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 ELIQUIS?
ELIQUIS contains the active ingredient apixaban. ELIQUIS is used to treat various
conditions.
2. What should I know before I use ELIQUIS?
Do not use if you have ever had an allergic reaction to apixaban or any of the ingredients
listed at the end of the CMI.
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 ELIQUIS and affect how it works.
4. How do I use ELIQUIS?
Your doctor will tell you how many tablets you need to take each day.
Swallow the tablet(s) whole with a full glass of water.
5. What should I know while using ELIQUIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using apixaban.
ELIQUIS should be temporarily stopped before surgery. Tell your surgeon, doctor or
dentist that you are using apixaban if you are going to have any surgery or procedure.
Your doctor will tell you when to stop and restart taking ELIQUIS after your surgery
or procedure.
Tell your doctor immediately if you become pregnant while taking this medicine.
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Things you should not do
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Do not stop using this medicine suddenly or lower the dosage without first checking
with your doctor.
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Driving or using machines
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ELIQUIS is not expected to affect your ability to drive a car or operate machinery;
however, use caution when performing these activities and notify your doctor if you
notice any changes to your ability.
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Looking after your medicine
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Store it in a cool dry place away from moisture, heat or sunlight.
Keep your tablets in the pack until it is time to take them.
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6. Are there any side effects?
Like all medicines, ELIQUIS can cause side effects. Your doctor will discuss potential
side effects with you and will explain the risks and benefits of your treatment. Some
side effects can be serious and you may require medical attention. Contact your doctor
immediately or go to the Emergency Department at your nearest hospital if you have
any signs or symptoms (changes to your normal self), particularly if they are getting
worse or do not go away.
Active ingredient(s): apixaban (a pix’ a ban)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ELIQUIS. 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 ELIQUIS.
Where to find information in this leaflet:
1. Why am I using ELIQUIS?
ELIQUIS contains the active ingredient apixaban. ELIQUIS belongs to a group of medicines called antithrombotic agents. It works by
inhibiting a blood clot forming substance called Factor Xa.
ELIQUIS is used to:
prevent blood clots in your veins after a hip or knee replacement surgery.
After an operation you are at an increased risk of getting blood clots.
treat blood clots occurring in deep veins (Deep Vein Thrombosis [DVT]) and clots in
your lungs (Pulmonary Embolism [PE]) and also to prevent these from recurring.
prevent stroke and blood clots in a condition called atrial fibrillation, which is
a type of abnormal heart rhythm.
With atrial fibrillation, part of the heart does not beat the way it should. This
can lead to blood clots forming and increase your risk of having a stroke.
2. What should I know before I use ELIQUIS?
Warnings
Do not use ELIQUIS if:
you are allergic to apixaban, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not use ELIQUIS if you have, or have had, any of the following medical conditions:
any disease or injury to a body organ that is actively bleeding or at high risk of
bleeding e.g. bleeding ulcer in the stomach or bowel, recent bleeding in the brain,
cancer at high risk of bleeding
liver disease which leads to an increased risk of bleeding
severely reduced kidney function. Your doctor will determine your kidney function
a recent operation on the brain, spinal column or eye(s)
recent brain or spine injury
abnormalities of any blood vessels that may lead to an increase in bleeding
any blood vessel abnormalities of your oesophagus or "gullet"
any disease or injury to a body organ that could lead to significant bleeding e.g.
stomach ulcers, bowel ulcers.
Do not use ELIQUIS if you are taking the following medicines:
medicines for fungal infections e.g. ketoconazole, itraconazole, voriconazole or posaconazole,
unless they are only applied to the skin
anti-viral medicines for HIV/AIDS e.g. ritonavir
other medicines to stop your blood from clotting e.g. heparin, enoxaparin, warfarin,
rivaroxaban or dabigatran.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
have ever been hospitalised for a heart condition (heart attack or unstable angina).
have ever received a stent placed in the coronary arteries of your heart.
are 75 years or older or if you have or have had any of the following medical conditions
which may lead to an increased risk of bleeding:
a heart condition known as bacterial endocarditis
type of stroke called "haemorrhagic stroke"
blood disorders that affect your ability to form clots and stop bleeding
recent or past ulcer of your stomach or bowel
moderate or mild kidney disease
liver disease
have a lung condition called bronchiectasis
have had a history of bleeding in your lungs
high blood pressure that is not controlled with medications.
Your doctor may decide to keep you under closer observation.
Tell your doctor if you:
have a prosthetic heart valve or severe rheumatic heart disease, especially mitral
stenosis (problem with the mitral valve in your heart).
know that you have a disease called antiphospholipid syndrome (a disorder of the immune
system that causes an increased risk of blood clots).
Your doctor who will decide if the treatment may need to be changed.
are having hip or knee replacement surgery and your operation involves a catheter
or injection into your spinal column e.g. for epidural or spinal anaesthesia or pain
reduction:
Tell your doctor immediately if you get numbness or weakness of your legs or problems
with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.
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
Check with your doctor if you are pregnant or intend to become pregnant.
ELIQUIS is not recommended for use in pregnant women. Your doctor can discuss with
you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
ELIQUIS is not recommended during breastfeeding. You should not breastfeed and take
ELIQUIS at the same time. The active ingredient in ELIQUIS may be present in breast
milk and poses a bleeding risk to the baby. You and your doctor should decide if you
will take ELIQUIS or breastfeed.
If you have not told your doctor about any of the above, tell him/her before you start
taking ELIQUIS.
Use in Children
There is not enough information to recommend the use of this medicine in children
and adolescents under the age of 18 years.
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 be affected by Eliquis or may affect how it works. You may need
different amounts of your medicines, or you may need to take different medicines.
Your doctor will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
medicines used to treat fungal infections such as ketoconazole, itraconazole, voriconazole
and posaconazole
anti-viral medicines for HIV/AIDS e.g. ritonavir
rifampin or rifampicin
medicines to treat epilepsy such as phenytoin, carbamazepine, phenobarbitone
St John's wort
medicines to treat depression such as sertraline, citalopram and venlafaxine
medicines used to treat pain and inflammation including non-steroidal anti-inflammatory
drugs (NSAIDs) such as naproxen or aspirin
other medicines used to prevent blood clots such as enoxaparin, clopidogrel, ticagrelor,
prasugrel, heparin, fondaparinux, bivalirudin, rivaroxaban, dabigatran, dipyridamole
quinidine
verapamil
diltiazem
amiodarone
the antibiotic, clarithromycin.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ELIQUIS.
4. How do I use ELIQUIS?
How much to use
Your doctor will tell you how many tablets you need to take each day.
If you are having hip or knee replacement surgery
The recommended dose is one 2.5 mg tablet taken twice a day.
If you have blood clots
The recommended dose to treat blood clots is two 5 mg tablets taken twice a day for
7 days, then one 5 mg tablet taken twice a day.
The recommended dose to prevent blood clots that recur is one 2.5 mg tablet taken
twice daily.
If you have atrial fibrillation
The recommended dose is normally one 5 mg tablet taken twice a day.
The recommended dose is one 2.5 mg tablet taken twice a day if you meet any two of
the following:
are 80 years or older
weigh 60 kilograms or under
have reduced kidney function.
When to take / use ELIQUIS
ELIQUIS should be used as directed by your doctor.
If you are having hip or knee replacement surgery, it is usual to start taking your
tablets 12 to 24 hours after your operation.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How long to take ELIQUIS
Continue taking your medicine for as long as your doctor tells you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, you may be at an increased risk of developing a blood
clot, which can lead to serious problems such as a stroke if you have atrial fibrillation.
If you are having hip or knee replacement surgery
If you have had a hip replacement, you will usually take the tablets for about 5 weeks.
If you have had a knee replacement, you will usually take the tablets for about 2
weeks.
If you have blood clots
To treat blood clots, you will usually take the tablets for up to 6 months. If necessary,
you may need to continue taking the tablets, usually at a lower dose, to prevent further
blood clots.
If you have atrial fibrillation
Continue taking your medicine for as long as your doctor tells you.
If you require cardioversion
If your abnormal heartbeat needs to be restored by a procedure called cardioversion,
take your medicine at the times your doctor tells you, to help prevent blood clots
that may result in strokes or other problems.
Continue taking your medicine for as long as your doctor tells you.
How to take ELIQUIS
Swallow the tablet(s) whole with a full glass of water.
If you are unable to swallow the tablet(s) whole, follow the steps below to crush
the tablet(s). This will help make sure that all of the crushed tablet(s) will be
taken.
use a mortar and pestle or a similar device to crush the tablet(s)
transfer the powder to a drinking glass or a small bowl
when using water, 5% dextrose in water or apple juice:
add a small amount of water/5% dextrose in water/apple juice (30 mL) to the mortar
and pestle/device and stir
transfer the water/5% dextrose in water/apple juice to the drinking glass
mix the powder with the water/5% dextrose in water/apple juice and drink right away
rinse the glass with a small amount of water/5% dextrose in water/apple juice and
drink right away.
when using apple sauce:
mix the powder with a small amount of apple sauce (30 g) in a small bowl and eat with
a spoon right away
add a small amount of water (30 mL) to the mortar and pestle/device and stir
transfer the water to the bowl and drink right away
rinse the bowl and the spoon with a small amount of water and drink right away.
If necessary, your doctor may also give you the crushed tablet(s) mixed in 60 mL of
water or 5% dextrose in water, through a nasogastric tube.
It does not matter if you take this medicine before or after food.
If you forget to use ELIQUIS
ELIQUIS should be used regularly at the same time each day. If you miss your dose
at the usual time, take your next tablet as soon as you remember, then continue taking
the tablets as normal (twice a day).
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, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much ELIQUIS
If you think that you or anyone else may have used too much ELIQUIS, 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.
Symptoms of an overdose may include bleeding that does not stop. If bleeding occurs,
surgery, blood transfusions, or other treatments that may reverse apixaban may be
required.
5. What should I know while using ELIQUIS?
Things you should do
If you are about to be started on any new medicine, remind your doctor, dentist or
pharmacist that you are taking ELIQUIS.
If you are going to have any surgery or procedure, including dental surgery, tell
your surgeon, doctor or dentist that you are taking this medicine.
ELIQUIS should be temporarily stopped before surgery.
Your doctor will tell you when to stop using ELIQUIS before your surgery or procedure.
Your doctor will also tell you when you can start taking ELIQUIS after your surgery.
Tell your doctor that you are taking ELIQUIS if your doctor is planning for you to
have an anaesthetic injection in your back (spinal or epidural injection).
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Things you should not do
Do not stop using this medicine suddenly or lower the dosage without first checking
with your doctor.
If you stop taking it suddenly, your condition may worsen, or you may have serious
side effects.
Do not take ELIQUIS to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Things to be careful of
ELIQUIS contains lactose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking it.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ELIQUIS
affects you.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack, they may not keep well.
Follow the instructions on the carton on how to take care of your medicine properly.
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 windowsills.
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. Heat and dampness can destroy some medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date or is damaged, take
it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
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.
It can be difficult to tell whether side effects are the result of taking ELIQUIS,
effects of your condition or side effects of other medicines you may be taking. For
this reason it is important to tell your doctor of any change in your condition.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Other side effects
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.
Some of the other possible side effects (for example, changes in liver or kidney function)
can only be found when your doctor does tests from time to time to check your progress.
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 ELIQUIS contains
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Active ingredient
(main ingredient)
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apixaban
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Other ingredients
(inactive ingredients)
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lactose
lactose monohydrate
microcrystalline cellulose
croscarmellose sodium
sodium lauryl sulfate
magnesium stearate
hypromellose
titanium dioxide
glycerol triacetate
yellow iron oxide (2.5mg tablets)
red iron oxide (5mg tablets)
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
What ELIQUIS looks like
ELIQUIS 2.5 mg tablets are yellow and round with "893" on one side and "2 1/2" on
the other.
They are packed in blister packs in cartons of 10, 14, 20, 30, 60 or 100 tablets.
ELIQUIS 5 mg tablets are pink and oval-shaped with "894" on one side and "5" on the
other.
They are packed in blister packs in cartons of 14, 20, 28, 56, 60, 100, 112, 120 and
168 tablets.
Not all pack sizes may be available.
ELIQUIS 2.5 mg tablet: AUST R 172244
ELIQUIS 5 mg tablet: AUST R 193474
Who distributes ELIQUIS
Sponsored and Supplied by:
Bristol-Myers Squibb Australia Pty Ltd
Level 2, 4 Nexus Court
Mulgrave VIC 3170 Australia.
Toll free number: 1800 067 567
Also distributed by:
Pfizer Australia Pty Ltd
Sydney NSW
Toll free number: 1800 675 229
ELIQUIS® (apixaban) is a registered trademark of Bristol-Myers Squibb Company
This leaflet was prepared in January 2024.