Patient leaflet - Amiodarone 30 mg / ml solution for injection/infusion in Pre-filled syringe
1. WHAT AMIODARONE INJECTION IS AND WHAT IT IS USED FOR
Amiodarone injection contains the active substance amiodarone hydrochloride, which 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’. Amiodarone injection is used only when other medicines cannot be used
- Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone injection is used only when other medicines cannot be used.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMIODARONE INJECTION
Do not use Amiodarone injection if:
- You are allergic to amiodarone hydrochloride, iodine or to any of the other ingredients of this medicine (listed in section 6). 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 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 should test your thyroid before giving you this medicine
- You have severe breathing problems
- You have serious blood circulation problems
- You have very low blood pressure
- You are taking certain other medicines which could affect your heartbeat (see ‘Taking other medicines’ below)
- You are pregnant or breastfeeding (see ‘Pregnancy and breast-feeding’ below).
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 having Amiodarone injection.
If you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking Amiodarone injection before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.
Warnings and precautions
Take special care with Amiodarone injection. Talk to your doctor, pharmacist or nurse before using Amiodarone injection if:
- You have a weak heart (‘cardiomyopathy’) or heart failure
- You have low blood pressure
You have liver problems
- You have any problems with your lungs including asthma
- You have any problems with your eyesight. This includes an illness called ‘optic neuropathy’ or ‘neuritis’
- You have a problem with your thyroid gland
- You are taking amiodarone tablets
- You are about to have an operation
- The person having the medicine is an infant or child under 3 years old
- You have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’
- You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic Epidermal Necrolysis)
- You currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring.
Tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:
- Slow or irregular heartbeat or heart rhythm problems
- Shortness of breath or worsening of existing shortness of breath
- Chest pain
- Light-headedness
- Palpitations
- Near-fainting or fainting.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Amiodarone injection.
Other medicines and Amiodarone injection
Tell your doctor, pharmacist 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, do not take this medicine and tell your doctor, if you are taking:
- Other medicines for an uneven heartbeat (such as quinidine, procainamide, disopyramide, sotalol or bretylium)
- Medicines for infections (such as intravenous erythromycin, co-trimoxazole, moxifloxacin or pentamidine injection)
- Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride 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)
- Sofosbuvir, used for the treatment of hepatitis C.
Tell your doctor if you are taking any of the following medicines:
- Medicines for infection (such as ciprofloxacin, ofloxacin or levofloxacin)
- 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.
The following medicines can increase the chance of you getting side effects, when taken with Amiodarone injections:
- Amphotericin (when given directly into a vein) used for fungal infections
- Corticosteroids used for inflammation such as hydrocortisone, betamethasone or prednisolone
- Water tablets (diuretics) such as furosemide
- General anaesthetics or high dose oxygen - used during surgery
- Tetracosactide - used to test some hormone problems
- Amiodarone tablets - used to control the uneven beating of the heart called ‘arrhythmias’.
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, tacrolimus and sirolimus - 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 relieve 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, pharmacist or nurse before having Amiodarone injection.
Amiodarone injection with food and drink
Do not drink grapefruit juice while using this medicine. This is because drinking grapefruit juice while taking Amiodarone injection can increase your chance of getting side effects.
Protect your skin from sunlight
Keep out of direct sunlight while using this medicine and for a few months after you have finished using Amiodarone injection. 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
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 this medicine.
Do not use this medicine if:
- You are pregnant, might become pregnant or think you may be pregnant
- You are breast-feeding or planning to breast feed.
Amiodarone injection contains iodine and benzyl alcohol
- 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: This medicine contains 200mg benzyl alcohol in each 10ml pre-filled syringe which is equivalent to 20mg/ml. Benzyl alcohol may cause allergic reactions.
- Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called ‘gasping syndrome’) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
- Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.
- Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called ‘metabolic acidosis’).
- Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called ‘metabolic acidosis’).
3. HOW TO USE AMIODARONE INJECTION
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
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, pharmacist 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, pharmacist or nurse.
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.
Use in children and adolescents:
- There is only limited information on the efficacy and safety in children. The doctor will carefully calculate the amount of Amiodarone injection depending on the child’s or adolescent’s body weight.
- Medicines administered intravenously containing benzyl alcohol should be used with caution in children under 3 years old (see also ‘Amiodarone injection contains Benzyl alcohol’).
- 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.
150 mm
10 4801 1 6012190
Amiodarone 30 mg/ml solution for injection/infusion in pre-filled syringe
10 4801 1 6012190 Amiodarone 30 mg/ml solution for injection/infusion in pre-filled syringe
(6012190) Date : 18_10_21, 19.11.21, R-10_12_21 
This medicinal product must not be mixed with other preparations in the same syringe. Do not inject other preparations in the same line.
If you take more Amiodarone injection than you should
Your doctor will carefully calculate how much Amiodarone injection you should get, therefore it is unlikely your doctor, pharmacist or nurse will give you too much of this medicine. But, if you think that you have been given too much or too little Amiodarone injection, tell your doctor, pharmacist or nurse.
If you are given too much Amiodarone injection 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 take 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 taking Amiodarone injection
It is important for you to keep having Amiodarone injection 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 medicine, ask your doctor, pharmacist or nurse.
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 see a doctor, pharmacist or nurse, or go to a hospital 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):
- 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 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
- 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.
Not known (frequency cannot be estimated from the available data):
- You have life-threatening irregular heartbeat (Torsades de pointes)
- Symptoms including blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome
- You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic Epidermal Necrolysis)
- Inflammation of the skin characterised by fluid filled blisters (bullous dermatitis)
- You have flu like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophila) and enlarged lymph nodes (DRESS).
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):
- Scaly and itching rashes (eczema)
Dizziness, lightheadedness, fainting. This may occur temporarily and is due to lowering of blood pressure.
Not known (frequency cannot be estimated from the available data):
- Inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)
- Seeing, hearing or feeling things that are not there (hallucinations)
- You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
- Severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis)
- You get 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’
- 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, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people):
- Slightly slower heartbeat
- 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
- Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate antidiuretic hormone secretion’ (SIADH).
Not known (frequency cannot be estimated from the available data):
- Life-threatening irregular heart rhythm
- Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and precautions)
- Hives (itchy, lumpy rash)
- Back pain
- Decrease in sex drive.
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Expiry date
Do not use this medicine after the expiry date, which is stated on the pre-filled syringe or carton after EXP. The expiry date refers to last day of that month. Your doctor or nurse will check that the date has not passed before giving this medicine to you.
Storage conditions
Do not store above 25°C. Store the syringe in the outer carton until needed.
Do not use this medicine if you notice container is damaged or particles/crystals are visible.
For single use only. Discard any unused product.
Do not throw away any medicine via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. They are responsible for disposing of any unused Amiodarone injection correctly. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Amiodarone injection contains
- The active substance is amiodarone hydrochloride. 1 ml of solution contains 30 mg amiodarone hydrochloride. Each 10 ml Pre-filled syringe contains 300 mg 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 colourless to pale yellow solution filled in clear glass pre-filled syringe.
Amiodarone injection is available in a pack containing 1 pre-filled syringe.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF,
United Kingdom
The leaflet was last revised in November 2021
Detailed information on this medicine is available on the website of MHRA, UK
10 4801 1 6012190
(6012190) Date : 18_10_21, 19.11.21, R-10_12_21