PACKAGE LEAFLET: INFORMATION FOR THE USER D05537 breastfeeding (unless treatment is considered absolutely chlorpromazine, thioridazine, haloperidol,

, thioridazine, haloperidol, fluphenazine, treating you that you are using Amiodarone
essential by your doctor) amisulpride, sertindole and pimozide Amiodarone Injection with food and drink
Amiodarone 30mg/ml • Do not give to your newborn baby (up to 4 weeks old), • Medicines to treat depression, such as lithium and tricyclic Do not drink grapefruit juice while using this medicine
Solution for injection/infusion unless recommended by your doctor. antidepressants, including doxepin, maprotiline and because it can increase amiodarone levels in your blood.
in pre-filled syringe • Do not use for more than a week in young children amitriptyline
(less than 3 years old), unless advised by your doctor or • Medicines used for digestive problems (e.g. cisapride). Protect your skin from sunlight
pharmacist. • Medicines for infections (e.g. moxifloxacin, erythromycin). Keep out of direct sunlight while using this medicine and
amiodarone hydrochloride for a few months after you have finished using it. This is
• Ask your doctor or pharmacist for advice if you are • Injections of pentamidine (used in certain types of
Read all of this leaflet carefully before you are pregnant or breast-feeding. pneumonia). because your skin will become much more sensitive to the
given this medicine because it contains important • Certain medicines to treat allergic reactions sun and may burn, tingle or severely blister if you do not
Do not use this medicine if any of the above applies to take the following precautions:
information for you. you and talk to your doctor or nurse. (antihistamines), such as terfenadine, astemizole and
D05537

• Keep this leaflet. You may need to read it again mizolastine • make sure you use a high factor sun cream
Amiodarone Injection must not be given to premature • always wear a hat and clothes which cover your arms
• If you have any further questions, ask your doctor, babies, neonates or a child up to 3 years old. • Medicines used to treat or prevent malaria, such as
pharmacist or nurse quinine, mefloquine, chloroquine and halofantrine and legs
• If you get any of the side effects talk to your doctor, Warnings and precautions: Pregnancy and breast-feeding
Talk to your doctor, pharmacist or nurse before you are If any of the above applies to you, do not use this medicine
pharmacist or nurse. This includes any side effects not and talk to your doctor or nurse. • Your doctor will prescribe amiodarone injection only in
listed in this leaflet. See section 4. given Amiodarone Injection if: exceptional circumstances, if the benefit of treatment
• You have mild to moderate low blood pressure Other medicines and Amiodarone Injection outweighs the risks during your pregnancy. Amiodarone
This medicine will be referred to as Amiodarone Injection • You have a weak heart or heart failure Tell your doctor, pharmacist or nurse if you are taking, have can be used during pregnancy in life-threatening
in the rest of this leaflet. • You have any problem with your thyroid gland. Your recently taken or might take any other medicine. circumstances only.
doctor will test your thyroid before giving you this • You should not be given amiodarone if you are breast-
What is in this leaflet: medicine. • Oral anticoagulants e.g. warfarin (used to thin the blood), feeding. If you are given amiodarone during pregnancy
• You have liver problems phenytoin (used to treat epilepsy) and digoxin (used to or breast-feeding, breast-feeding should be stopped. If
1. What Amiodarone Injection is and what it is used for treat certain heart conditions). Your doctor may reduce
2. What you need to know before you are given Amiodarone • You are receiving high dose oxygen therapy or have any you are pregnant or breast-feeding, think you may be
other problems with your lungs including asthma your dose of these medicines and your blood will need to pregnant or are planning to have a baby, ask your doctor
Injection be monitored before and after treatment
3. How Amiodarone Injection is given • You are due to have an operation involving general for advice before taking this medicine.
anaesthesia • Stimulant laxatives such as bisacodyl and senna, medicines
4. Possible side effects called diuretics or water tablets, steroids and the Driving and using machines
5. How to store Amiodarone Injection • You are elderly Some of the side effects in section 4 together with how you
• You currently take a medicine containing sofosbuvir antifungal medicine amphotericin (when given directly
6. Contents of the pack and other information into the vein). These can cause low levels of potassium feel after your treatment may make it unsafe for you to drive
for the treatment of hepatitis C as it may result in a or operate machinery. If you feel unwell, you must speak to
1. What Amiodarone Injection is and what it is life-threatening slowing of your heart beat. Your doctor in the blood, which can increase the risk of getting a fast
your doctor or nurse before driving or operating machinery.
used for may consider alternative treatments. If treatment with heart rate (tachycardia).
amiodarone and sofosbuvir is needed, you may require • Rifampicin (an antibiotic) and St. John’s Wort (a herbal Important information about some of the ingredients of
Amiodarone Injection contains the active substance additional heart monitoring. medicine) can cause lower levels of Amiodarone Injection Amiodarone Injection
amiodarone hydrochloride. It belongs to a group of in the body if they are taken at the same time
Check with your doctor, pharmacist or nurse if: Amiodarone Injection contains Benzyl Alcohol
medicines called anti-arrhythmics. • Medicines that can either be affected by or effect the level
• you have any problems with your eyesight. This includes This medicine contains 200mg of Benzyl Alcohol in each
It works by controlling the uneven beating of your heart of amiodarone in the body if taken at the same time:
an illness called ‘optic neuropathy’ or ‘neuritis’. 10ml syringe. Benzyl Alcohol may cause allergic reactions.
(called arrhythmias). • Ciclosporin, tacrolimus (immunosuppressants- used to
• the person having the medicine is an infant or child Ask your doctor or pharmacist for advice if you have liver or
Having the injection helps your heartbeat to return to help prevent rejection of transplants)
under 3 years old you have blistering or bleeding of kidney disease or if you are pregnant or breast‑feeding. This
normal. • Flecainide, used to treat irregular heart rhythms. Your
the skin, including around your lips, eyes, mouth, nose is because large amounts of benzyl alcohol can build-up
Amiodarone Injection is normally only given in a hospital doctor should monitor your treatment closely and may
and genitals. You may also have flu-like symptoms and in your body and may cause side effects (called “metabolic
when a quick response is needed or when tablets cannot be adjust your dose of flecainide.
fever. This may be something called ‘Stevens-Johnson acidosis”).
given. Amiodarone Injection can be used to: • Simvastatin, lovastatin, atorvastatin (drugs to reduce blood
syndrome’. Benzyl alcohol has been linked with toxic and allergic
• Treat uneven heartbeats where other medicines either cholesterol), as there is a risk of developing muscle pains
• you have a severe blistering rash in which layers of the reactions called gasping syndrome in infants and children
have not worked or cannot be used and kidney failure (rhabdomyolysis) if doses of more than
skin may peel off to leave large areas of raw exposed up to 3 years old
• Treat an illness called Wolff-Parkinson-White Syndrome. 20 mg of simvastatin are taken
skin over the body. You may also feel generally unwell, Do not give to your newborn baby (up to 4 weeks old),
This is where your heart beats unusually fast • Lidocaine (a local anaesthetic)
have a fever, chills and aching muscles (Toxic epidermal unless recommended by your doctor.
• Treat other types of fast or uneven heartbeats known as • Sildenafil (used for erectile dysfunction)
necrolysis). Do not use for more than a week in young children (less than
‘atrial flutter’ or ‘atrial fibrillation. • Fentanyl (used for pain relief) 3 years old), unless advised by your doctor or pharmacist.
Taking other medicines • Midazolam and triazolam (a sedative)
2. What you need to know before you are Tell your doctor immediately if you are taking a medicine • Ergotamine and dihydroergotamine (for migraine)
Ask your doctor or pharmacist for advice if you are pregnant
given Amiodarone Injection or breast-feeding.
containing sofosbuvir for the treatment of hepatitis C and • Colchicine (for gout)
You must not be given Amiodarone Injection if: during treatment you experience: • Beta-blockers, such as metoptolol and sotalol This medicine contains:
• You are allergic to amiodarone hydrochloride, iodine or • slow or irregular heartbeat or heart rhythm problems; • Calcium channel blockers diltiazem and verapamil, used to • Iodine: Amiodarone Injection contains approximately
to any of the other ingredients of this medicine (listed in • shortness of breath or worsening of existing shortness treat high blood pressure 112mg of iodine in a 10ml pre-filled syringe. Iodine is
section 6) of breath; • Indinavir (an anti-viral drug) present in amiodarone hydrochloride, the medicine your
• You have heart problems such as heart block, which can • chest pain; • Cimetidine (an anti-ulcer drug) infusion contains. Iodine can cause problems with your
cause a slow heart rate (such as sino-atrial heart block, • light-headedness; • Clarithromycin (an antibiotic) thyroid (see ‘Tests’ below)
sinus bradycardia, high grade AV block, bifascicular or • palpitations; • Ketoconazole and itraconazole (antifungal drugs) 3. How Amiodarone Injection is given
trifascicular block or sinus node disease) and you do not • near-fainting or fainting. • Tetracosactrin ( used in the treatment of inflammatory or Your doctor or nurse will normally give you Amiodarone
have a pacemaker The following medicine must not be taken with degenerative disorders) Injection. This is because it needs to be given as an injection
• You have heart failure or weakness of the heart muscle Amiodarone Injection as together they can cause a • Sofosbuvir, used for the treatment of hepatitis C or infusion into your vein in the hospital where the doctor
(cardiomyopathy) very severe fast heartbeat that can be fatal: • Corticosteroids - used for inflammation (e.g. prednisolone). can monitor your progress.
• You have or have had thyroid problems. Your doctor will • Medicines to treat irregular heart rhythms (anti- • Tetracosactide - used to test some hormone problems.
test your thyroid before giving you this medicine. • Amphotericin, when give directly into a vein - used for Dosage
arrhythmics), such as quinidine, procainamide, The daily dose of Amiodarone depends on the severity
• You have severe breathing problems. disopyramide and sotalol fungal infections.
• You have very low blood pressure Amiodadrone may increase the effects of the following of your illness. The dose and the treatment times will be
• Medicines to improve blood supply to the brain determined by your doctor, who will adjust these especially
• You are taking other medicines that can make your (e.g. vincamine) medicines:
heartbeat very quickly (these are listed below under the •Phenytoin - used to treat fits. for you.
• Antibiotics, such as erythromycin, moxifloxacin, Unless otherwise prescribed by your doctor, the usual dose
section ‘Taking other medicines’) co-trimoxazole and pentamidine Surgery
• You are pregnant, think you may be pregnant or are • Medicines to treat mental illness (anti-psychotics), such as If you are to have any surgery, you must tell the doctors
Continued overleaf

5537-B
is 5 mg per kg of body weight. Your medicine will be injected medicine as it has been prescribed. However, if you think tender and feel painful to move. This could be an illness
over a period of at least 3 minutes. you may have missed a dose, then talk to your doctor or Tell a doctor straight away if you notice any of the called ‘optic neuropathy’ or ‘neuritis’
nurse. following serious side effects - you may need urgent -Overgrowth of tissue found inside the body’s larger
When Amiodarone is given as an injection If you stop having Amiodarone Injection medical treatment: bones (bone marrow granulomas).
• you should not be given a dose greater than 5 mg per It is important for you to keep having Amiodarone Injections Very rare (affects less than 1 in 10,000 people) - Hypothyroidism (underactive thyroid) – you may feel
kg of body weight. until your doctor decides to stop them. If you stop having • Headache (which is usually worse in the morning or extremely tired, weak, ‘run-down’, restless or agitated,
• the dose should be given to you slowly over a period this medicine, the uneven heartbeats may come back and happens after coughing or straining), feeling sick (nausea), and experience weight loss or gain,constipation, aching
of at least 3 minutes (unless you are being given the this could be dangerous. fits, fainting, eyesight problems or confusion can occur. muscles, increased sweating and being unable to
medicine for resuscitation). These could be signs of problems with your brain stand the heat. You may be unable to cope with low
• the doctor must wait for at least 15 minutes before Tests temperatures
giving you another injection. • Your doctor will take regular tests to check how your liver - Back pain
is working. Amiodarone Injection can affect how your liver Tell your doctor if you have any of the following side
• repeated or continuous administration may cause effects: - Decrease in sex drive
inflammation of the vein and damage to the skin at works. If this happens, your doctor will decide whether
you should keep having this medicine Very common (may affect more than 1 in 10 people): Tell your doctor as soon as possible if you have any of
the injection site (the surrounding skin may feel warm • Blurred eyesight or seeing a coloured halo in dazzling
• Your doctor will do regular thyroid tests while you are these symptoms.
and tender and redness may be present) and in such light
situations a “central venous catheter” is recommended taking this medicine. This is because Amiodarone Reporting of side effects
for use by your doctor. Injection contains iodine which can cause problems with Common (may affect up to 1 in 10 people): If you get any side effects, talk to your doctor or pharmacist
your thyroid • Itchy, red rash (eczema) or nurse. This includes any possible side effects not listed
When Amiodarone is given as an infusion • Your doctor may also do other regular tests such as blood • Trembling when you move your arms or legs. in this leaflet. You can also report side effects directly via
• you should be given a dose of 5 mg/kg bodyweight tests, chest X-rays, ECG (electrical test of your heartbeat) • At the site where you are given the injection or infusion Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
diluted in 250 ml of 5% dextrose solution. and eye tests both before and while you are having you may experience: Pain, skin redness or a change in or search for MHRA Yellow Card in the Google Play or Apple
• the dose should be given to you over a period of 20 Amiodarone Injection. If you have any further questions skin colour, localised soft-tissue damage, fluid leakage, App Store. By reporting side effects you can help provide
minutes to 2 hours. on the use of this product, ask your doctor. swelling caused by fluid within the skin, inflammation more information on the safety of this medicine.
• The administration may be repeated 2-3 times per day. or inflamed blood vessels, abnormally hard tissue or
Most of the side effects which occur during treatment 4. Possible side effects infection 5. How to store Amiodarone Injection
occur if you are given too much Amiodarone. You • Slow or irregular heartbeat
Like all medicines, this medicine can cause side effects, Keep this medicine out of the sight and reach of children .
should therefore be given the lowest possible dose of • Low blood pressure and rapid heart rate which can
although not everybody gets them. Amiodarone Injection • Your doctor or pharmacist is responsible for storing
Amiodarone. This will keep side effects to a minimum. make you feel dizzy or faint. These side effects occur
may stay in your blood for up to a month after stopping Amiodarone Injection. They are also responsible for
See also “If you have received more Amiodarone than straight after injection. The effects are usually moderate
treatment. You may still get side effects in this time. disposing of any unused Amiodarone Injection correctly
you should”. and temporary. They can be serious if you are given too
Adults: • You should not be given Amiodarone Injection after the
Stop having Amiodarone Injection and tell a doctor or much Amiodarone too quickly. expiry date (EXP) which is stated on the outer packaging.
The usual dose is 5 mg for every kilogram of your weight nurse, or go to a hospital straight away if you notice any Uncommon (may affect up to 1 in 100 people)
given over a period of 20 minutes to 2 hours. The expiry date refers to the last day of that month. Your
of the following: • feeling numb or weak, tingling or burning feelings in doctor or nurse will check that the date has not passed
You may be given another dose of 10 to 20 mg for every • Anaphylactic shock (a life-threatening allergic reaction). any part of your body
kilogram of weight every 24 hours depending on your before giving this medicine to you
Signs may include a sudden rash, itching or lumpy rash • This medicine will be stored below 25ºC in the original
illness. (hives) and swelling of the face, lips, tongue or other Rare: (may affect up to 1 in 1,000 people)
In an emergency, your doctor may decide to give you container. Only clear solutions free of particles should be
parts of the body. You may also have shortness of breath, • The excipient benzyl alcohol may cause hypersensitivity used
a dose of 150 mg to 300 mg as a slow injection over 3 wheezing or trouble breathing. reactions.
minutes. • Reconstituted/diluted solution should be used
• Life-threatening skin reactions characterised by rash, Very rare (may affect less than 1 in 10,000 people): immediately.
Your doctor will monitor your response to Amiodarone
blisters, hives, peeling skin and pain (toxic epidermal Feeling unwell, confused or weak, feeling sick (nausea), • For single use only. Discard any unused product.
and the dose will be adjusted accordingly.
necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous loss of appetite, sweating, feeling irritable. This could be
Children and adolescents: dermatitis, drug reaction with eosinophilia and systematic an illness called ‘syndrome of inappropriate anti-diuretic 6. Contents of the pack and other information
• There is only limited information on the use in children. symptoms (DRESS). hormone secretion’ (SIADH) What Amiodarone Injection contains
The child’s doctor will carefully calculate the amount of - Newly occurring heart rhythm disorder or worsening of • Each 10ml pre-filled syringe contains 300mg of the active
• Excessive thyroid activity (hyperthyroidism, sometimes
Amiodarone Injection depending on the child’s body existing heart rhythm disorders leading to heart attack substance, amiodarone hydrochloride
fatal) causing:
weight. - Heart block that can lead to slow heart rate • The other ingredients are benzyl alcohol, polysorbate 80
- Weight loss
This medicine is not for use in neonates, infants and children - Weakness - Reduced heartbeat, which may lead to shock and water for injections
up to 3 years old. - Restlessness - Increased liver enzymes which can show up in tests What Amiodarone Injection looks like and contents of
Elderly: - Increased heart rate - Hot flushes, sweating and feeling sick if Amiodarone the pack
• As with all patients it is important that the minimum - Irregular heart rate Injection is given too quickly • Amiodarone Injection is a clear, pale yellow solution and is
effective dose is used. Your doctor will carefully calculate - You have life-threatening irregular heartbeat - Headache available as a single 10ml pre-filled syringe.
how much Amiodarone you should get and monitor your (Torsade de pointes) - Feeling sick (nausea)
- Sweating Marketing Authorisation Holder:
heart rate and thyroid function more closely. Your doctor - Angina Aurum Pharmaceuticals Limited
will change you over to amiodarone tablets as soon as - Heart failure - Lung damage
- Acute liver function disorders, with increased serum Bampton Road, Harold Hill Romford, Essex RM3 8UG, UK
possible. - Shaking, Sweating
- High temperatures levels and/or jaundice, including hepatic failure, Manufacturers:
If you are given too much Amiodarone Injection sometimes fatal. Macarthys Laboratories Limited
Your doctor will carefully calculate how much Amiodarone • Loss of eyesight in one eye or your eyesight becomes Brampton Road, Harold Hill,
dim and colourless. Your eyes may feel sore or tender and - Increase in pressure inside the skull, accompanied by
Injection you should get, therefore it is unlikely your doctor headache, vomiting. Romford
or nurse will give you too much of it. If, however, you have feel painful to move. This could be an illness called ‘optic Essex
received higher doses than those recommended you will neuropathy or neuritis’. RM3 8UG, United Kingdom
• Serious respiratory problems such as difficulty in Not known (frequency cannot be estimated from the
be carefully monitored by your doctor and will receive available data):
supportive therapy if necessary. breathing, wheezing or coughing, build-up of fluid in the Product Licence Number: PL 12064/0047
lungs, sometimes fatal. Sudden inflammation of the pancreas (pancreatitis (acute));
If you are given too much Amiodarone Injection the confusion (delirium); back and abdomen pain.
following effects may happen: feeling dizzy, faint, sick, tired, • Your heartbeat becomes very slow or stops beating. This leaflet was last revised in August 2021
• Your heartbeat becomes even more uneven or erratic. This -You may get more infections than usual. This could be
confused, constipation or sweating. caused by a decrease in the number of white blood cells
You may have an abnormally slow or fast heartbeat. Too can lead to a heart attack, so you should go to hospital
straight away (neutropenia)
much amiodarone can damage the heart and liver. -Severe reduction in the number of white blood cells
If you forget to have Amiodarone Injection • You get yellowing of the skin or eyes (jaundice), feel tired
or sick, loss of appetite, stomach pain or high temperature. which makes infections more likely (agranulocytosis).
Your doctor or nurse will have instructions on when to give -You get loss of eyesight in one eye or your eyesight
you this medicine. It is unlikely that you will not be given the These can be signs of liver problems or damage which can
be very dangerous becomes dim and colourless. Your eyes may feel sore or

D05537

5537-B