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TEVA UK Ref: 231-30-60901-X LEA AMIODARONE A/S TABS TUK Version: 1    16 April 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

AMIODARONE 100 mg AND 200 mg TABLETS

PATIENT INFORMATION LEAFLET

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 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 symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1.    What Amiodarone is and what it is used for

2.    What you need to know before you take Amiodarone

3.    How to take Amiodarone

4.    Possible side effects

5.    How to store Amiodarone

6.    Contents of the pack and other information

^ WHAT AMIODARONE IS AND WHAT IT IS USED FOR

•    Amiodarone is an anti-arrhythmic drug which slows nerve impulses in the heart muscle.

•    Amiodarone is used to treat recurrent abnormal heart rhythms including Wolff-Parkinson-White syndrome which is an abnormal heart rhythm condition present at birth.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIODARONE

Do NOT take Amiodarone if you:

•    are allergic (hypersensitive) to Amiodarone or any of the ™ ingredients of the medicine

•    are allergic (hypersensitive) to iodine

•    are taking drugs which may cause a life threatening irregular heart beat when taken in combination with Amiodarone (see Section 2, Taking other medicines)

•    have a disturbance in the electrical conduction of the heart

•    have an abnormally slow heart rate

•    have any other problems with your heartbeat and do not have a pacemaker fitted

•    have or have a family history of thyroid disorders. Your doctor should test your thyroid before giving you this medicine

•    are breast-feeding

•    are pregnant.

Warnings and precautions

Tell your doctor before you start to take this medicine if you:

•    have heart failure

•    have liver problems

•    have any problems with your lungs or have asthma

•    have problems with your eyesight. This includes an illness called 'optic neuritis'

•    are about to have an operation. In this case please inform the anaesthetist before the operation that you are taking Amiodarone.

•    are elderly (over 65 years of age). The 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.

•    have a slow pulse rate, particularly if you are elderly, or undergoing digitalis therapy.

Other medicines and Amiodarone

Do not take Amiodarone if you are taking

•    drugs for an abnormal heart rhythm e.g. quinidine, procainamide, disopyramide, sotalol, bretylium

•    medicines for schizophrenia e.g. chlorpromazine, thioridazine, fluphenazine, amisulpride, sertindole, pimozide, haloperidol

•    medicines for other mental illness such as lithium and tricyclic antidepressants e.g. doxepin, maprotiline, amitriptyline

•    certain antihistamines (used to treat allergic reactions, for example hay fever) e.g. terfenadine, mizolastine, astemizole

•    antimalarials e.g. quinine, mefloquine, chloroquine, halofantrine

•    or have had an injection of erythromycin, co-trimoxazole, moxifloxacin, pentamidine (all used to treat infections).

The following drugs should not be taken in combination with

Amiodarone

•    medicines to treat heart diseases such as verapamil, diltiazem

•    medicines for heart problems called beta blockers (e.g. atenolol, propranolol)

•    medicines for constipation (laxatives) such as bisacodyl or senna.

Talk to your doctor if you are taking any of the following:

•    tetracosactrin (used to assess adrenal gland function)

•    medicines for high cholesterol (statins) such as simvastatin,

lovastatin or atorvastatin tablets to thin your blood e.g. warfarin phenytoin (used to treat fits) digoxin (used to treat heart diseases) medicines for infection (such as ciprofloxacin, ofloxacin or levofloxacin).

The following medicines can increase the chance of you getting side effects, when taken with Amiodarone:

•    amphotericin (when given directly into a vein) - used for fungal infections

•    medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone

•    diuretics ("water tablets") e.g. bendroflumethiazide, furosemide or amiloride

•    general anaesthetics or high dose oxygen - used during surgery

•    tetracosactide - used to test some hormone problems.

Amiodarone may increase the effect of the following medicines:

ciclosporin and tacrolimus - used to help prevent rejection of transplants

medicines for impotence such as sildenafil, tadalafil or vardenafil fentanyl - used for pain relief

ergotamine, dihydroergotamine - used for migraines triazolam - used on a short-term basis to treat sleeping difficulties midazolam - used to relieve anxiety or to help you relax before surgery

flecainide - another medicine used for uneven heartbeats.Your doctor should monitor your treatment and may half your dose of flecainide

lidocaine - used as an anaesthetic.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or if you are to undergo surgery or any surgical procedure.

Amiodarone with food and drink

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking Amiodarone can increase your chance of getting side effects.

You should keep your consumption of alcohol to a minimum whilst taking these tablets as Amiodarone may increase the effect of alcohol on your liver.

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 high factor sun cream

•    Always wear a hat and clothes which cover your arms and legs. Pregnancy, breast-feeding and fertility

Do not take Amiodarone if you are pregnant or breast-feeding. Ask your doctor for advice before taking any medicine.

Driving and using machines

Amiodarone may cause dizziness and your eyesight may become blurred, if affected do not drive or operate machinery.

Important information about some of the ingredients of Amiodarone Tablets

Lactose (a type of sugar): Patients who are intolerant to lactose should note that Amiodarone tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Iodine: Amiodarone contain approximately 37.5 mg of iodine in a 100 mg tablet and approximately 75 mg of iodine in a 200 mg tablet. Iodine is present in amiodarone hydrochloride, the medicine your tablets contain. Iodine can cause problems to your thyroid (see 'Tests' below).

^ HOW TO TAKE AMIODARONE

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

The tablets should be swallowed preferably with a drink of water.

The usual dose is:

Adults including the elderly

200 mg three times a day for one week, then 200 mg twice daily for a further week. After this the dose is usually reduced to 200 mg a day or even less. In some cases, your doctor may then decide to either increase or lower the amount you take each day. This will depend on how you react to this medicine.

The doctor may give a lower dose of Amiodarone to elderly patients. Also, for elderly patients the doctor should check blood pressure and thyroid function regularly.

Children and adolescents

There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you take more Amiodarone than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause a very slow pulse rate. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Amiodarone

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amiodarone

Do not stop taking your medicine without talking to your doctor first even if you feel better.

Test

•    your blood may be tested regularly to check whether your liver is working properly

•    your doctor may do regular thyroid tests while you are taking this medicine. This is because Amiodarone contain iodine which can cause problems to your thyroid

•    your doctor may also do other regular tests such as blood tests, chest X-rays, ECG (electrical test of your heartbeat)

•    you should have your eyes tested regularly if you have been taking Amiodarone for a long time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Amiodarone can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Very common (affects more than 1 in 10 people)

•    Blurred eyesight or seeing a coloured halo in dazzling light. Common (affects less than 1 in 10 people)

•    Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. These could be signs of an illness called 'hyper-thyroidism'

•    Feeling extremely tired, weak or 'run-down', weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called 'hypo-thyroidism'

•    Trembling when you move your arms or legs

•    Blue or grey marks on parts of your skin exposed to sunlight, especially the face.

Uncommon (affects less than 1 in 100 people)

•    Pain, weakness, tingling loss of co-ordination, numbness in the muscles.

•    Irregular heart beat or worsening of irregular heart beat may lead to heart attack

•    Disturbances in the heart functions.

Very rare (affects less than 1 in 10,000 people)

•    Swelling of the testicles

•    Very slow heart beat in elderly patients or in patients with serious heart disease

•    Transient cessation of the electrical impulse of the heart muscle in elderly patients or in patients with serious heart disease

•    Red, scaly patches of skin, loss of hair or loosening of nails (called 'exfoliative dermatitis')

•    Feeling tired, faint, dizzy or having pale skin. These could be signs of anaemia

•    Severe reduction in blood cells which can cause weakness, bruising or make infections more likely

•    Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called 'syndrome of inappropriate anti-diuretic hormone secretion' (SIADH)

•    Impaired vision which may lead to blindness

•    Kidney problems

•    Difficulty in controlling movements

•    Difficulty in breathing or wheezing in patients with severe respiratory failure and especially in patients who are suffering from asthma.

Not known (frequency cannot be estimated from the available data)

•    Bleeding from the lungs. Symptoms you may feel are like oozing of bloody fluid from the nose or coughing up blood.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

•    Feeling sick (nausea) or being sick (vomiting)

•    Change in the way things taste

•    Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests

•    Burning more easily in the sun (see 'Protect your skin from sunlight' in Section 2).

Common (affects less than 1 in 10 people)

•    Slightly slower heart beat

•    Yellowing of the skin or whites of the eyes caused by a liver disease called 'Jaundice' which may lead to liver failure.

•    Nightmares

•    Problems sleeping

•    Inflammation of the lungs which causes breathlessness, cough, reduced exercise tolerance and raised temperature.

Very rare (affects less than 1 in 10,000 people)

•    Headache

•    Balance problems, feeling dizzy (vertigo)

•    Chronic liver malfunction

•    Difficulty in getting or maintaining an erection or in ejaculating

•    Hair loss, balding

•    Skin rash

•    Skin redness during radio-therapy

•    Headache, nausea and vomiting, buzzing in the ears, double vision and other visual disturbances. This could be an illness called 'benign intracranial hypertension'

•    Inflammation of blood vessels, often with skin rash.

Not known (frequency cannot be estimated from the available data)

•    Tiredness

•    Hives (itchy, lumpy rash)

•    A burning or prickling sensation in the hands, arms, legs, feet or in other parts of the body.

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.

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 at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE AMIODARONE

Keep this medicine out of the sight and reach of children. Do not

store above 25°C. Store Amiodarone in the original container. Do not transfer your tablets to another container. Do not use Amiodarone after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^ CONTENTS OF THE PACK AND OTHER INFORMATION

What Amiodarone Tablets contain:

•    The active ingredient is amiodarone hydrochloride 100 mg or 200 mg.

•    The other ingredients are lactose monohydrate, maize starch, sodium starch glycolate (Type A), povidone (E1201) and magnesium stearate (E572).

What Amiodarone looks like and contents of the pack:

•    The 100 mg tablets are white, circular biconvex tablet, engraved 1A1 with a breakline on the reverse.

•    The 200 mg tablets are white, circular biconvex tablet, engraved 1A3 with a breakline on the reverse.

The product is available in pack sizes* of 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250, 500, 1000 and 5000 tablets.

*Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in: 03/2014.

PL 00289/0319-0320

TEUZD

TEVA UK LIMITED    210x323