE HYDROCHLORIDE 50MG/ML SOLUTION FOR INJECTION

Active substance(s): AMIODARONE HYDROCHLORIDE / AMIODARONE HYDROCHLORIDE / AMIODARONE HYDROCHLORIDE

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Cordarone® X 150mg/3ml
Solution for Injection

2905
07.11.16[3]

(amiodarone hydrochloride)
PATIENT INFORMATION LEAFLET
Read all of the 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, 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
This medicine is available using the above name but will be referred to as
Cordarone X throughout the following leaflet.
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 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
2. BEFORE YOU HAVE CORDARONE X
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.
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.
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, disopyramide, sotalol or bretylium)
- Medicines for infections (such as intravenous erythromycin, cotrimoxazole, 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)
- 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’.
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.
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 Xrays, 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
- 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)
- 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
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
Keep out of the sight and reach of children.
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. Keep the ampoule in the outer carton. Only clear
solutions free of particles should be used.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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 amiodarone hydrochloride.
- The other ingredients are benzyl alcohol, polysorbate 80 and water for
injections.
What Cordarone X looks like and contents of the pack
Cordarone X is a clear, pale yellow solution available in colourless glass
ampoules with a blue scored dot and red neck ring. Ampoules are stored in
a plastic holding inside the carton.
Each carton contains 6 x 3ml ampoules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Sanofi Winthrop Industrie, 6 boulevard de l’Europe, 21800
Quetigny, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2905

Leaflet revision and issue date (Ref) 07.11.16[3]
Cordarone X is a trademark of Sanofi.

Amiodarone hydrochloride
50mg/ml Solution for Injection

2905
07.11.16[3]

PATIENT INFORMATION LEAFLET
Read all of the 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, 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
This medicine is available using the above name but will be referred to as
Amiodarone hydrochloride throughout the following leaflet.
In this leaflet:
1. What Amiodarone hydrochloride is and what it is used for
2. Before you have Amiodarone hydrochloride
3. How Amiodarone hydrochloride is given
4. Possible side effects
5. How to store Amiodarone hydrochloride
6. Further information
1. WHAT AMIODARONE HYDROCHLORIDE IS AND WHAT IT IS USED
FOR
Amiodarone hydrochloride 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.
Amiodarone hydrochloride is normally only given in a hospital when a quick
response is needed or when tablets cannot be given. Amiodarone
hydrochloride 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'.
Amiodarone hydrochloride is used only when other medicines cannot be
used
- Treat fast heartbeats which may happen suddenly and may be uneven.
Amiodarone hydrochloride is used only when other medicines cannot be
used
2. BEFORE YOU HAVE AMIODARONE HYDROCHLORIDE
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 Amiodarone hydrochloride (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 Amiodarone
hydrochloride.
Take special care with Amiodarone hydrochloride 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 Amiodarone hydrochloride.
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
Amiodarone hydrochloride can affect the way some other medicines work.
Also some medicines can affect the way Amiodarone hydrochloride 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, cotrimoxazole, 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)
- 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 Amiodarone hydrochloride:
- 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’.
Amiodarone hydrochloride 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 Amiodarone hydrochloride.
Taking Amiodarone hydrochloride with food and drink
Do not drink grapefruit juice while taking this medicine. This is because
drinking grapefruit juice while taking Amiodarone hydrochloride 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 Amiodarone
hydrochloride
This medicine contains:
- Iodine: Amiodarone hydrochloride 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: Amiodarone hydrochloride 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 AMIODARONE HYDROCHLORIDE IS GIVEN
Your doctor or nurse will normally give you Amiodarone hydrochloride. 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 Amiodarone hydrochloride 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 Amiodarone hydrochloride or have
any questions about how much Amiodarone hydrochloride 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 Amiodarone hydrochloride
depending on the child's or adolescent's body weight.
Elderly
- The doctor may give you a lower dose of Amiodarone hydrochloride and
monitor your heart rate and thyroid function more closely
If you have more Amiodarone hydrochloride than you should
Your doctor will carefully calculate how much Amiodarone hydrochloride 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 Amiodarone hydrochloride, 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 Amiodarone hydrochloride
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 Amiodarone hydrochloride
It is important for you to keep having Amiodarone hydrochloride 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.
Amiodarone hydrochloride 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 Amiodarone hydrochloride contains iodine which can cause
problems to your thyroid.
Your doctor may also do other regular tests such as blood tests, chest Xrays, ECG (electrical test of your heartbeat) and eye tests both before and
while you are having Amiodarone hydrochloride.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amiodarone hydrochloride can cause side effects,
although not everybody gets them. Amiodarone hydrochloride may stay in
your blood for up to a month after stopping treatment. You may still get side
effects in this time.
Stop having Amiodarone hydrochloride 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.
Stop having Amiodarone hydrochloride 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 Amiodarone hydrochloride
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
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 AMIODARONE HYDROCHLORIDE
Keep out of the sight and reach of children.
Do not use Amiodarone hydrochloride 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. Keep the ampoule in the outer carton. Only clear
solutions free of particles should be used.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
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 Amiodarone hydrochloride contains
- Each 3ml ampoule contains 150mg amiodarone hydrochloride.
- The other ingredients are benzyl alcohol, polysorbate 80 and water for
injections.
What Amiodarone hydrochloride looks like and contents of the pack
Amiodarone hydrochloride is a clear, pale yellow solution available in
colourless glass ampoules with a blue scored dot and red neck ring.
Ampoules are stored in a plastic holding inside the carton.
Each carton contains 6 x 3ml ampoules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Sanofi Winthrop Industrie, 6 boulevard de l’Europe, 21800
Quetigny, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2905

Leaflet revision and issue date (Ref) 07.11.16[3]

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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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