Sandoz Apixaban SDZ: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Apixaban SDZ 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:

Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ

• you are also taking prasugrel (EFFIENT^®) or ticagrelor

  (BRILINTA^®)

• Sandoz Apixaban SDZ 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. Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ) or any of the other ingredients of Sandoz Apixaban SDZ. 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 monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, hypromellose, magnesium stearate, titanium dioxide, triacetin. Tartrazine aluminum lake, sunset yellow FCF aluminum lake, iron oxide yellow (2.5 mg tablets only), iron oxide red (5 mg tablets only).

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 Sandoz Apixaban SDZ without first talking with your doctor. If you stop taking Sandoz Apixaban SDZ, blood clots may cause a stroke or other complications. This can be fatal or lead to severe disability.

BEFORE you use Sandoz Apixaban SDZ 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

Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ on pregnancy and the unborn child are not known. You should not take Sandoz Apixaban SDZ if you are pregnant. Contact your doctor immediately if you become pregnant while taking Sandoz Apixaban SDZ.

It is not known if Sandoz Apixaban SDZ passes into human breast milk. Ask your doctor or pharmacist for advice before taking Sandoz Apixaban SDZ while breast-feeding.

Anticoagulant-Related Nephropathy (ARN)

Some cases were reported in patients taking Sandoz Apixaban SDZ. 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 Sandoz Apixaban SDZ. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.

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 Sandoz Apixaban SDZ and some may decrease its effects. Your doctor will decide, if you should be treated with Sandoz Apixaban SDZ when taking these medicines and how closely you should be monitored.

Drugs that may interact with Sandoz Apixaban SDZ include:

Medicines that may increase the effects of Sandoz Apixaban SDZ: You are at an increased risk for bleeding if you take Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ:

• 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

Sandoz Apixaban SDZ can be taken with or without food.

Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ 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 (30 g) in a small bowl and eat with a spoon right away
  • add a small amount of water (30 mL) 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 Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ is appropriate for you, make sure you ask your doctor when and how best to switch and start taking Sandoz Apixaban SDZ.

If you have atrial fibrillation and stop taking Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ 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 Sandoz Apixaban SDZ until your doctor says otherwise.

Overdose:

Tell your doctor immediately if you have taken more than the prescribed dose of Sandoz Apixaban SDZ.

You may have an increased risk of bleeding. If bleeding occurs, surgery or blood transfusions may be required.

If you think you have taken too much Sandoz Apixaban SDZ, 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 Sandoz Apixaban SDZ; 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 Sandoz Apixaban SDZ.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines Sandoz Apixaban SDZ 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), Sandoz Apixaban SDZ 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.

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 Sandoz Apixaban SDZ contact your doctor or pharmacist.

HOW TO STORE IT

Keep at room temperature (15-30^oC).

Keep out of the reach and sight of children.

Do not use Sandoz Apixaban SDZ 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 SIDE EFFECTS

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

NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.

If you want more information about Sandoz Apixaban SDZ:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer 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.sandoz.ca or by calling 1-800-361-3062.

or by written request at:

110 de Lauzon

Boucherville QC

J4B 1E6

Or by e-mail at :

medinfo@sandoz.com

Last revised: May 26, 2025