Amiodarone 100mg and 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 any further questions, ask your doctor or pharmacist.

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

Index

T| What Amiodarone tablets are and what they are used for Before you take ^3 How to take

Possible side effects T| How to store "6 Further information

_T| What Amiodarone tablets are and what they are used for

Amiodarone tablets belong to a group of medicines called anti-arrhythmics. They work by regulating the heart rate. Amiodarone tablets may be used to treat:

•    severe disturbances of normal heart rhythm and irregular heart rhythm when other drugs cannot be used

•    all types of irregular heartbeats of a sudden nature including a racing heart and an irregular heart rhythm when other drugs cannot be used

•    Wolff-Parkinson-White Syndrome

•    or restore a normal heart rhythm and maintain it.

_2| Before you take

Do not take Amiodarone tablets and tell your doctor if you:

•    are allergic (hypersensitive) to amiodarone hydrochloride, iodine or any of the other ingredients (see section 6)

•    suffer from conduction problems of the heart, such as a slow heart beat or heart block. Amiodarone tablets should only be used in such patients who have a pacemaker fitted

•    have thyroid disease or have not yet had your thyroid function tested

•    have severely low blood pressure

•    have severe breathing difficulties

•    are taking the following other medicines:

-    medicines to treat irregular heart rhythms (such as quinidine, procainamide, disopyramide) or beta blockers (such as sotalol)

-    antibiotics (erythromycin injection, co-trimoxazole, moxifloxacin)

-    pentamidine injection (used to treat pneumonia in AIDS patients)

-    medicines to treat mental illness such as chlorpromazine, thioridazine, pimozide, haloperidol, fluphenazine, amisulpride, sertindole, lithium and other antidepressants such as amitriptyline

-    medicines to treat allergic reactions (terfenadine, mizolastine)

-    medicines to treat or prevent malaria (quinine, mefloquine, chloroquine or artemether/lumefantrine)

Check with your doctor or pharmacist before taking Amiodarone tablets if you:

•    suffer from heart failure

•    have porphyria (a genetic disease that can cause skin blisters, abdominal pain and brain or nervous system disorders).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    flecainide (to treat irregular heart rhythms)

•    diltiazem or verapamil (calcium channel blockers used to treat heart conditions)

•    rifampicin (antibiotic)

•    stimulant laxatives (e.g. bisacodyl, senna)

•    medicines that reduce blood potassium or magnesium levels such as diuretics ('water tablets'), steroids, tetracosactide or amphotericin

•    anaesthetics (general or local)

•    warfarin (to stop blood clotting)

•    phenytoin or carbamazepine (to treat epilepsy)

•    ergometrine (to treat migraines)

•    digoxin (to slow fast heart rate)

•    simvastatin (to lower cholesterol in the blood)

•    orlistat (to reduce obesity)

•    medicines to treat viral infections (atazanavir, indinavir, nelfinavir, ritonavir or saquinavir)

•    midazolam (a sedative)

•    fentanyl (strong pain killer)

•    sildenafil (for erection problems)

•    St Johns Wort (a herbal remedy)

•    ciclosporin, tacrolimus or sirolimus (immune system medicine)

Pregnancy and breast-feeding

Amiodarone tablets should be avoided during pregnancy and breast-feeding. If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amiodarone tablets may cause a 'spinning' sensation or affect your vision. Make sure you are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a sugar called lactose.

Continued on next page

Blood tests

Whilst taking Amiodarone tablets your doctor will regularly monitor your thyroid, liver or heart function.

Other precautions you should take

If you see another doctor or go into hospital, especially for an operation or if you require treatment with anaesthetics or high dose oxygen, let them know what medicines you are taking.

Q How to take

Always take Amiodarone tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

You are advised to moderate your alcohol intake and avoid grapefruit juice with this medicine.

Swallow the tablets with water.

Doses:

•    Adult

Initially: treatment should be started with 200mg three times a day for up to 1 week, then reduced to 200mg twice a day for a further week.

Maintenance: after the initial period the dose should be reduced to 200mg a day or less if appropriate.

•    Children and adolescents

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

•    Elderly take as prescribed. You may be given a lower dose.

If you take more Amiodarone tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If an overdose has been taken, there may be signs such as feeling or being sick, sweating, low blood pressure or changes in the heart beat.

If you forget to take Amiodarone tablets

If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

Q Possible side effects

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

Stop taking Amiodarone tablets and contact your doctor at once if the following allergic reaction happens: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or

notice any other effects not listed:

Very common (occurs in more than 1 in 10 users): visual disturbances (blurred vision, seeing coloured halos in dazzling light) feeling or being sick, taste disturbances particularly metallic taste, rise in some liver chemicals, sensitivity to sunlight (symptoms such as tingling, burning or redness of the skin can be minimised by limiting exposure to UV light, wearing suitable protective hats and clothing and by using a high factor sun screen).

Common (occurs in less than 1 in 10 users): overactive thyroid (weight loss, restlessness, weakness, chest pain and changes in heart rhythm) and underactive thyroid (weight gain, reduced activity, sensitivity to the cold or slow heart rate), tremor including shakiness of the arms and legs and lack of co-ordination, nightmares, problems sleeping, slow heart beat, difficulty breathing (which may be severe) including persistent cough, shortness of breath or fever, jaundice (yellowing of the skin or whites of the eyes) or liver failure, a slate grey or bluish discolouration of light exposed skin, particularly on the face.

Uncommon (occurs in less than 1 in 100 users): muscle disease and nerve disorders (tingling of the hands and feet, numbness or weakness), new or worsening of irregular heart rhythms sometimes leading to heart attack, heart block of various degrees, including torsade de points.

Rare (occurs in less than 1 in 1,000 users): treatment resistant raised thyroid function (sudden and severe rapid heart beat, sweating, anxiety, increased appetite, loss of weight).

Very rare (occurs in less than 1 in 10,000 users): changes in the numbers and types of your blood cells, bone marrow granulonas (inflamation of the bone marrow), hypersensitivity reaction involving blood vessel inflammation and kidney disease, cerebellar ataxia (problems walking and speaking and uncontrolled movements of the eyes), increased blood pressure in the skull (causing painful eyes, changes in vision, a bad headache especially behind the eyes), headache, 'spinning' sensation, visual problems that may lead to blindness, slowing of the heart rate in the elderly or those with existing conduction problems, asthma, liver disease or inflammation, types of skin rashes including shedding of cells, redness during radiotherapy, hair loss, swollen testicles, impotence, syndrome of inappropriate antidiuretic hormones secretion (a syndrome of excessive levels of antidiuretic hormones [hormones that help the kidneys, and body to retain water and certain levels of electrolytes in the blood to fall [such as sodium]).

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

Q How to store

Keep out of the reach and sight of children.

Do not store the tablets above 25°C and store in the original packaging.

Do not use Amiodarone tablets after the expiry date stated on the label/carton/bottle. 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.

0 Further information

What Amiodarone tablets contain

•    The active substance (the ingredient that makes the tablets work) is amiodarone hydrochloride. Each tablet contains either 100mg or 200mg of the active ingredient.

•    The other ingredients are maize starch, lactose monohydrate, povidone, magnesium stearate, colloidal anhydrous silica and pregelatinised starch.

What Amiodarone tablets look like and contents of the pack

Amiodarone tablets are white, circular, uncoated tablets. Pack sizes are 28 tablets

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

Date of last revision: January 2012.

If you would like a leaflet with larger text, please contact 01271 311257.

actavis

Continued top of next column

AAAD0635 _ 50629940