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AMIODARONE 200 MG TABLETS

Active substance(s): AMIODARONE HYDROCHLORIDE

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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, 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
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 radiotherapy
• liver disease or inflammation
• an increase in creatinine measured during blood tests
• increased blood pressure in the skull (causing painful eyes, changes in vision, a bad headache
especially behind the eyes)
• if you undergo surgery there may be a reaction to the high level of oxygen used, you should make
sure that the anaesthetist is informed that you are taking Amiodarone
• A spasm in the lungs known as bronchospasm especially if you have other breathing problems
including asthma
Not known (frequency cannot be estimated from the available data)
• Hives (itchy, lumpy rash)Granulomas, small red lumps on the skin or inside the body which are
seen by X-ray
Tests: Your doctor will take regular tests to check how your liver is working. Amiodarone Tablets can
affect how your liver works.
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 contains
Each tablet contains 100mg of Amiodarone Hydrochloride.
Each tablet contains 200mg of Amiodarone Hydrochloride.
The other ingredients are: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica,
pregelatinised 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 amended 07/2016

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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. 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 (see
section 4) please tell your doctor or pharmacist.
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 belongs to a group of drugs known as antiarrhythmics. It is used to control an irregular or
rapid heart rate (called arrhythmias) It is only used for severe disorders that do not respond to other
therapies or when other treatments cannot be used. Therapy should only be initiated and monitored
under hospital or specialist supervision.
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 if
• you are allergic/sensitive to iodine, amiodarone hydrochloride or any of the other ingredients
Amiodarone tablets (see section 6). Sign of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
• you suffer from conduction problems of the heart, such as a slow heart beat or heart block (which
may cause a very slow, very fast or irregular pulse or dizziness). Amiodarone Tablets should only
be used in such patients who 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 breastfeeding (see ‘Pregnancy and breast-feeding’ below)
• you have severe hypotension (low blood pressure)
• you have severe breathing difficulties
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Amiodarone Tablets if:
• you are pregnant, think you may be pregnant or planning to become pregnant
• 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 a family history of thyroid disorders, before starting treatment, your doctor may carry out
blood tests to look at your heart and thyroid functions.
• you have the rare hereditary condition porphyria (where urine and faeces exposed to light turn purple)
• you should avoid exposure of the skin to sunlight or sunlamps whilst using amiodarone.
• your liver and thyroid function may be monitored during treatment
• 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.
Make sure you tell your doctor and anaesthetist that you are taking amiodarone tablets if you need an
operation as Amiodarone tablets can interact with anaesthetics and high dose oxygen therapy.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is because Amiodarone Tablets can affect the
way some other medicines work. Also some medicines can affect the way Amiodarone Tablets works.
Do not take Amiodarone tablets if you are taking any of the following medicines:
• Anti-arrhythmic drugs used to treat irregular heartbeats (e.g. quinidine, procainamide, disopyramide,
sotalol, bretylium)
• Intravenous erythromycin, moxifloxacin, co-trimoxazole or pentamide which are used to treat
infections

POM

Marketing Authorization Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail: info@medreich.co.uk

PACKAGE LEAFLET: INFORMATION FOR THE USER

121XXXX-V1

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0095-0096/O/PIL/002/I







Anti-psychotics e.g. Chlorpromazine, amisulphride, sertindole, fluphenazine, thioridazine,
pimozide, haloperidol
Lithium and tricyclic anti-depressants e.g. Doxepin, maprotiline, amitriptyline
Certain antihistamines e.g. Terfenadine, astemizole
Anti-malarials e.g: Quinine, arthemether/lumefantrine, mefloquine, chloroquine, halofantrine.
Beta blockers and certain calcium channel inhibitors (diltiazem, verapamil)

Tell your doctor if you are taking any of the following medicine:
• Digoxin used for heart conditions
• Anticoagulants - used to thin the blood (e.g. warfarin)
• Phenytoin - used to treat epilepsy
• Flecainide - an anti-arrhythmic drug used to treat irregular heartbeats
• Diuretics (water tablets)
• Corticosteroids (e.g. triamcinolone, dexamethasone)
• Tetracosactrin used in Crohn’s disease, arthritis and osteoporosis
• Stimulant laxatives
• Cyclosporin, tracrolimus and sirolimus used to suppress the immune system
• Intravenous Amphotericin
• Ergometrine used to treat migraine
• Simvastatin used to treat high cholesterol
• Orlistat used for treatment of obesity
• The herbal remedy St John’s Wort
• Carbamazepine used to treat epilepsy and nerve pain
• Rifampicin used to treat infections
• Midazolam used as a sedative
• Lidocaine used as a local anaesthetic
• Fentanyl used for pain relief
• Sildenafil used for treatment of Erectile Dysfunction
Taking Amiodarone Tablets with food and drink:
Amiodarone tablets do not have to be taken with food. You should limit the amount of alcohol you
drink whilst taking these tablets. Grapefruit juice should be avoided whilst taking Amiodarone.
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:
Talk to your doctor if you are pregnant, planning to become pregnant or breast-feeding, before taking
Amiodarone Tablets because this medicine may harm your baby.
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
Driving and using machines:
This product may cause vertigo, drowsiness or blurred vision, so do not drive or operate machinery if
you are affected.
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 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
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
Children
• There are only limited data on the efficacy and safety in children. Your doctor will work out the
correct dose of child depending on how much they weigh.
Elderly
• The doctor may give you a lower dose of amiodarone. Also, the doctor should check your blood
pressure and thyroid function regularly
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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. Never take two doses
together.
If it is almost time to take the next dose, wait until then and then carry on as before.
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 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, bleeding and bruising more easily.
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 Tablets 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
• Muscle cramps, stiffness or spasm
Very rare (affects less than 1 in 10,000 people)
• Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’)
• 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.
Not Known
• Chest pain and shortness of breath and irregular heartbeat. These could be signs of a condition
called “Torsade de pointes”
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 ‘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
Rare (affects less than 1 in 1,000 people)
• treatment resistant raised thyroid function (sudden and severe rapid heartbeat, sweating, anxiety,
increased appetite, loss of weight).

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0095-0096/O/PIL/002/I

Font Type &
Size

Times New Roman
Heading - 12 pts
Body - 8 pts

RA artwork code 0095-0096/O/PIL/002/I
Version

V-1

Title: Art Work Approval Form

MEDREICH LIMITED
Product

Amiodarone Tablets - S/L - Eng - PIL

Specification: Printed on 56 - 60 GSM Maplitho paper.

Customer

MEDREICH PLC, UK
AWR No.:
Old Code: 1214772-V2

Colours:

2 - Pantone 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

Reason
for Issue
Related
FG Codes

1302077 / 78

Item Code

121XXXX-V1 (WOA)

Pharmacode No. XXXX
Layout No.:

Verified By

Approved By

PDC:

PDC:

MED/AMI/PIL/01
Format No.: CO-QA005-F03-02

NA

Regulatory:

Artwork made to

QC:

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

CD issued on

70%

CQA:
28.07.16(MA)

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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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