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This leaflet is Part III of a three-part "Product Monograph" published when ELIQUIS was approved for sale in Canada and is designed specifically for Consumers.
This leaflet is a summary and will not tell you everything about ELIQUIS. Contact your doctor or pharmacist if you have any questions about the drug.
About this medication
What the medication is used for:
ELIQUIS is used in adults for the following conditions:
· Knee or hip replacement surgery: To prevent blood clots from forming after knee or hip replacement surgery.
· Atrial fibrillation:To reduce the risk of stroke (damage to part of the brain caused by an interruption of its blood supply), and systemic embolism (the sudden blocking of a blood vessel by a blood clot) in people who have a heart condition called atrial fibrillation (irregular heart beat).
· Blood clots: To treat deep vein thrombosis (blood clots in the veins of your legs) and pulmonary embolism (blood clots in the blood vessels of your lungs) and reduce the risk of them occurring again.
What it does:
ELIQUIS belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming by blocking one of the molecules that causes blood clotting (known as Factor Xa).
When it should not be used:
- you are aware of body lesions at risk of bleeding, including bleeding in the brain (stroke).
- you have certain types of abnormal bleeding such as recent bleeding of a stomach ulcer.
- you have active bleeding, especially if you are bleeding excessively
- you have a severe liver disease which leads to increased risk of bleeding (hepatic coagulopathy)
- you are already taking medicines to prevent blood clots, e.g.warfarin (COUMADIN®), heparin, rivaroxaban (XARELTO®), dabigatran (PRADAXA®), unless your physician has decided to switch you to ELIQUIS
- you are also taking prasugrel (EFFIENT®) or ticagrelor (BRILINTA®)
- ELIQUIS should not be used during pregnancy, since its effects on pregnancy and the unborn child are not known
- you are taking oral ketoconazole (a drug used to treat fungus infection)
- while epidural or spinal catheters are in place or within the first five hours after their removal. Your doctor will know what precautionary measures are required. ELIQUIS is not recommended for patients receiving epidural pain control after surgery.
- you have an artificial heart valve
- you are younger than 18 years old.
you are allergic (hypersensitive) to apixaban (active ingredient of ELIQUIS) or any of the other ingredients of ELIQUIS. The ingredients are listed in the “What the nonmedicinal ingredients are:” section of this leaflet
What the medicinal ingredient is:
What the important nonmedicinal ingredients are:
Lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium laurylsulfate and magnesium stearate.
Coating ingredients: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, yellow iron oxide (2.5 mg) and red iron oxide (5 mg).
What dosage forms it comes in:
Film-coated tablets in yellow colour, 2.5 mg.
Film-coated tablets in pink colour, 5 mg.
Warnings & Precautions
Do not stop taking ELIQUIS without first talking with your doctor. If you stop taking ELIQUIS, blood clots may cause a stroke or other complications. This can be fatal or lead to severe disability.
BEFORE you use ELIQUIS talk to your doctor or pharmacist if you have any of the following:
- an increased risk of bleeding, such as:
- bleeding disorders
- an active or a recent ulcer of your stomach or bowel
- infection of the heart (bacterial endocarditis)
- recent bleeding in your brain (hemorrhagic stroke)
- very high blood pressure, not controlled by medical treatment
- a recent operation on your brain, spinal column or eye
- a severe kidney disease
- a mild or moderate liver disease
- a tube (catheter) inserted in your back
- had an injection into your spinal column within the previous 5 hours, such as an epidural, for anaesthesia or pain relief.
- had an operation for a hip fracture because this medicine has not been studied for this condition.
- you are 75 years of age or older.
ELIQUIS is not recommended in children and adolescents under 18 years of age.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The effects of ELIQUIS on pregnancy and the unborn child are not known. You should not take ELIQUIS if you are pregnant. Contact your doctor immediately if you become pregnant while taking ELIQUIS.
It is not known if ELIQUIS passes into human breast milk. Ask your doctor or pharmacist for advice before taking ELIQUIS while breast-feeding.
Interactions with this medication
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.
Some medicines may increase the effects of ELIQUIS and some may decrease its effects. Your doctor will decide, if you should be treated with ELIQUIS when taking these medicines and how closely you should be monitored.
Drugs that may interact with ELIQUIS include:
Medicines that may increase the effects of ELIQUIS:
- some medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole and posaconazole)
- some antiviral medicines for HIV / AIDS (e.g. ritonavir)
- other medicines that are used to reduce blood clotting (e.g. enoxaparin, clopidogrel, prasugrel)
- anti-inflammatory or pain medicines (e.g. aspirin or naproxen)
- medicines for high blood pressure or heart problems (e.g. diltiazem)
Medicines that may reduce the effects of ELIQUIS:
- medicines to treat tuberculosis or other infections (e.g. rifampin, rifampicin)
- medicines to prevent epilepsy or seizures (e.g. phenytoin, carbamazepine, or phenobarbital)
- St John’s Wort (a herbal supplement used for depression)
Proper use of this medication
ELIQUIS can be taken with or without food.
ELIQUIS should be taken regularly, as prescribed, to ensure best results. All temporary discontinuations should be avoided, unless recommended by your physician.
Usual adult dose:
Knee or hip replacement surgery:
Take one 2.5 mg tablet twice daily, one in the morning and one in the evening. Take the tablet at the same time every day, preferably 12 hours apart. Swallow the tablet whole with a drink of water. DO NOT chew the tablet. DO NOT stop taking this medication without advice from the doctor.
Always take ELIQUIS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
If you have trouble swallowing the tablet(s)
Follow the steps below to crush the ELIQUIS tablet(s). This will help make sure that all of the crushed tablet(s) will be taken.
- use a mortar and pestle or a similar device to crush the tablets(s)
- transfer the powder to a drinking glass or a small bowl
when using water:
- add a small amount of water (30 mL) to the mortar and pestle/device and stir
- transfer the water to the drinking glass
- mix the powder with the water and drink right away.
- rinse the glass with a small amount of water and drink right away
when using apple sauce:
- mix the powder with a small amount of apple sauce (30g) in a small bowl and eat with a spoon right away
- add a small amount of water (30mL) to the mortar and pestle/device and stir
- transfer the water to the bowl and drink right away
rinse the bowl and the spoon with a small amount of water and drink right away.
Length of treatment
After major hip operation you will usually take the tablets for up to 38 days.
After major knee operation you will usually take the tablets for up to 14 days.
Do not stop taking ELIQUIS without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early.
Atrial fibrillation (AF):
For most patients with AF, the recommended dose of ELIQUIS is 5 mg taken orally twice daily.
Depending on your age, weight or kidney function, your doctor may prescribe 2.5 mg twice daily.
If you are currently taking warfarin (another oral anticoagulant) or receive anticoagulant treatment given by injection, and your doctor has decided ELIQUIS is appropriate for you, make sure you ask your doctor when and how best to switch and start taking ELIQUIS.
If you have atrial fibrillation and stop taking ELIQUIS without talking to your doctor, you are at risk of suffering from a stroke or other complications due to blood clot formation, which can be fatal or lead to severe disability.
Treatment and prevention of blood clots in the veins of your legs or lungs:
Take 10 mg twice daily (two 5 mg tablets in the morning and two 5 mg tablets in the evening) for 7 days. For treatment after 7 days, take 5 mg twice daily (one 5 mg tablet in the morning and one 5 mg tablet in the evening).
After a minimum of 6 months of treatment, your doctor may prescribe ELIQUIS 2.5 mg twice daily (one 2.5 mg tablet in the morning and one 2.5 mg tablet in the evening).
Length of treatment
This is long-term treatment and you should continue to take ELIQUIS until your doctor says otherwise.
Tell your doctor immediately if you have taken more than the prescribed dose of ELIQUIS.
You may have an increased risk of bleeding. If bleeding occurs, surgery or blood transfusions may be required.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you have missed a dose, take the medicine as soon as you remember and continue with your remaining daily dose of ELIQUIS; then carry on taking one tablet, twice a day as normal.
Do not take a double dose to make up for a forgotten tablet of ELIQUIS.
Side effects and what to do about them
Like all medicines, ELIQUIS can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist if you experience any of the following symptoms after taking this medicine.
Like other similar medicines (anticoagulants), ELIQUIS may cause bleedings which could possibly lead to anemia, (a low blood cell count which may cause tiredness or paleness). In some cases this bleeding may not be obvious. Nausea (feeling sick) is also a common side effect.
Serious side effects, how often they happen & what to do about them
|Symptoms / Effects||Talk with your doctor or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
Rash, hives, swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing
|Anemia: fatigue, loss of energy, weakness, shortness of breath||x|
|Blood in the urine (that stains the urine pink or red)||x|
|Bruising and swelling,||x|
|Bleeding after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision||x|
|Bleeding in your stomach, bowel or blood in the stool||x|
|Bleeding from your nose||x|
|Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite||x|
Low Blood Pressure:
dizziness, fainting, lightheadedness. May occur when you go from lying or sitting to standing up
– into a muscle
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.
This is not a complete list of side effects. For any unexpected effects while taking ELIQUIS, contact your doctor or pharmacist.
How to store it
Keep at room temperature (15-30°C).
Keep out of the reach and sight of children.
Do not use ELIQUIS after the expiry date which is stated on the carton, the blister or 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 dispose of medicines no longer required. These measures will help to protect the environment.
Reporting suspected side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.
The Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at: www.bmscanada.ca and www.pfizer.ca or by contacting Bristol-Myers Squibb Canada, at 1-866-463-6267.
This leaflet was prepared by:
Bristol-Myers Squibb Canada, Montreal, Quebec H4S 0A4
and Pfizer Canada Inc. Kirkland, Quebec H9J 2M5
ELIQUIS is a registered trademark and Coumadin is a registered trademark of Bristol-Myers Squibb Company used under license by Bristol-Myers Squibb Canada. Other brands listed are trademarks of their respective owners.
Last revised: 16 June 2016