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Pharma code 1500

Tell your doctor before you start to take this medicine if you:
• have heart failure
• have liver problems
• have any problems with your lungs or have asthma
• have problems with your eyesight. This includes an illness
called ‘optic neuritis’
• are about to have an operation. In this case please inform the
anaesthetist before the operation that you are taking
• are elderly (over 65 years of age). The doctor will need to
monitor you more carefully
• You 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.
• have a slow pulse rate, particularly if you are elderly, or
undergoing digitalis therapy
Other medicines and Amiodarone
Do not take Amiodarone if you are taking
• drugs for an abnormal heart rhythm e.g. quinidine,
procainamide, disopyramide, sotalol, bretylium
• medicines for schizophrenia e.g. chlorpromazine, thioridazine,
fluphenazine, amisulpride, sertindole, pimozide, haloperidol
• medicines for other mental illness such as lithium and tricyclic
antidepressants e.g. doxepin, maprotiline, amitriptyline
• certain antihistamines (used to treat allergic reactions, for
example hay fever) e.g. terfenadine, mizolastine, astemizole
• antimalarials e.g. quinine, mefloquine, chloroquine,
• or if you have had an injection of erythromycin, co-trimoxazole,
moxifloxacin, pentamidine (all used to treat infections).
Following drugs should not be taken in combination with
• medicines to treat heart diseases such as verapamil, diltiazem
• medicines for heart problems called beta blockers (e.g.
atenolol, propranolol)
• medicines for constipation (laxatives) such as bisacodyl or senna

Pregnancy, breast-feeding and fertility
Do not take Amiodarone if you are pregnant or breast-feeding. Ask
your doctor for advice before taking any medicine.
Driving and using machines
Amiodarone may cause dizziness and your eyesight may become
blurred, if affected do not drive or operate machinery.
Important information about some of the ingredients of Amiodarone
Lactose (a type of sugar): Patients who are intolerant to lactose
should note that Amiodarone tablets contain a small amount of
lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
Iodine: Amiodarone contain approximately 37.5mg of iodine in a
100 mg tablet and approximately 75 mg of iodine in a 200mg tablet.
Iodine is present in amiodarone hydrochloride, the medicine your
tablets contain. Iodine can cause problems to your thyroid (see
‘Tests’ below).



Always take Amiodarone exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water.
The usual dose is:
Adults including the elderly
200 mg three times a day for one week, then 200 mg twice daily for
a further week. After this the dose is usually reduced to 200 mg a day
or even less. 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.
The doctor may give a lower dose of Amiodarone to elderly patients.
Also, for elderly patients the doctor should check blood pressure and
thyroid function regularly.

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Talk to your doctor if you are taking any of the following:
• tetracosactrin (used to assess adrenal gland function)
• medicines for high cholesterol (statins) such as simvastatin,
lovastatin or atorvastatin
Patient Information Leaflet
• tablets to thin your blood e.g. warfarin
• phenytoin (used to treat fits)
Read all of this leaflet carefully before you start taking this
• digoxin (used to treat heart diseases)
• medicines for infection (such as ciprofloxacin, ofloxacin or
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist. The following medicines can increase the chance of you getting side
• This medicine has been prescribed for you only. Do not pass it effects, when taken with Amiodarone:
on to others. It may harm them, even if their symptoms are the • amphotericin (when given directly into a vein) - used for fungal
same as yours.
• If any of the side effects gets serious, or if you notice any side
• medicines for inflammation (corticosteroids) such as
effects not listed in this leaflet, please talk to your doctor or
hydrocortisone, betamethasone or prednisolone
pharmacist. This includes any possible side effects not listed in • diuretics ("water tablets") e.g. bendroflumethiazide, furosemide or
this leaflet. See section 4.
• general anaesthetics or high dose oxygen - used during surgery
• tetracosactide - used to test some hormone problems.
1. What Amiodarone is and what it is used for
Amiodarone may increase the effect of the following medicines:
2. What you need to know before you take Amiodarone
• ciclosporin and tacrolimus - used to help prevent rejection of
3. How to take Amiodarone
4. Possible side effects
• medicines for impotence such as sildenafil, tadalafil or vardenafil
5. How to store Amiodarone
• fentanyl - used for pain relief
6. Contents of the pack and other Information
• ergotamine, dihydroergotamine - used for migraines
• triazolam- used on a short-term basis to treat sleeping difficulties
• midazolam - used to relieve anxiety or to help you relax before
• Amiodarone is an anti-arrhythmic drug which slows nerve
• flecainide - another medicine used for uneven heartbeats.Your
impulses in the heart muscle.
doctor should monitor your treatment and may half your dose of
• Amiodarone is used to treat recurrent abnormal heart rhythms
including Wolff-Parkinson-White syndrome which is an

– used as an anaesthetic
abnormal heart rhythm condition present at birth.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription or if you are to undergo surgery or any
surgical procedure.
Do NOT take Amiodarone if you:
• are allergic (hypersensitive) to Amiodarone or any of the
Amiodarone with food and drink
ingredients of the medicine
Do not drink grapefruit juice while taking this medicine. This is
• are allergic (hypersensitive) to iodine
because drinking grapefruit juice while taking Amiodarone can
• are taking drugs which may cause a life threatening irregular
increase your chance of getting side effects.
heart beat when taken in combination with Amiodarone (see
You should keep your consumption of alcohol to a minimum whilst
Section 2, Taking other medicines)
taking these tablets as Amiodarone may increase the effect of
• have a disturbance in the electrical conduction of the heart
alcohol on your liver.
• have an abnormally slow heart rate
• have any other problems with your heartbeat and do not have Protect your skin from sunlight
a pacemaker fitted
Keep out of direct sunlight while taking this medicine and for a few
• have or have a family history of thyroid disorders. Your doctor months after you have finished taking it. This is because your skin
should test your thyroid before giving you this medicine
will become much more sensitive to the sun and may burn, tingle or
• are breast-feeding
severely blister if you do not take the following precautions:
• are pregnant.
• Make sure you use high factor sun cream
• Always wear a hat and clothes which cover your arms and legs
Warnings and precautions

AMIODARONE 100 mg and 200 mg


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

• 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’
If you take more Amiodarone than you should
If you (or someone else) swallow a lot of the tablets all together, or if • Impaired vision which may lead to blindness

you think a child has swallowed any of the tablets, contact your
nearest hospital casualty department or your doctor immediately. An • Difficulty in controlling movements
• Difficulty in breathing or wheezing in patients with severe
overdose is likely to cause a very slow pulse rate. Please take this
respiratory failure and especially in patients who are suffering
leaflet, any remaining tablets and the container with you to the
from asthma
hospital or doctor so that they know which tablets were consumed.
• Headache
If you forget to take Amiodarone
• Balance problems, feeling dizzy (vertigo)
If you forget to take a tablet, take one as soon as you remember,
• Chronic liver malfunction
unless it is nearly time to take the next one. Do not take a double
• Difficulty in getting or maintaining an erection or in ejaculating
dose to make up for a forgotten dose.
• Hair loss, balding
• Skin rash
If you stop taking Amiodarone
Do not stop taking your medicine without talking to your doctor first • Skin redness during radio-therapy
• Headache, nausea and vomiting, buzzing in the ears, double
even if you feel better.
vision and other visual disturbances. This could be an illness
called ‘benign intracranial hypertension’
• your blood may be tested regularly to check whether your liver is • Inflammation of blood vessels, often with skin rash.
working properly
• your doctor may do regular thyroid tests while you are taking this Not known (frequency cannot be estimated from the available
medicine. This is because Amiodarone contain iodine which can
• Bleeding from the lungs. Symptoms you may feel are like
cause problems to your thyroid
oozing of bloody fluid from the nose or coughing up blood.
• your doctor may also do other regular tests such as blood tests,
• Metallic taste
chest X-rays, ECG (electrical test of your heartbeat)

• you should have your eyes tested regularly if you have been
• Hives (itchy, lumpy rash)
taking Amiodarone for a long time
• A burning or prickling sensation in the hands, arms, legs, feet
If you have any further questions on the use of this product, ask your
or in other parts of the body.
doctor or pharmacist.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
Like all medicines, Amiodarone can cause side effects, although not
Reporting of side effects
everybody gets them.
If you get any side effects, talk to your doctor, pharmacist or
If the following happens, stop taking the tablets and tell your doctor nurse. This includes any possible side effects not listed in this
immediately or go to the casualty department at your nearest
leaflet. You can also report side effects directly via the Yellow Card
Scheme at:
• an allergic reaction (swelling of the lips, face or neck leading to
By reporting side effects you can help provide more information
severe difficulty in breathing; skin rash or hives).
on the safety of this medicine.
This is a very serious but rare side effect. You may need urgent
medical attention or hospitalisation.
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)
• Blurred eyesight or seeing a coloured halo in dazzling light.
• Feeling sick (nausea) or being sick (vomiting)
• 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)
• 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 ‘hypo-thyroidism’
• Trembling when you move your arms or legs
• Blue or grey marks on parts of your skin exposed to sunlight,
especially the face
• Slightly slower heart beat
• Yellowing of the skin or whites of the eyes caused by a liver
disease called ‘Jaundice’ which may lead to liver failure.
• Nightmares
• Problems sleeping
• Inflammation of the lungs which causes breathlessness, cough,
reduced exercise tolerance and raised temperature
Uncommon (affects less than 1 in 100 people)
• Pain, weakness, tingling loss of co-ordination, numbness in the
• Irregular heart beat or worsening of irregular heart beat may lead
to heart attack
• Disturbances in the heart functions
Very rare (affects less than 1 in 10,000 people)
• Swelling of the testicles
• Very slow heart beat in elderly patients or in patients with serious
heart disease
• Transient cessation of the electrical impulse of the heart muscle in
elderly patients or in patients with serious heart disease
• 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
• Severe reduction in blood cells which can cause weakness,
bruising or make infections more likely

Keep this medicine out of the sight and reach of children. Do not
store above 25°C. Store Amiodarone in the original container. Do
not transfer your tablets to another container. Do not use
Amiodarone after the expiry date that is stated on the outer
packaging. 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



What Amiodarone Tablets contain:
• The active ingredient is amiodarone hydrochloride 100 mg or
200 mg.
• The other ingredients are lactose monohydrate, maize starch,
sodium starch glycolate (Type A), povidone (E1201) and
magnesium stearate (E572).
What Amiodarone looks like and contents of the pack:
• The 100 mg tablets are white, circular biconvex tablet,
engraved 1A1 with a breakline on the reverse.
• The 200mg tablets are white, circular biconvex tablet, engraved
1A3 with a breakline on the reverse.
The product is available in pack sizes* of 7, 10, 14, 20, 21, 28, 30,
50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250, 500, 1000
and 5000 tablets.
*Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in: May 2015
PL 00289/0319-0320

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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.