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Amiodarone Hydrochloride Tablets 200mg

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PACKAGE LEAFLET: INFORMATION FORTHE USER


_ _ _ _ _ n nogen Pharma\


1 Amiodarone Hydrochloride 200mg Tablets

I Amiodarone hydrochloride


.__J

Read all ofthis leaflet carefully before you start taking this medicine because it contains 'important information for you.

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

» If you have any further questions, ask your 1 doctor or pharmacist or nurse, b This medicine has been prescribed for you 1 only. Do not pass it on to others. It may harm I them, even if their signs of illness are the same 1 as yours.

b If you get any side effects, talk to your doctor or 1 pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

hat is in this leaflet:

|1. What Amiodarone Tablets are and what they are used for

. What you need to know before you take Amiodarone Tablets

3.    How to take Amiodarone Tablets

4.    Possible side effects

i5. Howtostore AmiodaroneTablets 6. Contents of the pack and other information


1. WHAT AMIODARONE TABLETS ARE AND WHAT THEY ARE USED FOR


Amiodarone Tablets are from a group of medicines called anti-arrhythmics which are used in the treatment of severe or life threatening cardiac arrhythmias (where the heart beats rapidly or irregularly). In particular a fast heart beat associated with Wolff-Parkinson-White Syndrome, treatment of severe rhythm disorders not responding to other drugs or used in treatment when other drugs cannot be used. These tablets can be used for stabilization and long term treatment.


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIODARONE TABLETS


Do not take Amiodarone Tablets ifyou:

b Are hypersensitive (allergic) to Amiodarone or I any of the other ingredients of Amiodarone I Tablets such as iodine. One 200mg tablet I contains approximately 75mg iodine (listed in I section 6)

l Have heart block, which may cause a very I slow, rapid or irregular pulse or dizziness l Suffer from or have a history of thyroid I problems. Your doctor may recommend regular check-ups to monitor your condition b Are pregnant or breastfeeding as you should check with your doctor beforehand (see 'Pregnancy and breastfeeding below).

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

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking this medicine ifyou: b Have heart failure or a heart condition such as a slow heart rate b Have liver problems

L Have problems with your lungs, shortness of breath or have asthma l Have problems with your eyesight. This includes an illness called 'optic neuritis' l Are about to have an operation b Are elderly (over 65 years of age). The doctor will need to monitor you more carefully b Are on digitalis therapy as this may affect the rhythm of your heart

b Are on radio-iodine uptake as this medicine contains iodine which may affect its uptake in the body

L Have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine b Have ever had thyroid problems. Your doctor should test your thyroid before giving you this medicine

L Tell your doctor or nurse you are taking these tablets if you are going to have surgery,

I including dental.


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:

b Make sure you use high factor sun cream b Always wear a hat and clothes which cover your arms and legs.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines. In particular, do not take this medicine and tell your doctor, if you are taking: b Other medicines for an uneven heartbeat (such as solatol, quinidine, procainamide, disopyramide or bretylium) b Medicines for infections (such as intra-venous erythromycin, co-trimoxazole, moxifloxacin or pentamidine)

b Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride or sertindole)

b Medicines for other mental illnesses (such as lithium, doxepin, maprotiline oramitriptyline) b Medicines for malaria (such as quinine, mefloquine, chloroquine or halofantrine) b Medicines used for hay fever, rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine)

Tell your doctor if you are taking any of the following medicines:

b Medicines that lengthen your heart beat (the QT interval) such as medicines for infection (such as clarithromycin) b Medicines for heart problems called beta-blockers and medicines called calcium channel blockers for chest pain (angina) or high blood pressure (such as diltiazem or verapamil) b Medicines for constipation (laxatives) such as bisacodyl or senna

b Medicines for high cholesterol (statins) such as simvastatin or atorvastatin

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

b Amphotericin (when given directly into a vein) -used for fungal infections b Medicines for inflammation (corticosteroids) b Water tablets (diuretics) b General anaesthetics or high dose oxygen -used during surgery

b Tetracosactide - used to test some hormone problems

Amiodarone Tablets may increase the effect of the following medicines:

b Ciclosporin and tacrolimus - used to help prevent rejection of transplants b Medicines for impotence such as sildenafil, tadalafil or vardenafil b Fentanyl - used for pain relief b Ergotamine - used for migraines b Midazolam - used to relieve anxiety or to help you relax before surgery b Colchicine - used for the treatment of gout b Flecainide - another medicine used for uneven heartbeats. Your doctor should monitor your treatment and may halfyour dose of Flecainide b Lidocaine - used as an anaesthetic b Warfarin - used to stop your blood from clotting b Digitalis - used for some heart conditions b Dabigatran - used to thin the blood

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant or planning on becoming pregnant before taking this medicine. Do not take if you are breast feeding or plan to breastfeed. This is because small amounts of this medicine may pass into the mother's milk.

Driving and using machines

You may have blurred eyesight after taking this medicine if this happens, do not drive or use any tools or machinery.


^Amiodarone Tablets with food and drink

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

Limit the amount ofalcohol you drinkwhile taking this medicine. This is because drinking alcohol while taking this medicine will increase the chance pf you having a problem with your liver. Talk to your doctor or pharmacist about the amount of ^Icohol you can drink.

Amiodarone Tablets contain lactose

Ilfyou have been told by your doctor that you have an intolerance to some sugars talk to your doctor before taking this medicine.

kmiodarone Tablets contain iodine

These tablets also contain 75mg of iodine in a EOOmg tablet and can cause problems to your thyroid.


3. HOW TO TAKE AMIODARONE TABLETS


•    You get yellowing of the skin or eyes (jaundice), feel tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage which can be very dangerous

•    Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of your lungs which can be very dangerous.

Uncommon (affects less than 1 in 100 people)

•    Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away.

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

•    You get loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called 'optic neuropathy or neuritis1

•    Your heart beat becomes very slow or stops beating.



L _


Always take Amiodarone Tablets exactly as your doctor has instructed you. You should checkwith |your doctor or pharmacist if you are unsure.

Taking this medicine

l Take this medicine by mouth m Swallow the tablets whole. Do not crush or chew your tablets

m If you feel the effect of your medicine is too weak or too strong do not change the dose , yourself, but ask your doctor.

How much to take

•    The usual dosage is 200mg, three times a day for one week

•    The dose will then be lowered to 200mg, twice a day for one week

•    The dose will then be lowered to 200mg once each day until you are told otherwise.

.In some cases your doctor may decide to either increase or lower the amount you take each day. |This will depend on how you react to this medicine.

Elderly:

The prescribed dose may be lower than the usual |dose.

Children and adolescents:

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

Ilfyou take more Amiodarone Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. Ifyou take too many tablets by mistake contact your nearest hospital pasualty department or tell your doctor immediately. Take your tablet pack with you.

Ilfyou stop taking Amiodarone Tablets

Keep taking Amiodarone Tablets until your doctor tells you to stop. Do not stop taking Amiodarone Tablets just because you feel better. If you stop taking this medicine the uneven heartbeats may come back, this could be dangerous.

Ifyou forget to take Amiodarone Tablets

Ilf you have forgotten to take a dose, leave out that dose completely. Take your next dose at the Inormal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.


Amiodarone may cause some patients to become sensitive to the sun or may cause a discolouration to the skin or a rash. You should avoid exposure of your skin to direct sunlight or sunlamps. Sunlight sensitivity may persist for some time after treatment stops and therefore sensible precautions should be taken to minimize the amount ofsun exposure to the skin.


Other side effects include:

Headaches, disturbed sleep patterns, nausea, vomiting, a metallic taste, painful swelling ofthe testicles, impotence, a slow pulse, shakiness, hair loss, muscle pain and weakness, difficulty in walking or balancing, inflammation ofthe veins and problems with the blood (you may notice bruising or nose bleeds).

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.


5. HOW TO STORE AMIODARONE TABLETS


Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Do not store above 25°C. Store in the original package.

In case of any visible signs of deterioration, you should discard the package.

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


Keep out of the sight and reach of children


6. CONTENTS OF THE PACK AND OTHER INFORMATION


4. POSSIBLE SIDE EFFECTS


Like all medicines, Amiodarone Tablets can cause hide effects, although not everyone gets them.

Ilfyou experience any ofthe following then STOP taking the medicine and contact a doctor limmediately

•    You get a pain in your chest that feels like pressure, squeezing or fullness. It may feel similar to heartburn or indigestion. Other symptoms may include discomfort in one or both arms, neck , jaw or stomach, shortness of breath, with feeling or being sick, feeling lightheaded and breaking out in a cold sweat. YOU

| SHOULD GO TO HOSPITAL IMMEDIATELY.

•    Your heart beat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to the hospital straightaway.

|* Allergic reactions may occur rarely, with

symptoms such as rash, itching, swelling ofthe face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up


What Amiodarone Tablets contain:

Amiodarone Tablets contain 200mg of the active substance amiodarone hydrochloride in each tablet.

The other ingredients are: maize starch, lactose monohydrate, povidone (K90) magnesium stearate, silica, colloidal anhydrous and pregelatinised starch.

What Amiodarone Tablets look like and contents of the pack

Each tablet is a white flat tablet marked with '200' on one side and a break line on the other side.

Amiodarone Tablets are supplied in packs of 28.

Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer:

NivoPharma SA PO BOX 40, Via Cantonale Manno-Lugano, 6928 Switzerland.

This leaflet was last revised in November 2014