WARFARIN SODIUM ORAL (COUMADIN) BOXED WARNING: BLEEDING RISK • Do not take this medicine if you have: · a bleeding disorder such as hemophilia; · a blood cell disorder such as anemia; · a stomach ulcer or bleeding in the stomach; · a history of aneurysm, blood clot, or bleeding in your brain; or · an infection of your heart, fluid or swelling around your heart. • Warfarin interacts with many other drugs, and these interactions can be dangerous, even fatal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE; LIVER PROBLEMS; PEPTIC ULCER; HIGH BLOOD PRESSURE. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. * DO NOT skip doses or discontinue unless directed by your doctor. WARNINGS/PRECAUTIONS: TOP * Consult your doctor before taking aspirin or aspirin containing products. * DO NOT change your eating habits of green leafy vegetables.. * Avoid taking over-the-counter (non-prescription) drugs without asking your doctor or pharmacist. * Notify doctor if there are symptoms that suggest BLEEDING, such as black tarry stools or "coffee ground" vomit. * DO NOT change your eating habits of fish, liver, green tea or tomatoes. * It is important that your doctor monitors your BLOOD STUDIES at regular intervals. * DO NOT DRINK alcoholic beverages or take alcohol-containing preparations while being treated with this medicine. * Inform doctor or dentist that you are taking this medicine BEFORE HAVING ANY KIND OF SURGERY including dental surgery or medical procedure. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * It is important that you keep your follow-up appointments with your doctor. * Do not switch brands without your doctor's approval. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Severe allergic reaction. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Hypersensitivity reactions. Other Common Side Effects: TOP Unusual bleeding or bruising; Nausea; Diarrhea; Severe skin itching with patches; Mouth ulcers; Skin inflammation; Baldness; Decreased appetite; Vomiting; Stomach discomfort or pain; Liver toxicity (yellow eyes or skin); Yellowing of eyes or skin. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved