2. What should I know before I take APIXABAN VIATRIS?
Do not take if you have ever had an allergic reaction to apixaban or any of the ingredients
listed at the end of the CMI.
3. What if I am taking other medicines?
Some medicines may interfere with APIXABAN VIATRIS and affect how it works.
4. How do I take APIXABAN VIATRIS?
Your doctor will tell you how many tablets you need to take each day depending on
your condition.
5. What should I know while taking APIXABAN VIATRIS?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking APIXABAN VIATRIS.
APIXABAN VIATRIS should be temporarily stopped before surgery. Tell you surgeon, doctor
or dentist that you are taking apixaban if you are going to have any surgery or procedure.
Your doctor will tell you when to stop and restart taking this medicine after your
surgery or procedure.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
|
|
Things you should not do
|
Do not stop taking this medicine suddenly or lower the dosage without first checking
with your doctor.
Do not take this medicine to treat any other complaints unless your doctor tells you
to.
|
|
Driving or using machines
|
This medicine 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.
|
|
Looking after your medicine
|
Store it in a cool dry place away from sunlight where the temperature stays below
25°C.
Keep it where young children cannot reach it.
|
6. Are there any side effects?
All medicines have 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.
Serious side effects can include bleeding, allergic reaction, swelling to some parts
of the body.
Active ingredient:
apixaban
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking APIXABAN VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking APIXABAN VIATRIS.
Where to find information in this leaflet:
1. Why am I taking APIXABAN VIATRIS?
APIXABAN VIATRIS contains the active ingredient apixaban. Apixaban belongs to a group of medicines called antithrombotic agents. It works by
inhibiting a blood clot forming substance called Factor Xa.
APIXABAN VIATRIS 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.
This medicine is not addictive.
2. What should I know before I take APIXABAN VIATRIS?
Warnings
Do not take APIXABAN VIATRIS if you have allergy to:
any medicine containing apixaban
any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can take 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 take APIXABAN VIATRIS 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 take APIXABAN VIATRIS 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.
Before you start to take it, tell 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.
Check with 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
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.
APIXABAN VIATRIS 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.
APIXABAN VIATRIS is not recommended during breastfeeding. You should not breastfeed
and take APIXABAN VIATRIS at the same time. The active ingredient in APIXABAN VIATRIS
may be present in breast milk and poses a bleeding risk to the baby.
You and your doctor should decide if you will take APIXABAN VIATRIS or breastfeed.
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 APIXABAN VIATRIS 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, phenobarbital
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 APIXABAN VIATRIS.
4. How do I take APIXABAN VIATRIS?
How much to take
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.
How to take it
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.
When to take it
Take the first tablet 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 it
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.
If you forget to take APIXABAN VIATRIS
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 take too much APIXABAN VIATRIS
If you think that you or anyone else may have used too much APIXABAN VIATRIS, you
may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (Australia telephone 13 11 26) for advice, 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, other treatments that may reverse apixaban may be required.
5. What should I know while taking APIXABAN VIATRIS?
Things you should do
If you are about to be started on any new medicine, remind your doctor, dentist and
pharmacist that you are taking APIXABAN VIATRIS.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
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.
APIXABAN VIATRIS should be temporarily stopped before surgery.
Your doctor will tell you when to stop taking APIXABAN VIATRIS before your surgery
or procedure, and when you can start taking APIXABAN VIATRIS after your surgery.
Tell your doctor that you are taking APIXABAN VIATRIS 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.
Call your doctor straight away 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.
Things you should not do
Do not stop taking your 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 APIXABAN VIATRIS 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how APIXABAN
VIATRIS 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 in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight where the temperature
stays below 25°C.; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
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.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date or is damaged, take
it to any pharmacy for safe disposal.
Do not take this medicine after the expiry date 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 APIXABAN
VIATRIS, 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.
Do not be alarmed by the list of side effects.
You may not experience any of them.
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 APIXABAN VIATRIS contains
|
Active ingredient
(main ingredient)
|
apixaban
|
|
Other ingredients
(inactive ingredients)
|
lactose
microcrystalline cellulose
sodium lauryl sulfate
croscarmellose sodium
magnesium stearate
Instacoat Universal A05R04319 Brown (ID 145053)
|
|
Potential allergens
|
lactose, sugars and trace quantities of sulfites
|
Do not take this medicine if you are allergic to any of these ingredients.
What APIXABAN VIATRIS looks like
APIXABAN VIATRIS 2.5 mg is a brown, film-coated, round, biconvex, beveled edge tablet
debossed with X 2 on one side of the tablet and M on other side (AUST R 411134: Blister,
AUST R 522882: Bottle).
APIXABAN VIATRIS 5 mg is a brown, film-coated, oval, biconvex, beveled edge tablet
debossed with X 5 on one side of the tablet and M on the other side (AUST R 411135:
Blister, AUST R 522883: Bottle).
Who distributes APIXABAN VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2026.
APIXABAN VIATRIS_cmi\Jul26/00