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AMIODARONE 150 MG/3 ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): AMIODARONE HYDROCHLORIDE

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IBI DOPPEL Amiodarone 150mg/3ml PIL V1
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12

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone 150mg/3ml Concentrate
for Solution for Injection/Infusion
Amiodarone hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Amiodarone is and what it is used for
2. What you need to know before you are given Amiodarone
3. How you will be given Amiodarone
4. Possible side effects
5. How to store Amiodarone
6. Contents of the pack and other information

1. What Amiodarone is and what it is used for
Amiodarone 150 mg/3 ml Concentrate for Solution for
Injection/Infusion (called Amiodarone 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.
Amiodarone is normally only given in a hospital when a
quick response is needed or when tablets cannot be
given.
Amiodarone 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 is used only
when other medicines cannot be used
• Treat fast heartbeats which may happen suddenly
and may be uneven. Amiodarone is used only when
other medicines cannot be used
2. What you need to know before you are given
Amiodarone
Do not use this medicine and tell your doctor,
pharmacist or nurse if you:
• are allergic to iodine, amiodarone, or any of the other
ingredients of Amiodarone (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
• have a slower than usual heartbeat (called ‘sinus
bradycardia’) or an illness called ‘sino-atrial’ heart block
• have any other problems with your heartbeat and do
not have a pacemaker fitted
• have or have previously had thyroid problems. Your
doctor should test your thyroid before giving you this
medicine
• have severe breathing problems
• have serious blood circulation problems
• have very low blood pressure
• are taking certain other medicines which could affect
your heartbeat (see ‘Other medicines and Amiodarone’
below)
• are pregnant or breast-feeding (see ‘Pregnancy and
breast-feeding’ below)
This product must not be given to children, premature
babies or neonates.
Do not use this medicine if any of the above apply to you.
If you are not sure, talk to your doctor, pharmacist or nurse
before using Amiodarone.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are
given Amiodarone.
Amiodarone should be given with care if you:
• have a weak heart (‘cardiomyopathy’) or heart failure
• have low blood pressure
• are an elderly person (> 60 years)
• have liver problems
• require oxygen treatment
• are to undergo a general anaesthetic
• have any problems with your eyesight. This includes
an illness called ‘optic neuritis’
• are taking certain other medicines – for list of medicines
see section “Other medicines and Amiodarone” below
If you are not sure if any of the above apply to you, talk to
your doctor, nurse or pharmacist before having Amiodarone.
Children
This medicine should not be given to neonates, infants
and children up to 3 years old.
Other medicines and Amiodarone
Tell your doctor, pharmacist or nurse if you are taking or
have recently taken or might take any other medicines.
This is because Amiodarone can affect the way some
other medicines work. Also some medicines can affect the
way Amiodarone works.

• 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)
• Gastrointestinal agents e.g. cisapride, droperidol
Tell your doctor if you are taking any of the following
medicines:
• 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
• Tetracosactrin (used in some blood tests or sometimes
in the treatment of Crohn's disease)
• Drugs which may change the levels of potassium or
magnesium in your blood e.g. diuretics (water tablets),
steroid tablets
• Monoamine oxidase inhibitors (medications used in
high blood pressure)
• 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.
• 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 treat 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.
Amiodarone with food and drink
Do not drink grapefruit juice while taking this medicine.
This is because drinking grapefruit juice while taking
Amiodarone can increase your chance of getting side
effects.
You should limit the amount of alcohol you drink whilst
being treated with this medicine.
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
Your doctor will prescribe Amiodarone only if he/she
considers the benefit of treatment outweighs the risks
during your pregnancy. Amiodarone can be used during
pregnancy in life-threatening circumstances only.
Driving and using machines
Your doctor will tell you how long to wait before driving a
car or using machines after you are given this medicine.

In particular, do not take this medicine and tell your
doctor, if you are taking:
• Medicines which may cause heart rhythm disturbance
(called torsades de pointes):
• Other medicines to treat irregular heartbeat (such as
quinidine, procainamide, disopyramide, sotalol or
bretylium)
• Some antibiotics (such as erythromycin injection,
co-trimoxazole, pentamidine injection)
• Medicines for schizophrenia (such as chlorpromazine,
thioridazine, fluphenazine, pimozide, haloperidol,
amisulpride or sertindole)

Amiodarone Injection contains:
• Iodine: Amiodarone Injection contains about 56 mg of
iodine in one ampoule of 3ml. Iodine is present in
amiodarone hydrochloride, the medicine your infusion
contains. Iodine can cause problems to your thyroid
(see ‘Tests’ below)
• Benzyl Alcohol: Amiodarone Injection contains benzyl
alcohol. It must not be given to premature or newborn
babies. Benzyl alcohol may cause toxic reactions and
allergic reactions in infants and children up to 3 years old.

The following information is intended for healthcare
professionals only

the integrity of the container. The solution should only be
used if it is clear, free from particles and the container is
undamaged and intact.

For single dose use only. Discard any unused solution
immediately after initial use.
Any unused product or waste material should be
disposed of in accordance with local requirements.
The dilution is to be made under aseptic conditions.
Before use, the sterile concentrate should be visually
inspected for clarity, particulate matter, discolouration and

Amiodarone should be administered by a central venous
route, except for cardiopulmonary resuscitation in case of
cardiac arrest related to ventricular fibrillation resistant to
defibrillation, where the peripheral venous route could be
used.

3. How you will be given Amiodarone
Your doctor or nurse will normally give you Amiodarone.
This is because it needs to be given as an infusion into
your vein in the hospital where the doctor can monitor
your progress.
Using 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, nurse or pharmacist.
If you are not sure why you are receiving Amiodarone or
have any questions about how much Amiodarone 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 (including elderly)
Starting dose
The standard recommended dose is 5 mg/kg bodyweight.
However, this may vary depending upon your age and
how well you respond to treatment. This medicine will be
diluted using 5% glucose solution before it is given to you
over a period of 20 minutes to 2 hours. It will be given
slowly, usually via a drip into a vein in your arm or chest.
Depending on your response, you may be given further
infusions up to 1200 mg (approximately 15 mg/kg
bodyweight) in up to 500 ml 5% glucose per 24 hours.
Maintenance dose:
10 - 20 mg per kg bodyweight in physiological glucose
solution can be given every 24 hours (on average 600 to
800 mg/ 24 hours up to a maximum of 1200 mg/ 24 hours,
equivalent to 4-5 ampoules, maximum 8 ampoules) for a
few days. In some conditions the medicine may be given
as a slow injection of 150-300 mg in 10-20 ml 5% glucose
over a minimum of 3 minutes. If Amiodarone is given in
this way you will be closely monitored. As soon as an
adequate response has been obtained using intravenous
treatment, you may be switched to oral treatment.
Elderly patients should be closely monitored during
treatment, particularly for thyroid function.
Use in children and adolescents
There are only limited data on the efficacy and safety in
children. Your doctor will decide on an appropriate dose.
Patients with liver and kidney problems
Although no dosage adjustment for patients with kidney
or liver abnormalities has been defined during chronic
treatment with oral amiodarone, close clinical monitoring
is prudent for elderly patients.
If you have any further questions on the use of this product,
ask your doctor or the other healthcare professionals.
If you use more Amiodarone than you should
Your doctor will carefully calculate how much Amiodarone
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, 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 use Amiodarone
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 using Amiodarone
It is important for you to keep having Amiodarone until
your doctor decides to stop. If you stop having this
medicine the uneven heartbeats may come back. This
could be dangerous.
Tests
Your doctor may do regular thyroid tests while you are
taking this medicine. This is because Amiodarone 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
Amiodarone.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Amiodarone may stay
in your blood for up to a month after stopping treatment.
You may still get side effects in this time.
If any of the following happen, tell your doctor
immediately. These are very serious side effects and you
may need urgent medical attention.
• breathing difficulties
• chest pain
• severe allergic reaction - you may experience a
sudden itchy rash (hives), swelling of the hands, feet,
ankles, face, lips, mouth or throat (which may cause
difficulty in swallowing or breathing), you may feel you
are going to faint and there may be inflammation of
some of your blood vessels.
If you experience any of the following tell your doctor as
soon as possible.
Very common (may affect more than 1 in 10 people)
• blurred eyesight or seeing a coloured halo in dazzling
light
• burning more easily in the sun (see ‘Protect your skin
from sunlight’ in Section 2)

Cardiopulmonary resuscitation
Administration by a central venous catheter is
recommended when it is immediately available, if not, the
administration must be done by a peripheral venous
route, using a large peripheral vein and with a flow as
important as possible, or possibly, by a slow injection over
a minimum of 3 minutes, followed by administration of
200 ml of infusion fluid. Do not give other medicinal
substances in the same syringe with amiodarone.
Amiodarone can cause severe irritation of the vein,
therefore adequate rinsing after bolus injection must be
ensured. In treatment of prolonged, refractory ventricular

Common (may affect up to 1 in 10 people)
• itchy, red rash (eczema)
• generally moderate slow heart rate
• decrease in blood pressure
• local injection site reactions including swelling, pain,
redness, infection, and pigmentation changes (blue or
grey marks on parts of your skin exposed to sunlight,
especially the face)
• 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
• muscle weakness
• nightmares
• problems sleeping
Uncommon (may affect up to 1 in 100 people)
• feeling numb or weak, tingling or burning feelings in
any part of your body
• dizziness
Rare (may affect up to 1 in 1,000 people)
• the excipient benzyl alcohol may cause hypersensitivity
reactions
Very rare (may affect up to 1 in 10,000 people)
• chest pain or palpitations, or abnormal heart rhythm
• nausea
• liver disorders
• generalised allergic reactions such as swelling of the
face, lips and/or tongue, shortness of breath,
headaches, breathing difficulties (with or without fever)
• inability to breathe
• hot flushes
• sweating
• red, scaly patches of skin, loss of hair or loosening of
nails (called ‘exfoliative dermatitis’)
• 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’
• skin rash
• skin redness during radio-therapy
• moving unsteadily or staggering, slurred or slow speech
• 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
• balance problems, feeling dizzy (vertigo)
• headache
• 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)
• seeing or hearing things that are not real (hallucinations)
• sudden inflammation of the pancreas (pancreatitis
(acute)); confusion (delirium); life threatening skin reactions
characterised by rash, blisters, peeling skin and pain (toxic
epidermal necrolysis (TEN), Stevens- Johnson syndrome
(SJS), bullous dermatitis, Drug reaction with eosinophilia
and systematic symptoms (DRESS)).
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
This medicine will be kept by your doctor or pharmacist in
a safe place where children cannot see or reach it.
Do not use Amiodarone after the expiry date which is
stated on the carton and label after EXP. The expiry date
refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze.
Storage at low temperature could cause the formation of
precipitate. Store in the original container.
Do not use unless solution is clear. Only clear solutions
free of particles should be used. Reject any portion not
used immediately after the opening of the ampoule. After
dilution, use the solution immediately and reject any
portion unused.
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. Contents of the pack and other information
What Amiodarone contains
The acitve substance is amiodarone hydrochloride
The other ingredients are Polysorbate 80, Benzyl alcohol,
Hydrochloride acid or Sodium Hydroxide, Water for injection.
What Amiodarone looks like and contents of the pack
Amiodarone is a pale yellow solution and is available as
3 ml glass ampoules in cartons of 5 or 10 units.
Marketing Authorisation Holder:
Ibigen S.r.l. - Via Fossignano, 2
04011 Aprilia (LT) - Italy
Manufacturer:
Doppel Farmaceutici Srl
Via Volturno
48, Quinto de’ Stampi
20089 Rozzano (MI), Italy
This leaflet was last revised in 04/2016

fibrillation, after administration of adrenaline and
defibrillation, administer 300 mg as bolus injection and
repeat, if necessary, with 150 mg bolus injection.

30114257.001

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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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