Consumer Information for: RIVA RIVAROXABAN

RIVA 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)

RIVA 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.

RIVA RIVAROXABAN 15 mg and 20 mg tablets are used to treat and prevent blood clots in the veins of the arms or legs, or in the blood vessels of the lungs in:

• children and adolescents below 18 years of age who weigh from 30 kg to 50 kg (15 mg tablets)

• children and adolescents below 18 years of age who weigh more than 50 kg (20 mg tablets)

RIVA RIVAROXABAN will be given to your child once they complete at least 5 days of treatment with an injectable blood thinner.

RIVA 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.

Medicinal ingredient: rivaroxaban

Non-medicinal ingredients: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Croscarmellose Sodium, Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate, Sodium Lauryl Sulphate. The filmcoating contains: FD & C Yellow #5 (for the 2.5 mg), Hypromellose, Iron Oxide Red (for the 10 mg, 15 mg and 20 mg), Iron Oxide Yellow (for the 2.5 mg), Polyethylene Glycol, Titanium Dioxide.

Film-coated tablets: 2.5 mg, 10 mg, 15 mg and 20 mg.

• 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. RIVA RIVAROXABAN tablets contain lactose.

Do not stop taking or giving RIVA RIVAROXABAN to your child without first talking to your healthcare professional. If you or your child stop taking RIVA 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 RIVA 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 or your child 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 RIVA 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/your child’s back to give certain medicines

• You/your child take NSAIDs or a medicine to prevent blood from clotting

• You/your child have a history of difficult or repeated epidural or spinal punctures

• You/your child have a history of problems with the spinal column or have had surgery on the spinal column

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

Tell your healthcare professional right away if you/your child develops 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 or your child are going to have any surgeries, including dental procedures, while taking RIVA RIVAROXABAN. There is an increased risk of bleeding if you or your child take RIVA RIVAROXABAN during these procedures. It can be life-threatening.

• Your healthcare professional may ask you or your child to stop taking RIVA RIVAROXABAN before the surgery, and to resume taking RIVA RIVAROXABAN after the procedure. It is important that you or your child take RIVA RIVAROXABAN before and after the procedure exactly at the times the healthcare professional has instructed.

Children and adolescents:

• RIVA RIVAROXABAN 2.5 mg and 10 mg tablets are not to be used in children and adolescents under 18 years of age.

• RIVA RIVAROXABAN should not be used in children and adolescent under 18 years of age for any conditions other than the treatment and prevention of blood clots in the veins of the legs or arms, or blood vessels in the lungs.

Pregnancy:

• RIVA RIVAROXABAN should not be used during pregnancy. Taking it during pregnancy may harm an unborn baby.

• Your healthcare professional may ask you or your child (depending on their age), to use a highly effective birth control method while taking RIVA RIVAROXABAN.

• If you or your child discover that you/they are pregnant while taking RIVA RIVAROXABAN, contact your healthcare professional as soon as possible.

Breastfeeding: RIVA RIVAROXABAN should not be used while breastfeeding. It may pass into breast milk and harm a breastfed baby. RIVA RIVAROXABAN will only be given to you/your child once you/they have stopped breastfeeding.

Check-ups and testing: Your healthcare professional may:

• evaluate your/your child’s risk of bleeding before starting RIVA 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/your child start taking RIVA RIVAROXABAN and during treatment to check if your/your child’s kidneys are working properly

Depending on the test results, your healthcare professional may discontinue your/your child’s treatment with RIVA RIVAROXABAN.

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

• 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

• 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

• Medicines used to treat HIV/AIDS, such as cobicistat and ritonavir

• Medicines used to treat fungal infections, such as ketoconazole, itraconazole and posaconazole

• 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

RIVA 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 RIVA RIVAROXABAN and ASA.

• Take or give your child:

  • RIVA RIVAROXABAN tablets exactly as your healthcare professional tells you

  • RIVA RIVAROXABAN tablets at the same time every day to help you remember it

  • RIVA RIVAROXABAN 2.5 mg and 10 mg tablets with or without food

  • RIVA RIVAROXABAN 15 mg and 20 mg tablets with food

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

• Tell your child’s healthcare professional if your child has trouble swallowing RIVA RIVAROXABAN tablets. They may prescribe your child another rivaroxaban product.

• RIVA RIVAROXABAN tablets may be crushed and mixed with apple sauce. 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 or the child the crushed RIVA RIVAROXABAN tablet also via a tube.

• It is not recommended to crush and mix a 2.5 mg RIVA RIVAROXABAN tablet and an acetylsalicylic acid (ASA, or ASPIRIN) tablet together with applesauce.

• Do not stop taking or giving RIVA RIVAROXABAN to your child without talking to the healthcare professional first.

• If you or the child spits up the dose or vomits:

  • less than 30 minutes after taking RIVA RIVAROXABAN, take or give a new dose

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

Contact the healthcare professional if you or the child repeatedly spits up the dose or vomits after taking RIVA RIVAROXABAN.

• 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 RIVA RIVAROXABAN for 35 days.

If you have had a major knee operation, you will usually take RIVA 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 RIVA RIVAROXABAN until your healthcare professional says otherwise.

Children: RIVA RIVAROXABAN is available for children as tablets. Your child’s healthcare professional will decide the right dose of RIVA RIVAROXABAN for your child depending on their body weight.

Always give RIVA RIVAROXABAN to your child exactly as the healthcare professional tells you to. You should check with your child’s healthcare professional if you are not sure.

Children should keep scheduled visits with their healthcare professional. This is because their dose of RIVA RIVAROXABAN should be adjusted as their weight changes.

• 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 RIVA 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 RIVA

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 RIVA RIVAROXABAN doses.

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

Taking too much RIVA RIVAROXABAN may cause excessive bleeding.

• If you take RIVA 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 RIVA 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 RIVA RIVAROXABAN as usual.

• If you or your child takes RIVA RIVAROXABAN 10 mg, 15 mg or 20 mg tablets once a day and miss a dose, take or give your child the missed dose as soon as you remember on the same day. If this is not possible, you or your child should skip the missed dose and take the next dose on the following day as usual. Do not take or give your child a double dose to make up for the one that was missed.

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

As RIVA RIVAROXABAN acts on the blood clotting system, most side effects are related to signs of bruising or bleeding.

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

Patients treated with RIVA RIVAROXABAN may also experience the following side effects:

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

In general, the side effects observed in children treated with RIVA RIVAROXABAN were similar in type to those observed in adults and were primarily mild to moderate in severity.

Side effects that were observed more often in children include: Very common: headache, fever, nose bleeding, vomiting.

Common: raised heartbeat, blood tests may show an increase in bilirubin, low number of platelets which are cells that help blood to clot, heavy menstrual bleeding observed in girls.

Uncommon: blood tests may show an increase in a subcategory of bilirubin (direct bilirubin).

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

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.

• Keep RIVA RIVAROXABAN tablets at room temperature (15°C - 30 °C).

• Keep out of the reach and sight of children.

• Do not use RIVA RIVAROXABAN after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.

• 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.

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by contacting the sponsor Laboratoire Riva Inc. at: 1-800-363-7988.

This leaflet was prepared by:

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Quebec J7C 3V4

www.labriva.com

Last revised: AUG 25 , 2023