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 RIVAROXABAN-TEVA?
RIVAROXABAN-TEVA contains the active ingredient rivaroxaban. RIVAROXABAN-TEVA reduces
the tendency of blood to form clots and is used to treat a number of conditions. For
more information, see Section
1. Why am I using RIVAROXABAN-TEVA? in the full CMI.
2. What should I know before I use RIVAROXABAN-TEVA?
Do not use if you have ever had an allergic reaction to rivaroxaban 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 RIVAROXABAN-TEVA and affect how it works.
4. How do I use RIVAROXABAN-TEVA?
Follow all directions given to you by your doctor and other health professionals carefully
including:
How many tablets to take each day
If you need to take these tablets with food
5. What should I know while using RIVAROXABAN-TEVA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using RIVAROXABAN-TEVA.
Take RIVAROXABAN-TEVA exactly as your doctor has prescribed.
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Things you should not do
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Do not stop taking your medicine or lower the dosage without checking with your doctor
first.
Do not take RIVAROXABAN-TEVA 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.
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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 RIVAROXABAN-TEVA
affects you.
If this medicine makes you feel faint or dizzy, do not drive or use machinery.
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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 it where young children cannot reach it.
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6. Are there any side effects?
All medicines have side effects. Sometimes they are serious, most of the time they
are not. In serious cases, you may need medical attention. It is important to be aware
of them so that you can identify any symptoms if they occur.
Serious side effects can include bleeding, severe allergic reactions, gastrointestinal-related,
renal-related, respiratory-related, nervous system-related, musculoskeletal-related,
skin-related and/or injury/wound-related reactions.
Film coated tablets
Active ingredient(s):
Rivaroxaban
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using RIVAROXABAN-TEVA. 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 RIVAROXABAN-TEVA.
Where to find information in this leaflet:
1. Why am I using RIVAROXABAN-TEVA?
RIVAROXABAN-TEVA contains the active ingredient Rivaroxaban. RIVAROXABAN-TEVA is an anticoagulant. It works by inhibiting the blood clotting protein
called Factor Xa, thus reducing the tendency of blood to form clots.
RIVAROXABAN-TEVA 10, 15 and 20 mg tablets are used to:
Prevent blood clots in your veins after a hip or knee replacement operation because
after an operation you are at an increased risk of getting blood clots
Prevent blood clots in your brain (stroke) and/or other blood vessels in your body
if you have a form of irregular heart rhythm called non-valvular atrial fibrillation
Treat blood clots in the veins of your legs (deep vein thrombosis, DVT) and clots
in your lung (pulmonary embolism, PE) and to prevent blood clots from re-occurring
in your legs and/or lungs.
RIVAROXABAN-TEVA 2.5 mg tablets twice daily along with aspirin 100 mg once daily,
is used to:
prevent major heart related events (stroke, heart attack and death from heart related
conditions) if you have poor blood flow in the blood vessels of your heart (coronary
artery disease or CAD) and/or arms and legs (peripheral artery disease or PAD).
2. What should I know before I use RIVAROXABAN-TEVA?
Warnings
Do not use RIVAROXABAN-TEVA if:
You are allergic to rivaroxaban, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
You are bleeding excessively or at an increased risk of bleeding
You have liver disease which leads to an increased risk of bleeding
You have end stage kidney disease or if you are undergoing dialysis (a procedure used
to remove waste products from the blood). Your doctor will know how to determine your
kidney function.
You are taking medicines for fungal infections e.g. ketoconazole, or itraconazole,
voriconazole, or posaconazole, unless they are only applied to the skin
You are taking anti-viral medicines for HIV/AIDS e.g. ritonavir
You had bleeding in the brain within the last 6 months.
Check with your doctor if:
you have any other medical conditions
you take any medicines for any other condition
you have kidney disease. Doctors will need to take special care in patients with moderate
or severe kidney disease. Your doctor will do tests to determine how severe your kidney
disease is.
you have kidney disease and undergoing dialysis (a procedure used to remove waste
products from the blood)
you have prosthetic heart valves
you have liver disease
a doctor has told you that you have a severe form of antiphospholipid syndrome (a
disease which can cause blood clots)
you have an increased risk of bleeding such as:
bleeding disorders
very high blood pressure, not controlled by medical treatment
an active ulcer or a recent ulcer of your stomach or bowel
a problem with the blood vessels in the back of your eyes
recent bleeding in your brain
a recent operation on your brain, spinal column or eye
abnormalities in blood vessels of your spine or brain
a lung disease where your bronchi are widened (bronchiectasis), or history of bleeding
in the lungs
you have a coronary artery disease with severe symptomatic heart failure
you have CAD and/or PAD and had the following:
a bleed in your brain (stroke) or
a blood clot in your brain (ischaemic, non-lacunar stroke) in the previous month or
a blockage of the small arteries in the brain (lacunar stroke)
you have an active cancer – this may also mean you have an increased risk of bleeding.
An active cancer means that in the last 6 months you:
have been diagnosed with cancer
had a relapse of cancer
were being treated for cancer
You have an intolerance to some sugars. RIVAROXABAN-TEVA contains lactose. Contact
your doctor before taking it.
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 this medicine if you are pregnant or intend to become pregnant. Women should use a reliable contraceptive while taking RIVAROXABAN-TEVA.
Do not use RIVAROXABAN-TEVA if you are breastfeeding. It is not known whether rivaroxaban passes into human breast milk.
Mechanical heart valve
Tell your doctor if you have a mechanical heart valve.
RIVAROXABAN-TEVA may not be suitable for you because it has not been studied in patients
with a mechanical heart valve.
Surgery
Tell your doctor, dentist or pharmacist if you need to have an operation (including
dental work) while you are taking RIVAROXABAN-TEVA.
It is very important to take RIVAROXABAN-TEVA and any other medications you might
be on, before and after the operation exactly at the times you have been told by your
doctor.
During any invasive procedure or operation, if it involves a catheter or injection
into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
it is very important to take RIVAROXABAN-TEVA before and after the injection or removal
of the catheter exactly at the times you have been told by your doctor
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.
If you have not told your doctor about any of the above, tell them before you start
taking RIVAROXABAN-TEVA.
Use in children
This medicine should not be used in a child 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 interfere with RIVAROXABAN-TEVA and affect how it works.
other medicines to reduce blood clotting e.g. enoxaparin, clopidogrel or warfarin
some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs)
or serotonin norepinephrine reuptake inhibitors (SNRIs))
anti-inflammatory and pain-relieving medicines e.g. naproxen or medicines used for
the protection of heart disease e.g. acetylsalicylic acid (aspirin).
Your doctor may decide to keep you under closer observation. If your doctor thinks
that you are at increased risk of developing stomach or bowel ulcers, he may also
use a preventative ulcer treatment.
If you have CAD and/or PAD, your doctor may ask you to take your RIVAROXABAN-TEVA
2.5 mg tablet twice daily with aspirin 100 mg once daily.
Medicines that may
reduce
the effect of RIVAROXABAN-TEVA include:
medicines for treatment of epilepsy (phenytoin, carbamazepine)
St John’s Wort, a herbal product used for depression
Rifampicin, an antibiotic
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect RIVAROXABAN-TEVA.
4. How do I use RIVAROXABAN-TEVA?
How much to take/ use
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To prevent clots in your veins after a hip or knee replacement operation,
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The dose is one RIVAROXABAN- TEVA 10 mg tablet once a day with or without food.
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To prevent blood clots in brain (stroke) and other blood vessels,
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The usual dose is one RIVAROXABAN-TEVA 20 mg tablet once daily.
If your kidneys are not working properly, your doctor may reduce your dose to one
RIVAROXABAN-TEVA 15 mg tablet once daily.
RIVAROXABAN-TEVA 15 mg and 20 mg tablets are to be taken with food.
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To treat blood clots in your legs and clots in your lungs and for preventing blood
clots from reoccurring,
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The usual dose is one RIVAROXABAN-TEVA 15 mg tablet TWICE daily for the first three
weeks, followed by one RIVAROXABAN-TEVA 20 mg tablet ONCE daily.
After 6 to 12 months treatment your doctor may decide to continue treatment with either
one RIVAROXABAN-TEVA 20 mg tablet ONCE a day or one RIVAROXABAN-TEVA 10 mg tablet
ONCE a day.
RIVAROXABAN-TEVA 15 mg and 20 mg tablets are to be taken with food.
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To prevent major heart related events if you have CAD and/or PAD
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The dose is one RIVAROXABAN-TEVA 2.5 mg tablet twice daily. You must also take one
100 mg aspirin tablet once a day.
RIVAROXABAN-TEVA 2.5 mg tablets can be taken with or without food. Swallow the tablets
preferably with water.
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If you have difficulty swallowing the tablet whole, talk to your doctor about other
ways to take RIVAROXABAN-TEVA. The tablet may be crushed and mixed with water or apple
puree immediately before you take it. This drink should be immediately followed by
food.
If necessary, the crushed RIVAROXABAN-TEVA tablet may be given to you through a stomach
tube.
After giving the crushed RIVAROXABAN-TEVA tablet via the stomach tube, you or your
carer should flush the tube with water. If you are taking the 15 or 20 mg RIVAROXABAN-TEVA
tablet, you should be fed via the stomach tube straight after your dose of RIVAROXABAN-TEVA.
Follow the instructions provided and use RIVAROXABAN-TEVA until your doctor tells
you to stop.
When to take / use RIVAROXABAN-TEVA
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Following hip or knee replacement operation:
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Take the first tablet 6 to 10 hours after your operation or as advised by your doctor.
Then take a tablet every day for the duration prescribed, unless your doctor tells
you to stop.
If you have had a hip replacement you will usually take the tablets for 5 weeks. If
you have had a knee replacement you will usually take the tablets for 2 weeks. Your
doctor will advise you about the exact duration.
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For prevention of stroke or treatment or prevention of blood clots in your legs and/or
lungs
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Take the tablet(s) every day until your doctor tells you to stop. Your doctor will
decide how long you must continue your treatment.
If your heart beat needs to be restored to normal by a procedure called cardioversion,
take RIVAROXABAN-TEVA according to your doctor’s instructions. If you need a procedure
to treat blocked blood vessels in your heart (called a percutaneous coronary intervention
– PCI with an insertion of a stent), the dose may be changed by your doctor.
Your doctor will advise you about any changes to the amount of RIVAROXABAN-TEVA you
should take.
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For prevention of major heart related events if you have CAD and/or PAD
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Your doctor will tell you when to start treatment with RIVAROXABAN-TEVA 2.5 mg twice
daily with aspirin 100 mg once daily. Your doctor will decide how long you must continue
treatment.
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It is important that you follow instructions from your doctor and not to miss or stop
taking your medicine or lower the dosage without checking with your doctor
RIVAROXABAN-TEVA has been prescribed to you by your doctor to treat and/or prevent
a serious medical condition.
Try to take the tablet(s) at the same time every day to help you remember.
If you forget to use RIVAROXABAN-TEVA
RIVAROXABAN-TEVA should be used at the same time each day.
If you are taking one RIVAROXABAN-TEVA 10 mg, or one 15 mg, or one 20 mg tablet ONCE
a day: If you have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking a tablet once
a day as normal. Do not take a double dose to make up for a forgotten tablet.
If you are taking one RIVAROXABAN-TEVA 15 mg tablet TWICE a day
and have missed a dose, take it as soon as you remember. If you forget to take a dose;
you can take two RIVAROXABAN-TEVA 15 mg tablets at the same time to get a total dose
of 30 mg in one day. The following day onwards, you should take one RIVAROXABAN-TEVA
15 mg tablet twice a day as normal, until required.
If you are taking RIVAROXABAN-TEVA 2.5 mg tablet TWICE a day
and have missed a dose, you can take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much RIVAROXABAN-TEVA
If you think that you have used too much RIVAROXABAN-TEVA, you may need urgent medical
attention.
Taking too much RIVAROXABAN-TEVA increases the risk of bleeding.
You should immediately:
phone the Poisons Information Centre
(In Australia 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 RIVAROXABAN-TEVA?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking RIVAROXABAN-TEVA.
Take your medicine exactly as prescribed.
Call your doctor straight away if:
you need to have a surgical or dental procedure.
your doctor is planning for you to have an anaesthetic injection in your back (spinal
or epidural injection).
are prescribed other medications during the course of therapy with RIVAROXABAN-TEVA.
you become pregnant while you are taking RIVAROXABAN-TEVA.
Remind any doctor, dentist or pharmacist you visit that you are using RIVAROXABAN-TEVA.
Things you should not do
Do not take RIVAROXABAN-TEVA 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.
Do not stop taking your medicine or lower the dosage without checking with your doctor
first because RIVAROXABAN-TEVA treats and prevents serious conditions.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how RIVAROXABAN-TEVA
affects you.
If this medicine makes you feel faint or dizzy, do not drive or use machinery.
Looking after your medicine
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.
Keep it where young children cannot reach it.
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.
Do not use this medicine after the expiry date.
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.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Bleeding:
prolonged or excessive bleeding from gums, nose etc.
heavy menstrual bleeding
Like other similar medicines (anticoagulants), RIVAROXABAN-TEVA may cause bleeding,
which may potentially be life threatening. In some cases this bleeding may not be
obvious. There is no antidote available to reverse the effects of RIVAROXABAN-TEVA,
however there are measures your health professional can take to control / stop the
bleeding.
Allergy:
signs such as rash, itching or hives on skin, swelling of the face, lips, tongue,
or other parts of the body, shortness of breath, wheezing or trouble breathing
Gastrointestinal-related:
Signs of liver problems such as yellowing of the skin and/or eyes (jaundice)
blood in the urine or stool
vomiting or coughing up blood
Renal-related:
blood in urine, reduced urine output, swelling of the ankles, feet and legs, increased
time for blood to clot, and heavy bleeding. These symptoms may be related to a condition
called anticoagulant-related nephropathy.
Respiratory-related:
breathlessness, chest pain
Nervous system-related:
dizziness, fainting
exceptional weakness
Musculoskeletal-related:
unexplained swelling
numbness in the arms and legs
Skin-related:
skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and
genitals
extensive skin rash associated with fever
Injury/wound-related:
oozing from a surgical wound
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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.
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Your doctor may need to monitor and conduct blood tests, as RIVAROXABAN-TEVA can affect
your liver or pancreatic enzymes. You may not experience any specific symptoms.
Your doctor may decide to keep you under observation or change how you should be treated.
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
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 RIVAROXABAN-TEVA contains
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Active ingredient
(main ingredient)
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Rivaroxaban
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Other ingredients
(inactive ingredients)
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Sodium lauryl sulfate
lactose monohydrate
hypromellose
croscarmellose sodium
magnesium stearate
in the 2.5 mg and 10 mg tablets: Opadry II 85F22055 Yellow (ARTG PI no. 141496) and
Opadry II 85F34156 Pink (ARTG PI no. 141494)
in the 15 mg and 20 mg tablets: Opadry II 85F230074 Orange (ARTG PI no. 140367) and
Opadry II 85F25401 Red (ARTG PI no. 141493)
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What RIVAROXABAN-TEVA looks like
RIVAROXABAN-TEVA 2.5 mg
is a yellow, film coated, round tablet, debossed with “T” on one side of the tablet
and “2R” on the other side. It is packed in blister packs in cartons of 60 and 100
tablets and bottles of 28, 112 and 252 tablets (Blisters: AUST R 369533, Bottles:
AUST R: 369548).
RIVAROXABAN-TEVA 10 mg
is a pink, film coated, round tablet, debossed with “T” on one side of the tablet
and “1R” on the other side. It is packed in blister packs in cartons of 10, 15, 30
and 100 tablets and bottles of 28, 112 and 252 tablets (Blisters: AUST R 369539, Bottles:
AUST R: 369549).
RIVAROXABAN-TEVA 15 mg
is an Orange, film coated, round tablet, debossed with “T” on one side of the tablet
and “3R” on the other side. It is packed in blister packs in cartons of 28, 42 and
100 tablets and bottles of 28, 112 and 252 tablets (Blisters: AUST R 369538, Bottles:
AUST R: 369535).
RIVAROXABAN-TEVA 20 mg
is a red, film coated, round tablet, debossed with “T” on one side of the tablet
and “7R” on the other side. It is packed in blister packs in cartons of 28 and 100
tablets and bottles of 28, 112 and 252 tablets (Blisters: AUST R 369547, Bottles:
AUST R: 369545).
Not all pack sizes may be marketed.
Who distributes RIVAROXABAN-TEVA
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
This leaflet was prepared in March 2024.