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.

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

3. What if I am taking other medicines?

Some medicines may interfere with RIVAROXABAN-TEVA 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 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

More instructions can be found in Section 4. How do I use RIVAROXABAN-TEVA? in the full CMI.

5. What should I know while using RIVAROXABAN-TEVA?

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

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.

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.

RIVAROXABAN-TEVA

Film coated tablets

Active ingredient(s): Rivaroxaban

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

• 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

• 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

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

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.