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Generic Name: Capecitabine (cap-eh-SITE-ah-been)
Brand Name: Xeloda

Xeloda may cause serious and sometimes fatal bleeding problems when taken with anticoagulants (eg, warfarin). Bleeding problems have occurred during therapy and for up to 1 month after stopping therapy with Xeloda . This risk is greater in patients with cancer and those who are 60 years of age and older. If you take anticoagulants while taking Xeloda , your doctor will perform frequent blood tests (eg, prothrombin time, international normalized ratio) to make sure your blood is clotting normally. Be sure to keep all doctor and lab appointments while using Xeloda . Contact your doctor immediately if you develop any signs of bleeding problems such as unusual bleeding, bruising, or black, tarry stools.

Xeloda is used for:

Treating certain types of breast cancer or colon cancer in some patients. It may be used alone or with other medicines in some cases.

Xeloda is an antimetabolite. It works by interfering with the production of proteins necessary for cancer cell growth and reproduction.

Do NOT use Xeloda if:

  • you are allergic to any ingredient in Xeloda or to 5-fluorouracil
  • you have severe kidney problems or the enzyme deficiency dihydropyrimidine dehydrogenase (DPD) deficiency

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xeloda :

Some medical conditions may interact with Xeloda . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant or planning to become pregnant
  • if you are taking any prescription (particularly blood thinners) or nonprescription medicine, herbal preparation, or dietary supplement (vitamin E, aspirin, ibuprofen, naproxen)
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart, kidney, or liver problems; bone marrow problems; or pain, redness, swelling, tingling, or tenderness of the palms of the hands or soles of the feet (erythrodysesthesia syndrome)
  • if you have nausea, vomiting, diarrhea, inflammation or sores in the mouth, or an infection
  • if you are undergoing chemotherapy or radiation therapy, or if you take folic acid or vitamins that contain folic acid

Some MEDICINES MAY INTERACT with Xeloda . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Xeloda
  • Leucovorin because the risk of severe intestinal problems, diarrhea, and dehydration may be increased
  • Hydantoins (eg, phenytoin) because side effects may be increased by Xeloda

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xeloda may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xeloda :

Use Xeloda as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Xeloda with food or within 30 minutes after a meal. Swallow the tablets with water.
  • Xeloda comes with an additional patient leaflet. Read it carefully and reread it each time you get Xeloda refilled.
  • If you miss a dose of Xeloda , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xeloda .

Important safety information:

  • Xeloda may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Xeloda . Using Xeloda alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Xeloda may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
  • Xeloda may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Xeloda . Vaccinations may be less effective.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Xeloda .
  • LAB TESTS, including blood cell counts and blood electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Talk with your doctor about using an effective method of birth control while taking Xeloda .
  • Use Xeloda with caution in the ELDERLY because they may be more sensitive to its effects, especially nausea; vomiting; diarrhea; and pain, redness, and swelling of the hands or feet.
  • Use Xeloda with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Xeloda has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Xeloda . Talk with your doctor about using effective methods of birth control while taking Xeloda . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Xeloda during pregnancy. It is unknown if Xeloda is excreted in breast milk. Do not breast feed while taking Xeloda .

Possible side effects of Xeloda :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back, joint, or muscle pain; constipation; dizziness; eye irritation; fatigue; headache; itchy or dry skin; loss of appetite; mild nausea, vomiting, or diarrhea; stomach pain; taste changes; tiredness; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bloody diarrhea; chest pain; decreased amount of urine; dry mouth; fast or irregular heartbeat; fever higher than 100.5 degrees F, chills, or sore throat; hair loss; leg pain or swelling; moderate to severe nausea, vomiting, or diarrhea; mood or mental changes; numbness, pain, tingling, blistering, swelling, or redness in the palms of the hands or soles of the feet; pain, redness, swelling, or sores in the mouth or throat; unusual bleeding or bruising; unusual tiredness; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include diarrhea; nausea; stomach irritation and bleeding; vomiting.

Proper storage of Xeloda :

Store Xeloda at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xeloda out of the reach of children and away from pets.

General information:

  • If you have any questions about Xeloda , please talk with your doctor, pharmacist, or other health care provider.
  • Xeloda is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xeloda . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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