AMIODARONE HYDROCHLORIDE 200MG TABLETS

Active substance: AMIODARONE HYDROCHLORIDE

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Package leaflet: Information for the user
Amiodarone Hydrochloride 200 mg Tablets
Amiodarone Hydrochloride

Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible
side effects not listed in the leaflet.
The name of your medicine is Amiodarone Hydrochloride 200 mg tablets; however for simplicity it
will be referred to as Amiodarone throughout the leaflet.
What is 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
1. What Amiodarone is and what it is used for.
Your tablet contains amiodarone hydrochloride, which belongs to a class of medicines known as
antiarrhythmics. Amiodarone can help to suppress and prevent an abnormal or irregular heart rhythm
and so return your heart rhythm to normal. Amiodarone can be used to treat heart conditions that
result in rapid or increased heart rates, caused by heart disease, or a hereditary disease called WolffParkinson-White syndrome (where your heart beats unusually fast). Amiodarone can be used to treat
uneven heartbeats where other medicines either have not worked or cannot be used.
2. What you need to know before you take Amiodarone
Do not take Amiodarone if:






you are allergic (hypersensitive) to amiodarone, iodine or any of the other ingredients of this
medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
you have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘sino-atrial’
heart block
you have any other problems with your heartbeat and do not have a pacemaker fitted
you have or have had thyroid problems. Your doctor should test your thyroid before giving you
this medicine
you are already taking certain medicines which may cause irregular heart rhythm, showing as an
abnormal ECG (electrical test of your heartbeat), or monoamine-oxidase inhibitors (MAOI) to
treat your depression (see section ‘Taking other medicines’)



you are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)

Amiodarone must not be given to children, premature babies or neonates.
Warnings and precautions
You should tell your doctor before taking this medicine if you:
 have or have had heart failure or suffer from breathlessness and swollen ankles
 have liver problems
 have any problems with your lungs or have asthma
 have any problems with your eyesight This includes an illness called ‘optic neuritis’
 are about to have an operation or may be given general anaesthetic
 are elderly (over 65 years of age). The doctor will need to monitor you more carefully
 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.
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. You should apply a high factor sun cream, wear a hat and clothes to cover your
arms and legs (section 4).
Other medicines and amiodarone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The following medicines may cause irregular heart rhythm, showing as an abnormal ECG and should
not be used with amiodarone due to increased risk of an irregular heart rhythm or missed beats
(Torsades de Pointes).
 any other antiarrhythmic medicine to control your heart rhythm including quinidine,
disopyramide, procainamide, sotalol, bretylium, flecainide or bepridil
 medicines to treat mental illness or depression eg chlorpromazine, pimozide, thioridazine,
haloperidol, lithium, doxepin, maprotiline, amitriptyline or sertindole
 antihistamine medicines used for hayfever, rashes or other allgeries eg terfenadine, astemizole,
mizolastine
 antimalarial medicine eg quinine, mefloquine, halofantrine, chloroquine
 medicine for infection given by injection containing erythromycin, co-trimoxazole, pentamidine,
corticosteroids, amphotericin, moxifloxacin
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription, or the following:










digoxin for your heart
phenytoin to treat epilepsy
monoamine-oxidase inhibitor (MAOI) eg phenelzine to treat depression
medicines to lower cholesterol eg. simvastatin or pravastatin
medicines for infection such as ciprofloxacin, ofloxacin or levofloxacin
medicines lowering the body’s natural defences eg. ciclosporin, tacrolimus
medicines for constipation (laxatives) eg. senna or bisacodyl
medicines for heart problems called beta-blockers such as propranolol
medicines called calcium channel blockers for chest pain (angina) or high blood pressure (such
as diltiazem or verapamil)

 anticoagulants (e.g. warfarin, to help thin the blood)
The following medicine 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 (corticosteriods) such as hydrocortisone, betamethasone or
prednisolone
 diuretics (‘water tablets’ e.g. frusemide)
 general anaesthetics or high dose oxygen- used during surgery
 tetracosactide- used to test some hormone problems
Amiodarone may increase the effect of the other medicines:
 ciclosporin and tacrolimus- used to prevent rejection of transplants
 medicines used for impotence such as sildenafil, tadalafil or vardenafil
 fentanyl- used for pain relief
 ergotamine- used for pain relief
 midazolam- used to relieve anxiety or to help you relax
 flecainide- another medicine used for uneven heartbeats. Your doctor should monior your
treatment and may half your dose of flecainide.
 lidocaine- used as an anaesthetic
Amiodarone with food, drink and alcohol
You should take your tablets regularly and avoid drinking excessive amounts of alcohol during your
treatment. This is because drinking alcohol while taking this medicine will increase the chance of you
having problems with your liver. Talk to your doctor or pharmacist about the amount of alcohol you
can drink.
Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice
while taking amiodarone tablets can increase your chance of getting side effects.
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 or pharmacist for advice before taking this medicine
Do not take amiodarone if you are pregnant or intend to become pregnant.
Do not breast-feed your baby if you are taking amiodarone. Small amounts of this medicine can pass
into breast milk and harm your baby.
Driving and using machines
You may have blurred vision after taking this medicine. You should not drive, especially at night or
operate machinery until your eyesight is clear.
Amiodarone contains lactose
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking this medicine. Your tablets also contains
iodine please see section ‘Tests’ below for more information.
3. How to take Amiodarone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Swallow the tablets whole or divide them into equal halves if necessary. Do not crush or chew your
tablets. If you feel your condition is not improving while taking your medicine, tell your doctor.

Do not stop taking your medicine without consulting your doctor.
Adults
The usual starting dose is 200 mg three times a day for up to a week, then 200mg twice a day for
another week. After this your doctor will reduce the dose of amiodarone again, usually to 200 mg
once a day, which will still control your heart rhythm.
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 the medicine.
Elderly
Elderly patients do not require a different dosage but if too high a dose is employed they may be more
susceptible to problems and thyroid function should be closely monitored.
Your doctor may change the dose depending on your condition. You should continue taking your
medicine until advised otherwise by your doctor.
Use in children and adolescents
There are only limited data on the efficacy and safety in children. Your doctor will decide on an
appropriate dose.
The tablet can be divided into equal doses.
If you take more Amiodarone than you should
If you have taken too many tablets, consult with your doctor or the nearest emergency department
immediately. Take the medicine pack with you. You may notice the following symptoms of overdose:
feeling dizzy, faint or tiredness, confusion, slow heartbeat, being sick and damage to your liver.
If you forget to take Amiodarone
Take your tablets as soon as you remember. However, if it is almost time for your next dose, do not
take the missed dose, take the next dose on time. Do not take a double dose to make up for a forgotten
dose, just carry on as before.
If you stop taking Amiodarone
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Tests
Each tablet also contains 75 mg of iodine. Iodine can cause problems to your thyroid; your doctor will
regularly monitor your iodine level.
Your doctor may also arrange for you to have other regular tests before and during treatment such as
blood tests, test on liver function, chest X-rays, ECG (electrical test of your heartbeat) and eye tests.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and seek medical attention immediately if you begin to itch, get short of
breath or feel wheezy, and develop swelling of the face, hands, feet, mouth, throat or eyes.

Amiodarone tablets may stay in your blood for up to a month after stopping treatment. You may still
get side effects in this time.
Tell your doctor if you suffer from any of the below side effects. Your doctor may need to stop your
medicine and you may need medical attention.
Very common side effects (may affect more than 1 in 10 people):
 raised level of liver enzymes in the blood,
 visual halos or night glare - these side
which can be seen in your blood test
effects will usually disappear as
treatment continues
 skin becomes very sensitive to the sun and
 feeling or being sick
a rash can develop often on the face,
which may blister– see also section 2 –
Take special care with Amiodarone
 taste changes
Common side effects (may affect up to 1 in 10 people):
 Difficulty breathing or tightness in the
 chest infection or chest pain
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
 a slow beating heart
 feeling unusually tired, unwell, weight loss
or feverish
 thyroid problems, especially in the elderly,
 an irregular heart rhythm or missed beats
which can mean you gain or lose weight,
you may notice a change in heart rate or
become less active or more restless than
usual
 skin becomes grey or bluish
 abdominal pain or yellowing of the skin or
whites of the eyes, dark urine, pale
stools. These can be signs of liver
problems or damage which can be very
dangerous
 nightmares, sleep problems
 shaking of the hands
 confusion
 depression
Uncommon side effects (may affect up to 1 in 100 people):
 worsening of the heart rhythm, heart block.
 pins and needles in the fingers or toes
This can lead to a heart attack, you
should go to your doctor straight away
 muscle pain and weakness
Very rare side effects (may affect up to 1 in 10,000 people):
 severe liver problems
 confusion, fits, loss of consciousness
 flaky red skin, rash
 a very slow heart beat (more likely in the
elderly)
 vertigo
 loss of vision, worsening of eyesight
 sore or tender eyes
 numbness in the limbs
 severe skin reactions

 uncontrolled muscle movements
 severe headache
 unusual bruising/bleeding of skin
 looking pale, feeling tired, breathlessness








loss of balance, shaking
suffering more infections than usual
impotence,
painful swelling of the testicles
metallic taste
hair loss

 red swollen blood vessels (vasculitis)
 kidney problems
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side
effects not listed in this leaflet.
5. How to store Amiodarone
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the carton, blister and bottle. The expiry date
refers to the last day of that month.
Do not store above 25ºC. Store in the original package.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of pack and other information
What Amiodarone Tablets contain
Each tablet contains 200 mg of the active ingredient amiodarone hydrochloride.
The other excipients are lactose, cellulose, microcrystalline, crospovidone, povidone, silica, colloidal
dioxide, talc and magnesium stearate.
What Amiodarone looks like and contents of the pack
Tablets are round white uncoated with break line, marked ‘AM 200’ on one side and ‘G’ on the other.
Amiodarone is available in bottles or blister packs of 10, 20, 28, 30, 50, 60 or 90 tablets. Not all pack
sizes will be marketed.
Marketing Authorisation Holder

Generics [UK] Limited t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL
United Kingdom
Manufacturer

McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

This leaflet was last revised in: June 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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