What is the most important safety information I should know about XELODA?

It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN^®). XELODA may increase the effect of this medicine. This could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots. He or she will change the dose of the blood thinner, if needed.

Who should not take XELODA?

Do not take XELODA if:

• You are nursing a baby. XELODA may pass through your breast milk and to the baby and harm the baby
• You are allergic to the chemotherapy medicines 5-FU and capecitabine or to any of the ingredients in XELODA
• Your body doesn't have enough of the enzyme DPD (dihydropyrimidine dehydrogenase)

What should I tell my doctor before taking XELODA?

Tell your doctor if you:

• Are pregnant or think you may be pregnant. XELODA may harm your unborn child. Men and women should use effective birth control while taking XELODA
• Take a blood thinner, such as warfarin
• Take phenytoin (DILANTIN^®)
• Have kidney, liver, or heart problems
• Take folic acid, a B complex vitamin, or a multivitamin containing folic acid

Stop taking XELODA immediately and contact your doctor right away if you have any of these serious common side effects or any other side effects that worry you:

• Diarrhea* — at least 4 more bowel movements each day than is normal for you or if you wake up because you need to have a bowel movement
• Throwing up (vomiting)* — more than once in 24 hours
• Feeling sick to your stomach (nausea)* — if you don't feel like eating and if the amount of food you eat each day is much less than usual
• Pain, redness, swelling, or sores in your mouth (stomatitis)*
• Hand-and-foot syndrome — pain, swelling, or redness of your hands or feet that prevents normal activity
• Fever or infection — a temperature of 100.5°F or higher or other signs of infection

If you do have any of the side effects listed above, or if you have other side effects that worry you, your doctor can change your dose of XELODA or stop your XELODA treatment for a while. This may help to reduce the side effects and stop them from getting worse.

What are the other common side effects of XELODA?

• Constipation*
• Loss of appetite*
• Stomach area pain* or upset stomach
• Too much water loss from the body (dehydration)*
• Rash or dry, itchy, discolored skin
• Nail problems
• Hair loss
• Tiredness or weakness
• Dizziness or headache
• Pain, including chest, back, joint, or muscle pain
• Trouble sleeping
• Problems with your sense of taste