Taro-Warfarin: Uses, Side Effects and Dosage

Serious warnings and precautions box

Risk of bleeding:

The most common side effect of TARO-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 TARO-WARFARIN for a long time or if you take TARO-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. Notify your healthcare professional right away of any unusual bleeding or if signs or symptoms of bleeding occur (see “What are possible side effects from using TARO-WARFARIN?”) and the Serious side effects and what to do about them table, below, for more information on this and other serious side effects.”).

What TARO-WARFARIN is used for:

This medicine is used in adults. It helps prevent and treat blood clots:

• in the veins (venous thrombosis)
• in an artery in the lungs (pulmonary embolism)
• caused by irregular heartbeat (atrial fibrillation) with clots that dislodge and travel through the bloodstream (embolization)

It can also be used as an add-on treatment to prevent:

• blood clots after a heart attack (myocardial infarction), which could lead to a stroke or another

  heart attack

• mini-strokes (transient cerebral ischemic attacks) caused by abnormal blood clotting inside blood vessels.

How TARO-WARFARIN works:

TARO-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.

• TARO-WARFARIN begins to reduce blood clotting within 24 hours after taking the drug. The full effect may take 72 to 96 hours to occur. The anti-clotting effects of a single dose of TARO-WARFARIN last 2 to 5 days, but it is important for you to take your dose every day.

The ingredients in TARO-WARFARIN are:

Medicinal ingredient: warfarin sodium

Non-medicinal ingredients: magnesium stearate, lactose anhydrous, pregelatinized corn starch and colour dye which varies in each tablet strength:

1. 1 mg: Pink color - D&C Red #6 - Lake
2. 2 mg: Lavender - FD&C Blue #2 - Lake and FD&C Red #40 - Lake

2.5 mg: Green - FD&C Blue #2 - Lake and D&C Yellow #10 - Lake

1. 3 mg: Tan - FD&C Red #40 - Lake, D&C Yellow #10 - Lake and FD&C Blue #2 -Lake

4 mg: Blue - FD&C Blue # 1- Lake

5 mg: Peach - D&C Yellow #10 - Lake and D&C Red #6 - Lake

6 mg: Teal - D&C Yellow #10 - Lake and FD&C Blue #2 - Lake

1. 7.5 mg: Yellow - D&C Yellow #10 - Lake 10 mg: White - Dye free

TARO-WARFARIN comes in the following dosage forms:

TARO-WARFARIN tablets are available in 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5, and 10 mg strengths.

Each round, single-scored tablet is imprinted on one side with the word “WARFARIN” and the numeric strength of the tablet. The other side of the tablet is imprinted with the name “TARO”.

Be sure to check that the tablet shows “WARFARIN” and the right numeric strength before you take it.

Do not use TARO-WARFARIN if:

• you are allergic to warfarin or any of the other ingredients in TARO-WARFARIN (see The ingredients in TARO-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 TARO-WARFARIN. This is very important because your unborn baby could be seriously harmed if you take TARO-WARFARIN while you are pregnant. Your baby could be born with birth defects or could die.
• 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 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 consume alcohol or suffer from alcohol abuse.
• you practice any activity or sport that may result in serious injury.
• you have psychosis (a mental health problem).
• 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 TARO-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 TARO-WARFARIN dose and should be avoided

• plan to have any surgery or a dental procedure. Tell all of your healthcare professionals and dentists that you are taking TARO-WARFARIN. They should talk to the healthcare professional who

  • prescribed TARO-WARFARIN for you. This should be done before you have any surgery or dental procedure. Your TARO-WARFARIN may need to be stopped for a short time or you may need your dose adjusted

• are pregnant or planning to become pregnant Do not take TARO-WARFARIN during pregnancy.

  Use effective measures to avoid pregnancy while taking TARO-WARFARIN. This is very important because your unborn baby could be seriously harmed if you take TARO-WARFARIN while you are pregnant. Your baby could be born with birth defects or could die.

• are breastfeeding. TARO-WARFARIN 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 TARO-WARFARIN, both you and your baby should be carefully monitored for bleeding problems
• 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 TARO-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 TARO-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 and cause pain. You may also experience other symptoms such as rash, gangrene (lack of blood supply to a body part), intense pain in the leg, foot, toes, back or in your side. You may need medical care right away to prevent death or loss (amputation) of your affected body part. 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.
• Calciphylaxis: TARO-WARFARIN may cause calcium build up in small blood vessels of the fat and skin tissues (calciphylaxis). This can cause hardening of your blood vessels.
• TARO-WARFARIN should not be used if you have low platelet levels (thrombocytopenia) as this can be serious or life-threatening.
• 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 TARO-WARFARIN. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.

Blood Testing:

• To decide on the dosage of TARO-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 TARO-WARFARIN is right for you.
• When you start taking TARO-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 provider are very important for the success of TARO-WARFARIN therapy. You will need to have these tests on a regular basis while you take TARO-WARFARIN. This will help keep your INR in the best range for your medical condition. Discuss with your healthcare professional the 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 TARO-WARFARIN if you are pregnant. TARO-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 TARO-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. TARO-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 TARO-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 TARO-WARFARIN. They should talk to the healthcare professional who prescribed TARO-WARFARIN for you before you have any procedure. You may need to stop taking TARO-WARFARIN for a short time before the procedure or you may need your dose adjusted.

• Certain illnesses can affect your TARO-WARFARIN therapy. Call your health professional if you:

  • are throwing up
  • have loose or runny stools
  • have an infection
  • have a fever.
• Carry identification stating that you are taking TARO-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 TARO-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

  • 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 antifungal 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 TARO-WARFARIN.

• Natural health products that may interact with TARO-WARFARIN include:

  • bromelains
  • coenzyme Q10
  • danshen (Colocasia antiquorum)
  • dong quai (Angelica sinensia)
  • echinacea
  • garlic
  • ginkgo biloba
  • ginseng
  • St. John’s wort
• Grapefruit products that are part of your normal diet such as grapefruit, grapefruit juice or other grapefruit containing products.
• Cranberry products are part of your normal diet as cranberries, cranberry juice or other cranberry containing products.
• Other foods (eg, certain green vegetables such as broccoli which are rich in vitamin K) can also interact with TARO-WARFARIN
• Other medicines that contain warfarin. Warfarin is the active ingredient in TARO-WARFARIN.

How to take TARO-WARFARIN:

• Be sure to check that the tablet has “TARO-WARFARIN” written on one side and the correct numeric strength before you take it.
• Take TARO-WARFARIN exactly the way your healthcare professional tells you and take it at the same time every day.

• You can take TARO-WARFARIN either with food or on an empty stomach.

• Your dosage may change from time to time depending on your response to TARO-WARFARIN.
• Do not start, stop, or change any medicine except on advice of your healthcare professional.
• 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 TARO-WARFARIN.

Usual dose:

The dose of TARO-WARFARIN may be different for each patient. Your healthcare professional will monitor your INR levels and will decide what dose is best for you. This dose may change from time to time.

Overdose:

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 on the next day to make up for a missed dose.

Possible side effects from using TARO-WARFARIN:

These are not all the possible side affects you may have when taking TARO-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

If you think you, or a person you are caring for, have taken too much TARO-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.

• 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

TARO-WARFARIN affects blood clotting, so most side effects are related to bleeding. TARO-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

These are not all of the side effects of TARO-WARFARIN. For more information, ask your healthcare professional or pharmacist.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Storage:

• Store the tablets at room temperature (15 °C to 30 °C).
• Protect from light.
• Keep tablets in air tight container.
• Keep out of reach and sight of children.

If you want more information about TARO-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 (https://health-product.canada.ca/dpd-bdpp/); the manufacturer’s website at www.taro.ca, or by calling 1-800-268-1975.

Date of Authorization: 2026-04-08

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 (www.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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.