Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Cordarone X?
Cordarone X contains the active ingredient amiodarone hydrochloride. Cordarone X is
used to control a fast or irregular heartbeat. For more information, see Section
1. Why am I using Cordarone X? in the full CMI.
2. What should I know before I use Cordarone X?
Do not use if you have ever had an allergic reaction to amiodarone hydrochloride,
iodine, or any of the ingredients listed at the end of the CMI. Do not use Cordarone
X if you have or have had any thyroid problems, heart problems that may cause you
to faint, low blood pressure, severe problems breathing, heart disease or failure,
shock, are pregnant, intend to become pregnant or are breastfeeding.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Cordarone X and affect how it works.
4. How do I use Cordarone X?
Tablets: Your doctor will tell you how many Cordarone X tablets you should take. Swallow
Cordarone X tablets whole, with water or another liquid such as tea or milk.
Injection: The injectable dose will only be given in hospitals.
5. What should I know while using Cordarone X?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Cordarone X.
Attend your doctor appointments so that your progress can be checked.
Tell your doctor straight away if you become pregnant or intend to become pregnant.
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Things you should not do
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Do not stop using this medicine suddenly without checking with your doctor.
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Things to be careful of
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Always use a sunscreen and wear a hat and protective clothing when you are outdoors.
Do not use a sunlamp.
Avoid drinking large quantities of grapefruit juice.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Cordarone
X affects you.
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Looking after your medicine
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Tablets: Keep it in a cool, dry place where the temperature stays below 30°C. Protect
from light.
Injection: If you need to store it before taking it to a hospital, make sure it is
stored in a place where the temperature stays between 8 to 25°C. Do not refrigerate.
Protect from light.
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6. Are there any side effects?
Treatment with amiodarone may cause serious lung, liver and eye damage and may worsen
heart problems. Serious side effects may include changes to heartbeat such as pounding,
rapid or very slow heartbeat; allergic reaction; blurring or deterioration of vision,
sensitisation of eyes to light; severe blisters and bleeding in the lips, eyes, mouth,
nose and genitals; yellow skin or eyes, faintness, light-headedness; nausea, vomiting,
stomach pain, unusual tiredness, passing dark-coloured urine; clumsiness and lack
of coordination, affecting balance and manner of walking, limb or eye movements/speech;
chest pain, cough or spitting up blood. For more information, including what to do
if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
amiodarone hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Cordarone X. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Cordarone X.
Where to find information in this leaflet:
1. Why am I using Cordarone X?
Cordarone X contains the active ingredient amiodarone hydrochloride. Cordarone X is a Class III antiarrhythmic agent.
Cordarone X is used to control a fast or irregular heartbeat.
It works by lengthening the gap between one heart beat and the next, helping to bring
the heart rate to a slower and more regular pace.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
2. What should I know before I use Cordarone X?
Warnings
Do not use Cordarone X if you:
are allergic to amiodarone hydrochloride, iodine, or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
have or have had any thyroid problems
have heart problems that may cause you to faint.
If you have a pacemaker, your doctor may allow the use of it.
Do not use Cordarone X injection if you have:
low blood pressure
severe problems in breathing
heart disease or failure
shock.
Check with your doctor if you:
have any other medical conditions, especially the following:
other heart conditions
blood pressure problems
liver problems
thyroid problems
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not use Cordarone X if you are pregnant or intend to become pregnant.
Cordarone X is best avoided in the 3 months before pregnancy and throughout the duration
of pregnancy. This is because it can stay in the body for several months even after
you stop taking it.
Check with your doctor if you are pregnant or intend to become pregnant.
Do not use Cordarone X if you are breastfeeding.
Cordarone X can be found in breast milk.
If you are breastfeeding and must be using or given Cordarone X, alternative feeding
arrangements such as bottle feeding should be made for your baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children
Cordarone X is not recommended for use in children.
Neonates (children less than one month of age) or premature neonates
Do not use Cordarone X injection in neonates (children less than one month of age)
or premature neonates.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Cordarone X and affect how it works.
These include:
medicines for your heart
medicines for your blood pressure
medicines which reduce the activity of your immune system, such as ciclosporin, cortisone
or tacrolimus
diuretics (water tablets)
antibiotics, including intravenous erythromycin and pentamidine
stimulant laxatives e.g. bisacodyl, castor oil, senna
MAO inhibitors (a type of medicine used to treat depression)
antipsychotics (medicines used to treat certain mental and emotional conditions)
phenytoin (a medicine used to treat epilepsy)
warfarin and other medicines which thin the blood
simvastatin and other statins (medicines used to lower cholesterol)
colchicine (a medicine used to treat gout)
digoxin (a medicine used to treat heart conditions)
medicines to treat a fast or irregular heart beat such as flecainide and sotalol
fentanyl (a medicine used to treat pain)
sildenafil (Viagra)
triazolam (a medicine used to treat insomnia)
ergotamine (a medicine used to treat migraine)
general anaesthesia
lidocaine (a topical anaesthetic)
amphotericin B (a medicine used to treat fungal infections)
antiviral medication e.g. sofosbuvir, daclatasvir, simeprevir, ledipasvir.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Cordarone X.
4. How do I use Cordarone X?
How much to take (tablets)
The usual starting dose is 200 mg three times a day for 1 week.
Therapy is then reduced and continued with 200 mg two times a day for a further week.
The dose may then be reduced to 200 mg once per day.
Follow the instructions provided by your doctor and use Cordarone X until your doctor
tells you to stop.
Your doctor or pharmacist will tell you how many Cordarone X tablets you should take.
The directions given to you by your doctor or pharmacist may be different from the
information in this leaflet.
When to take Cordarone X (tablets)
Cordarone X tablets will be started as soon as possible once your heart beat is controlled.
An overlap of up to 2 days with the injection may occur.
Swallow Cordarone X tablets whole, with water or another liquid such as tea or milk.
How much is given (injection)
The usual dose is 5 mg/kg given slowly over a period of 20 minutes to 2 hours.
Further doses may also be given based upon your response to the treatment. An overlap
of up to 2 days with the tablets may occur.
How to give it (injection)
The injectable dose will only be given in hospitals.
If you forget to take Cordarone X (tablets)
Cordarone X tablets should be taken regularly at the same time each day. If you miss
your dose at the usual time, take it as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, or have trouble remembering when to take your medicine,
ask your doctor or pharmacist.
If you take too much Cordarone X
If you think that you have used too much Cordarone X, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre by calling 13 11 26, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Cordarone X?
Things you should do
Be sure to attend all of your doctor appointments so that your progress can be checked.
To help prevent unwanted side effects, your doctor may need to perform the following
tests, depending on the length of treatment with Cordarone X:
ECG
eye tests
chest X-rays
liver function tests
thyroid tests.
Take Cordarone X exactly as your doctor has prescribed.
Tell your doctor if you become or intend to become pregnant while using Cordarone
X.
Remind any doctor, dentist or pharmacist you visit that you are using Cordarone X.
Things you should not do
Do not stop using this medicine suddenly without checking with your doctor.
Do not use Cordarone X to treat any other complaints unless your doctor says it is
safe.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Things to be careful of
Always use sunscreen and wear a hat and protective clothing when you are outdoors.
Do not use a sunlamp.
Using Cordarone X may make your skin more sensitive to the sun or sunlamps. This can
range from an increased tendency to tan to intense redness and swelling of the skin.
If you are going to have surgery, tell the anaesthetist that you are using Cordarone
X.
This medicine may affect some of the medicines that may be needed, such as general
anaesthetics.
Tell your doctor or medical professional that you are using Cordarone X before you
are given any medical procedure or any new medicines.
Avoid drinking large quantities of grapefruit juice as it may affect the absorption
of Cordarone X.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Cordarone
X affects you.
There is no evidence that amiodarone impairs the ability to drive a vehicle or operate
machinery.
Looking after your medicine
Tablets
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the box or blister pack they may not keep well.
Keep it in a cool, dry place where the temperature stays below 30°C. Protect from
light.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Do not use this medicine after the expiry date printed on the pack. Do not use Cordarone
X if the packaging is torn or shows signs of tampering.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Injection
If you need to store it before taking it to a hospital, make sure it is stored in
a place where the temperature stays between 8 to 25°C. Do not refrigerate. Protect
from light.
Cordarone X injection should only be given to you in a hospital.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Treatment with amiodarone may cause serious lung, liver and eye damage and may worsen
heart problems.
Your doctor will monitor you very carefully for side effects. This will involve blood
tests to check how well your liver and thyroid are functioning. It will also involve
regular chest x-rays, ECGs and eye tests.
Your doctor will tell you how often you need to have these tests. This will depend
on how long you are on Cordarone X for and what dose you are on.
Less serious side effects
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Less serious side effects
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What to do
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Alertness and sleep-related:
tremor, insomnia or other sleep disorders, vivid dreams or nightmares.
Allergy-related:
allergic condition which causes joint pain, skin rashes, fever and kidney problems
rash or hives.
Sight, hearing, smell, taste or touch-related:
small cloudy spots forming on the eyeball. These usually go away after you stop the
drug and they rarely affect your sight.
metallic taste
a feeling of "pins and needles" or numbness in the hands, legs or feet.
Heart-related:
slow heartbeat.
Hormone-related:
symptoms of an overactive thyroid including increase in appetite, weight loss, restlessness,
heat intolerance, increased sweating, tremors, swelling of your neck (goitre) and
a rapid heart rate
symptoms of an underactive thyroid including tiredness, lethargy, muscle weakness,
cramps, feeling the cold, a slow heart rate, dry and flaky skin, hair loss, a deep
and husky voice and weight gain.
Skin and muscle-related:
muscle weakness, uncontrolled movements or poor coordination.
increased skin sensitivity to sunlight - always wear a sunscreen
bluish skin discolouration
pain or swelling at the site where you were injected.
Stomach and gut-related:
constipation
loss of appetite.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Alertness and sleep-related:
faintness or light-headedness.
Allergy-related:
signs of an allergic reaction, such as shortness of breath, wheezing or other difficulty
in breathing, swelling of the face, lips, mouth, tongue or throat; rash, itching or
hives on the skin.
Heart and chest-related:
changes to heartbeat such as a pounding heart, very rapid or very slow heartbeat
chest pain, cough or spitting up of blood.
Sight-related:
blurring or deterioration of vision, sensitisation of eyes to light.
Skin-related:
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
yellowing of the skin or eyes (jaundice, a symptom of liver changes).
Other:
nausea or vomiting, stomach pain, yellow skin, unusual tiredness or passing dark-coloured
urine
clumsiness and lack of coordination, affecting balance and manner of walking, limb
or eye movements and/or speech.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
These may be serious side effects of Cordarone X. If any of these symptoms occurs
or you suspect any other drug reaction, please consult your doctor immediately.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems .
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Cordarone X contains
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Active ingredient
(main ingredient)
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Tablets
100 mg tablets: each tablet contains amiodarone hydrochloride 100 mg.
200 mg tablets: each tablet contains amiodarone hydrochloride 200 mg
Injection
Each 3mL ampoule contains amiodarone hydrochloride 150 mg.
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Other ingredients
(inactive ingredients)
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Tablets
lactose monohydrate
maize starch
povidone
anhydrous colloidal silica
magnesium stearate.
Injection
benzyl alcohol
polysorbate 80
water for injections.
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Potential allergens
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Tablets
sugars (lactose).
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Do not take this medicine if you are allergic to any of these ingredients.
Cordarone X 100 mg tablets are white to off-white biconvex tablets embossed on one side with '100' and 'action
potential' and scored on other (AUST R 15359).
Cordarone X 200 mg tablets are white to off-white biconvex tablet embossed with '200' and 'action potential'
on one side and scored on the other (AUST R 15361).
Each box contains 30 tablets.
Cordarone X injection is a clear, pale yellow solution. The injection comes as a 3 mL ampoule. Each box
contains 6 ampoules (AUST R 15360).
Who distributes Cordarone X
Distributed by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
This leaflet was prepared in November 2024.
®Registered Trademark
cordarone-x-ccdsv20-cmiv16-05nov24