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AMIODARONE 200MG TABLETS BP

Active substance(s): AMIODARONE HYDROCHLORIDE

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TEVA UK Ref:

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

Version:

2

18 January 2016

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 1500

REG0060723

Version 3.6

Approved

Page 1 of 3

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

• medicines for constipation (laxatives) such as bisacodyl or senna
• medicines for high cholesterol (statins) such as simvastatin or
atorvastatin
The following medicines can increase the chance of you getting side
Patient Information Leaflet
effects, when taken with Amiodarone:
• amphotericin (when given directly into a vein) - used for fungal
Read all of this leaflet carefully before you start taking this
infections
medicine.
• medicines for inflammation (corticosteroids) such as
• Keep this leaflet. You may need to read it again.
hydrocortisone, betamethasone or prednisolone
• If you have any further questions, ask your doctor or pharmacist. • diuretics ("water tablets") e.g. bendroflumethiazide, furosemide or
• This medicine has been prescribed for you only. Do not pass it
amiloride
on to others. It may harm them, even if their symptoms are the • general anaesthetics or high dose oxygen - used during surgery
same as yours.
• tetracosactide - used to test some hormone problems.
• If any of the side effects gets serious, or if you notice any side
Amiodarone may increase the effect of the following medicines:
effects not listed in this leaflet, please talk to your doctor or
• ciclosporin and tacrolimus - used to help prevent rejection of
pharmacist. This includes any possible side effects not listed in
transplants
this leaflet. See section 4.
• medicines for impotence such as sildenafil, tadalafil or vardenafil
IN THIS LEAFLET:
• fentanyl - used for pain relief
• ergotamine, dihydroergotamine - used for migraines
1. What Amiodarone is and what it is used for
• triazolam- used on a short-term basis to treat sleeping difficulties
2. What you need to know before you take Amiodarone
• midazolam - used to relieve anxiety or to help you relax before
3. How to take Amiodarone
surgery
4. Possible side effects
• flecainide - another medicine used for uneven heartbeats.Your
5. How to store Amiodarone
doctor should monitor your treatment and may half your dose of
6. Contents of the pack and other Information
flecainide

lidocaine
– used as an anaesthetic
1 WHAT AMIODARONE IS AND WHAT IT IS USED FOR
• warfarin – used to stop your blood from clotting

colchicine
– used for the treatment of gout
• Amiodarone is an anti-arrhythmic drug which slows nerve
• digitalis – used for some heart conditions
impulses in the heart muscle.
• Amiodarone is used to treat recurrent abnormal heart rhythms • dabigatran - used to thin the blood
including Wolff-Parkinson-White syndrome which is an
Please tell your doctor or pharmacist if you are taking or have
abnormal heart rhythm condition present at birth.
recently taken any other medicines, including medicines obtained
• Amiodarone is used to treat fast heartbeats which may happen without a prescription or if you are to undergo surgery or any
suddenly and may be uneven. Amiodarone Tablets are used
surgical procedure.
only when other medicines cannot be used.
Amiodarone with food and drink
Do not drink grapefruit juice while taking this medicine. This is
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
because drinking grapefruit juice while taking Amiodarone can
AMIODARONE
increase your chance of getting side effects.
Do NOT take Amiodarone if you:
You should keep your consumption of alcohol to a minimum whilst
• are allergic (hypersensitive) to Amiodarone or any of the
taking these tablets as Amiodarone may increase the effect of
ingredients of the medicine
alcohol on your liver.
• are allergic (hypersensitive) to iodine
• are taking drugs which may cause a life threatening irregular
Protect your skin from sunlight
heart beat when taken in combination with Amiodarone (see
Keep out of direct sunlight while taking this medicine and for a few
Section 2, Taking other medicines)
months after you have finished taking it. This is because your skin
• have a disturbance in the electrical conduction of the heart
will become much more sensitive to the sun and may burn, tingle or
• have an abnormally slow heart rate
severely blister if you do not take the following precautions:
• have any other problems with your heartbeat and do not have • Make sure you use high factor sun cream
a pacemaker fitted
• Always wear a hat and clothes which cover your arms and legs
• have or have a family history of thyroid disorders. Your doctor
Pregnancy, breast-feeding and fertility
should test your thyroid before giving you this medicine
• Tell your doctor before taking this medicine if you are pregnant,
• are breast-feeding
might become pregnant or think you may be pregnant.
• are pregnant.
Amiodarone Tablets are not normally given during pregnancy
Signs of an allergic reaction include: a rash, swallowing or
• Do not take if you are breast-feeding or plan to breast-feed. This is
breathing difficulties, swelling of your lips, face, throat or tongue
because small amounts of this medicine may pass into the
mothers’ milk
Warnings and precautions
Ask your doctor or pharmacist for advice before taking any medicine
Tell your doctor before you start to take this medicine if you:
if you are pregnant or breast-feeding.
• have heart failure
• have liver problems
Driving and using machines
• have any problems with your lungs or have asthma
Amiodarone may cause dizziness and your eyesight may become
• have problems with your eyesight. This includes an illness
blurred, if affected do not drive or operate machinery.
called ‘optic neuritis’
Important information about some of the ingredients of Amiodarone
• are about to have an operation. In this case please inform the
Tablets
anaesthetist before the operation that you are taking
Lactose (a type of sugar): Patients who are intolerant to lactose
Amiodarone.
should note that Amiodarone tablets contain a small amount of
• are elderly (over 65 years of age). The doctor will need to
lactose. If you have been told by your doctor that you have an
monitor you more carefully
• You have a pacemaker or implantable cardioverter defibrillator intolerance to some sugars, contact your doctor before taking this
medicinal product.
(ICD). Your doctor will check that your device is working
properly shortly after you start taking the tablets or if your dose Iodine: Amiodarone contain approximately 37.5mg of iodine in a
is changed.
100 mg tablet and approximately 75 mg of iodine in a 200mg tablet.
Iodine is present in amiodarone hydrochloride, the medicine your
Other medicines and Amiodarone
tablets contain. Iodine can cause problems to your thyroid (see
Do not take Amiodarone if you are taking
‘Tests’ below).
• drugs for an abnormal heart rhythm e.g. quinidine,
procainamide, disopyramide, sotalol, bretylium
• medicines for schizophrenia e.g. chlorpromazine, thioridazine,
3 HOW TO TAKE AMIODARONE
fluphenazine, amisulpride, sertindole, pimozide, haloperidol
Always
take Amiodarone exactly as your doctor has told you. You
• medicines for other mental illness such as lithium and tricyclic
should check with your doctor or pharmacist if you are not sure.
antidepressants e.g. doxepin, maprotiline, amitriptyline
The tablets should be swallowed preferably with a drink of water.
• certain antihistamines (used to treat allergic reactions, for
example hay fever) e.g. terfenadine, mizolastine, astemizole
The usual dose is:
• antimalarials e.g. quinine, mefloquine, chloroquine, halofantrine Adults including the elderly
• or if you have had an injection of erythromycin, co-trimoxazole, 200 mg three times a day for one week, then 200 mg twice daily for
moxifloxacin, pentamidine (all used to treat infections).
a further week. After this the dose is usually reduced to 200 mg a day
Tell your doctor if you are taking any of the following medicines:
or even less. In some cases, your doctor may then decide to either
• medicines that lengthen your heart beat (the QT interval) such increase or lower the amount you take each day. This will depend on
as medicines for infection (such as clarithromycin,
how you react to this medicine.
ciprofloxacin, ofloxacin or levofloxacin)
The doctor may give a lower dose of Amiodarone to elderly patients.
• medicines for heart problems called beta-blockers (such as
Also, for elderly patients the doctor should check blood pressure and
propranolol)
thyroid function regularly.
• medicines called calcium channel blockers – for chest pain
(angina) or high blood pressure (such as diltiazem or
verapamil)

AMIODARONE 100 and 200 mg
TABLETS

TEVA UK Ref:

Version:

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

2

18 January 2016

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children and adolescents
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 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.
If you forget to take Amiodarone
If you forget to take a tablet, take one as soon as you remember,
unless it is nearly time to take the next one. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Amiodarone
Do not stop taking your medicine without talking to your doctor first
even if you feel better.
Test
• your blood may be tested regularly to check whether your liver is
working properly
• your doctor may do regular thyroid tests while you are taking this
medicine. This is because Amiodarone 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)
• you should have your eyes tested regularly if you have been
taking Amiodarone for a long time
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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.
• Headache
• Balance problems, feeling dizzy (vertigo)
• Chronic liver malfunction
• Difficulty in getting or maintaining an erection or in ejaculating
• Hair loss, balding
• Skin rash
• Skin redness during radio-therapy
• Headache, nausea and vomiting, buzzing in the ears, double
vision and other visual disturbances. This could be an illness
called ‘benign intracranial hypertension’
• Inflammation of blood vessels, often with skin rash.
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.
• Severe allergic reaction (anaphylactic reaction, anaphylactic
shock)
• Sudden inflammation of the pancreas (pancreatitis (acute))
• Decreased appetite
• Unusual muscle movements, stiffness, shaking and
restlessness (parkinsonism)
• Abnormal sense of smell (parosmia)
• Confusion (delirium)
• Life-threatening skin reactions characterised by rash, blisters,
peeling skin and pain (toxic epidermal necrolysis (TEN),
Stevens- Johnson syndrome (SJS), bullous dermatitis, Drug
POSSIBLE
SIDE
EFFECTS
4
reaction with eosinophilia and systematic symptoms (DRESS)).
Like all medicines, Amiodarone can cause side effects, although not • Metallic taste
• Tiredness
everybody gets them.
• Hives (itchy, lumpy rash)
If the following happens, stop taking the tablets and tell your doctor
• A burning or prickling sensation in the hands, arms, legs, feet
immediately or go to the casualty department at your nearest hospital:
or in other parts of the body.
• an allergic reaction (swelling of the lips, face or neck leading to
• Chest pain and shortness of breath and irregular heartbeat.
severe difficulty in breathing; skin rash or hives).
These could be signs of a condition called “Torsade de
This is a very serious but rare side effect. You may need urgent
pointes”
medical attention or hospitalisation.
• Granulomas, small red lumps on the skin or inside the body
Tell your doctor or pharmacist if any of the following side effects get
which are seen by X-ray
serious or lasts longer than a few days:
If any of the side effects get serious, or if you notice any side
Very common (affects more than 1 in 10 people)
effects not listed in this leaflet, please tell your doctor or
• Blurred eyesight or seeing a coloured halo in dazzling light.
pharmacist.
• Feeling sick (nausea) or being sick (vomiting)
Reporting of side effects
• Changes in the amount of liver enzymes at the beginning of
If you get any side effects, talk to your doctor, pharmacist or
treatment. This can be seen in blood tests
nurse. This includes any possible side effects not listed in this
• Burning more easily in the sun (see ‘Protect your skin from
leaflet. You can also report side effects directly via the Yellow Card
sunlight’ in Section 2)
Scheme at: www.mhra.gov.uk/yellowcard
Common (affects less than 1 in 10 people)
By reporting side effects you can help provide more information
• Feeling extremely restless or agitated, weight loss, increased
on the safety of this medicine.
sweating and being unable to stand the heat. These could be signs
of an illness called ‘hyper-thyroidism’
5 HOW TO STORE AMIODARONE
• Feeling extremely tired, weak or ‘run-down’, weight gain, being
unable to stand the cold, constipation and aching muscles. These Keep this medicine out of the sight and reach of children. Do not
could be signs of an illness called ‘hypo-thyroidism’
store above 25°C. Store Amiodarone in the original container. Do
• Trembling when you move your arms or legs
not transfer your tablets to another container. Do not use
• Blue or grey marks on parts of your skin exposed to sunlight,
Amiodarone after the expiry date that is stated on the outer
especially the face
packaging. The expiry date refers to the last day of that month.
• Slightly slower heart beat
Medicines should not be disposed of via wastewater or household
• Yellowing of the skin or whites of the eyes caused by a liver
waste. Ask your pharmacist how to dispose of medicines no
disease called ‘Jaundice’ which may lead to liver failure.
longer required. These measures will help to protect the
• Nightmares
environment.
• Problems sleeping
• Inflammation of the lungs which causes breathlessness, cough,
6 CONTENTS OF THE PACK AND OTHER INFORMATION
reduced exercise tolerance and raised temperature
What Amiodarone Tablets contain:
• Constipation.
• The active ingredient is amiodarone hydrochloride 100 mg or
• Itchy, red rash (eczema)
200 mg.
Uncommon (affects less than 1 in 100 people)
• The other ingredients are lactose monohydrate, maize starch,
• Pain, weakness, tingling loss of co-ordination, numbness in the
sodium starch glycolate (Type A), povidone (E1201) and
muscles.
magnesium stearate (E572).
• Irregular heart beat or worsening of irregular heart beat may lead
What Amiodarone looks like and contents of the pack:
to heart attack
• The 100 mg tablets are white, circular biconvex tablet,
• Disturbances in the heart functions
engraved 1A1 with a breakline on the reverse.
• Dry mouth.
• The 200mg tablets are white, circular biconvex tablet, engraved
Very rare (affects less than 1 in 10,000 people)
1A3 with a breakline on the reverse.
• Swelling of the testicles
The product is available in pack sizes* of 7, 10, 14, 20, 21, 28, 30,
• Very slow heart beat in elderly patients or in patients with serious 50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250, 500, 1000
heart disease
and 5000 tablets.
• Transient cessation of the electrical impulse of the heart muscle in *Not all pack sizes may be marketed
elderly patients or in patients with serious heart disease
Marketing Authorisation Holder and Manufacturer
• Red, scaly patches of skin, loss of hair or loosening of nails (called Marketing Authorisation holder and company responsible for
‘exfoliative dermatitis’)
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG
• Feeling tired, faint, dizzy or having pale skin. These could be signs
This leaflet was last revised in: January 2016
of anaemia
PL 00289/0319-0320
• 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’
60901-Z
(SIADH)
210 x 323

REG0060723

Version 3.6






Approved

Page 2 of 3

Expand view ⇕

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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