Patient Medication Information: uses, side effects, how to take - Bio-Apixaban
ABOUT THIS MEDICATION
What the medication is used for:
BIO-APIXABAN 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:
Bio-APIXABAN 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 Bio-APIXABAN
- you are also taking prasugrel (EFFIENT®) or ticagrelor (BRILINTA®)
- Bio-APIXABAN 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. BIO-APIXABAN is not recommended for patients receiving epidural pain control after surgery
- you have an artificial heart valve
- you are younger than18 years old.
- you are allergic (hypersensitive) to apixaban (active ingredient of Bio-APIXABAN) or any of the other ingredients of Bio-APIXABAN. The ingredients are listed in the “What the nonmedicinal ingredients are:” section of this leaflet
What the medicinal ingredient is:
Apixaban
What the nonmedicinal ingredients are: Lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate 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 AND PRECAUTIONS
Do not stop taking Bio-APIXABAN without first talking with your doctor. If you stop taking Bio-APIXABAN, blood clots may cause a stroke or other complications. This can be fatal or lead to severe disability.
| IMPORTANT: PLEASE READ |
BEFORE you use Bio-APIXABAN 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
- severe kidney disease
- mild or moderate liver disease
- have antiphospholipid syndrome
- 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.
Bio-APIXABAN 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 Bio-APIXABAN on pregnancy and the unborn child are not known. You should not take Bio-APIXABAN if you are pregnant. Contact your doctor immediately if you become pregnant while taking Bio-APIXABAN.
It is not known if Bio-APIXABAN passes into human breast milk. Ask your doctor or pharmacist for advice before taking Bio-APIXABAN 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 Bio-APIXABAN and some may decrease its effects. Your doctor will decide, if you should be treated with Bio-
APIXABAN when taking these medicines and how closely you should be monitored.
Drugs that may interact with Bio-APIXABAN include:
Medicines that may increase the effects of Bio-APIXABAN:
You are at an increased risk for bleeding if you take Bio-APIXABAN with one of these drugs:
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)
some medicines for bacterial infections (e.g.
clarithromycin)
antidepressants/anti-anxiety (SSRIs, SNRIs)
(e.g. fluoxetine, citalopram, sertraline, escitalopram, venlafaxine, duloxetine)
Medicines that may reduce the effects of Bio-APIXABAN:
- 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
Bio-APIXABAN can be taken with or without food.
Bio-APIXABAN 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:
| IMPORTANT: PLEASE READ |
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 Bio-APIXABAN 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 Bio-APIXABAN tablet(s). This will help make sure that all of the crushed tablet(s) will be taken.
Steps
use a mortar and pestle or a similar device to
crush the tablet(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 Bio-APIXABAN 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 Bio-APIXABAN 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 anti-coagulant) or receive anti-coagulant treatment given by injection, and your doctor has decided Bio-APIXABAN is appropriate for you, make sure you ask your doctor when and how best to switch and start taking Bio-APIXABAN.
If you have atrial fibrillation and stop taking Bio-APIXABAN 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 Bio-APIXABAN 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 Bio-APIXABAN until your doctor says otherwise.
Overdose:
Tell your doctor immediately if you have taken more than the prescribed dose of Bio-APIXABAN
You may have an increased risk of bleeding. If bleeding occurs, surgery or blood transfusions may be required.
| IMPORTANT: PLEASE READ |
If you think you have taken too much Bio-APIXABAN, contact your healthcare
professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you have missed a dose, take the medicine as soon as you remember and continue with your remaining daily dose of Bio-APIXABAN; 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 Bio-APIXABAN.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Bio-APIXABAN 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 (anti-coagulants), Bio-APIXABAN 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 | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||||
| Only if severe | In all cases | |||||
Allergic Reaction: Rash, hives, swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing | √ | |||||
| 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 seek immediate medical help | ||||
| Only if severe | In all cases | |||||
Anemia: fatigue, loss of energy, weakness, shortness of breath | √ | |||||
| Blood in the urine (that stains the urine pink or red) | √ | |||||
| Bruising and swelling | √ | |||||
Bleeding:
| √ | |||||
| Bleeding after your operation including bruising and swelling, blood or liquid leaking from the surgical wound/incision | √ | |||||
| Bleeding in your stomach, bowel or blood in the stool | √ | |||||
| Bleeding from your nose | √ | |||||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | √ | |||||
Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up | √ | |||||
| IMPORTANT: PLEASE READ |
| 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 seek immediate medical help | ||||
| Only if severe | In all cases | |||||
Bleeding:
| √ | |||||
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 Bio-APIXABAN, 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 Bio-APIXABAN 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 waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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
(https://www.canada.ca/en/health-canada/services/drugs-health-
products/medeffectcanada/ adverse-reaction-reporting.html) for information on how to report online, by mail or by fax;
- Or by calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about <Bio-APIXABAN>:
- 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://canada.ca/en/health- camada/services/drugs-health-products/drug- products/drug-product-database.html) or by contacting the sponsor, Biomed Pharma.
Biomed Pharma
info@biomed-pharma.ca
+1- 888-731-6703