Mint-Rivaroxaban: Uses, Side Effects and Dosage

What is MINT-RIVAROXABAN used for?

MINT-RIVAROXABAN 10 mg, 15 mg and 20 mg are used in adults to:

• prevent blood clots after major hip or knee surgery
• treat and prevent blood clots in the veins of your legs or lungs
• prevent blood clots in your brain (stroke) and in other blood vessels in your body if you have atrial fibrillation

How does MINT-RIVAROXABAN work?

MINT-RIVAROXABAN is an anticoagulant. It helps prevent blood clots from forming by directly blocking the activity of clotting Factor-Xa.

What are the ingredients in MINT-RIVAROXABAN?

Medicinal ingredients: rivaroxaban

Non-medicinal ingredients: Cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, red iron oxide, sodium lauryl sulfate, titanium dioxide

MINT-RIVAROXABAN comes in the following dosage forms:

• Film coated tablets; 10 mg, 15 mg and 20 mg

Do not use MINT-RIVAROXABAN if you:

• are allergic to rivaroxaban or any of the other ingredients of MINT-RIVAROXABAN. MINT-RIVAROXABAN tablets contain lactose
• are actively bleeding, especially if you are bleeding excessively

• 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 medications to treat HIV/AIDS, such as cobicistat or 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 leads to an increased risk of bleeding
• are pregnant, think you might be pregnant or plan on becoming pregnant
• are breastfeeding
• are younger than 18 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MINT-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
  • if you 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 16 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. MINT-RIVAROXABAN tablets contain lactose.

Other warnings you should know about:

Do not stop taking MINT-RIVAROXABAN without first talking to your healthcare professional. If you stop taking MINT-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 MINT-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 MINT-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 MINT-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 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 MINT-RIVAROXABAN. There is an increased risk of bleeding if you take MINT-RIVAROXABAN during these procedures. It can be life-threatening.
• Your healthcare professional may ask you to stop taking MINT-RIVAROXABAN before the surgery, and to resume taking MINT-RIVAROXABAN after the procedure. It is important that you take MINT-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 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 MINT-RIVAROXABAN. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.

Pregnancy:

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

Breastfeeding: MINT-RIVAROXABAN should not be used while breastfeeding. It may pass into breast milk and harm a breastfed baby. MINT-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 MINT-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 MINT-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 MINT-RIVAROXABAN.

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

The following may interact with MINT-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

• 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

How to take MINT-RIVAROXABAN :

• Take:

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

  • MINT-RIVAROXABAN 10 mg tablets with or without food

  • MINT-RIVAROXABAN 15 mg and 20 mg tablets with food
• Swallow tablet whole, preferably with water. Do not split tablets.
• MINT-RIVAROXABAN tablets may be crushed and mixed with applesauce. Take the applesauce mixture right away after you have mixed it. A crushed 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 MINT-RIVAROXABAN tablet also via a tube.
• Do not stop taking MINT-RIVAROXABAN without talking to the healthcare professional first.

• If you spit up the dose or vomit:

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

Contact the healthcare professional if you repeatedly spit up the dose or vomit after taking MINT-RIVAROXABAN

Usual dose:

• Prevention of blood clots after major hip or knee surgery

  Usual adult dose: Take one 10 mg 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 MINT-RIVAROXABAN for 35 days.

  If you have had a major knee operation, you will usually take MINT-RIVAROXABAN for 14 days.

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

  • Day 1 to 21: Take one 15 mg tablet TWICE a day (in the morning and evening) with food.
  • Day 22 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 long-term treatment and you should continue to take MINT-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 MINT-RIVAROXABAN until your healthcare professional says otherwise.

  The recommended maximum daily dose is 20 mg.

Overdose:

Taking too much MINT-RIVAROXABAN may cause excessive bleeding.

Missed Dose:

• If you take MINT-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 MINT-RIVAROXABAN as usual.
• If you take MINT-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.

What are possible side effects from using MINT-RIVAROXABAN?

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

As 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 MINT-RIVAROXABAN may also experience the following side effects:

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

MINT-RIVAROXABAN can cause abnormal blood test results. The healthcare professional may perform blood tests before you take MINT-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.

Serious side effects and what to do about them

Serious side effects and what to do about them

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.

Reporting Side Effects

Storage:

• Keep at room temperature (15°C-30°C).
• Keep out of reach and sight of children.
• Do not use MINT-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.

If you want more information about MINT-RIVAROXABAN:

• 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; the manufacturer’s website www.mintpharmaceuticals.com .

Last Revised: OCT 18, 2024