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Capecitabine Tablet

IMPORTANT: HOW TO USE THIS INFORMATION: This synopsis does NOT encompass all conceivable details about this product. It doesn't guarantee that the product is safe, beneficial, or suitable for you. This information shouldn't be perceived as personal medical counsel and doesn't replace the guidance provided by your healthcare provider. Always seek comprehensive information about this product and your unique health requirements from your healthcare professional.




WARNING: Individuals on capecitabine and certain anticoagulants, like warfarin or phenprocoumon, may have an increased probability of severe, occasionally lethal, bleeding. Your risk could be greater due to having cancer, or if you are above the age of 60. Bleeding episodes have been reported both during the course of treatment and up to a month following the discontinuation of capecitabine.

If you are using an anticoagulant, blood lab tests (INR/PT) will be closely checked. Tell your doctor right away if you have any signs of bleeding or bruising (such as bloody/black/tarry stools). You should be tested for a DPD enzyme deficiency before you start treatment with capecitabine. Ask your doctor for more details.

USES: Capecitabine is used to treat breast, colon, or rectal cancer. It works by slowing or stopping the growth of cancer cells.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking capecitabine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Administer this medicine orally as per your doctor's instructions, typically twice daily - once in the morning and once in the evening. Ingest the tablets without crushing or splitting them, using a full glass of water (8 ounces/240 milliliters), within half an hour post-meal. If you experience difficulty swallowing the tablets in their whole form, seek guidance from your healthcare provider. Your physician may advise you to consume this medication following a specific treatment cycle. Adhere meticulously to your doctor's directions.

The dosage is based on your medical condition, body size, and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, headache, dizziness, trouble sleeping, or changes in taste may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea frequently occurs as a side effect of this medication. Consume an ample amount of liquids unless instructed otherwise. Your doctor may recommend a medicine like loperamide to alleviate diarrhea. Persistent vomiting or diarrhea could lead to dehydration. Reach out to your doctor immediately if you observe any signs of dehydration, including noticeably reduced urine output, abnormal dryness of the mouth or thirst, or feelings of dizziness or light-headedness.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended. Also, temporary nail changes may occur.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Stop taking capecitabine and tell your doctor right away if any of these very serious side effects occur: severe nausea/vomiting (vomiting 2 or more times per day, unable to eat or keep food/fluids in your stomach), painful redness/swelling/sores in mouth or on your tongue.

Capecitabine may make you develop a skin problem called hand-foot syndrome. To help prevent this, protect your hands and feet from heat or increased pressure. Avoid activities such as using hot dishwater, taking tub baths, jogging, long walks, or using garden or household tools such as screwdrivers. Symptoms may include pain, swelling, redness, blisters, or numbness of the hands/feet. Your doctor may prescribe medication (such as balm) to help with symptoms. If symptoms affect your usual activities, get medical help right away.

For men and women of childbearing age, this medication may affect your ability to have children. Ask your doctor for more details.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn't go away, fever, chills, cough).

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, mental/mood changes (such as depression), swelling of the ankles/feet, vision changes, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine.

Get medical help right away if you have any very serious side effects, such as: chest/jaw/left arm pain, unusual sweating, fainting, slow/fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash/blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking capecitabine, tell your doctor or pharmacist if you are allergic to it; or to 5-fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lack of a certain enzyme (dihydropyrimidine dehydrogenase - DPD), blood disorders (such as bone marrow suppression), heart problems (such as heart failure), kidney disease, liver problems.

Capecitabine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this medication, especially nausea, vomiting, diarrhea, and hand-foot syndrome.

Inform your doctor if you're pregnant or intend to conceive. You should avoid becoming pregnant while undergoing treatment with capecitabine, as it could potentially harm an unborn child. Seek advice on dependable methods of contraception. Women who could bear children should utilize trustworthy contraceptive methods during the course of treatment and for six months following the final dose. Men with partners who could bear children should also use reliable birth control methods during treatment and for three months following the final dose. If you or your partner conceive, immediately consult your doctor about the risks and benefits associated with capecitabine.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended during treatment and for 2 weeks after the last dose. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning section.

Interactions between drugs can alter the effectiveness of your medications or heighten your susceptibility to significant side effects. This document doesn't encapsulate all potential drug interactions. Maintain a record of all the products you use, including prescription drugs, over-the-counter medicines, and herbal products, and share this list with your doctor and pharmacist. Don't initiate, cease, or modify the dose of any medications without the approval of your doctor.

A product that may interact with this drug is: allopurinol.

Capecitabine is very similar to fluorouracil. Do not use medications containing fluorouracil while using capecitabine.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Lab and/or medical tests (such as bilirubin, complete blood counts, kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time and check with your doctor. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.