Product Monograph Part III for ^PrXARELTO^®

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)

---

^PrXARELTO^®

rivaroxaban
10 mg tablet
Bayer Inc.
Submission Control Number 119111

The Consumer Information Section (Part III) of the Product Monograph for XARELTO has been submitted by the drug sponsor and is attached for your information.

The attached version accompanied the Notice of Compliance issued on September 15, 2008, and does not necessarily reflect the most current information for the product.

For the most up-to-date product information, please consult your health care professional.

Due to the fact that the information originated with an organization that is not subject to the Official Languages Act, the document may only appear in the language in which it was written. Translations of the document are the responsibility of the sponsor involved.

Part III: Consumer Information

^PrXARELTO^®

rivaroxaban tablets

This leaflet is Part 3 of a three-part "Product Monograph" published when XARELTO was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about XARELTO. Contact your doctor or pharmacist if you have any questions about the drug.

About this Medication

What the medication is used for:

XARELTO is used to prevent blood clots in your veins after a major operation on your legs, either on your hip or your knee. These blood clots could dislodge and travel to the lungs causing serious health risks. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.

What it does:

XARELTO belongs to a group of medicines called anticoagulants (blood thinners). XARELTO works by directly inhibiting clotting factor Xa, an essential component to the blood-clotting process. It helps to prevent the development of unwanted blood clots (thrombosis) in blood vessels.

When it should not be used:

Do not take XARELTO:

• if you have severe liver disease which leads to an increased risk of bleeding
• if you have severely reduced kidney function. Your doctor will know how to determine your kidney function
• if you are bleeding excessively
• if you are aware of body lesions at risk of bleeding, including bleeding in the brain within the last 6 months
• if you are pregnant or breastfeeding
• if you are allergic (hypersensitive) to rivaroxaban (active ingredient of XARELTO) or any of the other ingredients of XARELTO. The ingredients are listed in the "What the nonmedicinal ingredients are" section of this leaflet

What the medicinal ingredient is:

The active substance is rivaroxaban.

What the nonmedicinal ingredients are:

cellulose microcrystalline, croscarmellose sodium, ferric oxide red, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, titanium dioxide.

What dosage forms it comes in:

Film coated tablets, 10 mg

XARELTO 10 mg film-coated tablets are light red, round, film-coated tablets marked with the Bayer Cross on one side and 10 and a triangle on the other side.

Warning and Precautions

It has been reported that taking XARELTO may result in bleeding, which can be serious or life-threatening. Stroke (bleeding inside the brain) and bleeding into the body cavity below the diaphragm, which contains the stomach, intestine, liver, and other organs, can occur.

Lactose is a nonmedicinal ingredient in XARELTO. Do not take XARELTO if a doctor has told you that you have one of the following rare hereditary diseases:

• Galactose intolerance
• Lapp lactase deficiency
• glucose-galactose malabsorption

Take special care with XARELTO:

• if you have an increased risk of bleeding such as
  • bleeding disorders
  • very high blood pressure, not controlled by medical treatment
  • active ulcer or a recent ulcer of your stomach or bowel
  • a problem with the blood vessels in the back of your eyes (retinopathy)
  • recent bleeding in your brain (stroke, intracranial or intracerebral bleeding)
  • a recent operation on your brain, spinal column or eye

Tell your doctor before you take XARELTO, if any of these apply to you. Your doctor may decide to keep you under closer observation.

If your operation involves a catheter or injection into your spinal column (eg, for epidural or spinal anesthesia or pain reduction):

• it is very important to take XARELTO 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

Pregnancy and breastfeeding

If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking XARELTO. If you become pregnant while you are taking XARELTO, immediately tell your doctor, who will decide how you should be treated.

Interactions with this Medication

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking:

• some medicines for fungal infections (eg, ketoconazole) unless they are only applied to the skin
• antiretroviral medicines for HIV/AIDS (eg, ritonavir [NORVIR^®] and lopinavir/ritonavir [KALETRA^®])
• other medicines to reduce blood clotting (eg, enoxaparin [LOVENOX^®] or clopidogrel [PLAVIX^®])
• anti-inflammatory and pain relieving medicines (eg, naproxen [NAPROSYN^®] or acetylsalicylic acid [ASPIRIN^®])

Tell your doctor before taking XARELTO, because its effect may be increased. Your doctor may decide to keep you under closer observation.

Proper use of this Medication

Usual dose

Always take XARELTO exactly as your doctor has told you. You should continue taking the tablets until they are finished. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet (10 mg) once a day.

Swallow the tablet preferably with water. It can be taken with or without food.

Take the first tablet 6 to 10 hours after your operation. Then take a tablet every day until your doctor tells you to stop. Try to take the tablet at the same time every day to help you to remember it.

If you have had a major hip operation, you will usually take the tablets for 35 days.

If you have had a major knee operation , you will usually take the tablets for 14 days.

Children and adolescents

Don't give XARELTO tablets to people under 18 years of age. There is not enough information on its use in children and adolescents.

Overdose

Contact your doctor or your regional Poison Control Centre immediately if you have taken too many XARELTO tablets. Taking too much XARELTO increases the risk of bleeding.

Missed Dose

If you have missed a dose, take it as soon as you remember. 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.

Stopped Treatment

Don't stop taking XARELTO without talking to your doctor first, because XARELTO prevents the development of a serious condition.

Side Effects and what to do about them

Like all medicines, XARELTO can cause side effects, although not everybody gets them.

Like other similar medicines (blood thinners), XARELTO may cause bleeding. In some cases bleeding may not be obvious, such as unexplained swelling.

The most common side effect seen with XARELTO is nausea.

Serious side effects, how often they happen and what to do about them

Symptom / Effect		Talk with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
		Only if severe	In all cases
Uncommon	Bleeding from the surgical wound, an injury or other procedure		√
	Anemia (Exceptional weakness, tiredness, paleness, dizziness, headache)		√
Un-common	Liquid oozing from the surgical wound		√
	Unexpected bruising or bleeding after operation		√
	Bleeding from bowel, blood in stools/ black stools, or when you vomit		√
	Genital bleeding in elderly and patients at risk of extensive abnormal menstrual bleeding		√
	Genital bleeding in all other groups excluding the above population	√
	Nose bleed (with a duration of >5 minutes)		√
	Bleeding gums when you brush your teeth (with a duration of >5 minutes)		√
	Blood in your urine, red/pink tinge to urine		√
	Low blood pressure (lightheaded-ness, dizziness, and/or fainting)		√
	Localized swelling, swelling in your limbs		√
	Itchy skin or rash		√
Rare	Impaired liver function (jaundice/ yellowing of the skin or eyes, dark urine)		√
	Bleeding into a joint (stiff, sore, hot or painful joint)		√
	Bleeding into the rectum or from hemorrhoids		√

You should be aware that prescription medicines carry some risks and that all possible risks may not be known at this stage.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If you think you have an allergic reaction to XARELTO (symptoms such as red and lumpy skin, rash, hives, swelling, trouble breathing), it is important that you seek medical advice from your doctor straight away.

This is not a complete list of side effects. For any unexpected effects while taking XARELTO, contact your doctor or pharmacist.

How to store it

Keep at room temperature (15°C-30°C).

Keep out of the reach and sight of children.

Do not use XARELTO 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reporting Suspected Side Effects

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance by:

Toll-free telephone: 866-234-2345
Toll-free fax: 866-678-6789

Online: www.healthcanada.gc.ca/medeffect

By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney's Pasture, AL 0701C
Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.bayer.ca or obtained by contacting the sponsor, Bayer Inc., at 1-800-265-7382.

This leaflet was prepared by:

Bayer Inc.
77 Belfield Road
Toronto, Ontario M9W 1G6
Canada

Last revised: September 10, 2008

^©2008, Bayer Inc.

^®XARELTO is a trademark of Bayer AG, used under license by Bayer Inc.

All other trademarks are the property of their respective owners.