Patient Medication Information: uses, side effects, how to take - Apo-Warfarin (Apotex, 3 mg)
Serious warnings and precautions box
Risk of bleeding:
The most common side effect of APO-WARFARIN is bleeding. The bleeding may be serious and life-threatening. You may be more at risk for bleeding if you have:
- a history of bleeding in your stomach or intestines (ulcers)
- high blood pressure
- heart disease
- problems with the blood circulation in your brain
- anemia (decreased number of red blood cells)
- cancer
- kidney disease
- experienced trauma or injury to your body.
Talk to your healthcare professional if you have any of the above conditions. You may also have a higher risk of bleeding if you take APO-WARFARIN for a long time or if you take APO-WARFARIN with certain other drugs. An INR level of 4.0 or greater is also a risk for bleeding. INR is a blood test that tells the level of blood clotting you have. Your healthcare professional will work to keep your INR within a range that is right for you. This will help lower the risk of bleeding. Talk to your healthcare professional right away if you have any unusual bleeding or if signs or symptoms of bleeding occur. See the Serious side effects and what to do about them table, below, for more information on this and other serious side effects.
What APO-WARFARIN is used for:
- APO-WARFARIN is an anticoagulant drug. “Anti” means against, and “coagulant” refers to blood clotting. An anticoagulant helps reduce clots from forming in the blood.
- APO-WARFARIN is a narrow therapeutic index drug, which means that there is a narrow window between too much and too little of the drug. Too much drug may cause you to bleed more. Too little drug may let a harmful clot form.
How APO-WARFARIN works:
APO-WARFARIN partially blocks the re-use of vitamin K in your liver. Vitamin K is needed to make clotting factors. The clotting factors help the blood to clot and prevent bleeding. Vitamin K is found naturally in foods such as leafy, green vegetables and certain vegetable oils.
The ingredients in APO-WARFARIN are:
Medicinal ingredient: warfarin sodium
Non-medicinal ingredients: brilliant blue FCF AL lake 12 %, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sunset yellow aluminum lake 40%.
APO-WARFARIN comes in the following dosage form:
Tablet: 3 mg.
Do not use APO-WARFARIN if:
- you are allergic to warfarin or any of the other ingredients in APO-WARFARIN (see The ingredients in APO-WARFARIN are:).
- you are pregnant, in particular if you have a high risk pregnancy. Women who are able to get pregnant must use effective birth control to avoid pregnancy while taking APO-WARFARIN. This is very important because your unborn baby could be seriously harmed if you take APO-WARFARIN while you are pregnant. Your baby could be born with birth defects. Pregnancy loss or stillbirth can also occur.
- you are prone to bleeding due to problems with blood clotting, have low levels of platelets in your blood (thrombocytopenia) or have a deficiency of clotting proteins.
- you have recently had or are planning to have surgery of the eyes, central nervous system, or any other major surgery.
you have certain conditions such as:
- stomach or intestinal bleeding or ulcers
- bleeding in the lungs or kidneys, bladder or urethra
- cerebral hemorrhage (bleeding in the brain)
- heart infection
- swelling of the heart membrane or fluid in the heart
- a brain aneurysm (swelling of an artery that supplies blood to the brain)
- you recently had or are planning to have any medical procedure that can increase the risk of bleeding, such as spinal puncture or spinal anesthesia.
- you have severe uncontrolled high blood pressure.
- you practice any activity or sport that may result in serious injury.
- you have psychosis (a mental health problem), suffer from alcohol abuse, have memory problems, or any other condition that makes understanding and following instructions difficult.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-WARFARIN. Talk about any health conditions or problems you may have, including if you:
- fall often.
- have liver or kidney problems or a heart problem called congestive heart failure.
- have high blood pressure.
- have diabetes.
- have a low blood count.
- have cancer.
- have a history of stroke or “mini-stroke” (transient ischemic attack).
- drink alcohol or have problems with alcohol abuse. Alcohol can affect your APO-WARFARIN dose and should be avoided.
- have a catheter, a tube used to drain fluid from the body.
- have a deficiency in protein C or protein S, a condition where your body lacks the natural proteins that prevent blood clotting.
- have a vitamin K deficiency or are in a poor nutritional state.
- have a hereditary resistance to warfarin, the medicinal ingredient in APO-WARFARIN.
- are taking streptokinase or urokinase, medicines used to dissolve blood clots.
- are 60 years of age or older. You may be more likely to experience certain side effects and may need a lower dose.
Other warnings you should know about:
- Tissue necrosis or gangrene (death of skin tissue): This can happen soon after starting APO-WARFARIN. It happens because blood clots form and block blood flow to an area of your body. This can include “purple toe syndrome” where your toes may look purple or dark in colour. Talk to your healthcare professional right away if you notice symptoms of tissue necrosis such as rash and intense pain in the leg, foot, toes, back or side. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
- Calciphylaxis: APO-WARFARIN may cause calcium build up in small blood vessels of the fat and skin tissues. This can cause hardening of your blood vessels.
- Anticoagulant-Related Nephropathy (ARN): Some cases were reported in patients taking warfarin. 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 APO-WARFARIN. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.
Blood Tests and monitoring:
- To decide on the dosage of APO-WARFARIN you need, your healthcare professional will regularly take a small amount of your blood. This will help to find out how fast your blood clots. This is often recorded as an INR (International Normalized Ratio). INR tests are very important. They help your healthcare professional determine what dosage of APO-WARFARIN is right for you.
- When you start taking APO-WARFARIN, you may have INR tests every day for a few days, then periodically on a regular basis. Your healthcare professional will determine how often you need to have these tests done. These INR tests and regular visits to a healthcare professional are very important for the success of APO-WARFARIN therapy. You will need to have these tests on a regular basis while you take APO-WARFARIN. This will help keep your INR in the best range for your medical condition. Talk to your healthcare professional about the INR range that is right for you.
Pregnancy and breastfeeding:
- Talk to your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant.
- You should not take APO-WARFARIN if you are pregnant. APO-WARFARIN can cause birth defects in your baby or result in loss of the pregnancy or stillbirth.
- If you are a woman who is able to get pregnant you must use effective birth control while you are taking APO-WARFARIN. Talk to your healthcare professional about the birth control options that are right for you.
- Talk to your healthcare professional if you are breastfeeding or planning to breastfeed. APO-WARFARIN passes into breastmilk and may cause your baby to bleed. Talk to your healthcare professional about the best way to feed your baby. If you choose to breastfeed while taking APO-WARFARIN, both you and your baby should be carefully monitored for bleeding problems.
- Surgery: If you plan to have surgery or a dental procedure tell all of your healthcare professionals and dentists that you are taking APO-WARFARIN. They should talk to the healthcare professional who prescribed APO-WARFARIN for you before you have any procedure. You may need to stop taking APO-WARFARIN for a short time before the procedure or you may need your dose adjusted.
Certain illnesses can affect your APO-WARFARIN dose. Tell your healthcare professional if you:
- are throwing up
- have loose or runny stools
- have an infection
- have a fever.
- Carry identification stating that you are taking APO-WARFARIN.
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 APO-WARFARIN:
- Medicines to treat pain and inflammation called Non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen, celecoxib, diclofenac and naproxen.
- Blood thinners such as aspirin, clopidogrel, apixaban, rivaroxaban, dabigatran, ticagrelor, prasugrel, ticlopidine and dipyridamole.
- Antidepressants in the class called selective serotonin reuptake inhibitors (SSRI) such as sertraline, paroxetine, fluoxetine, escitalopram and citalopram.
- Medicines to treat bacterial or fungal infections such as amoxicillin, penicillin, azithromycin, ciprofloxacin, erythromycin, doxycycline, fluconazole, ketoconazole, voriconazole and itraconazole.
- Medicines to treat seizures such as phenytoin and phenobarbital.
- Certain medicines used treat to abnormal heart rhythms.
- Certain medicines used to treat conditions of the thyroid gland.
- Medicines in the class called corticosteroids used to reduce inflammation and immune response such as hydrocortisone and prednisone.
- Medicines in the class called statins used to lower cholesterol such as atorvastatin, lovastatin and simvastatin.
- Medicines in the class called proton pump inhibitors (PPIs) used to treat heartburn (reflux) or stomach ulcers such as pantoprazole, lansoprazole and omeprazole.
- Other medicines that contain warfarin. Warfarin is the medicinal ingredient in APO-WARFARIN.
Natural health products that may interact with APO-WARFARIN include:
- bromelains
- coenzyme Q10
- danshen (Colocasia antiquorum)
- dong quai (Angelica sinensia)
- echinacea
- garlic
- ginkgo biloba
- ginseng
- St. John’s wort
APO-WARFARIN may interact with food:
- Eat a normal balanced diet. Avoid big changes in your diet. Talk to your healthcare professional before you go on a diet.
- Eat a consistent amount of green, leafy vegetables. Do not make big changes in your diet. These vegetables have high amounts of Vitamin K. The amount of vitamin K in your daily diet may affect therapy with APO-WARFARIN.
- Tell your healthcare professional if cranberry juice or other cranberry products are part of your normal diet.
- Tell your healthcare professional if grapefruit, grapefruit juice or other grapefruit products are part of your normal diet.
How to take APO-WARFARIN:
- Take APO-WARFARIN exactly the way your healthcare professional tells you and take it at the same time every day.
- You can take APO-WARFARIN either with food or on an empty stomach.
- Your dosage may change from time to time depending on your response to APO-WARFARIN.
- Do not start, stop, or change any medicine without talking to your healthcare professional.
Usual dose:
Your healthcare professional will monitor your INR levels and will decide on the dose that is best for you.
Overdose:
If you think you, or a person you are caring for, have taken too much APO-WARFARIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose of this medication, take it as soon as you remember on the same day, and talk to your healthcare professional. Do not take two doses at the same time to make up for a missed dose.
Possible side effects from using APO-WARFARIN:
These are not all the possible side effects you may have when taking APO-WARFARIN. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- abdominal pain including cramping
- diarrhea, gas, bloating
- nausea, vomiting
- bitter sour metallic taste, change in taste
- difficulty in swallowing
- bleeding gums
- itching, rash, redness
- red or purple spots on skin
- loss of hair in patches (alopecia)
- tiredness, fatigue
- lack of energy
- dizziness, headache
- feeling cold, chills, fever
- generally feeling unwell, paleness
- swelling of the hands, legs, or feet
- joint pain, muscle pain
- tingling or pricking sensation
APO-WARFARIN affects blood clotting, so most side effects are related to bleeding. APO-WARFARIN can cause bleeding that can be serious and sometimes lead to death.
Your healthcare professional will work to keep your INR within a range that is right for you. This will help lower the risk of bleeding.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Unknown | |||
| Adrenal hemorrhage (bleeding from the adrenal glands): pain in the abdomen or sides, nausea, vomiting, dizziness, weakness, fatigue, muscle aches | √ | ||
| Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | √ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | √ | ||
| Angina (not enough oxygen to the heart muscle): squeezing, pressure, heaviness, tightness, chest pain, discomfort in the shoulder, arm, back, throat, jaw or teeth | √ | ||
| Anticoagulant-related nephropathy (serious kidney damage caused by anticoagulant medicines): bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly. | √ | ||
| Blood pressure disorders: dizziness, fainting, unconsciousness, shock (pale cold clammy skin, shallow rapid breathing, anxiety, dry mouth, low urine output, dark urine) | √ | ||
| Calciphylaxis (accumulation of calcium in blood vessels, fat and skin tissues): intense pain, web-like purple, red or brown patches on the skin, particularly the abdomen, thighs and buttocks, blisters or ulcers | √ | ||
| Embolism (clots from blood and fat): cold arm or leg, no pulse and lack of movement of the arm or leg, pain in the affected area, numbness and weakness, shortness of breath, purple spots on the skin, fast heartbeat, fever, fatigue, weight loss, loss of appetite, muscle pain | √ | ||
| Eye hemorrhage (bleeding in the eye): bright red patch on white part of the eye | √ | ||
| Gastrointestinal (GI) bleeding (bleeding anywhere along the GI tract between mouth and anus): blood in vomit, black tarry stool, bright red blood in your stool or coming from rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness | √ | ||
| Hemarthrosis (bleeding into joint spaces): joint pain, swelling, redness, warmth, stiffness, reduced range of motion | √ | ||
| Hepatic hemorrhage (liver bleeding): vomiting blood, lightheadedness, pain in right upper abdominal region, blood in stool, fast heartbeat | √ | ||
| Intracranial hemorrhage (bleeding in the brain): sudden, severe headache, confusion, nausea and vomiting, seizures, coma, loss of consciousness | √ | ||
| Kidney disorders (acute kidney injury): blood in urine, decreased urine output, swelling in limbs, fatigue, shortness of breath, confusion, nausea | √ | ||
| Liver disorders (including hepatitis): nausea, fever, fatigue, vomiting, abdominal pain, loss of appetite, dark colored urine, light-colored stools, yellowing of the skin or whites of the eyes (jaundice) | √ | ||
| Lung disorders: bleeding from the nose, bleeding from the mouth, blood in sputum, difficulty breathing, cough, wheezing, shortness of breath, chest pain | √ | ||
| Pericardial hemorrhage (bleeding in the sac surrounding the heart): shortness of breath, chest fullness, sharp chest pain that may get worse when breathing or lying down, palpitations, swelling in abdomen and legs, dizziness or lightheadedness | √ | ||
| Priapism (prolonged painful erection): long-lasting (greater than 4 hours in duration) and painful erection of the penis | √ | ||
| Retroperitoneal hemorrhage (bleeding into the area behind the abdominal lining): abdominal, upper leg or groin pain, shock (lightheadedness, dizziness, sweating, fast heartbeat) | √ | ||
| Skin reactions: itching, hives, wheals at joints, red and warm swollen area of skin that spreads quickly, severe pain, large blisters which rupture easily | √ | ||
| Spinal hematoma (blood around the spinal cord): pain, numbness, difficulty in walking, loss of bowel/bladder movement | √ | ||
| Splenic rupture (burst or torn spleen): pain in the left upper abdominal area or left shoulder tip area | √ | ||
| Tissue necrosis and gangrene (including “purple toe syndrome”): intense pain in foot and leg, bluish purple discolouration of the toe, intense pain in the back or side, skin sores or ulcers, skin discolouration | √ | ||
| Vaginal hemorrhage: bleeding between periods, bleeding after sex, large clots, heavy bleeding during your period | √ | ||
| Rare | |||
| Tracheal or tracheobronchial calcification (hardening of the cartilage in the windpipe): recurrent infection, breathlessness, cough, blood in sputum | √ | ||
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
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature 15°C to 30°C.
Protect from light and moisture.
Keep out of reach and sight of children.
If you want more information about APO-WARFARIN:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-
- product-database.html); the manufacturer’s website (http://www.apotex.ca/products); or by calling 1-800-667-4708.
Date of Authorization: 2026-01-22