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AMIODARONE HYDROCHLORIDE 50 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION/INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amiodarone Hydrochloride 50mg/ml Concentrate for Solution for
Injection/Infusion
Amiodarone Hydrochloride
(referred to as Amiodarone Injection in this leaflet)
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 further questions, please ask your doctor or nurse.
• If you get any of the side effects talk to your doctor or nurse. This includes any possible 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 breastfeeding
• 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 or pharmacist 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 56mg of iodine in a 3ml ampoule. 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
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, Amiodarone 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 3ml ampoule contains 150mg 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 3ml ampoules in cartons of
10.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex, RM3 8UG
United Kingdom
Manufacturer
Rotexmedica GmbH, Arnzneimittelwerk, Bunsenstrasse 4, D-22946 Trittau, Germany
MA Number: PL 12064/0123
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

Expand Transcript

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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