Amiodarone 100 mg Tablets Amiodarone 200 mg 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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Amiodarone Tablets

3.    How to take Amiodarone Tablets

4.    Possible side effects

5.    How to store Amiodarone Tablets

6.    Further information

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

Amiodarone belongs to a group of drugs known as antiarrhythmics. It is used to control an irregular or rapid heart rate. It is only used for severe disorders that do not respond to other therapies or when other treatments cannot be used. Therapy should only be initiated and monitored under hospital or specialist supervision.

2.    BEFORE YOU TAKE AMIODARONE TABLETS Do not take Amiodarone Tablets

•    If you allergic/sensitive to amiodarone or any of the other ingredients in Amiodarone tablets

•    If you are allergic to iodine.

•    If you suffer from conduction problems of the heart, such as a slow heart beat or heart block (which may cause a very slow, very fast or irregular pulse or dizziness). Amiodarone Tablets should only be used in such patients who have a pacemaker fitted

•    If you have or had any problems with your thyroid.

•    If you are breastfeeding

•    Have severe hypotension (low blood pressure)

•    Have severe breathing difficulties

Take special care with Amiodarone Tablets

Please tell your doctor before you start to take your tablets:

•    If you are pregnant, think you may be pregnant or planning to become pregnant

•    If you suffer from heart failure as you may need to take these tablets

in conjunction with other therapies which will be advised by your doctor.

•    If you have a family history of thyroid disorders, before starting treatment

your doctor may carry out blood tests to look at your heart and thyroid functions.

•    Have the rare hereditary condition porphyria (where urine and faeces exposed to light turn purple)

•    You should avoid exposure of the skin to sunlight or sunlamps whilst using amiodarone.

•    Your liver and thyroid function may be monitored during treatment

Make sure you tell your doctor and anaesthetist that you are taking amiodarone tablets if you need an operation as Amiodarone tablets can interact with anaesthetics and high dose oxygen therapy.

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.

Do not take Amiodarone tablets if you are taking any of the following medicines:

•    Anti-arrhythmic drugs used to treat irregular heartbeats (e.g. quinidine, procainamide, disopyramide, sotalol, bretylium)

•    Intravenous erythromycin, moxifloxacin, co-trimoxazole or pentamide which are used to treat infections

•    Anti-psychotics e.g. Chlorpromazine, amisulphride, sertindole, fluphenazine, thioridazine, pimozide, haloperidol

•    Lithium and tricyclic anti-depressants e.g. Doxepin, maprotiline, amitriptyline

•    Certain antihistamines e.g. Terfenadine, astemizole

•    Anti-malarials e.g: Quinine, arthemether/lumefantrine, mefloquine, chloroquine, halofantrine.

•    Beta blockers and certain calcium channel inhibitors (diltiazem, verapamil)

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

•    Digoxin used for heart conditions

•    Anticoagulants - used to thin the blood (e.g. warfarin)

•    Phenytoin - used to treat epilepsy

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•    Phenytoin - used to treat epilepsy

•    Flecainide - an anti-arrhythmic drug used to treat irregular heartbeats

•    Diuretics (water tablets)

•    Corticosteroids (e.g. triamcinolone, dexamethasone)

•    Tetracosactrin used in Crohn's disease, arthritis and osteoporosis

•    Stimulant laxatives

•    Cyclosporin, tracrolimus and sirolimus used to suppress the immune system

•    Intravenous Amphotericin

•    Ergometrine used to treat migraine

•    Simvastatin used to treat high cholesterol

•    Orlistat used for treatment of obesity

•    The herbal remedy St John's Wort

•    Carbamazepine used to treat epilepsy and nerve pain

•    Rifampicin used to treat infections

•    Midazolam used as a sedative

•    Lidocaine used as a local anaesthetic

•    Fentanyl used for pain relief

•    Sildenafil used for treatment of Erectile Dysfunction Taking Amiodarone Tablets with food and drink:

Amiodarone tablets do not have to be taken with food. You should limit the amount of alcohol you drink whilst taking these tablets. Grapefruit juice should be avoided whilst taking Amiodarone.

Pregnancy and breast-feeding:

Talk to your doctor if you are pregnant, planning to become pregnant or breast-feeding, before taking Amiodarone Tablets because this medicine may harm your baby.

Driving and using machines:

This product may cause vertigo, drowsiness or blurred vision, so do not drive or operate machinery if you are affected.

Important information about some of the ingredients in Amiodarone Tablets:

Do not take these tablets if you have been told you have an intolerance to some sugars as these tablets contain lactose.

3.    HOW TO TAKE AMIODARONE TABLETS

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

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole. Do not crush or chew your tablets

•    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 Adults

•    The usual starting dose is 200 mg three times each day for one week

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

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

•    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

Children

•    Your doctor will work out the correct dose for your child depending on how much they weigh. Elderly

•    The doctor may give you a lower dose of amiodarone. Also, the doctor should check your blood pressure and thyroid function regularly

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

If you take more Amiodarone Tablets than you should

If you take too many tablets or someone else takes your tablets, consult your nearest hospital casualty department or your doctor for advice. Take this leaflet, and any tablets that you still have to show the doctor.

If you forgot to take Amiodarone Tablets

If you forget to take a dose at the right time, take it as soon as you remember. Never take two doses together.

If it is almost time to take the next dose, wait until then and then carry on as before.

If you stop taking Amiodarone Tablets

It can be dangerous to stop taking your tablets without your doctor's advice first.

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

4.    POSSIBLE SIDE EFFECTS

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

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Stop taking Amiodarone Tablets and see a doctor or go to a hospital straight away if:

•    You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swollen eyelids, face, lips, throat or tongue, bleeding and bruising more easily.

Common (affects less than 1 in 10 people)

•    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 neuritis'

•    Your heartbeat becomes very slow or stops beating. If this happens, go to hospital straight away

Stop taking Amiodarone Tablets and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Uncommon (affects less than 1 in 100 people)

•    Feeling numb or weak, tingling or burning feelings in any part of your body

•    Muscle cramps, stiffness or spasm

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

•    Skin rash caused by narrow or blocked blood vessels (called 'vasculitis')

•    Moving unsteadily or staggering, slurred or slow speech

•    Feeling faint, dizzy, unusually tired and short of breath. These could be signs of a very slow heartbeat (especially in people over 65 years old) or other problems with your heart's natural beat

Some cases of bleeding in the lungs have been reported in patients taking Amiodarone tablets. You should tell your doctor straight away if you cough up any blood.

Tell your doctor as soon as possible if you have any of the following side effects: 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 'hyperthyroidism'

•    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 'hypothyroidism'

•    Trembling when you move your arms or legs

•    Blue or grey marks on parts of your skin exposed to sunlight, especially the face Rare (affects less than 1 in 1,000 people)

•    treatment resistant raised thyroid function (sudden and severe rapid heartbeat, sweating, anxiety, increased appetite, loss of weight).

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

•    Swelling of the testicles

•    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

•    You may bleed or bruise more easily than usual. This could be because of a blood disorder (called 'thrombocytopenia')

•    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)

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, often a metallic 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

Common (affects less than 1 in 10 people)

•    Slightly slower heart beat

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

•    Headache

•    Balance problems, feeling dizzy (vertigo)

•    Difficulty in getting or maintaining an erection or in ejaculating

•    Hair loss, balding

•    Skin rash

•    Skin redness during radiotherapy

•    liver disease or inflammation

•    an increase in creatinine measured during blood tests

•    increased blood pressure in the skull (causing painful eyes, changes in vision, a bad headache especially behind the eyes)

•    if you undergo surgery there may be a reaction to the high level of oxygen used, you should make sure that the anaesthetist is informed that you are taking Amiodarone

•    A spasm in the lungs known as bronchospasm especially if you have other breathing problems including asthma

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

•    Hives (itchy, lumpy rash)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme

Tel: Freephone 0808 100 3352 Website: www.mhra.gov.uk/yellowcard

5.    HOW TO STORE AMIODARONE TABLETS

•    Keep out of the reach and sight and children.

•    Do not take the tablets after the expiry date stated on the pack; the expiry date refers to last day of the month.

•    Do not store above 25 °C.

•    Store in the original packaging.

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

6.    FURTHER INFORMATION What Amiodarone Tablets contains

Each 100 mg tablet contains: Amiodarone Hydrochloride (active ingredient) 100 mg.

Each 200 mg tablet contains: Amiodarone Hydrochloride (active ingredient) 200 mg.

The other ingredients are:

lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, pregelatinised starch and magnesium stearate.

What Amiodarone Tablets look like and contents of the pack Pack sizes:

The tablets are available in packs of 28 tablets.

The 100 mg tablets are round, white tablets with a break line on one side and embossed '100' on the reverse side.

The 200 mg tablets are round, white tablets with a break line on one side and embossed '200' on the reverse side.

This leaflet was last amended 05/2013.

PL 21880/0095 PL 21880/0096

Marketing Authorization Holder:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK E-mail : info@medreich.co.uk