Patient Information

What is the most important information I should know about COUMADIN (Warfarin Sodium Tablets, USP)? What is COUMADIN? Who should not take COUMADIN? What should I tell my healthcare provider before starting COUMADIN? How should I take COUMADIN? What should I avoid while taking COUMADIN? What are the possible side effects of COUMADIN? How should I store COUMADIN?

General information about COUMADIN How does COUMADIN work? How much COUMADIN (Warfarin Sodium) do I take? Why are regular blood tests so important? What are some things that can make my PT/INR results change? What if…? Do I have to pay attention to the Vitamin K in my diet? Indications and Important Safety Information

What is the most important information I should know about COUMADIN?

• Take your COUMADIN exactly as prescribed to lower the chance of blood clots forming in your body. (See “What is COUMADIN?”).
• COUMADIN is very important for your health, but it can cause serious and life-threatening bleeding problems. To benefit from COUMADIN and also lower your chance for bleeding problems, you must:
  • Get your regular blood test to check for your response to COUMADIN (Warfarin Sodium Tablets, USP). This blood test is called a PT/INR test. The PT/INR test checks to see how fast your blood clots. Your healthcare provider will decide what PT/INR numbers are best for you. Your dose of COUMADIN will be adjusted to keep your PT/INR in a target range for you.
  • Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:
    • pain, swelling, or discomfort
    • headaches, dizziness, or weakness
    • unusual bruising (bruises that develop without known cause or grow in size)
    • nose bleeds
    • bleeding gums
    • bleeding from cuts takes a long time to stop
    • menstrual bleeding or vaginal bleeding that is heavier than normal
    • pink or brown urine
    • red or black stools
    • coughing up blood
    • vomiting blood or material that looks like coffee grounds
• Many other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements can interact with COUMADIN and:
  • affect the dose you need, or
  • increase COUMADIN (Warfarin Sodium) side effects.

  Tell your healthcare provider about all the medicines, vitamins, and herbal supplements you take. Do not stop medicines or take anything new unless you have talked to your healthcare provider. Keep a list of your medicines with you at all times to show your healthcare provider and pharmacist.

• Do not take other medicines that contain warfarin. Warfarin is the active ingredient in COUMADIN.
• Some foods can interact with COUMADIN and affect your treatment and dose.
  • Eat a normal, balanced diet. Talk to your doctor before you make any diet changes. Do not eat large amounts of leafy green vegetables. Leafy green vegetables contain Vitamin K. Certain vegetable oils also contain large amounts of Vitamin K. Too much Vitamin K can lower the effect of COUMADIN.
  • Avoid drinking cranberry juice or eating cranberry products.
  • Avoid drinking alcohol.
• Always tell all of your healthcare providers that you take COUMADIN.
• Wear or carry information that you take COUMADIN.

What is COUMADIN (Warfarin Sodium Tablets, USP)?

COUMADIN is an anticoagulant medicine. It is used to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions such as blood clots in the legs or lungs.

Who should not take COUMADIN?

Do not take COUMADIN if:

• your chance of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if COUMADIN is right for you. Talk to your healthcare provider about all of your health conditions.
• you are pregnant or plan to become pregnant. COUMADIN can cause death or birth defects to an unborn baby. Use effective birth control if you can get pregnant.
• you are allergic to warfarin or to anything else in COUMADIN.

What should I tell my healthcare provider before starting COUMADIN (Warfarin Sodium Tablets, USP)?

Tell your healthcare provider about all of your health conditions, including if you:

• have bleeding problems
• fall often
• have liver or kidney problems
• have high blood pressure
• have a heart problem called congestive heart failure
• have diabetes
• drink alcohol or have problems with alcohol abuse. Alcohol can affect your COUMADIN dose and should be avoided
• are pregnant or planning to become pregnant. See “Who should not take COUMADIN?”
• are breast-feeding. COUMADIN may increase bleeding in your baby. Talk to your doctor about the best way to feed your baby. If you choose to breast-feed while taking COUMADIN, both you and your baby should be carefully monitored for bleeding problems.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. See “What is the most important information I should know about COUMADIN?”

How should I take COUMADIN (Warfarin Sodium Tablets, USP)?

• Take COUMADIN exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to COUMADIN.
• You must have regular blood tests and visits with your healthcare provider to monitor your condition.
• Take COUMADIN at the same time every day. You can take COUMADIN either with food or on an empty stomach.
• If you miss a dose of COUMADIN, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of COUMADIN the next day to make up for a missed dose.
• Call your healthcare provider right away if you take too much COUMADIN.
• Call your healthcare provider if you are sick with diarrhea, an infection, or have a fever.
• Tell your healthcare provider about any planned surgeries, medical or dental procedures. Your COUMADIN may have to be stopped for a short time or you may need your dose adjusted.
• Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.

What should I avoid while taking COUMADIN (Warfarin Sodium Tablets, USP)?

• Do not start, stop, or change any medicine without talking with your healthcare provider.
• Do not make changes in your diet, such as eating large amounts of green, leafy vegetables.
• Do not change your weight by dieting, without first checking with your healthcare provider.
• Avoid drinking alcohol.
• Do not do any activity or sport that may cause a serious injury.

What are the possible side effects of COUMADIN (Warfarin Sodium Tablets, USP)?

• COUMADIN is very important for your health, but it can cause serious and life-threatening bleeding problems. See “What is the most important information I should know about COUMADIN?”
• Serious side effects of COUMADIN also include:
  • death of skin tissue (skin necrosis or gangrene). This can happen soon after starting COUMADIN. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
  • “purple toes syndrome.” Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.

Other side effects with COUMADIN include allergic reactions, liver problems, low blood pressure, swelling, low red blood cells, paleness, fever, and rash. Call your healthcare provider if you have any side effect that bothers you. These are not all of the side effects of COUMADIN. For more information, ask your healthcare provider or pharmacist.

How should I store COUMADIN (Warfarin Sodium Tablets, USP)?

• Store COUMADIN at room temperature between 59° and 86° F. Protect from light.
• Keep COUMADIN and all medicines out of the reach of children.

General Information about COUMADIN (Warfarin Sodium Tablets, USP)

Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use COUMADIN for a condition for which it was not prescribed. Do not give COUMADIN to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about COUMADIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COUMADIN that was written for healthcare professionals.

If you would like more information, call 1-800-321-1335.

How does COUMADIN (Warfarin Sodium Tablets, USP) work?

• Your liver makes clotting factors that help the blood clot and prevent bleeding. However, some blood clots can cause serious medical problems. COUMADIN blocks the formation of clotting factors in the liver that are dependent on Vitamin K, thus preventing the formation of blood clots.

How much COUMADIN (Warfarin Sodium Tablets, USP) do I take?

• Your doctor determines how much COUMADIN you need (the dose and schedule) by giving you regular blood tests. Your dosage may change over time, depending on the results of these blood tests. No matter what dosage of COUMADIN you take, make sure you always take the dosage your healthcare provider prescribes for you. Carefully follow the prescribing instruction given by your healthcare professional.

Why are regular blood tests so important?

What is the blood test and what is it used for?

• The blood test is called a PT/INR test. PT/INR stands for Prothrombin Time and International Normalized Ratio. These tests are used to see how quickly your blood clots and whether you’re getting the right amount of COUMADIN. Only a small amount of blood is taken each time. The number tells your healthcare provider if COUMADIN is helping you maintain the appropriate PT/INR level for your condition. Your healthcare provider will tell you what PT/INR level is right for you.

How often do I have my blood tested?

• Your healthcare provider will determine how often you will need blood tests. Your COUMADIN dosage may be carefully adjusted (raised or lowered) to keep your PT/INR level right for your condition. The results are usually available the same day. When you get these results, ask your healthcare provider if you will need to change your dosage of COUMADIN (Warfarin Sodium).

When you have your blood tested, be sure to:

• Go to the laboratory on the date and time scheduled.
• Go to the same laboratory each time, because the results you get may differ from one laboratory to another.
• Ask your healthcare provider what dose you should take that day, and each day until you have your next blood test.
• If your dose is changed, make a note of your new dose on your calendar or in a place easily visible to you.

What are some things that can make my PT/INR results change?

• Many over-the-counter or prescription drugs, vitamins and herbal supplements, certain foods, and certain medical conditions can interact with COUMADIN (Warfarin Sodium Tablets, USP) and change your PT/INR. (See “What is the most important information I should know about COUMADIN?”.) For a list of possible interactions with COUMADIN, see the full Prescribing Information (written for healthcare providers). In addition, you should discuss your particular medicines, herbal supplements, diet, and medical conditions with your healthcare provider.

• Prescription drugs
  • Many different medications, used to treat many different conditions, may affect your body’s response to COUMADIN. They may increase or decrease your PT/INR level.
  • Some common prescription medications may interact with COUMADIN. Please see the full Prescribing Information (written for healthcare providers), and speak with your healthcare provider about this information and your particular medicines. This is very important because your healthcare provider may need to adjust the dosage of these medications as well as COUMADIN.
  • Do not take other drugs that contain warfarin. Warfarin is the active ingredient in COUMADIN. If you take other warfarin medication while taking COUMADIN (Warfarin Sodium Tablets, USP), you may get an overdose of warfarin. Remember, COUMADIN tablets look different from other warfarin tablets, and have different markings on them, so it is possible to take both by mistake.

• Non-prescription drugs
  • Many nonprescription, or over-the-counter, medications, including aspirin and other pain relievers, may affect your body’s response to COUMADIN. Be sure to discuss your particular nonprescription medicines with your healthcare provider.

• Herbal medicines
  • Many different common herbal medicines or botanicals may affect your body’s response to COUMADIN. They may increase or decrease your PT/INR level. For a list of these herbal medicines, see the full Prescribing Information (written for healthcare providers), and discuss them with your healthcare provider. Many herbal medicines have several common names and scientific names. In addition, their potency (or strength) may vary from one brand to another.

• Vitamins
  • Vitamins may also affect how your body responds to COUMADIN (Warfarin Sodium Tablets, USP), and change your PT/INR level. Too much Vitamin K, in particular, can lower the blood-thinning effect of COUMADIN. You should tell your healthcare provider if you are taking any vitamin supplement, including a Vitamin K supplement.

What other medical procedures and conditions should my healthcare provider know about?

• Before starting COUMADIN, tell your healthcare provider about all of your health conditions. If you are having surgery, including dental surgery, tell the healthcare provider performing the procedure that you are taking COUMADIN. You may be told by your healthcare provider to stop taking COUMADIN before your procedure. In addition, you may need to have a blood test before having your procedure. For information about checking your PT/INR, see “Why are regular blood tests so important?”.

What if…?

I stop taking COUMADIN–how long will the blood-thinning effects of COUMADIN (Warfarin Sodium Tablets, USP) continue?

• If your healthcare provider stops your COUMADIN therapy, the anticlotting effect may last for about 2 to 5 more days.

I want to travel–is there anything special I should do?

• Speak with your healthcare provider first. He or she may ask you to take a PT/INR test before your trip, or arrange for you to take the test while you’re away.
• Two things to keep in mind:
  • While traveling, be mindful of taking your COUMADIN at the same time every day. It is very important to maintain a consistent amount of Vitamin K in your diet. You should avoid drastic changes in your dietary habits.
  • Be sure to take enough COUMADIN for your entire trip. You should also carry your medications with you at all times; do not put them in checked baggage or leave them in the car.

What if I cut myself or I start bleeding?

• Because COUMADIN (Warfarin Sodium Tablets, USP) affects clotting, it may take longer for bleeding to stop if you are cut or injured.
  • If your cut is small, apply constant pressure until the bleeding stops. This may take up to 10 minutes. If the bleeding doesn't stop, keep applying pressure and seek medical attention.
  • If your cut is large, apply constant pressure and get help immediately by going to the emergency room or calling for medical help.

  To avoid cutting yourself while shaving:

  • Rather than using a razor with a razor blade, use an electric razor or hair-removing cream.

  To reduce gum bleeding while brushing your teeth:

  • Use a soft toothbrush, and brush and floss gently.

Do I have to pay attention to the Vitamin K in my diet?

Can the foods I eat affect my response to COUMADIN (Warfarin Sodium Tablets, USP)?

• The foods that contain Vitamin K can interfere with the blood-thinning effects of COUMADIN. It is very important to maintain a consistent amount of Vitamin K in your diet. Avoid drastic changes in your dietary habits. For instance, eating large amounts of green leafy vegetables, when you normally do not, can increase the amount of Vitamin K in your system.

Should I stay on the same general diet every day?

• Do not make any major changes to your diet without speaking with your healthcare provider first. If you change your eating habits, your healthcare provider may give you a blood test more frequently to see if your COUMADIN is working effectively.

How can I tell how much Vitamin K is in the food I eat?

• Many foods have low amounts of Vitamin K, including beverages, dairy products, bread, cereal, and meat. Leafy green vegetables, such as kale, parsley, spinach, and turnip greens, as well as broccoli and brussels sprouts, contain large amounts of Vitamin K. Speak with your healthcare provider if you have any questions about the Vitamin K content in your food.

How much alcohol may I have?

• Drinking alcohol can change your PT/INR. Be sure to speak with your healthcare provider about the amount of alcohol you consume.