A Patient s Guide to Using * COUMADIN

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1 A Patient s Guide to Using * COUMADIN (Warfarin Sodium Tablets, USP) Crystalline Please see Full Prescribing Information available on this website.

2 This booklet is about a medicine called COUMADIN (Warfarin Sodium Tablets, USP) Crystalline Please read this booklet because it answers many questions you may have about this medicine. This booklet does not take the place of talking to your healthcare provider (such as your doctor, nurse or pharmacist). If you have any other questions, or if you don t understand something in this booklet, ask your healthcare provider. This booklet also has a patient identification card and dosage calendar at the back. The information in this brochure has been developed and derived from nearly 50 years of experience with COUMADIN (Warfarin Sodium Tablets, USP) Crystalline, the Bristol-Myers Squibb Company brand of warfarin sodium. Our intent is that this material should be used to assist with the management of patients on COUMADIN. COUMADIN (Warfarin Sodium Tablets, USP) Crystalline What It Is and What It Does 3 How to Take It 7 Blood Tests 9 Possible Side Effects and Drug Interactions 11 Do s and Don ts 15 What If...? 19 Your Diet and Vitamin K 21 Dosage Calendar 27 Please see Full Prescribing Information available on this website. What s Inside...

What is COUMADIN? (Warfarin Sodium Tablets, USP) Crystalline COUMADIN is an anticoagulant. Anti means against, and coagulant refers to blood clotting.

3 What is COUMADIN? (Warfarin Sodium Tablets, USP) Crystalline COUMADIN is an anticoagulant. Anti means against, and coagulant refers to blood clotting. An anticoagulant helps reduce clots from forming in the blood. 3 Why do I need COUMADIN? Your doctor wants you to take COUMADIN because your body may make clots that you don t need. These clots can cause serious medical problems. A clot can move to another part of your body. For example, if a clot moves to your brain, it can cause a stroke. COUMADIN is used to help prevent and treat blood clots: in the legs and lungs associated with an irregular, rapid heartbeat called atrial fibrillation associated with heart-valve replacement If you have had a heart attack, COUMADIN is used to: lower the risk of death lower the risk of another heart attack lower the risk of stroke Please see Full Prescribing Information available on this website. lower the risk of blood clots moving to other parts of the body If you have any other questions about COUMADIN and your condition, or if you don t understand something in this patient information booklet, contact your healthcare provider. 4 What It Is and What It Does

How does COUMADIN work? (Warfarin Sodium Tablets, USP) Crystalline COUMADIN blocks the formation of vitamin K- dependent clotting factors in your liver.

4 How does COUMADIN work? (Warfarin Sodium Tablets, USP) Crystalline COUMADIN blocks the formation of vitamin K- dependent clotting factors in your liver. Vitamin K is needed to make clotting factors that help the blood to clot and prevent bleeding. Vitamin K is found naturally in foods such as leafy, green vegetables and certain vegetable oils. 5 COUMADIN reduces the body s ability to make blood clots. It can help stop harmful clots from forming and keeps clots from getting larger. COUMADIN does not break up existing blood clots. COUMADIN generally 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 COUMADIN last 2 to 5 days, but it is important for you to take your dose as prescribed by your healthcare provider. Please see Full Prescribing Information available on this website. 6 What It Is and What It Does

5 How much do I take? Your doctor determines how much COUMADIN (Warfarin Sodium Tablets, USP) Crystalline you need to take (your dosage) by giving you blood tests. This blood test is called a prothrombin time test, or protime (PT) for short, and is reported as International Normalized Ratio (INR). (Turn to pages 9-10 to read more about PT/INR.) Your dosage may change, so make sure you take the right dose of COUMADIN daily. When do I take it? Try to take your COUMADIN at the same time every day. Take it exactly the way your healthcare provider (your doctor, nurse, or pharmacist) tells you. If you forget to take a pill, tell your healthcare provider. Take the missed dose as soon as possible on the same day. DO NOT take a double dose of COUMADIN the next day to make up for the missed dose. Will my dosage change? Your dosage may change from time to time. Make sure you take the right dose (amount of COUMADIN ) on the right day, as your healthcare provider tells you. Use the calendar starting on page 27 to help you. How to Take It Please see Full Prescribing Information available on this website. 7

6 Why do I need blood tests? To help your healthcare provider establish the dosage of COUMADIN (Warfarin Sodium Tablets, USP) Crystalline you need. Your healthcare provider will take a small amount of your blood to find out your PT/INR. PT/INRs are very important. They help your healthcare provider see how fast your blood is clotting and whether your dosage of COUMADIN should change. When will I have to take a PT/INR test? When you start taking COUMADIN, you may have PT/INR tests every day for a few days, then perhaps one time every week. This will help your healthcare provider give you the dosage of COUMADIN that is right for you. What things may change my PT/INR test results? protime PT/INR tests will be needed at periodic intervals throughout your course of therapy to help keep your PT/INR in the best range for your medical condition. It is important to follow the PT/INR schedule recommended by your healthcare provider. Several things, such as sickness, diet, other medicines (prescription and over-thecounter), or physical activities, may affect your PT/INR. Tell your healthcare provider about changes in your health, your medicines or your lifestyle. INR Please see Full Prescribing Information available on this website. Blood Tests 9 10

7 11 What are the possible side effects of COUMADIN? (Warfarin Sodium Tablets, USP) Crystalline Your healthcare provider can tell you about possible side effects of COUMADIN, which include bleeding and allergic reactions. The most common side effect of COUMADIN is bleeding in any tissue or organ. Numerous factors including travel, changes in diet, environment, general health, and medication may affect your response to COUMADIN. To lower the risk of bleeding, your PT/INR should be kept within a range that is right for you. Please contact your healthcare provider right away if you experience signs or symptoms of bleeding, such as: headache, dizziness, or weakness bleeding from shaving or other cuts that does not stop nosebleeds bleeding of gums when brushing your teeth throwing up blood unusual bruising (black-andblue marks on your skin) for unknown reasons red or dark brown urine red or black color in your stool more bleeding than usual when you get your menstrual period or unexpected bleeding from the vagina unusual pain or swelling Please see Full Prescribing Information available on this website. Serious, but rare, side effects of COUMADIN include skin necrosis (death of skin tissue) and purple toes syndrome, either of which may require removal of unhealthy tissue and/or amputation of the affected area. Talk with your healthcare provider for further information on these side effects. 12 Possible Side Effects and Drug Interactions

8 What should I know about drug interactions and diet? COUMADIN (Warfarin Sodium Tablets, USP) Crystalline interacts with many drugs, including prescription and nonprescription (over-the-counter) drugs. For this reason, it is important for you to check with your healthcare provider before starting, changing, or stopping any drug. Some of the nonprescription drugs that may interact with COUMADIN include: acetaminophen (**Tylenol ); aspirin and aspirincontaining ointments and skin **The brands listed are the registered trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company. 13 creams; ibuprofen (**Motrin, **Advil, Nuprin ); naproxen (**Aleve, **Orudis KT ); H 2 -receptor antagonists, such as cimetidine (**Tagamet ) or ranitidine (**Zantac ); and vitamin supplements containing vitamin K. Other drugs may affect your response to COUMADIN. Please check with your healthcare provider for additional information. Herbal medications may interact with COUMADIN. Be aware that most herbal preparations are not standardized and potency may vary from one lot to another. Inform your healthcare provider if you intend to take herbal and/or natural products since you may need to be monitored more closely. Please see Full Prescribing Information available on this website. 14 Possible Side Effects and Drug Interactions

9 What else should I do? COUMADIN (Warfarin Sodium Tablets, USP) Crystalline has helped many people, but like all medicines, it has the potential to cause side effects, including bleeding in any tissue or organ. This is why it is important that you always follow your healthcare provider s directions exactly. To the right is a list of things you should do while taking COUMADIN. 15 Do s Do take your COUMADIN exactly as your healthcare provider tells you. Do keep eating habits and activities similar every day. Do get your blood tested when you are supposed to. The calendar starting on page 27 can help you remember. I am using COUMADIN, an anticoagulant. Please tell this immediately to anyone providing medical care to me. BOOD TYPE Do tell your healthcare provider about any other medicines you are taking (prescription and over-thecounter) and herbal/nutritional supplements. Also, ask your healthcare provider before you change, start, or stop taking any other medicines. Do tell your healthcare provider when you get sick, get hurt, or get a cut that won t stop bleeding. Do look for signs of bleeding. (Refer to Possible Side Effects section on page 11.) Do tell anyone giving you medical or dental care that you are taking COUMADIN. Carry identification stating that COUMADIN is being taken. Do refill your prescriptions according to your healthcare provider s orders. Please see Full Prescribing Information available on this website. 16 Do s and Don ts

What other things should I consider? Carry the patient identification card located in the back of this booklet. You may wish to wear a Medical Alert bracelet.

10 What other things should I consider? Carry the patient identification card located in the back of this booklet. You may wish to wear a Medical Alert bracelet. (Ask your healthcare provider where you can get one.) What should I not do? Do not take an extra tablet to catch up. (See page 19 for more information on a missed dose.) Do not take COUMADIN (Warfarin Sodium Tablets, USP) Crystalline if you are pregnant or may become pregnant. (See page 19 for more information on pregnancy and COUMADIN.) Be aware that COUMADIN and generic warfarin tablets represent the same medication and should not be taken together, as overdosage may result. Since COUMADIN and generic warfarin have different tablet shapes and markings, there is a chance that you may take both products together by mistake. What should I avoid? 1. Avoid drastic changes in your dietary habits. 2. Avoid alcohol consumption. 3. Avoid any activity or sport that may result in a traumatic injury. Do s and Don ts Do not take any other medicines before asking your healthcare provider. 17 Do not take generic warfarin tablets with COUMADIN unless specifically directed by your healthcare provider. Please see Full Prescribing Information available on this website. 18

11 What if...? What if I cut myself, get a cut that won t stop bleeding, or have an injury? Tell your healthcare provider immediately. Your healthcare provider will decide if you need medical attention. What if I become pregnant? Do not take COUMADIN (Warfarin Sodium Tablets, USP) Crystalline if you are or may become pregnant. This is very important because COUMADIN should not be taken during pregnancy. Tell your healthcare provider if you are or may become pregnant. What if I forget to take a COUMADIN tablet? DO NOT TAKE ANOTHER TABET TO CATCH UP! If you forget to take a tablet, tell your healthcare provider. Take the missed dose as soon as possible on the same day, but DO NOT take a double dose of COUMADIN the next day to make up for the missed dose. What if COUMADIN therapy is stopped? If your healthcare provider stops your COUMADIN therapy, the anticoagulant effects may last for about 2 to 5 days. What if I want to travel while I take COUMADIN? You can travel, but tell your healthcare provider before you go. You may need to take a PT/INR test before you leave, or your healthcare provider may arrange for you to have one while on your trip. Remember to keep your eating habits and activity level as close to your everyday routine as possible. Also, make sure to take enough COUMADIN with you. Please see Full Prescribing Information available on this website. What if I want to participate in a sport or physical activity? Ask your healthcare provider first. Your healthcare provider may want you to avoid any activity or sport that may result in a serious fall or other injury. What If...? 19 20

Why do I need to pay attention to my diet? Many foods you eat have vitamin K in them, and vitamin K helps your blood make clots. Why should I stay on the same general diet every day?

12 Why do I need to pay attention to my diet? Many foods you eat have vitamin K in them, and vitamin K helps your blood make clots. Why should I stay on the same general diet every day? arge changes in the amount of vitamin K you eat may affect the way your COUMADIN (Warfarin Sodium Tablets, USP) Crystalline works. It is important for you to keep your diet consistent so the amount of vitamin K you eat is consistent. Please contact your healthcare provider before making major changes to your diet. Tell your healthcare provider if you change your diet because you are sick. Should I avoid foods with a lot of vitamin K? No. Just keep your diet consistent. Some foods that are important to a healthy diet are high in vitamin K, like leafy, green vegetables and some beans and peas. How much vitamin K is in the foods I eat? On the next few pages is a chart that shows some foods and if they have a high, medium, or low amount of vitamin K in them. To compare foods against each other, the same amount of each food was tested, so some portion sizes may seem bigger or smaller than usual. Remember, it is more important that you keep your diet consistent. KFood containing fat substitutes, such as Olestra (**Olean ), are supplemented with fat-soluble vitamins including vitamin K. Does cooking, freezing, or These foods should be considered a source of vitamin K in much vitamin K is in them? drying foods change how the diet. There is little information about the effects of cooking, freezing, In addition, you may want to or drying on the vitamin K content of foods. It appears that the See the chart on pages avoid herbal teas that have tonka beans, melilot (sweet vitamin K content of cooked, for more information. clover), or sweet woodruff in frozen, or dried foods is about them. the same as fresh foods. **The brand listed is the registered trademark of its respective owner and is not a trademark of Bristol-Myers Squibb Company. Please see Full Prescribing Information available on this website. 22 Your Diet and Vitamin K 21

13 Vitamin K Food ist H = High M = Medium = ow 23 The amount of vitamin K in food may affect therapy with COUMADIN (Warfarin Sodium Tablets, USP) Crystalline. Eat a normal, balanced diet maintaining a consistent amount of vitamin K. All foods are acceptable; however, avoid drastic changes in dietary habits. It is important to check with your healthcare provider before making any major changes to your diet. In general, leafy, green vegetables and certain legumes and vegetable oils contain high amounts of vitamin K. Foods that appear to contain low amounts of vitamin K include roots, bulbs, tubers, the fleshy portion of fruits, fruit juices, and other beverages. ikewise, cereal grains and their milled products appear to be low in vitamin K. Foods* BEVERAGES Coffee caffeinated, brewed, decaffeinated, instant Cola regular and diet Fruit juices assorted types Milk Tea black, brewed; green, brewed Water tap GRAIN PRODUCTS Bagel plain Bread assorted types Vitamin K 1 Content Foods* Cereal assorted types Flour assorted types Oatmeal instant, dry Rice white Spaghetti dry DAIRY PRODUCTS Butter Cheddar cheese Eggs Sour cream Yogurt Vitamin K 1 Content Portion Vitamin K 1 Foods* Size Content FATS AND DRESSINGS Margarine 7 Tbsp M Mayonnaise 7 Tbsp H Oils: Canola 7 Tbsp H Salad Soybean Oils: Olive 7 Tbsp M Oils: Corn Sesame 7 Tbsp Peanut Sunflower Safflower FRUITS Apple Banana Blueberries Cantaloupe Grapes Foods* Grapefruit emon Orange Peach MEAT Beef Chicken Ham Mackerel Pork Shrimp Tuna Turkey Please see Full Prescribing Information available on this website. 24 Vitamin K 1 Content

14 Vitamin K Food ist H = High M = Medium = ow Portion Vitamin K 1 Foods* Size Content Portion Vitamin K 1 Foods* Size Content Portion Vitamin K 1 Foods* Size Content Portion Vitamin K 1 Foods* Size Content VEGETABES Eggplant 1 1 / 4 cups Potato CONDIMENTS AND SWEETENERS Asparagus 7 spears M Endive raw 2 cups H Pumpkin Honey Avocado 1 small M Green scallion raw 2 / 3 cup H Sauerkraut canned 1 / 2 cup Jell-O Gelatin Beans green 3 / 4 cup Kale raw leaf 3 / 4 cup H Spinach raw leaf 1 1 / 2 cups H Peanut butter Broccoli 1 / 2 cup H Brussels sprouts 5 sprouts H Cabbage 1 1 / 2 cups H Cabbage red 1 1 / 2 cups M ettuce raw 1 3 / 4 cups H bibb red leaf ettuce iceberg, raw 5 leaves M Mushroom 1 1 / 2 cups Tomato Turnip greens raw 1 1 / 2 cups H chopped Watercress raw 3 cups chopped H Pickle dill 1 medium M Sugar white, granulated Carrot 2 / 3 cup Cauliflower 1 cup Celery 2 1 / 2 stalks Collard greens 1 / 2 cup H Corn 2 / 3 cup Cucumber peel removed 1 cup Mustard greens raw 1 1 / 2 cups H Onion Parsley 1 1 / 2 cups H chopped Peas green, cooked Pepper green, raw 2 / 3 cup M * ist is a partial listing of foods. For more complete information, see references 1 and 2. Portions in chart for foods of medium and high vitamin K content were calculated from estimated portions provided in Reference 4. Portion sizes for foods low in vitamin K content apply to 3.5 ounces for beverages and meats, medium-sized whole fruits and 1 cup or less for other foods listed unless otherwise stated. Although dried tea leaves are high in vitamin K content, brewed tea is not a significant source of vitamin K. The brand listed is the registered trademark of its respective owner and is not a trademark of Bristol-Myers Squibb Company. 1. Booth S, Sadowski JA, Pennington JAT. Phylloquinone (Vitamin K1) content of foods in the U.S. Food and Drug Administration s total Diet Study. J Agric Food Chem 1995,43: Booth S, Sadowski JA, Weihrauch J, Ferland G. Vitamin K1 (phylloquinone) content of foods: a provisional table. J Food Comp Anal 1993;6: National Research Council. Recommended Daily Allowances, 10th ed.; National Academy Press: Washington DC, Pennington JA, Church HN: Food Values of Portions Commonly Used, 16th Edition, J.P. ippincott Company, Booth S, Madabushi HT, Davidson KW, Sadowski JA. Tea and coffee brews are not dietary sources of vitamin K1 (phylloquinone). JAM Diet Assoc 1995;95: Please see Full Prescribing Information available on this website. 26

15 Keep this handy card in your wallet or purse. Keep this handy card in your wallet or purse. The other side of this card shows the different strengths, numbers, and colors of COUMADIN (Warfarin Sodium Tablets, USP) Crystalline. Be sure to check that the tablet shows COUMADIN and the right number before you take it. Information for emergencies is to the right. 1. Tear along dotted lines. 2. Write in information. 3. Fold in half. 4. You may wish to carry this card with you. FOD HERE NAME I am using COUMADIN (Warfarin Sodium Tablets, USP) Crystalline, an anticoagulant that helps prevent blood clots from forming. Please tell this immediately to anyone providing medical care to me. BIRTHDATE WEIGHT BOOD TYPE OTHER MEDICATIONS/CONDITIONS IN EMERGENCY, NOTIFY: NAME REATIONSHIP ADDRESS PHONE DOCTOR S NAME DOCTOR S PHONE I am using COUMADIN, an anticoagulant that helps prevent blood clots from forming. Please tell this immediately to anyone providing medical care to me. PEASE SEE IMPORTANT INFORMATION INSIDE. Patient Identification Card This card shows the different strengths, number, and colors of COUMADIN and has information for emergencies on the other side. FOD HERE 1. Tear along dotted lines. 2. Write in information on other side. 3. Fold in half. 4. You may wish to carry this card with you. The most common side effect of COUMADIN is bleeding in any tissue or organ. Princeton, NJ 08543

16 Important things to remember Take your tablet of COUMADIN at the same time every day as directed by your healthcare provider. Stick to your PT/INR test schedule. Call your healthcare provider if you have questions, problems, lifestyle changes, or symptoms possibly related to the use of COUMADIN. Call your healthcare provider immediately if you find any signs of bleeding. Do not take or discontinue any other medication, including over-the-counter medications and herbal products, except on advice of your healthcare provider. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables. COUMADIN is contraindicated in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus in utero. Furthermore, there have been reports of birth malformations in children born to mothers who have been treated with warfarin during pregnancy. Please see Full Prescribing Information available on this website AM PM YOUR DOCTOR S PHONE NUMBER Princeton, NJ Bristol-Myers Squibb Company Printed in USA T1-H001 04/02 *COUMADIN (Warfarin Sodium), the COUMADIN color logo, COUMACARE SM, COORS OF COUMADIN, and the color and configuration of COUMADIN tablets are trademarks of Bristol-Myers Squibb Company. Any unlicensed use of these trademarks is expressly prohibited under the U.S. Trademark Act.

Treatment with Warfarin (Coumadin)

Patient Education Treatment with Warfarin (Coumadin) Warfarin (Coumadin) is a medication that is used to treat and prevent blood clots in the legs, lungs, heart, brain, and other parts of the body. What