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AMIODARONE 100 MG TABLETS

Active substance(s): AMIODARONE HYDROCHLORIDE / AMIODARONE HYDROCHLORIDE / AMIODARONE HYDROCHLORIDE

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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 ‘hyperthyroidism’
• 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)
Not known (frequency cannot be estimated from the available data)
• Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis
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, often a metallic 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
• Constipation
• Scaly and itchy rash (eczema)
Uncommon (affects less than 1 in 100 people)
• Dry mouth
Very rare (affects less than 1 in 10,000 people)
• Headache
• Skin rash
• Hair loss, balding
• Skin redness during radiotherapy
• Balance problems, feeling dizzy (vertigo)
• Difficulty in getting or maintaining an erection or in ejaculating
Not known (frequency cannot be estimated from the available data)
• Hives (itchy, lumpy rash)
• Feeling less hungry
• Granulomas, small red lumps on the skin or inside the body which are seen by X-ray
• Movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs (Parkinsonism)
• Feeling confused or seeing or hearing things that are not there
• A distorted sense of smell (parosmia)
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. 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 Tablets
• Keep out of the reach and sight and children.
• Do not take the tablets after the expiry date stated on the pack; the expiry date refers to last day of the month.
• Do not store above 25 °C.
• Store in the original packaging.
Medicines should not be disposed with the help of 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
Each 100 mg tablet contains: Amiodarone Hydrochloride (active ingredient) 100 mg.
Each 200 mg tablet contains: Amiodarone Hydrochloride (active ingredient) 200 mg.
The other ingredients are: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica,
pre-gelatinised starch and magnesium stearate.
What Amiodarone Tablets look like and contents of the pack
Pack sizes: The tablets are available in packs of 28 tablets.
The 100 mg tablets are round, white tablets with a break line on one side and embossed ‘100‘on the reverse side.
The 200 mg tablets are round, white tablets with a break line on one side and embossed ‘200’ on the reverse side.
PL 21880/0095
PL 21880/0096
This leaflet was last revised in July 2017
POM
Marketing Authorization Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail: info@medreich.co.uk
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121XXXX-V1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone 100 mg Tablets
Amiodarone 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 or pharmacist.
• 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Amiodarone Tablets are and what they are 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 Tablets are and what they are used for
Amiodarone Tablets contain a medicine called amiodarone hydrochloride. This belongs to a group of
medicines called anti-arrhythmics.
It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking the tablets help
your heartbeat to return to normal.
Amiodarone Tablets 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 Tablets are used only when other medicines cannot be used.
• Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Tablets are
used only when other medicines cannot be used.
2. What you need to know before you take Amiodarone Tablets
Do not take Amiodarone Tablets and tell your doctor if:
• You are allergic/sensitive to iodine, amiodarone hydrochloride or any of the other ingredients of
Amiodarone tablets (see 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 had any problems with your thyroid. Your doctor should test your thyroid before
giving you this medicine.
• You are taking certain other medicines which could affect your heartbeat (see ‘Taking other
medicines’ below).
• You are pregnant or breastfeeding (see ‘Pregnancy and breast-feeding’ below).
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Amiodarone Tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Amiodarone Tablets if:
• You have liver problems
• You have any problems with your lungs or have asthma
• You have any problems with your eyesight. This includes an illness called ‘optic neuritis’
• You suffer from heart failure as you may need to take these tablets in conjunction with other
therapies which will be advised by your doctor
• You have the rare hereditary condition porphyria (where urine and faeces exposed to light turn purple)
• You are about to have an operation
• You 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
• You have blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like
symptoms and fever. This could be a condition called Stevens-Johnson syndrome
• You have a severe blistering rash in which layers of the skin may peel off to leave large areas of
raw exposed skin over the body. You may also feel generally unwell; have a fever, chills and
aching muscles (Toxic Epidermal Necrolysis)
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Amiodarone Tablets.
Other medicine and Amiodarone Tablets: Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes medicines obtained without a prescription,
including herbal medicines. This is because Amiodarone Tablets can affect the way some other
medicines work. Also some medicines can affect the way Amiodarone Tablets work.
Do not take Amiodarone tablets if you are taking any of the following medicines:
• Other medicines for an uneven heartbeat (such as solatol, quinidine, procainamide, disopyramide
or bretylium)
• Medicines for infections (such as intra-venous erythromycin, co-trimoxazole, moxifloxacin or pentamidine)
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0095-0096/O/PIL/003/I

Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide,
haloperidol, amisulpride or sertindole)
Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline)
Medicines used for hay fever, rashes or other allergies called antihistamines (such as terfenadine,
astemizole or mizolastine)
Medicines for malaria (such as quinine, mefloquine, chloroquine or halofantrine)
Medicines for hepatitis C treatment (such as sofosbuvir, daclatasvir, simeprevir or ledispasvir)

How much to take
Adults
• The usual starting dose is 200 mg three times each day for one week
• The dose will then be lowered to 200 mg twice each day for one week
• The dose will then be lowered to 200 mg once each 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 this medicine

Tell your doctor if you are taking any of the following medicines:
• Medicines that lengthen your heart beat (the QT interval) such as medicines for infection (such as
clarithromycin, ciprofloxacin, ofloxacin or levofloxacin)
• 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)
• Medicines for constipation (laxatives) such as bisacodyl or senna
• Medicines for high cholesterol (statins) such as simvastatin or atorvastatin

Children and adolescents
• Amiodarone Tablets should not be given to children and adolescents.
Elderly
• The doctor may give you a lower dose of amiodarone. Also, the doctor should check your blood
pressure and thyroid function regularly.







The following medicines can increase the chance of you getting side effects, when taken with
Amiodarone Tablets:
• Amphotericin (when given directly into a vein) – used for fungal infections
• Medicines for inflammation (corticosteroids) 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 Tablets may increase the effect of the following medicines:
• Ciclsporin 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
• Colchicine – used for the treatment of gout
• 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
• Warfarin – used to stop your blood from clotting
• Dabigatran – used to thin the blood
• Phenytoin - used to treat epilepsy
• Digitalis – used for some heart conditions
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Amiodarone Tablets.
Taking Amiodarone Tablets with food and drink: Amiodarone tablets do not have to be taken with
food. 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.
Limit the amount of alcohol you drink whilst 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.
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 and breast-feeding:
• Tell your doctor before taking this medicine if you are pregnant, might become pregnant or think
you may be pregnant Amiodarone Tablets are not normally given during pregnancy.
• Do not take if you are breast-feeding or plan to breast-feed. This is because small amounts of this
medicine may pass into the mother’s milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
Driving and using machines: This product may cause vertigo or blurred vision, so do not drive or
operate machinery.
Important information about some of the ingredients in Amiodarone Tablets:
This medicine contains:
• Lactose (a type of sugar): If you have been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
• Iodine: Amiodarone Tablets contain 37.5mg of iodine in a 100 mg tablet and 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).
3. How to take Amiodarone Tablets
Always take Amiodarone Tablets exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole. Do not crush or chew your tablets
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself,
but ask your doctor
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If you take more Amiodarone Tablets than you should: If you take too many tablets or someone else
takes your tablets, consult your nearest hospital casualty department or your doctor for advice. Take this
leaflet, and any tablets that you still have to show the doctor. The following effects may happen:
Feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.
If you forgot to take Amiodarone Tablets: If you forget to take a dose at the right time, take it as
soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Amiodarone Tablets: It can be dangerous to stop taking your tablets without your
doctor’s advice first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Amiodarone Tablets can cause side effects, although not everybody gets them.
The active ingredient in 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 Amiodarone Tablets 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.
• You have blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like
symptoms and fever. This could be a condition called Stevens-Johnson syndrome.
• You have a severe blistering rash in which layers of the skin may peel off to leave large areas of
raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and
aching muscles (Toxic Epidermal Necrolysis).
• You have inflammation of the skin characterised by fluid filled blisters (bullous dermatitis).
• You have flu like symptoms and a rash on the face followed by an extended rash with a high
temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph nodes (DRESS).
• 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.
• Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you
should go to hospital straight away.
• 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’.
Stop taking Amiodarone Tablets and see a doctor straight away if you notice any of the following
serious side effects - you may need urgent medical treatment:
• Feeling numb or weak, tingling or burning feelings in any part of your body
• 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
• Chest pain and shortness of breath and irregular heartbeat. These could be signs of a condition
called “Torsade de pointes”
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
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0095-0096/O/PIL/003/I

Times New Roman

Font Type &
Size

Heading - 12 pts

Colours

Body - 8 pts

Black

RA artwork code 0095-0096/O/PIL/003/I

Red 032 C

Version

Title: Art Work Approval Form

MEDREICH LIMITED
Product

Amiodarone Tablets - S/L - English - PIL

Customer

MEDREICH PLC, UK

Reason
for Issue

AWR No.:

Related
FG Codes

1302077 / 78

Item Code

121XXXX-V1 (WOA)

Specification: Printed on 40 - 45 GSM news print paper.

Revision of text from customer (Old Code: 1216004-V1)

Pharmacode No. XXXX
Layout No.:

Verified By

Approved By

PDC:

PDC:

MED/AMI/PIL/05
Format No.: CO-QA005-F03-02

V-1

NA

Regulatory:

Colours:

2 - Red 032 C and Black

Dimensions:

260 x 260 mm (Open size), 130 x 33 mm (Folded size)

No. of Folds
(only for PIL)

4

Artwork made to

QC:

WIN/192.168.1.33/PDC/Artworks/Medreich/Amiodarone Hydrochloride/PIL/Amiodarone Tablets SL Eng PIL.ai
Internal Approval issued on

CD issued on

70%

CQA:
03(GW)/04.05.17(MA)/
30.06/03(RR)/26.07.17(AK)

Expand Transcript

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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