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AMIODARONE 30MG/ML INJECTION

Active substance(s): AMIODARONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

D03231

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.
• 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 of the side effects talk to your doctor, pharmacist or nurse.
This includes any side effects not listed in this leaflet. See section 4.

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
You must not be given Amiodarone Injection if:
• You are allergic to amiodarone hydrochloride, iodine or to any of the other
ingredients of this medicine (listed in section 6)
• You have heart problems such as heart block, which can cause a slow heart
rate (such as sino-atrial heart block, sinus bradycardia, high grade AV block,
bifascicular or trifascicular block or sinus node disease) and you do not have
a pacemaker
• You have heart failure or weakness of the heart muscle (cardiomyopathy)
• You have or have had thyroid problems. Your doctor will test your thyroid
before giving you this medicine
• You have severe breathing problems
• You have very low blood pressure
• You are taking other medicines that can make your heartbeat very quickly
(these are listed in below under the section ‘Taking other medicines’)
• You are pregnant, think you may be pregnant or are breastfeeding (unless
treatment is considered absolutely essential by your doctor)
Do not use this medicine if any of the above applies to you and talk to
your doctor or nurse.
Amiodarone Injection must not be given to premature babies or
neonates.
Warnings and precautions:
Talk to your doctor or nurse before you are given Amiodarone Injection if:
• You have mild to moderate low blood pressure
• You have been drinking a lot of alcohol
• You are receiving high dose oxygen therapy
• You are due to have an operation involving general anaesthesia
• You are elderly
Taking other medicines
The following drugs must not be taken with Amiodarone Injection as
together they can cause a very severe fast heartbeat that can be fatal:
• Medicines to treat irregular heart rhythms (anti-arrhythmics), such as
quinidine, procainamide, disopyramide and sotalol
• Antibiotic injections, such as erythromycin, co-trimoxazole and pentamidine
• Medicines to treat mental illness (anti-psychotics), such as chlorpromazine,
thioridazine, haloperidol and pimozide
• Medicines to treat depression, such as lithium and tricyclic antidepressants,
including doxepin, maprotiline and amitriptyline
• Certain medicines to treat allergic reactions (antihistamines), such as
terfenadine, astemizole
• Medicines used to treat or prevent malaria, such as quinine, mefloquine,
chloroquine and halofantrine
If any of the above applies to you, do not use this medicine and talk to your
doctor or nurse.
Other medicines and Amiodarone Injection
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicine, including medicines obtained without a prescription.
• Oral anticoagulants e.g. warfarin (used to thin the blood), phenytoin (used
to treat epilepsy) and digoxin (used to treat certain heart conditions). Your
doctor may reduce your dose of these medicines and your blood will need to
be monitored before and after treatment
• Stimulant laxatives such as bisacodyl and senna, medicines called diuretics
or water tablets, steroids and the antifungal medicine amphotericin. These
can cause low levels of potassium in the blood, which can increase the risk of
getting a fast heart rate (tachycardia).
• Rifampicin (an antibiotic) and St. John’s Wort (a herbal medicine) can cause
lower levels of Amiodarone Injection in the body if they are taken at the
same time
• Medicines that can either be affected by or effect the level of amiodarone in
the body if taken at the same time:
• Cyclosporin, tacrolimus (immunosuppressants)
• Flecainide, used to treat irregular heart rhythms
• Simvastatin and atorvastatin (drugs to reduce blood cholesterol), as there is a
risk of developing muscle pains and kidney failure (rhabdomyolysis) if doses
of more than 20 mg of simvastatin are taken
• Lidocaine (a local anaesthetic)
• Sildenafil (used for erectile dysfunction)
• Fentanyl (used for pain relief)
• Midazolam (a sedative)
• Ergotamine (for migraine)
• Beta-blockers, such as metoptolol, sotalol and bretylium
• Calcium channel blockers diltiazem and verapamil, used to treat high blood
pressure
• Indinavir (an anti-viral drug)
• Cimetidine (an anti-ulcer drug)
• Clarithromycin (an antibiotic)
• Ketoconazole and itraconazole (antifungal drugs)
• Dextromethorphan (cough medicine).
Amiodarone Injection with food and drink
Do not drink grapefruit juice while using this medicine because it can increase
amiodarone levels in your blood.
Protect your skin from sunlight
Keep out of direct sunlight while using this medicine and for a few months
after you have finished using 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 using 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

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 recommended dose is 5 mg for every kilogram of your bodyweight. This
is given by intravenous infusion over a period of 20 minutes to 2 hours
• You may be given another infusion of approximately 15 mg for every
kilogram of your bodyweight 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.
This medicine is not for use in premature babies or neonates.
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.
Continued overleaf

100mm Measurement Verification Bar

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 will 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:
• Severe allergic reactions causing:
- Swelling of hands, feet, lips, mouth, tongue or throat
- Difficulty in breathing
- Itchy skin rash (hives)
- Diarrhoea
- Stomach pains
• Excessive thyroid activity (hyperthyroidism) causing:
- Weight loss
- Weakness
- Restlessness
- Increased heart rate
- Irregular heart rate
- Angina
- Heart failure
• Rhabdomylosis (this can occur when some medicines used to reduce blood
cholesterol, called statins, are taken with Amiodarone), which
can cause:
- muscle pain, tenderness, weakness or cramps
- breakdown of muscle tissue causing kidney damage, which may lead to
swelling of the hands or feet, shortness of breath, darker urine than
normal and abnormal blood test results
Tell your doctor if you have any of the following side effects:
Common (may affect up to 1 in 10 people):
Itchy, red rash (eczema)
Very rare (affects less than 1 in 10,000 people):
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):
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)
Effects on the heart and circulation
• Slow or irregular heartbeat
• Abnormal heart rhythm leading to heart attack
• Heart block that can lead to slow heart rate
• Low blood pressure which can make you feel dizzy or faint
• Reduced heartbeat, which may lead to shock
• Inflammation of blood vessels (vasculitis) seen as weight loss, fever and aches
and pains
• Reduced numbers of platelets in the blood causing bleeding and bruising
• Loss of red blood cells causing tiredness
Effects on the lungs
• Hypersensitivity pneumonitis, alveolar/interstitial pneumonia or fibrosis,
pleuritis, bronchiolitis obliterans organising pneumonia, pulmonary
haemorrhage, respiratory distress syndrome (severe fluid build-up in the
lungs) causing:
-Fever
-Chest pains
-Difficulty breathing.
• Wheezing and breathing difficulties in patients with asthma
Effects on the liver
• Cirrhosis causing bruising and bleeding
• Hepatitis and jaundice causing a yellow colour to the whites of your eyes
and your skin
• Increased liver enzymes which can show up in tests
• An enlarged liver causing jaundice
Effects on the thyroid gland
• Decreased thyroid activity and hypothyroidism causing weight gain,
tiredness, aches and pains and a slow heart beat
• Thyrotoxicosis causing weight loss, a rapid heart rate, shaking, sweating
and an enlarged thyroid gland at the front of the neck
Effects on nerves and muscles
• Nerve disease (neuropathy) causing burning, numbness and pins and
needles
• Muscle disease (myopathy) causing tiredness, weakness and muscle pain
• Nightmares
• Vertigo
• Headache
• Sleeplessness
• Tiredness
• Tingling.
• Shaking.
• A lack of co-ordination
Effects on eyes:
• blurred vision
Effects on the skin:
• Sensitivity to sunlight (photosensitivity) causing skin discolouration, rash,
tingling, burning, redness when exposed to sun and blistering of the skin,
when severe. Avoid exposing your skin to the sun or to sun-lamps after
receiving this injection, cover the skin and use high factor sun cream.
Other effects:
• Pain and irritation at the site of the injection
• Hot flushes, sweating and feeling sick if Amiodarone Injection is given too
quickly
• Increased pressure in the skull (raised intracranial hypertension)
• Being sick
• A metallic taste in the mouth.
• Impotence
• Pain, redness and swelling of the testicles
• Hair loss
• Moderate kidney problems with increased creatinine show in tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 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 outer packaging. 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 product.

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:
Aurum Pharmaceuticals Limited,
Bampton Road, Harold Hill Romford, Essex RM3 8UG, UK
Manufacturers:
Agila Specialties Polska Sp.z.o.o.
10 Daniszewska St.
03-230 Warsaw, Poland
or
Agila Specialities Private Limited
Opp lim, Bilekahalli, Bannerghatta Road, Bangalore, IN-560076, India
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 July 2016

3231-E

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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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