SUMMARY CMI

RIVOXA^®

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 RIVOXA?

• RIVOXA contains the active ingredient rivaroxaban. Rivaroxaban works by inhibiting the blood clotting protein called Factor Xa, thus reducing the tendency of blood to form clots. For more information, see Section 1. Why am I using RIVOXA in the full CMI.

2. What should I know before I use RIVOXA?

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. Do not use if you are bleeding excessively or at an increased risk of bleeding. Do not use if you have ever had an allergic reaction to rivaroxaban or any other ingredient mentioned in Section 7. of this CMI.

For more information, see Section 2. What should I know before I use RIVOXA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with RIVOXA and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use RIVOXA?

Your doctor will decide with you on how to use RIVOXA. More instructions can be found in Section 4. How do I use RIVOXA in the full CMI.

5. What should I know while using RIVOXA?

For more information, see Section 5. What should I know while using RIVOXA? in the full CMI.

6. Are there any side effects?

Like other similar medicines (anticoagulants), RIVOXA 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 RIVOXA, however there are measures your health professional can take to control / stop the bleeding. Please see your doctor if you experience any symptoms of bleeding.

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.

FULL CMI

RIVOXA^® (Ri-Vox-Aa)

Active ingredient(s): rivaroxaban

Consumer Medicine Information (CMI)

This leaflet provides important information about using RIVOXA. 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 RIVOXA.

Where to find information in this leaflet:

1. Why am I using RIVOXA?
2. What should I know before I use RIVOXA?
3. What if I am taking other medicines?
4. How do I use RIVOXA?
5. What should I know while using RIVOXA?
6. Are there any side effects?
7. Product details

1. Why am I using RIVOXA?

The active substance is rivaroxaban. It belongs to a group of medicines called anticoagulants. It works by inhibiting the blood clotting protein called Factor Xa, thus reducing the tendency of blood to form clots.

RIVOXA 2.5 mg tablets twice daily along with aspirin 100 mg once daily, has been prescribed to you for:

• Prevention of 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).

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed RIVOXA for another reason.

RIVOXA is a prescription medicine. It should only be used in adults under medical supervision.

2. What should I know before I use RIVOXA?

Warnings

Do not use RIVOXA if:

• you are allergic to any medicine containing rivaroxaban.
• any of the ingredients listed at the end of this leaflet

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
• 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 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.
• If you are taking medicines for fungal infections e.g. ketoconazole, or itraconazole, voriconazole, or posaconazole, unless they are only applied to the skin
• if you are taking anti-viral
• medicines for HIV/AIDS e.g. ritonavir
• if you had bleeding in the brain within the last 6 months.
• If you are not sure whether you should start using RIVOXA, talk to your doctor or pharmacist.
• Tell your doctor if you have a mechanical heart valve
• RIVOXA may not be suitable for you because it has not been studied in patients with mechanical heart valve.
• This medicine should not be used in a child under the age of 18 years.
• Do not take this medicine after the expiry date printed on the pack and blister.
• The expiry date is printed on the carton and on each blister after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired, return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering.

If the packaging is damaged, return it to your pharmacist or disposal.

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives or dyes.
• have an active cancer

Tell your doctor if you have or have had any of the following medical conditions:

• if you have kidney disease. Doctor 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.
• if you have kidney disease and undergoing dialysis (a procedure used to remove waste products from the blood)
• if you have prosthetic heart valves
• if you have liver disease
• if a doctor has told you that you have a severe form of antiphospholipid syndrome (a disease which can cause blood clots)
• if 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

If 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).
  Your doctor may decide to keep you under closer observation.

In the event of a surgery

Tell your doctor, dentist or pharmacist if you need to have an operation (including dental work) while you are taking RIVOXA.

It is very important to take RIVOXA 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 RIVOXA 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 anesthesia, because urgent care is necessary

If you have not told your doctor about any of the above, tell them before you start taking RIVOXA.

RIVOXA contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, 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 RIVOXA.
• Do not use RIVOXA if you are breastfeeding. It is not known whether rivaroxaban passes into human breast milk.

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am 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 RIVOXA because its effect may be increased.

Some medicines and RIVOXA may interfere with each other.

These include:

• 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))

These medicines may be affected by RIVOXA, may increase the effect of RIVOXA or may affect how well RIVOXA works. You may need different amounts of your medicines, or you may need to take different medicines.

Tell your doctor if you are taking 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 RIVOXA 2.5 mg tablet twice daily with aspirin 100 mg once daily.

If you are taking

• medicines for treatment of epilepsy (phenytoin, carbamazepine)
• St John's Wort, a herbal product used for depression
• Rifampicin, an antibiotic

Tell your doctor before taking RIVOXA, because its effect may be reduced.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect RIVOXA.

4. How do I use RIVOXA?

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pharmacist label, ask your doctor or pharmacist for help.

How much to take / use

To prevent major heart related events if you have CAD and/or PAD, the dose is one RIVOXA 2.5 mg tablet twice daily. You must also take one 100 mg aspirin tablet once a day. RIVOXA 2.5 mg tablets can be taken with or without food. Swallow the tablets preferably with water.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take RIVOXA. 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 RIVOXA tablet may be given to you through a stomach tube.

After giving the crushed RIVOXA tablet via the stomach tube, you or your carer should flush the tube with water.

When to take / use RIVOXA

For prevention of major heart related events if you have CAD and/or PAD, your doctor will tell you when to start treatment with RIVOXA 2.5 mg twice daily with aspirin 100 mg once daily. Your doctor will decide how long you must continue treatment.

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. RIVOXA 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 RIVOXA

If you are taking RIVOXA 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 RIVOXA

If you think that you have used too much RIVOXA, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (In Australia by calling 13 11 26 (Australia), or (In New Zealand by calling 0800POISON or 0800 764 766) for advice
• 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.

You may need urgent medical attention.

Taking too much RIVOXA increases the risk of bleeding.

5. What should I know while using RIVOXA?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking RIVOXA.

Take RIVOXA exactly as your doctor has prescribed.

Remember to carry your patient alert card in your wallet with you at all times.

Tell all doctors, dentists and pharmacists who are treating you that you are taking RIVOXA.

Tell your doctor if you need to have a surgical or dental procedure.

Tell your doctor that you are using RIVOXA, 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 RIVOXA.

If you become pregnant while you are taking RIVOXA, immediately tell your doctor.

Things you should not do

Do not take RIVOXA 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 RIVOXA treats and prevents serious conditions.

Driving or using machines

If this medicine makes you feel faint or dizzy, do not drive or use machinery.

Looking after your medicine

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 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window sill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

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.

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?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking RIVOXA.

All medicines have side effects. Sometimes they are serious, most of the time they are not. In serious cases, you may need medical attention.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Your doctor may need to monitor and conduct blood tests, as RIVOXA can affect your liver or pancreatic enzymes.

You may not experience any specific symptoms.

Like other similar medicines (anticoagulants), RIVOXA 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 RIVOXA, however there are measures your health professional can take to control / stop the bleeding. Please see your doctor if you experience any symptoms of bleeding.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• exceptional weakness, unexplained swelling
• breathlessness, chest pain
• signs of allergy 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
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice)
• prolonged or excessive bleeding from gums, nose etc.
• numbness in the arms and legs
• dizziness, fainting
• oozing from a surgical wound
• vomiting or coughing up blood
• blood in the urine or stool
• heavy menstrual bleeding
• skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals

Serious side effects

• extensive skin rash associated with fever
• 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

Your doctor may decide to keep you under observation or change how you should be treated.

Tell your doctor as soon as possible if you experience any of the following side effects and they worry you.

• tiredness, pale skin and breathlessness
• bruising
• feeling sick (nausea)
• headache
• diarrhoea, indigestion, or stomach pain
• pain in the arms or legs
• constipation
• fever
• frequent infections such as severe chills, sore throat and mouth ulcers
• mild rash, itchy skin
• fast heart beat

These side effects are usually mild.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 RIVOXA contains

Do not take this medicine if you are allergic to any of these ingredients.

What RIVOXA looks like

RIVOXA 2.5 mg – Light yellow, circular, biconvex film coated tablets, debossed with "123" on one side and “2.5” on other side. (AUST R 398241)

Who distributes RIVOXA

Pharmacor pty ltd.
Suite 803, Level 8, Tower A, The Zenith, 821 Pacific Highway, Chatswood NSW 2067
www.pharmacor.com.au
phone: 1300 138 805

This leaflet was prepared in June 2024.

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.

The educational material (patient alert card and prescribers guide) can be accessed from this link

Published by MIMS February 2025