PACKAGE LEAFLET: INFORMATION FOR THE USER    D02448

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. 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 any further questions, ask your doctor or nurse

•    If you get any of the side effects talk to your doctor or nurse. This includes any 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 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 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 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

Continued overleaf

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, 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:

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 25^oC 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 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    Manufacturer

Aurum Pharmaceuticals Ltd    Martindale Pharmaceuticals

Bampton Road, Harrold Hill    Bampton Road, Harold Hill

Romford, Essex RM3 8UG    Romford, Essex RM3 8UG

or

Agila Specialties Polska Sp.z.o.o.

10 Daniszewska St.

03-230 Warsaw, Poland or

Federa SA

Font Saint Landry 10 Brussels B-1120, Belgium

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 02/2013

Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom

Aurum

2448-B