Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

The name of this medicine is Cordarone X tablets. Its active ingredient is amiodarone hydrochloride.

Each Cordarone X 200 mg tablet contains 200 mg amiodarone hydrochloride. Each Cordarone X 100mg tablet contains 100 mg amiodarone hydrochloride.

Each Cordarone X tablet also contains lactose, maize starch, povidone, colloidal silica and magnesium stearate.

Cordarone X tablets are gluten free.

Cordarone X tablets are round, white, tablets with a break line on one side and on the other an action potential symbol over 100 marked on the 100 mg tablets and an action potential symbol over 200 marked on the 200 mg tablets. They are supplied in cartons of 28 tablets.

Cordarone X is an anti-arrhythmic drug.

The Product Licence/Authorisation holder is:

Sanofi Winthrop Ltd Sanofi Winthrop Ireland Ltd

One Onslow Street United Drug House

Guildford Belgard Road

Surrey Tallaght

GU1 4YS Dublin 24

The manufacturer is: Sanofi Winthrop Ltd, Edgefield Avenue, Fawdon, Newcastle Upon Tyne NE3 3TT.

Cordarone X is used to control an irregular or rapid heart rate.

You should not take Cordarone X if you:

• have heart block - which may cause a very slow, very fast or irregular pulse or dizziness.
• have or have had thyroid problems.
• have an allergy to iodine.
• are breast feeding.
• are hypersensitive to amiodarone.

Special care is needed (check with your doctor) if you:

• have liver problems.
• are pregnant or likely to become pregnant.
• have heart failure.

If you need an operation make sure you tell your doctor that you are taking Cordarone X.

If taken with some other medicines the effects of Cordarone X or the effects of the other medicines may be changed. Please check with your doctor if you are taking any of the following:

The usual dose of Cordarone X is 200 mg three times a day for one week, 200 mg twice a day for one week and then 200 mg daily. In some patients this may be reduced to 100 mg a day. The correct dose for you will have been decided by your doctor. Check the label and if you're not sure ask your doctor or pharmacist.

Swallow the tablets with a drink of water.

Keep taking your medicine until your doctor tells you to stop. Do not stop taking it because you feel better. If you stop the tablets your condition may get worse.

As with all medicines an overdose could be dangerous. If you have taken an overdose tell your doctor or go to the nearest hospital casualty department immediately.

If you forget a dose take it as soon as you remember. Do not take two doses at once.

Cordarone X can cause some patients to become sensitive to the sun of may cause a discolouration of the skin or a rash. You should avoid exposure of your skin to direct sunlight of sunlamps. If you are sensitive then this may persist for some time after treatment stops. You should take sensible precautions when you are in the sun; wear a wide brimmed hat and keep arms and legs covered; apply a total sun block cream to exposed areas of skin.

Cordarone X may occasionally cause headaches, disturbed sleep patterns, nausea, vomiting, a metallic taste, an enlarged liver, painful swelling of the testicles, a slow pulse, shakiness or difficulty in walking or balancing. You need only see your doctor about these effects if they become troublesome.

If you experience any of the following you should see your doctor as soon as possible as you may have to stop taking the tablets.

• jaundice (yellowing of the skin or eyes)
• extreme restlessness and/or loss of weight
• extreme tiredness and/or gain of a lot of weight
• persistent cough and/or shortness of breath or fever
• pins and needles, weakness of hands or legs, cramps
• and loss of balance.
• difficulties with your vision
• anything else which is unusual or unexpected.

Your doctor may want to arrange regular blood tests and eye examinations to monitor your medical condition.

Do not take this medicine after the expiry date which you will find on the pack.

These tablets should be stored away from the light.

Date of last revision of leaflet June 1994.

This leaflet does not contain all the information about your medicine. Pharmaceutical companies are not able to discuss your personal medical case. If you have any questions or are not sure about anything ask your doctor or pharmacist.