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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone 200mg tablets

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or your pharmacist.

-    This medicine has been prescribed for you personally and you should not pass it on to others

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What amiodarone is and what it is used for

2.    Before you take amiodarone

3.    How to take amiodarone

4.    Possible side effects

5.    How to store amiodarone

6.    Further information

1.    WHAT AMIODARONE IS AND WHAT IT IS USED FOR

Amiodarone belongs to a group of medicines called anti-arrhythmics. Anti-arrhythmics control or prevent abnormal heart rhythms.

Amiodarone is used to control severe irregular or rapid heart rate, that has not responded to or cannot be controlled by other therapies or treatments.

2.    BEFORE YOU TAKE AMIODARONE Do not take amiodarone:

Amiodarone must not be given to children, premature babies or neonates.

•    if you are hypersensitive (allergic) to amiodarone, iodine or any of the other ingredients of amiodarone tablets

•    if you have been told you have bradycardia (very slow or irregular pulse) or heart block (problems with the electrical signals that control your heartbeat).

•    if you have or have had thyroid problems

•    if you are taking other medicines for heart rhythm problems, antibiotics, antihistamines for allergy, medicines for malaria or medicines for depression or mental illness. See “Taking other medicines” for further information.

Take special care with amiodarone :

Tell your doctor if:

•    you have heart failure

•    you need an operation under general anaesthetic. It is important that the doctor in charge knows you are taking amiodarone.

Taking amiodarone with food and drink:

You should reduce the amount of alcohol that you normally drink when taking amiodarone tablets.

Pregnancy and breast feeding

You should not take amiodarone if you are pregnant, planning pregnancy or breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amiodarone may sometimes affect your vision or cause tiredness. If you experience these, take care before you drive or use machines.

Important information about some of the ingredients of amiodarone

Amiodarone contains lactose a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking other medicines:

Taking another medicine while you are taking amiodarone can affect how it or the other medicine works.

Tell your doctor immediately if you are taking any of the following medicines as they must not be taken with amiodarone:

•    other medicines to treat heart rhythm problems such as sotalol or bretylium, qunidine, procainamide or disopyramide

•    medicines to treat infection such as erythromycin, co-trimoxazole, or pentamidine.

•    Medicines for depression or mental illness such as doxepin, maprotiline, amitriptyline, chlorpromazine, thioridazine, pimozide, haloperidol

•    antihistamines, used to treat allergies and hayfever such as terfenadine, astemizole

•    medicines used to treat or prevent malaria such as quinine, mefloquine, chloroquine and halofantrine

Please check with your doctor if you are also taking any of the following medicines:

•    diuretics (water tablets)

•    amphotericin used for fungal infections

•    digoxin, used for heart failure

•    anticoagulants, used to thin the blood (e.g. warfarin) phenytoin for epilepsy

•    aspirin for pain

•    beta-blockers, used to treat high blood pressure, angina or an irregular heart beat (e.g.atenolol, propranolol)

•    some calcium channel blockers, used to treat high blood pressure and angina (e.g. verapamil, diltiazem)

•    ciclosporin, used following transplant surgery

•    steroids and tetracosactrin, used to reduce inflammation

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you may have bought yourself without a prescription.

3.    HOW TO TAKE AMIODARONE Adults and elderly

Amiodarone should be started and usually monitored only under hospital or specialist supervision.

The usual dose of amiodarone is one tablet (200mg) three times a day for the first week, followed by one tablet twice a day for the second week and then one tablet a day until your doctor tells you to stop.. Unless told otherwise, take your tablets with water.

Your doctor will decide the dose that is best for you. Always follow any instructions or warnings that appear on the label that the pharmacist has put on the pack. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.