AMIODARONE HYDROCHLORIDE 100MG TABLETS

Active substance: AMIODARONE HYDROCHLORIDE

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Package leaflet: Information for the patient
Amiodarone Hydrochloride 100 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 this leaflet
The name of your medicine is Amiodarone Hydrochloride 100 mg tablets; however for
simplicity it will be referred to as Amiodarone throughout the leaflet.
What is in this leaflet:
1. What Amiodarone Tablets is and what it is used for
2. What you need to know before you take Amiodarone Tablets
3. How to take Amiodarone Tablets
4. Possible side effects
5. How to store Amiodarone Tablets
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.
It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking
the tablets helps your heartbeat to return to normal.
Amiodarone can be used to
• Treat uneven heartbeats where other medicines either have not worked or cannot be
used
• Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats
unusually fast
• Treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial
fibrillation. Amiodarone is used only when other medicines cannot be used
• Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone is
used only when other medicines 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 taking certain other medicines which could affect your heartbeat (see ‘Other
medicines and amiodarone’ below)
 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 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.
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
Other medicines and Amiodarone
Tell your doctor or pharmacist if you are taking, have recently 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):
 other medicines for an uneven heartbeat (such as quinidine, disopyramide,
procainamide, sotalol, bretylium)
 medicines to treat mental illness or depression (such as chlorpromazine, pimozide,
thioridazine, fluphenazine, pimozide, amisulpiride, haloperidol, lithium, doxepin,
maprotiline, amitriptyline or sertindole)
 medicines used for hay fever, rashes or other allergies called antihistamines (such
as: terfenadine, astemizole, mizolastine)
 antimalarial medicine (such as quinine, mefloquine, halofantrine, chloroquine)
 medicines for infections (such as intravenous erythromycin, co-trimoxazole,
moxifloxacin or pentamidine).
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:

 medicines for high cholesterol (statins) such as simvastatin, lovastatin or
atorvastatin
 medicines for infection such as ciprofloxacin, ofloxacin or levofloxacin
 medicines for constipation (laxatives) such as 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)
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
 water tablets (diuretics)
 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 help prevent rejection of transplants
 medicines for impotence such as sildenafil, tadalafil or vardenafil
 fentanyl- used for pain relief
 ergotamine- used for migraines
 midazolam- used to relieve anxiety or to help you relax before surgery
 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
Limit the amount of alcohol you drink while taking this medicine. 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. This is because small
amounts of this medicine can pass into breast milk and harm your baby.
Driving and using machines
You may have blurred eyesight after taking this medicine. If this happens, you should not
drive or operate machinery until your eyesight is clear.

Important information about some of the ingredients of Amiodarone
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 contain 37.5 mg of iodine in a 100 mg tablet. Iodine is present in
amiodarone hydrochloride, the medicine your tablets contain. Iodine can cause problems
to your thyroid (see ‘Tests’ below).
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 one week, the dose will then be
lowered to 200 mg twice a day for another week.
After this your doctor will reduce the dose of Amiodarone again, usually to 200 mg once
a 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 the medicine.
Elderly
The doctor may give you a lower dose of Amiodarone Tablets. Also, the doctor should
check your blood pressure and thyroid function regularly.
Use in children and adolescents
There is only limited data on the efficacy and safety in children. Your doctor will decide
on an appropriate dose.
The score line is only to facilitate breaking for ease of swallowing and not to divide 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 effects: 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 tablet 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
Your doctor will take regular tests to check how your liver is working. Amiodarone
tablets can affect how your liver works.
If this happens, your doctor will decide whether you should keep taking these tablets.
Your doctor may do regular thyroid tests while you are taking this medicine. This is
because Amiodarone tablets 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) and eye tests both before and while you are taking
Amiodarone tablets.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them. Amiodarone tablets may stay in your blood for up to a month after stopping
treatment. You may still get side effects in this time.
Stop taking this medicine 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
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 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
Very rare (affects less than 1 in 10,000 people)
• Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’)
• Headache (which is usually worse in the morning or happens after coughing or
straining), feeling sick (nausea) fits, fainting, eyesight problems or confusion can occur
These could be signs of problems with your brain
• 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 ‘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 ‘hypothyroidism’
• 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)
• Muscle cramps, stiffness or spasm
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
• 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
• Nightmares
• Problems sleeping
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 radio-therapy
Not known (frequency cannot be estimated from the available data)
• Hives (itchy, lumpy rash)
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 use this medicine after the expiry date which is stated on the carton, blister and
bottle after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in original packaging. Keep in outer carton.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.
6.

Contents of the pack and other information

What Amiodarone contains
Each tablet contains 100 mg of the active ingredient amiodarone hydrochloride
The other ingredients are: lactose, microcrystalline cellulose, povidone, crospovidone,
colloidal silica, dioxide, talc, magnesium stearate
What Amiodarone looks like and contents of the pack
White biconvex uncoated tablets marked ‘AM’ breakline ‘100’ on one side and ‘G’ on
the reverse.
Amiodarone is available in bottles or blister packs of 20, 28, 30, 50, 60, 84, 90, 100 or
112 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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