Xeloda (Capecitabine)

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Capecitabine may cause serious or life-threatening bleeding when taken along with anticoagulants ('blood thinners') such as warfarin (Coumadin®). Tell your doctor if you are taking warfarin. Your doctor will order laboratory tests to monitor how fast your blood clots and may need to change your dose of warfarin. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding; vomiting or spitting up blood or brown material that resembles coffee grounds; bloody or black, tarry stools; blood in urine; red or dark-brown urine; or easy bruising.

Capecitabine is used in combination with other medications to treat breast cancer that has come back after treatment with other medications. It is also used alone to treat breast cancer that has not improved after treatment with other medications. Capecitabine is also used to treat colon or rectal cancer (cancer that begins in the large intestine) that has gotten worse or spread to other parts of the body. It is also used to prevent colon cancer from spreading in people who have had surgery to remove the tumor. Capecitabine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells.

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.

Before taking capecitabine,
• tell your doctor and pharmacist if you are allergic to capecitabine, fluorouracil (Adrucil, 5-FU), any other medications, or any of the ingredients in capecitabine tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: phenytoin (Dilantin), leucovorin, and folic acid (in multivitamins). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Other medications may also interact with capecitabine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have been told that you have or ever had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (a lack of a naturally occurring enzyme in your body). Your doctor may probably tell you not to take capecitabine.
• tell your doctor if you have or have ever had kidney, liver, or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not plan to have children while you are taking capecitabine. You should use a reliable method of birth control to prevent pregnancy in yourself or your partner during your treatment with capecitabine. Capecitabine may harm the fetus.tell your doctor if you are breast-feeding. You should not breast-feed during your treatment with capecitabine.

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

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Capecitabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain or upset stomach
• constipation
• loss of appetite
• change in ability to taste food
• increased thirst
• unusual tiredness or weakness
• dizziness
• headache
• hair loss
• skin rash
• back, join, or muscle pain
• red, swollen, itchy, or teary eyes
• trouble falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• diarrhea
• nausea
• vomiting
• sores in the mouth
• swelling, pain, redness, or peeling of skin on the palms and soles of the feet
• fever, chills, sore throat, or other signs of an infection
• swelling of the hands, feet, ankles, or lower legs
• chest pain or pressure
• fast heartbeat
• dark urine
• yellowing of skin or eyes

Capecitabine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.