AMIODARONE HYDROCHLORIDE 200MG TABLETS

Active substance: AMIODARONE HYDROCHLORIDE

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PACKAGE LEAFLET

Package leaflet: Information for the patient
[Product Name] 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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible
side effects not listed in the leaflet.
The name of your medicine is Amiodarone Hydrochloride 200 mg tablets; however for simplicity it
will be referred to as Amiodarone throughout the leaflet.
What is in this leaflet:
1. What Amiodarone is and what it is used for
2. What you need to know before you take Amiodarone
3. How to take Amiodarone
4. Possible side effects
5. How to store Amiodarone
6. Contents of the pack and other information

1. What Amiodarone is and what it is used for.
Your tablet contains amiodarone hydrochloride, which belongs to a class of medicines known as
antiarrhythmics. Amiodarone can help to suppress and prevent an abnormal or irregular heart rhythm
and so return your heart rhythm to normal.
Amiodarone 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 is used only when other medicines cannot be used.
 Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone is used only
when other medicines cannot be used.
2. What you need to know before you take Amiodarone
Do not take Amiodarone if:
 you are allergic to amiodarone or to any of the other ingredients of this medicine (listed in section
6) or to iodine. 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 have had thyroid problems. Your doctor should test your thyroid before giving you
this medicine.
you are taking certain other medicines which could affect your heartbeat or monoamine-oxidase
inhibitors (MAOI) to treat your depression (see section ‘Taking Other medicines and Amiodarone’
below).
you are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below).

Warnings and precautions
Talk to your doctor or pharmacist before taking Amiodarone if you:
 have had heart failure or suffer from breathlessness and swollen ankles
 have liver problems
 have any problems with your lungs or have asthma
 have any problems with your eyesight This includes an illness called ‘optic neuritis’
 are about to have an operation or may be given general anaesthetic
 are elderly (over 65 years of age). The doctor will need to monitor you more carefully
 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.
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.
Other medicines and Amiodarone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The following medicines may cause irregular heart rhythm, showing as an abnormal ECG and should
not be used with amiodarone due to increased risk of an irregular heart rhythm or missed beats
(torsades de pointes).
 other medicines for an uneven heartbeat (such as quinidine, disopyramide, procainamide, sotalol,
bretylium, flecainide or bepridil).
 medicines to treat mental illness or depression, such as chlorpromazine, pimozide, thioridazine,
haloperidol, lithium, doxepin, maprotiline, amitriptyline or sertindole.
 medicines used to treat hayfever, rashes or other allergies (antihistamines such as terfenadine,
astemizole, mizolastine).
 antimalarial medicine (such as quinine, mefloquine, halofantrine, chloroquine).
 medicines for infections (such as intravenous erythromycin, co-trimoxazole, moxifloxicin or
pentamidine).
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription, or the following:
 monoamine-oxidase inhibitor (MAOI), such as phenelzine to treat depression.
 medicines for high cholesterol, such as simvastatin, lovastatin, atorvastatin or pravastatin.
 medicines for infection, such as ciprofloxacin, ofloxacin or levofloxacin.
 medicines for constipation (laxatives), such as senna or bisacodyl.
 medicines for heart problems (beta-blockers), such as propranolol.
 medicines called calcium channel blockers (such as diltiazem or verapamil), for chest pain
(angina) or high blood pressure.

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 (corticosteriods) 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 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, used for migraine.
 midazolam, used to relieve anxiety or to help you relax before surgery.
 flecainide, another medicine used for uneven heartbeats. Your doctor should monior your
treatment and may half your dose of flecainide.
 lidocaine, used as an anaesthetic.
Amiodarone with food, drink and alcohol
Limit the amount of alcohol you drink while 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.
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.
Pregnancy and breast-feeding
Do not take amiodarone if you are pregnant or intend to become pregnant.
Do not breast-feed your baby if you are taking amiodarone. Small amounts of this medicine can pass
into breast milk and harm your baby.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may have blurred eyesight after taking this medicine. If this happens to you, you should not drive
or operate machinery until your eyesight is clear.
Amiodarone contains lactose (a type of sugar).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
Amiodarone contains iodine
Your tablets contain 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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Swallow the tablets whole or divide them into equal halves if necessary. The tablet can be divided into
equal doses. Do not crush or chew your tablets. If you feel your condition is not improving while
taking your medicine, tell your doctor.
Do not stop taking your medicine without consulting your doctor.
Adults
The recommended dose is 200 mg three times a day for the first week, then 200 mg twice a day for
the second week. After this your doctor will reduce the dose of amiodarone again, usually to 200 mg
once a 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 respond to the medicine.
Elderly
The doctor may give you a lower dose of amiodarone. Also, the doctor should check your blood
pressure and thyroid function regularly.
Use in children and adolescents
There are only limited data on the efficacy and safety in children, therefore this medicine is not
recommended for children.
If you take more Amiodarone than you should
If you have taken too many tablets, immediately consult with your doctor or the nearest emergency
department. Take the medicine pack with you. You may notice the following effects of overdose:
feeling dizzy, faint or tiredness, confusion, slow heartbeat, being sick and damage to your liver.
If you forget to take Amiodarone
Take your tablets as soon as you remember. However, if it is almost time for your next dose, do not
take the missed dose, take the next dose on time. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Amiodarone
Keep taking this medicine until your doctor tells you to stop. Do not stop taking this medicine just
because you feel better. If you stop taking this medicine the uneven heartbeats may come back. This
could be dangerous.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Tests
Your doctor will take regular tests to check how your liver is working during the treatment and for
several months after you stop taking this medicine. Amiodarone 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, while you are taking and a few months after you stop taking
Amiodarone.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Amiodarone may stay in your blood for up to a month after stopping treatment. You may still get side
effects in this time.
Stop taking this medicine 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.
Common (may affect up to 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 (may affect up to 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 (may affect up to 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 and see a doctor straight away if you notice any of the following serious
side effects - you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)
• Feeling numb or weak, tingling or burning feelings in any part of your body.
Very rare (may affect up to 1 in 10,000 people)
• 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.
Some cases of bleeding in the lungs have been reported in patients taking Amiodarone. 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 (may affect more than 1 in 10 people)
• Blurred eyesight or seeing a coloured halo in dazzling light.
Common (may affect up to 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 (May affect up to 1 in 100 people)
• Muscle cramps, stiffness or spasm.
Very rare (may affect up to 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’).
• You may get infections frequently with symptoms such as fever, severe chills and sore throat or
mouth ulcers (called ‘leucopoenia’).
• 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).
• Fever, night sweats and fatigue.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than
a few days:
Very common (may affect 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 sunlight’ in Section 2).
Common (may affect up to 1 in 10 people)
• Slightly slower heartbeat.
• Nightmares.
• Problems sleeping.
Very rare (may affect up to 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 radio-therapy.
Not known (frequency cannot be estimated from the available data)
• Hives (itchy, lumpy rash).
• Metallic taste

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 [to be completed nationally with
national reporting system].
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 use this medicine after the expiry date which is stated on the carton, blister and bottle after
EXP. The expiry date refers to the last day of that month.
Storage conditions for blister packs:
Do not store above 25ºC. Store in the original package in order to protect from light and moisture.
Storage conditions for polypropylene containers:
Do not store above 25°C. Keep the container tightly closed in order to protect from light and
moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of pack and other information
What Amiodarone Tablets contain
The active substance is amiodarone hydrochloride. Each tablet contains 200 mg of amiodarone
hydrochloride.
The other ingredients are lactose monohydrate (see section 2, ‘This medicine contains lactose’),
microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, talc and magnesium
stearate.
What Amiodarone looks like and contents of the pack
This medicine comes as round white uncoated with break line, marked ‘AM 200’ on one side and ‘G’
on the other.
Amiodarone is available in containers or blister packs of 10, 20, 28, 30, 50, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
McDermott Laboratories Ltd (t/a Gerard Laboratories)
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland

Generics [UK] Ltd
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
This leaflet was last revised in: 04/2014 [To be completed nationally]

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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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