Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about XARELTO.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking XARELTO against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT XARELTO IS USED FOR
XARELTO is used to prevent blood clots in your veins after a hip or knee replacement operation.
Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.
Your doctor may have prescribed XARELTO for another reason.
Ask your doctor if you have any questions about why XARELTO has been prescribed for you.
XARELTO is a prescription medicine. It should only be used in adults under medical supervision.
The active substance is rivaroxaban. It belongs to a group of medicines called antithrombotic agents. It works by inhibiting blood clotting Factor Xa.
BEFORE YOU TAKE XARELTO
When you must not take it
Do not take XARELTO:
if you are allergic (hypersensitive) to rivaroxaban or any of the other ingredients of XARELTO. The ingredients are listed at the end of this leaflet
if you are bleeding excessively or at an increased risk of bleeding
if you have liver disease which leads to an increased risk of bleeding
if you are pregnant or breast feeding
if you have severely reduced kidney function. Your doctor will know how to determine your kidney function.
If you are taking medicines for fungal infections e.g. ketoconazole (e.g. NIZORAL™), unless they are only applied to the skin, or itraconazole, voriconazole, or posaconazole
if you are taking anti-viral medicines for HIV/AIDS e.g. ritonavir (e.g. KALETRA™)
if you had bleeding in the brain within the last 6 months
If you are not sure whether you should start using XARELTO, talk to your doctor or pharmacist.
Do not use XARELTO if you are pregnant or intend to become pregnant. Women should use a reliable contraceptive while taking XARELTO.
Do not use XARELTO if you are breast-feeding. It is not known whether rivaroxaban passes into human breast milk.
XARELTO should not be taken by people under 18 years of age. There is not enough information on its use in children and adolescents.
Do not use XARELTO if the packaging is torn or shows signs of tampering.
Do not use XARELTO after the expiry date printed on the carton and on each blister after "EXP" (e.g. 11 09 refers to November 2009). The expiry date refers to the last day of that month.
Before you start to take XARELTO
Tell your doctor before you take XARELTO, if any of the following apply to you:
if you have kidney disease and are taking medication that may affect XARELTO
if you have an increased risk of bleeding such as:
- bleeding disorders
- very high blood pressure, not controlled by medical treatment
- 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.
Your doctor may decide to keep you under closer observation.
If your operation 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 XARELTO 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 XARELTO.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while taking XARELTO because its effect may be increased.
Tell your doctor if you are taking:
other medicines to reduce blood clotting e.g. enoxaparin (e.g. CLEXANE™), clopidogrel (e.g. PLAVIX™) or warfarin
anti-inflammatory and pain relieving medicines e.g. naproxen (e.g. NAPROSYN™) or aspirin (e.g. ASPRO™ or CARTIA™)
Your doctor may decide to keep you under closer observation.
HOW TO TAKE XARELTO
Always take XARELTO exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take
The dose is one tablet (10 mg) once a day. Swallow the tablet preferably with water. It can be taken with or without food.
When to take XARELTO
Take the first tablet 6 -10 hours after your operation. Then take a tablet every day until your doctor tells you to stop. Try to take the tablet at the same time every day.
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 exact duration.
If you forget to take XARELTO
If you have missed a dose, take it as soon as you remember. 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 take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26; New Zealand: 0800 POISON or 0800 747 766 0800 747 766) if you think that you or anyone else may have taken too much XARELTO.
Do this even if there are no signs of discomfort or poisoning. Taking too much XARELTO increases the risk of bleeding.
WHILE YOU ARE TAKING XARELTO
Things you must do
Take XARELTO exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking XARELTO.
Tell your doctor if you need to have a surgical or dental procedure.
Tell your doctor that you are using XARELTO, if your doctor is planning for you to have an anaesthetic injection in your back (spinal or epidural injection).
Tell your doctor if other medications are prescribed to you during the course of therapy with XARELTO.
If you become pregnant while you are taking XARELTO, immediately tell your doctor.
Things you must not do
Do not give XARELTO to anyone else, even if they have the same condition as you.
Do not use XARELTO to treat any other complaints unless your doctor tells you to.
Do not stop taking XARELTO without talking to your doctor first, because XARELTO prevents the development of a serious condition.
Things to be careful of
XARELTO contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking XARELTO.
There is no evidence that XARELTO will affect your ability to drive or use machines.
All medicines have side effects. Sometimes they are serious, most of the time they are not. In serious cases, you may need medical attention.
Tell your doctor if you experience any of the following side effects:
long or excessive bleeding
exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling
Your doctor may decide to keep you under observation or change how you should be treated.
Like other similar medicines (antithrombotic agents), XARELTO may cause bleedings. In some cases these bleedings may not be obvious.
The following side effects have been reported for XARELTO:
Common side effects
(may affect up to 1 in 10 people)
bleeding following your operation
feeling sick (nausea)
blood tests may show a temporary increase in some liver enzymes
Uncommon side effects
(may affect up to 1 in 100 people)
bleeding in your stomach or bowel, genital bleeding, nose bleed
blood in your urine
oozing from surgical wound
raised heart beat (tachycardia)
low blood pressure
feeling unwell (weakness, tiredness), headache, dizziness, fainting
stomach ache, indigestion (constipation, diarrhoea, dyspepsia, vomiting)
localized swelling, swelling in your limbs (oedema)
pain in your limbs
rash, itchy skin, hives
impaired function of your kidneys
blood tests may show a temporary increase in some liver and pancreatic enzymes or in the number of platelets (thrombocythaemia)
Rare side effects
(may affect up to 1 in 1000 people)
impaired function of your liver
allergic skin reactions
In addition the following side effects have been reported for XARELTO: adrenal bleeding, bleeding from the whites of your eyes or bleeding from stomach ulcer leading to death, yellowing of the skin and eye (jaundice), hypersensitivity (rash, hives, shortness of breath) and coughing blood.
Tell your doctor or pharmacist if any of the side effects worsens, or if you notice any side effects not listed in this leaflet.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
AFTER USING XARELTO
Keep your tablets in their 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.
Store the tablets in a cool dry place where the temperature stays below 30°C. Do not keep your tablets in the car on a hot day. Do not store the tablets in the bathroom, near the sink, or on a window-sill. Heat and damp can destroy some tablets.
Keep out of the reach and sight of children. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Return any unused medicine to your pharmacist.
What it looks like
XARELTO 10 mg film-coated tablets are light red, round, film-coated tablets marked with the BAYER-cross on one side and 10 and a triangle on the other side. XARELTO is packed in blister packs in cartons of 5, 10, 15, 30 and 100 tablets.
Not all pack sizes may be marketed.
rivaroxaban 10 mg
sodium lauryl sulfate
iron oxide red
Bayer Healthcare AG, Germany
Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble, NSW 2073
Bayer New Zealand Limited
3 Argus Place, Hillcrest,
North Shore, Auckland 0627 New Zealand
Australian Registration Numbers
XARELTO 10 mg
AUST R 147400
Date of Preparation
® Registered Trademark of Bayer AG, Germany
© Bayer Australia Ltd
All rights reserved.
Published by MIMS/myDr January 2009
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