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AMIODARONE 30MG/ML INJECTION

Active substance(s): AMIODARONE HYDROCHLORIDE

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Package leaflet: information for the user

D02448

Amiodarone 30mg/ml Injection
amiodarone hydrochloride
Read all of this leaflet carefully before you are given this medicine
because it contains important information for you. In certain
emergency situations this may not be possible; however your doctor
will retain the leaflet for you to read later.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or nurse
• If you get any of the side effects talk to your doctor or nurse. This
includes any side effects not listed in this leaflet.

What is in this leaflet:
1. What Amiodarone Injection is, and what it is used for
2. What you need to know before you are given Amiodarone Injection
3. How Amiodarone Injection is given
4. Possible side effects
5. How to store Amiodarone Injection
6. Contents of the pack and other information

1. What Amiodarone Injection is and what it is used for
Amiodarone Injection contains the active substance amiodarone
hydrochloride. It 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 Injection is normally only given in a hospital when a quick
response is needed or when tablets cannot be given. Amiodarone Injection
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.

2. What you need to know before you are given
Amiodarone Injection
Do not have Amiodarone Injection if:
• you are allergic (hypersensitive) to:
- iodine
- amiodarone
- any of the other ingredients of Amiodarone Injection (listed in Section 6
of this leaflet).
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 which causes irregular heartbeats 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 will test your thyroid
before giving you this medicine
• you have severe breathing problems, serious blood circulation problems,
low blood pressure, weak heart (cardiomyopathy) or heart failure.
• you are taking certain other medicines which could affect your heartbeat
(see ‘Other medicines and Amiodarone Injection’ below)
• the person that would be given the medicine is a premature or new born
baby, or a child up to 3 years old
• you are pregnant or breast-feeding (see ‘Pregnancy and breastfeeding’
below)
Do not have this medicine if any of the above applies to you. If you are not
sure, talk to your doctor or nurse before having Amiodarone Injection.
Warnings and precautions:
Talk to your doctor or nurse before having Amiodarone Injection if you
• have a weak heart (cardiomyopathy) or heart failure
• have low blood pressure
• have liver problems
• have any problems with your lungs, including asthma
• are about to have an operation
If you are not sure if any of the above applies to you, talk to your doctor or
nurse before having Amiodarone Injection.
Other medicines and Amiodarone Injection
Please tell your doctor or nurse if you are taking, have recently taken or
might take any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Amiodarone Injection
can affect the way some other medicines work. Also some medicines can
affect the way Amiodarone Injection works. In particular, tell your doctor if you
are taking:
• Other medicines for an uneven heartbeat (such as quinidine,
procainamide, disopyramide, sotalol or bretylium)
• Medicines used to treat bacterial infections (such as intravenous
erythromycin, co-trimoxazole or moxifloxacin)
• 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 used to treat or prevent certain types of pneumonia (such as
pentamidine injection)
• 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)
• Certain laxatives - medicines for constipation. These can cause low blood
levels of potassium which can increase the risk of irregular heartbeats
• Medicines for high cholesterol (statins) such as simvastatin, atorvastatin or
lovastatin
The following medicines can increase the chance of you getting side
effects, when taken with Amiodarone Injection:
• Amphotericin used for fungal infections (when given directly into a vein)
• Corticosteroids used for inflammation 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
Amiodarone Injection 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
• Fentanyl - used for pain relief
• Ergotamine - used for migraines
• Midazolam - used to relieve anxiety or to help you relax before surgery
• Lidocaine – used as an anaesthetic
Amiodarone Injection with food and drink
Do not drink grapefruit juice while taking this medicine. This is because
drinking grapefruit juice while taking Amiodarone Injection can increase the
level of Amiodarone in your blood.
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 a high factor sun cream
• always wear a hat and clothes which cover your arms and legs
Pregnancy and breast-feeding
• Your doctor will prescribe amiodarone injection only in exceptional
circumstances, if the benefit of treatment outweighs the risks during your
pregnancy
• You should not be given amiodarone if you are breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking any
medicine.
Driving and using machines
Some of the side effects in section 4 together with how you feel after your
treatment may make it unsafe for you to drive or operate machinery. If you feel
unwell, you must speak to your doctor or nurse before driving or operating
machinery.
Important information about some of the ingredients of Amiodarone
Injection
This medicine contains:
• Iodine: Amiodarone Injection contains approximately 112mg of iodine in
a 10ml pre-filled syringe. Iodine is present in amiodarone hydrochloride,
the medicine your infusion contains. Iodine can cause problems with your
thyroid (see ‘Tests’ below)
• Benzyl Alcohol: Amiodarone Injection contains 20mg/ml benzyl alcohol as
preservative. It may cause toxic and allergic reactions in infants and children
up to 3 years old
Continued overleaf

3. How Amiodarone Injection is given
Your doctor or nurse will normally give you Amiodarone Injection. 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 tablets as soon as possible
• If you feel the effect of your medicine is too weak or too strong, tell your
doctor or nurse
If you are not sure why you are receiving Amiodarone Injection or have any
questions about how much Amiodarone Injection is being given to you, speak
to your doctor.
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 is only limited information on the use in children. The child’s doctor
will carefully calculate the amount of Amiodarone Injection depending on
the child’s body weight.
Elderly:
• The doctor may give you a lower dose of Amiodarone Injection and monitor
your heart rate and thyroid function more closely.
If you are given too much Amiodarone Injection
Your doctor will carefully calculate how much Amiodarone Injection you
should get, therefore it is unlikely your doctor or nurse will give you too much
of it. If you think that you have been given too much or too little Amiodarone
Injection, tell your doctor or nurse.
If you are given too much Amiodarone Injection the following effects
may happen: feeling dizzy, faint, sick, tired or confused. You may have an
abnormally slow or fast heartbeat. Too much amiodarone can damage the
heart and liver.
If you forget to have Amiodarone Injection
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 Injection
It is important for you to keep having Amiodarone 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 Injection 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 Injection contains iodine which can cause
problems with 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 Amiodarone Injection
If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. Amiodarone Injection 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 Injection and tell a doctor or nurse, or go to a
hospital straight away if you notice any of the following:
Very rare (may affect up to 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 the 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 Injection and see a doctor straight away if you
notice any of the following serious side effects - you may need urgent
medical treatment:
Very rare (may affect up to 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. These could be signs of problems with your brain
Tell your doctor as soon as possible if you have any of the following side
effects:
Common (may affect up to 1 in 10 people)
• Dizziness, light-headedness, 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 if any of the following side effects gets serious or lasts
longer than a few days:
Common (may affect up to 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 Injection
Very rare (may affect up to 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 (cannot be estimated from the available data)
• Hives (itchy, lumpy rash)
• Back pain
If you get any side effects, talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet.

5. How to store Amiodarone Injection
• Your doctor or pharmacist is responsible for storing Amiodarone Injection in
a safe place where children cannot see or reach it. They are also responsible
for disposing of any unused Amiodarone Injection correctly
• You should not be given Amiodarone Injection after the expiry date (EXP)
which is stated on the carton. The expiry date refers to the last day of that
month. Your doctor or nurse will check that the date has not passed before
giving this medicine to you
• This medicine will be stored below 25oC in the original container. Only clear
solutions free of particles should be used
• For single use only. Discard any unused solution

6. Contents of the pack and other information
What Amiodarone Injection contains
• Each 10ml pre-filled syringe contains 300mg of the active substance,
amiodarone hydrochloride
• The other ingredients are benzyl alcohol, polysorbate 80 and water for
injections
What Amiodarone Injection looks like and contents of the pack
• Amiodarone Injection is a clear, pale yellow solution and is available as a
single 10ml pre-filled syringe.
Marketing Authorisation Holder
Manufacturer
Aurum Pharmaceuticals Ltd
Martindale Pharmaceuticals
Bampton Road, Harrold Hill
Bampton Road, Harold Hill
Romford, Essex RM3 8UG
Romford, Essex RM3 8UG
or

Agila Specialties Polska Sp.z.o.o.

10 Daniszewska St.

03-230 Warsaw, Poland
or

Federa SA

Font Saint Landry 10

Brussels B-1120, Belgium
MA number: PL 12064/0047
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 or contact Medical Information at the above address.
This leaflet was last revised in 02/2013

100mm Measurement Verification Bar

2448-B

DEVELOPMENT ARTWORK
Component Code: D02448
Paper size: 100 x 510mm
Version Control Date

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Version A Created 28/02/13 AC
Version B

06/03/13 AC

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Grand Fromage Creative Ltd
Amherst House, 22 London Road
Sevenoaks, Kent TN13 2BT
t:+44 (0)1732 456 187
e:alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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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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