Capecitabine is used alone or in combination chemotherapy to treat colon cancer, breast cancer, or colorectal cancer.

Capecitabine is sometimes used when cancer has spread to other parts of the body (metastatic).

Capecitabine may also be used for purposes not listed in this medication guide.

Taking a blood thinner (warfarin, Coumadin, Jantoven) can increase your risk of severe bleeding during and shortly after treatment with capecitabine. This risk is higher in adults older than 60.

Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. It is usually taken after a meal (within 30 minutes of breakfast and dinner) and with a glass of water. Your doctor will decide how many times you should repeat this cycle. Take capecitabine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take capecitabine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may adjust your dose of capecitabine or stop your treatment for a period of time depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Swallow the tablets whole; do not split, chew, or crush them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Capecitabine is usually taken twice per day, and may be only part of a treatment program that may also include other medications taken on different schedules. Follow your doctor's dosing instructions very carefully.

Take with food or within 30 minutes after eating a meal.

Swallow the tablet whole with water and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet.

Capecitabine is given in a 3-week treatment cycle, and you may only need to take the medicine only on certain days of this cycle.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

You may need frequent medical tests and your cancer treatments may be delayed based on the results. Capecitabine can have long lasting effects on your body. You may also need medical tests for a short time after your last dose.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

You should not take capecitabine if you are allergic to capecitabine or fluorouracil, or if you have:

• severe kidney disease.

Tell your doctor if you have ever had:

• a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency;

• liver or kidney disease;

• heart problems; or

• if you use a blood thinner and you have routine "INR" or prothrombin time tests.

Capecitabine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Diarrhea may occur and could be severe. Stop taking capecitabine and tell your doctor right away if the number of bowel movements you usually have per day increases by 4 or more, or if you have bowel movements at night.

Capecitabine may cause serious side effects. Stop using capecitabine and call your doctor at once if you have:

• severe diarrhea;

• bloody diarrhea with severe stomach pain and fever;

• severe nausea or loss of appetite that causes you to eat much less than usual;

• vomiting (more than once in 24 hours);

• fever above 100.5 degrees;

• sores or ulcers in your mouth, redness or swelling of your mouth or tongue, trouble eating or swallowing;

• jaundice (yellowing of the skin or eyes);

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• "hand and foot syndrome"--pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;

• heart problems--chest pain, irregular heartbeats, swelling in your lower legs, rapid weight gain, feeling lightheaded or short of breath; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of capecitabine may include:

• nausea, vomiting, diarrhea, stomach pain;

• feeling weak or tired;

• hand and foot syndrome; or

• jaundice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking a blood thinner (warfarin, Coumadin, Jantoven) can increase your risk of severe bleeding during and shortly after treatment with capecitabine. This risk is higher in adults older than 60.

Tell your doctor if you also take allopurinol.

Other drugs may affect capecitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to capecitabine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.