Xeloda

What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

There is no specific information comparing use of capecitabine in children with use in other age groups.

Geriatric

Patients 80 years of age or older may be more sensitive to the effects of capecitabine. Severe diarrhea, nausea, or vomiting may be more likely to occur in these patients. Patients 60 years of age and older and/or who are also taking an anticoagulant (blood thinner), may be more likely to have blood clotting problems.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to capecitabine or to any ingredients in this medicine or
• Allergy to 5-fluorouracil or
• Shortage of an enzyme called dihydropyrimidine dehydrogenase that your body needs—Capecitabine should not be used.

• Bone marrow depression or
• Cancer—May increase risk of blood clotting problems.

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body.

• Heart disease—The risk of a side effect that affects the heart may be increased.

• Infection—Capecitabine decreases your body's ability to fight infection.

• Kidney disease, moderate or severe—The risk of side effects that affect the kidneys may be increased. Capecitabine should not be used in patients with severe kidney disease.

• Liver disease—The amount of capecitabine in the body may be increased in patients with liver disease. Also, the risk of a side effect that affects the liver may be increased.