AMIODARONE 200MG TABLETS

Active substance: AMIODARONE HYDROCHLORIDE

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TEVA UK Ref:

231-30-60901-X LEA AMIODARONE A/S TABS TUK

Version:

1

16 April 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

PATIENT INFORMATION LEAFLET






lovastatin or atorvastatin
tablets to thin your blood e.g. warfarin
phenytoin (used to treat fits)
digoxin (used to treat heart diseases)
medicines for infection (such as ciprofloxacin, ofloxacin or
levofloxacin).

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 only. 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 talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

The following medicines 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 (corticosteroids) such as
hydrocortisone, betamethasone or prednisolone
• diuretics (”water tablets”) e.g. bendroflumethiazide, furosemide
or amiloride
• general anaesthetics or high dose oxygen - used during surgery
• tetracosactide - used to test some hormone problems.

IN THIS LEAFLET:

Amiodarone may increase the effect of the following 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, 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
surgery
• flecainide – another medicine used for uneven heartbeats.Your
doctor should monitor your treatment and may half your dose of
flecainide
• lidocaine – used as an anaesthetic.

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6.

What Amiodarone is and what it is used for
What you need to know before you take Amiodarone
How to take Amiodarone
Possible side effects
How to store Amiodarone
Contents of the pack and other information

1

WHAT AMIODARONE IS AND WHAT IT IS USED FOR

Pharma code 1500

• Amiodarone is an anti-arrhythmic drug which slows nerve
impulses in the heart muscle.
• Amiodarone is used to treat recurrent abnormal heart rhythms
including Wolff-Parkinson-White syndrome which is an abnormal
heart rhythm condition present at birth.

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMIODARONE

Do NOT take Amiodarone if you:
• are allergic (hypersensitive) to Amiodarone or any of the
ingredients of the medicine
• are allergic (hypersensitive) to iodine
• are taking drugs which may cause a life threatening irregular
heart beat when taken in combination with Amiodarone (see
Section 2, Taking other medicines)
• have a disturbance in the electrical conduction of the heart
• have an abnormally slow heart rate
• have any other problems with your heartbeat and do not have a
pacemaker fitted
• have or have a family history of thyroid disorders. Your doctor
should test your thyroid before giving you this medicine
• are breast-feeding
• are pregnant.
Warnings and precautions
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 Amiodarone.
• 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, halofantrine
• or have had an injection of erythromycin, co-trimoxazole,
moxifloxacin, pentamidine (all used to treat infections).
The following drugs should not be taken in combination with
Amiodarone
• 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.
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,

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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.
Amiodarone with food and drink
Do not drink grapefruit juice while taking this medicine. This is
because drinking grapefruit juice while taking Amiodarone can
increase your chance of getting side effects.
You should keep your consumption of alcohol to a minimum whilst
taking these tablets as Amiodarone may increase the effect of
alcohol on your liver.
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.
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
Tablets
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 37.5 mg of iodine in a
100 mg tablet and approximately 75 mg of iodine in a 200 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 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.
Children and adolescents
There are only limited data on the efficacy and safety in children.
Your doctor will decide on an appropriate dose.

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Top of page cut-off to middle of registration mark: 44 mm.

AMIODARONE 100 mg AND 200 mg
TABLETS

TEVA UK Ref:

231-30-60901-X LEA AMIODARONE A/S TABS TUK

Version:

1

16 April 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you take more Amiodarone than you should
If you (or someone else) swallow a lot of the tablets all together, or if
you think a child has swallowed any of the tablets, contact your
nearest hospital casualty department or your doctor immediately. An
overdose is likely to cause a very slow pulse rate. Please take this
leaflet, any remaining tablets and the container with you to the
hospital or doctor so that they know which tablets were consumed.

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
If you forget to take Amiodarone
sunlight’ in Section 2).
If you forget to take a tablet, take one as soon as you remember,
Common (affects less than 1 in 10 people)
unless it is nearly time to take the next one. Do not take a double
• Slightly slower heart beat
dose to make up for a forgotten dose.
• Yellowing of the skin or whites of the eyes caused by a liver
If you stop taking Amiodarone
disease called ‘Jaundice’ which may lead to liver failure.
Do not stop taking your medicine without talking to your doctor first • Nightmares
even if you feel better.
• Problems sleeping
• Inflammation of the lungs which causes breathlessness, cough,
Test
reduced exercise tolerance and raised temperature.
• your blood may be tested regularly to check whether your liver is
working properly
Very rare (affects less than 1 in 10,000 people)
• your doctor may do regular thyroid tests while you are taking this • Headache
medicine. This is because Amiodarone contain iodine which can
• Balance problems, feeling dizzy (vertigo)
cause problems to your thyroid
• Chronic liver malfunction
• your doctor may also do other regular tests such as blood tests,
• Difficulty in getting or maintaining an erection or in ejaculating
chest X-rays, ECG (electrical test of your heartbeat)
• Hair loss, balding
• you should have your eyes tested regularly if you have been
• Skin rash
taking Amiodarone for a long time.
• Skin redness during radio-therapy
If you have any further questions on the use of this product, ask your • Headache, nausea and vomiting, buzzing in the ears, double
vision and other visual disturbances. This could be an illness
doctor or pharmacist.
called ‘benign intracranial hypertension’
• Inflammation of blood vessels, often with skin rash.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Amiodarone can cause side effects, although not
everybody gets them.
If the following happens, stop taking the tablets and tell your doctor
immediately or go to the casualty department at your nearest
hospital:
• an allergic reaction (swelling of the lips, face or neck leading to
severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent
medical attention or hospitalisation.
The following side effects have been reported:
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 ‘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.
Uncommon (affects less than 1 in 100 people)
• Pain, weakness, tingling loss of co-ordination, numbness in the
muscles.
• 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
• 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)
• Impaired vision which may lead to blindness
• Kidney problems
• Difficulty in controlling movements
• Difficulty in breathing or wheezing in patients with severe
respiratory failure and especially in patients who are suffering
from asthma.
Not known (frequency cannot be estimated from the available data)
• Bleeding from the lungs. Symptoms you may feel are like oozing
of bloody fluid from the nose or coughing up blood.

Not known (frequency cannot be estimated from the available data)
• Tiredness
• Hives (itchy, lumpy rash)
• A burning or prickling sensation in the hands, arms, legs, feet or
in other parts of the body.
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 pharmacist.
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

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 environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

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 200 mg 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: 03/2014.
PL 00289/0319-0320

60901-X
210 x 323

REG0060723

Version 1.2

Approved

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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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