Taro-Rivaroxaban: Uses, Side Effects and Dosage

What Taro-Rivaroxaban is used for:

Taro-Rivaroxaban 10 mg, 15 mg and 20 mg tablets are used in adults to:

• prevent blood clots after major hip or knee surgery
• treat and prevent blood clots in the veins of the legs, arms or lungs
• prevent blood clots in the brain (stroke) and other blood vessels in the body of patients who have atrial fibrillation (irregular heart rhythm)

Taro-Rivaroxaban 2.5 mg tablets are used in combination with acetylsalicylic acid (ASA) in adults to:

• prevent stroke, heart attack or severe leg or arm pain in patients with peripheral artery disease who are at high risk. This is a condition where the blood vessels that carry blood away from the heart to other parts of the body (arteries) are narrowing due to plaque buildup.
• prevent stroke, heart attack, severe leg or arm pain, or death in patients with coronary heart disease. This is a condition where the blood vessels supplying blood to the heart (coronary arteries) become narrow or blocked due to plaque buildup. This causes a lack of oxygen in the heart. These patients may also have peripheral artery disease.

How Taro-Rivaroxaban works:

Taro-Rivaroxaban belongs to a group of medicines called anticoagulants (blood thinners). It helps prevent blood clots from forming by directly blocking the activity of a clotting factor called Factor-Xa.

The ingredients in Taro-Rivaroxaban are:

Medicinal ingredient: rivaroxaban

Non-medicinal ingredients:

croscarmellose sodium, low-substituted hydroxyl propyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate

1. 2. 5 mg tablet coating: Hypromellose 2910 (HPMC), Lactose Monohydrate, Macrogol/PEG 3350, Titanium dioxide, Iron Oxide Yellow, Iron Oxide Black. Light Yellow, film coated, round tablets.

10 mg tablet coating: Hypromellose 2910 (HPMC), Lactose Monohydrate, Macrogol/PEG 3350, Titanium dioxide, Iron Oxide Yellow FD&C Blue No. 1 and FD&C Red No. 40 Pink, film coated, round tablets.

15 mg tablet coating: Hypromellose 2910 (HPMC), Lactose Monohydrate, Macrogol/PEG 3350, Titanium dioxide, Iron Oxide Red, Carmine and FD&C Yellow No. 6. Red, film coated, round tablets.

20 mg tablet coating: Hypromellose 2910 (HPMC), Lactose Monohydrate, Macrogol/PEG 3350,

Titanium dioxide and Iron Oxide Red. Dark red, film coated, round tablets.

Taro-Rivaroxaban comes in the following dosage forms:

• Tablets: 2.5 mg, 10 mg, 15 mg and 20 mg

Do not use Taro-Rivaroxaban if you:

• are allergic to rivaroxaban or to any other ingredients in Taro-Rivaroxaban. Taro-Rivaroxaban tablets contain lactose.
• are actively bleeding, especially if you are excessively bleeding

• have any injuries or conditions that may increase your risk of bleeding. This includes:

  • active or recent bleeding in the brain
  • active or recent bleeding in the stomach or gut
  • have difficulties to stop bleeding (bleeding disorder)
• take medicines to treat HIV/AIDS, such as cobicistat and ritonavir
• take medicines to treat fungal infections, such as ketoconazole, itraconazole and posaconazole
• take dronedarone, a medicine used to control an abnormal heart rhythm called atrial fibrillation

• take any other medicines used to prevent or treat blood clots. This includes:

  • warfarin, dabigatran, apixaban, edoxaban, heparin
  • low molecular weight heparin (LMWH), such as enoxaparin and dalteparin
  • heparin derivatives, such as fondaparinux
• have severe liver disease, which can lead to an increased risk of bleeding
• are pregnant, think you might be pregnant or plan on becoming pregnant
• are breastfeeding

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-Rivaroxaban. Talk about any health conditions or problems you may have, including if you:

• have an increased risk of bleeding. This includes if you:

  • have severe kidney problems or reduced kidney function
  • are taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to relieve pain and reduce inflammation, such as ibuprofen, naproxen and celecoxib
  • are taking acetylsalicylic acid (ASA, or ASPIRIN) or any other medicines used to prevent stroke or heart disease, such as clopidogrel, prasugrel and ticagrelor
  • are taking medicines to treat depression or other psychological conditions
  • have low levels of platelets in the blood or your platelets do not work properly
  • have very high blood pressure, not controlled by medical treatment
  • have or have had an ulcer in the stomach or bowel
  • have a problem with the blood vessels in the back of the eyes (retinopathy)
  • have problems with the blood vessels in the brain or spinal column
  • had surgery on the brain, spinal column or eyes
  • have bronchiectasis, which is a chronic disease where the bronchial tubes of the lungs become damaged, widened, and thickened
  • have a history of bleeding into the lungs
  • are older than 75 years of age
  • have been diagnosed with cancer, had a relapse of cancer or have been treated for cancer in the last 6 months
  • have liver problems
  • are having surgery for any reason, including an operation that involves a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia or pain reduction)
• have damaged heart valves or heart valve disease
• have a prosthetic heart valve
• have antiphospholipid syndrome, also known as Hughes syndrome. This is a disorder of the immune system that causes an increased risk of blood clots.
• have a stent, which is a small metal coil inserted into a blocked blood vessel to restore blood flow by keeping it open
• have a history of stroke, with or without bleeding in the brain
• are taking rifampicin, a medicine used to treat bacterial infections, including tuberculosis
• are taking medicines used to prevent epilepsy or seizures, such as phenytoin, carbamazepine and phenobarbital
• are lactose intolerant. Taro-Rivaroxaban tablets contain lactose.

Other warnings you should know about:

Do not stop taking without first talking to your healthcare professional. If you taking Taro-Rivaroxaban, blood clots may form and cause a stroke, heart attack, or other serious complications. This can lead to severe disability or even death.

Risk of Bleeding: As with other blood thinners, taking Taro-Rivaroxaban may increase the risk of bleeding from any part of the body, including internal organs. It may be serious or even life-threatening. Tell your healthcare professional right away if you have any unusual bleeding or bruising. For examples of bleeding, see the Serious side effects and what to do about them table below.

Spinal or epidural blood clots (hematoma): People who take Taro-Rivaroxaban and have medicine injected into their spinal or epidural area, or have a spinal puncture, have a risk of forming a spinal or epidural blood clot. This can cause long-term or permanent loss of the ability to move (paralysis). The risk of developing a spinal or epidural blood clot is higher if:

• A thin tube called an epidural catheter is placed in your back to give certain

  medicines

• You take NSAIDs or a medicine to prevent blood from clotting
• You have a history of difficult or repeated epidural or spinal punctures
• You have a history of problems with the spinal column or have had surgery on the spinal column

If you take Taro-Rivaroxaban and receive spinal anesthesia or have a spinal puncture, your healthcare professional will watch you closely for symptoms of spinal or epidural blood clots.

Tell your healthcare professional right away if you develop the following symptoms after an epidural or a spinal procedure:

• back pain
• tingling
• numbness
• muscle weakness (especially in your legs and feet)
• or loss of control of the bowels or bladder (incontinence)

Surgery:

• Tell your healthcare professional if you are going to have any surgeries, including dental procedures, while taking Taro-Rivaroxaban. There is an increased risk of bleeding if you take Taro-Rivaroxaban during these procedures. It can be life-threatening.
• Your healthcare professional may ask you to stop taking Taro-Rivaroxaban before the surgery, and to resume taking Taro-Rivaroxaban after the procedure. It is important that you take Taro-Rivaroxaban before and after the procedure exactly at the times the healthcare professional has instructed.

Anticoagulant-Related Nephropathy (ARN):

Some cases were reported in patients taking Taro-Rivaroxaban. It is a type of serious kidney damage caused by anticoagulant medicines. ARN causes bleeding in the kidneys, sometimes with the presence of blood in the urine. This leads to the kidneys being unable to function properly. Your healthcare professional may monitor the health of your kidneys during your treatment with Taro-Rivaroxaban. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.

Children and adolescents:

• Taro-Rivaroxaban is not indicated in children less than 18 years of age.

Pregnancy:

• Taro-Rivaroxaban should not be used during pregnancy. Taking it during pregnancy may harm an unborn baby.
• Your healthcare professional may ask you to use a highly effective birth control method while taking Taro-Rivaroxaban.
• If you discover that you are pregnant while taking Taro-Rivaroxaban, contact your healthcare professional as soon as possible.

Breastfeeding: Taro-Rivaroxaban should not be used while breastfeeding. It may pass into breast milk and harm a breastfed baby. Taro-Rivaroxaban will only be given to you once you have stopped breastfeeding.

Check-ups and testing: Your healthcare professional may:

• evaluate your risk of bleeding before starting Taro-Rivaroxaban and regularly during treatment. This includes performing blood tests to check the amount of red blood cells in the blood, and monitoring blood pressure.
• do blood tests before you start taking Taro-Rivaroxaban and during treatment to check if your kidneys are working properly

Depending on the test results, your healthcare professional may discontinue your

treatment with Taro-Rivaroxaban.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

The following may interact with Taro-Rivaroxaban:

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to relieve pain and reduce inflammation, such as ibuprofen, naproxen and celecoxib

• Acetylsalicylic acid (ASA, or ASPIRIN), used to relieve fever and pain
• Medicines used to prevent stroke or heart disease, such as clopidogrel, prasugrel and ticagrelor
• Dronedarone, a medicine used to control an abnormal heart rhythm called atrial fibrillation
• Medicines used to treat bacterial infections, such as clarithromycin and rifampicin
• Medicines used to control epilepsy or seizures, such as phenytoin, carbamazepine and phenobarbital
• Medicines used to treat depression or other psychological conditions, such as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
• St. John’s Wort (also known as Hypericum perforatum), a herbal remedy used to treat

depression

Taro-Rivaroxaban 2.5 mg tablets are prescribed with acetylsalicylic acid (ASA). Ask your healthcare professional first before taking any other NSAIDs. They will determine if it is beneficial for you to take it during your treatment with Taro-Rivaroxaban and ASA.

Serious drug interactions with Taro-Rivaroxaban include:

• Certain treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein (P-gp), such as

  • medicines used to treat HIV/AIDS, such as cobicistat and ritonavir
  • medicines used to treat fungal infections, such as ketoconazole, itraconazole and posaconazole

• Other anticoagulant medicines to prevent or treat blood clots, including

  • unfractionated heparin (UFH), except at doses used to maintain a patent central venous or arterial catheter,
  • low molecular weight heparins (LMWH), such as enoxaparin and dalteparin,
  • heparin derivatives, such as fondaparinux, and
  • oral anticoagulants, such as warfarin, dabigatran, apixaban, edoxaban

How to take Taro-Rivaroxaban:

• Take:

  • Taro-Rivaroxaban tablets exactly as your healthcare professional tells you
  • Taro-Rivaroxaban tablets at the same time every day to help you remember it

  • Taro-Rivaroxaban 2.5 mg and 10 mg tablets with or without food

  • Taro-Rivaroxaban 15 mg and 20 mg tablets with food

• Swallow tablet whole, preferably with water. Do not split tablets.

  .

• Taro-Rivaroxaban tablets may be crushed and mixed with applesauce. Take the applesauce mixture right away after you have mixed it. A crushed 2.5 mg or 10 mg tablet can be taken with or without food. Eat food right after taking a crushed 15 mg or 20 mg tablet. The healthcare professional may give you the crushed Taro-Rivaroxaban tablet also via a tube.
• It is not recommended to crush and mix a 2.5 mg Taro-Rivaroxaban tablet and an acetylsalicylic acid (ASA, or ASPIRIN) tablet together with applesauce.
• Do not stop taking Taro-Rivaroxaban without talking to the healthcare professional first.

If you spit up the dose or vomit:

• less than 30 minutes after taking Taro-Rivaroxaban, take or give a new dose
• more than 30 minutes after taking Taro-Rivaroxaban, do not take or give a new dose. In this case, take or give the next Taro-Rivaroxaban dose at the usual time.

Contact the healthcare professional if you repeatedly spit up the dose or vomit after taking Taro-Rivaroxaban.

Usual dose:

• Prevention of blood clots after major hip or knee surgery

  Usual adult dose: Take one 10 mg tablet once a day with or without food.

  Take the first tablet 6 to 10 hours after your operation. Then take a tablet every day until your healthcare professional tells you to stop.

  If you have had a major hip operation, you will usually take Taro-Rivaroxaban for 35 days. If you have had a major knee operation, you will usually take Taro-Rivaroxaban for 14 days.

• Treatment and prevention of blood clots in the veins of the legs or arms, or blood vessels of the lungs

  Adults:

  • Day 1 to 21: Take one 15 mg tablet TWICE a day (in the morning and evening) with food.
  • Day 22 and onwards: Take one 20 mg tablet ONCE a day with food.

After at least 6 months treatment, your healthcare professional may decide to continue treatment with either one 20 mg tablet once a day or one 10 mg tablet once a day.

The 10 mg tablet may be taken with or without food.

This is a long-term treatment and you should continue to take Taro-Rivaroxaban until your healthcare professional says otherwise.

• Prevention of blood clots in your brain (stroke) and in other blood vessels of your body if you have atrial fibrillation

  Usual adult dose: Take one 20 mg tablet once a day with food.

  If your kidneys are not working properly, your healthcare professional may prescribe 15 mg once a day with food.

  This is a long-term treatment and you should continue to take Taro-Rivaroxaban until your healthcare professional says otherwise.

  The recommended maximum daily dose is 20 mg.

• Prevention of stroke, heart attack, severe leg or arm pain, or death if you have coronary artery disease and/or peripheral artery disease

  Usual adult dose: Take one 2.5 mg tablet twice a day with or without food. Take Taro-Rivaroxaban around the same time every day (for example, one tablet in the morning and one in the evening).

  Also take 1 tablet of 75 mg – 100 mg of acetylsalicylic acid (ASA, or ASPIRIN) once a day. Take the ASA tablet at the same time as one of your Taro-Rivaroxaban doses.

  This is long-term treatment and you should continue to take your treatment until your healthcare professional says otherwise.

Overdose:

Taking too much Taro-Rivaroxaban may cause excessive bleeding.

Missed dose:

• If you take Taro-Rivaroxaban 2.5 mg tablets twice a day and miss a dose, skip the missed dose and take the next dose as usual.
• If you take Taro-Rivaroxaban 15 mg tablets twice a day and miss a dose, take the missed dose as soon as you remember. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. Do not take more than two 15 mg tablets in one day. The next day, take Taro-Rivaroxaban as usual.
• If you take Taro-Rivaroxaban 10 mg, 15 mg or 20 mg tablets once a day and miss a dose, take the missed dose as soon as you remember on the same day. If this is not possible, you should skip the missed dose and take the next dose on the following day as usual. Do not take a double dose to make up for the one that was missed.

Possible side effects from using Taro-Rivaroxaban:

These are not all the possible side effects you may have when taking Taro-Rivaroxaban. If you experience any side effects not listed here, tell your healthcare professional.

As Taro-Rivaroxaban acts on the blood clotting system, most side effects are related to signs of

If you think you, or a person you are caring for, have taken too much Taro-Rivaroxaban, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll- free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.

bruising or bleeding. In some cases, bleeding may not be obvious, such as unexplained swelling.

Patients treated with Taro-Rivaroxaban may also experience the following side effects:

Nausea, vomiting, stomach ache, constipation, diarrhea, indigestion, and decreased general strength and energy.

Taro-Rivaroxaban can cause abnormal blood test results. The healthcare professional may perform blood tests before you take Taro-Rivaroxaban and regularly during treatment. They will tell you if the test results are abnormal and if you need treatment to correct these side effects.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

• Keep Taro-Rivaroxaban tablets at room temperature (15°C - 30°C).
• Keep out of the reach and sight of children.
• Do not use Taro-Rivaroxaban after the expiry date which is stated on the bottle and on each blister after EXP. The expiry date refers to the last day of that month.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

If you want more information about Taro-Rivaroxaban:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975

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Date of Authorization: DEC 17, 2025