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Amiodarone Hydrochloride 100mg Tablets

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PATIENT INFORMATION LEAFLET

Amiodarone Hydrochloride 100mg & 200mg Tablets (Amiodarone Hydrochloride)

Read this leaflet carefully before you start using this medicine because it contains important information for you.

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

■    If you have any further questions, ask your doctor or pharmacist.

■    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

■    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1    What Amiodarone is and what it is used for    C    ssible side effects

2    What you need to know before you take Amiodarone    E    How to store Amiodarone

3    How to take Amiodarone    ®    Contents of the pack and other    information


What Amiodarone is and what it is used for

Amiodarone Hydrochloride belongs to a group of medicines called anti-arrhythmic. These work by controlling an irregular or rapid heart beat (called 'arrhythmia')

They are only used for serious conditions which do not respond to other treatments or when other treatments cannot be used. Treatment with Amiodarone is normally under hospital or specialist supervision.

Amiodarone Hydrochloride (referred to as Amiodarone

throughout this leaflet) can be used to treat the following:

■    To treat uneven heartbeats where other medicines either have not worked or cannot be used

■    To treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast

■    To treat other types of fast or uneven heartbeats known as 'atrial flutter' or 'atrial fibrillation'. Amiodarone Tablets are used only when other medicines cannot be used.

■    To treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Tablets are used only when other medicines cannot be use

What you need to know before you take Amiodarone

Do not take Amiodarone if:

■    you are allergic (hypersensitive) to iodine, amiodarone hydrochloride or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information”)

■    you have a slower than usual heartbeat (called 'sinus bradycardia') or an illness called 'sinoatrial' heart block

■    you have any other problems with your heart and do not have a pacemaker fitted

■    you have or have had thyroid problems

■    you are pregnant or breast-feeding (see Section 2 "Pregnancy and breast- feeding”)

you are taking certain other medicines which could affect your heart beat (see" Other medicines and Amiodarone”)

Warnings and precautions

Talk to your doctor before taking Amiodarone if:

■    you have heart failure

■    you have shortness of breath, a dry cough or have any problems with your lungs

■    you have liver problems

■    you suffer from blurred or decreased vision

■    you are to have an operation under anaesthetic or a high dose of oxygen

■    you are exposed to direct sunlight. You should avoid exposure of your skin to direct sunlight or sunlamps You should take sensible precautions when you are in the sun; wear a wide brimmed hat and keep your arms and legs covered; apply total sun block cream to exposed areas of the skin

■    you are elderly as your doctor will need to monitor you more carefully

■    you have a pacemaker or implantable cardioverter defibrillator (ICD). Your doctor will check that your device is working properly shortly after you start taking the tablets or if your dose is changed

■    you have been taking amiodarone for long periods, as your doctor may need to monitor you to avoid delayed side effects

■    you suffer from nerve or muscular disorders

Your doctor may want to arrange tests such as blood tests, chest x-rays and eye examinations before and during treatment with these tablets.

Other medicines and Amiodarone

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines not to be taken with Amiodarone

■    Medicines used to treat irregular heart rhythms, such as quinidine, procainamide, disopyramide, sotalol (beta -blocker) and bretylium

■    Medicines for infections, such as erythromycin injection, co-trimoxazole and moxifloxacin (antibiotics)

■    Pentamidine injection (used to treat infections such as pneumonia in AIDs patients)

■    Medicines used to treat mental illnesses, such as chlorpromazine, thiordazine, pimozide, haloperidol, fluphenazine, amisulpiride and sertindole

■    Lithium and other anti-depressants, such as doxepin, maprotiline and amitriptyline

■    Some medicines used to treat allergies and hay fever (antihistamines), such as terfenadine, astemizole and mizolastine

■    Medicines to treat or prevent malaria, such as quinine, mefloquine, chloroquine and halofantrine

Other medicines which may interact with or be affected by Amiodarone

■    Digoxin (used to treat heart failure)

■    Warfarin (anticoagulant, used to thin the blood)

■    Phenytoin (used to treat epilepsy)

■    Medicines used to treat high blood pressure, angina or an irregular heart beat, such as atenolol and propranolol (beta blockers)

■    Verapamil and diltiazem, used to treat high blood pressure and chest pain (calcium channel inhibitors)

■    Medicines used to treat constipation (laxatives) such as bisacodyl and senna

■    Medicines which may cause a drop in blood potassium or magnesium levels, such as diuretics (water tablets)

■    Medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone

■    Tetracosactide (used to test some hormone problems)

■    Amphotericin injection used to treat fungal infection

■    General anaesthetics or high dose oxygen, used during surgery

■    Ciclosporin and tacrolimus, used after transplant operations

■    Dabigatran- used to thin the blood

■    Medicines for high cholesterol (statins) such as simvastatin, atorvastatin and lovastatin

■    Flecainide, used for irregular heart rhythms

■    Medicines for infections, such as clarithromycin, ciprofloxacin, levofloxacin, and ofloxacin

■    Lidocaine, used as an anaesthetic

■    Sildenafil, used for impotence

■    Fentanyl, used for pain relief

■    Midazolam, used to relieve anxiety or to help you relax before surgery

■    Triazolam, used as a sedative for severe sleep problems

■    Ergotamine or dihydroergotamine, used to treat migraine

■    Colchicine, a medicine used to treat gout

Taking Amiodarone with food and drink

■    Grapefruit juice should be avoided during treatment with Amiodarone. Grapefruit juice may increase the amount of Amiodarone in the blood.

■    You should limit the amount of alcohol you drink whilst taking these tablets.

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 for advice before taking this medicine.

Pregnancy

Do not take Amiodarone if you are pregnant, trying to become pregnant or think you may be pregnant unless your doctor decides that it is essential.

Breast-feeding

If you are breast-feeding you should not take this medicine as small amounts of this medicine may pass into the breast milk.

Driving and using machines

Amiodarone may cause blurred vision. If this happens, do not drive or use any tools or machines.

Amiodarone contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

How to take Amiodarone

Always take Amiodarone exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

■    These tablets are to be taken orally

■    These tablets should be swallowed whole with a glass of water.

■    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.

The recommended dose is:

Adults

Initially: The usual starting dose is 200mg three times a day for the first week. The dose should then be reduced to 200mg twice a day for a further week.

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