Sandoz Capecitabine: Uses, Side Effects and Dosage

Serious warnings and precautions box

What Sandoz Capecitabine is used for:

Sandoz Capecitabine is used to treat patients with:

• Stage III colon cancer (Duke’s stage C) which is a condition where the cancer of the colon has spread to other areas. It is used after surgery has been performed.
• Cancer of the colon or rectum that is called metastatic. Metastatic means the cancer has spread

Serious side effects include:

• Severe dehydration may cause rapid loss of kidney functions including kidney failure. This may lead to death.
• Sudden death due to heart problems including irregular heartbeat.
• Severe skin reactions such as hand-and foot syndrome, Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]
• Severe toxicity including death in patients who do not have an enzyme called dihydropyrimidine dehydrogenase (DPD). If you lack this enzyme you should not take Sandoz Capecitabine. Your healthcare professional might check to see if you have this enzyme before you can take Sandoz Capecitabine.
• Increased bleeding in patients also taking medicines that thin the blood. This can happen as soon as a few days after you start taking Sandoz Capecitabine. It can also happen later during treatment and possibly even within 1 month after you stop taking Sandoz Capecitabine. Before you start taking Sandoz Capecitabine, tell your healthcare professional if you are also taking a blood thinner medicine, like warfarin. Your healthcare professional might check the clotting time of your blood before you take Sandoz Capecitabine and while you are taking it.

See “Serious side effects and what to do about them” table for more information.

• to other parts of the body.
• Metastatic cancer of the colon or rectum in combination with another cancer medicine called oxaliplatin. In these patients, it is used after another medicine called irinotecan was tried previously.
• Breast cancer that is advanced or metastatic after therapy with other medicines has not worked.
• Breast cancer that is advanced or metastatic in combination with another cancer medicine called docetaxel. In these patients it is used when other medicines have not worked.

How Sandoz Capecitabine works:

Sandoz Capecitabine belongs to a family of medicines called fluoropyrimidines. These medicines interfere with the growth of cells that divide rapidly in the body, like cancer cells. Sandoz Capecitabine is converted to the medicine fluorouracil in the body. It prevents the growth of cancer cells and kills them.

The ingredients in Sandoz Capecitabine are:

Medicinal ingredient: capecitabine

Non-medicinal ingredients: Croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide.

Sandoz Capecitabine comes in the following dosage forms:

Tablets; 150 mg and 500 mg

Do not use Sandoz Capecitabine if you:

• are allergic to capecitabine, 5-fluorouracil.
• are allergic to any of the other non-medicinal ingredients in Sandoz Capecitabine.
• have severe kidney problems.
• have been told that you do not have the enzyme called dihydropyrimidine dehydrogenase (DPD).
• are being treated now or have been treated in the last 4 weeks with brivudine, sorivudine or similar classes of medicines as treatment of herpes zoster (chickenpox or shingles).

It is not known if Sandoz Capecitabine is safe and effective in patients younger than 18 years of age.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Capecitabine. Talk about any health conditions or problems you may have, including if you:

• are allergic to other medications, food and dyes.
• are taking phenytoin or fosphenytoin. Your healthcare professional may need to check the levels of phenytoin in your blood more often.
• are taking docetaxel
• have heart problems
• have liver problems
• have kidney problems

• are pregnant, plan to become pregnant or are breastfeeding or are planning to breastfeed.

• are 60 years of age or older.

Other warnings you should know about:

• Sandoz Capecitabine may impair fertility in females and males
• Female Patients: You should not become pregnant while you are taking Sandoz Capecitabine. This is because it can harm your unborn child. Before you start taking Sandoz Capecitabine, it is recommended that you test to make sure you are not pregnant. You must use effective birth control while you are taking Sandoz Capecitabine and for six months after you stop taking it. Talk to your healthcare professional about effective methods of birth control.
• Male Patients: You should not father a child if you are taking Sandoz Capecitabine. If your female partner is of childbearing age you must use effective birth control while you are taking Sandoz Capecitabine and for 3 months after you stop taking it. Talk to your healthcare professional about effective methods of birth control for you and your partner.
• You should stop breastfeeding during treatment with Sandoz Capecitabine and for 2 weeks after the final dose.
• If you are over 65 years old, you may be more sensitive to the toxic side effects of Sandoz Capecitabine. Watch more carefully for possible diarrhea, nausea, and vomiting.
• If you experience persistent or severe hand-and-foot syndrome while taking Sandoz Capecitabine, it can eventually lead to loss of fingerprints. This could impact your identification by fingerprint scan.

• Driving and using machines: Sandoz Capecitabine may make you feel dizzy, nauseous or tired. This may affect your ability to drive a car or operate machines. Before driving or using machines, wait until you are feeling well again.

• Your healthcare professional may tell you to decrease the dose or stop Sandoz Capecitabine treatment for a while if side effects appear. If caught early, most of these side effects usually improve after you stop taking Sandoz Capecitabine. If they do not improve within 2 to 3 days, call your healthcare professional again. After side effects have improved, your healthcare professional will tell you whether to start taking Sandoz Capecitabine again and what is the right dose for you.

• Testing and check-ups: Your healthcare professional may do certain tests before you start taking Sandoz Capecitabine and while you are taking it. These tests may include:

  • a test to check for dihydropyrimidine dehydrogenase (DPD) deficiency (a missing or low level of an enzyme in your body) before you begin treatment, unless you need to start treatment right away.
  • regular blood tests to check your blood clotting (PT or INR) if you are also taking a blood thinner such as warfarin or another coumarin anticoagulant.
  • blood tests and careful checks if you have liver problems or kidney problems.
  • a pregnancy test if you are a female who could become pregnant, before you start treatment.
  • regular blood tests to check the level of phenytoin in your blood if you are also taking phenytoin or fosphenytoin.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Sandoz Capecitabine:

• Medicine used to treat seizures such as Phenytoin and Fosphenytoin.
• Blood thinner medicine such as warfarin and phenprocoumon.
• Aluminum hydroxide and magnesium hydroxide-containing antacids used to treat heartburn and acid indigestion.
• Leucovorin, a medicine used to prevent the harmful effects of cancer chemotherapy medication.
• Certain medicines used specifically for treating viral infections such as sorivudine and brivudine.

How to take Sandoz Capecitabine:

• Take Sandoz Capecitabine exactly as your healthcare professional tells you to.
• Swallow tablets whole with water.
• Take Sandoz Capecitabine within 30 minutes after finishing a meal.
• Do not crush or cut Sandoz Capecitabine tablets.
• If you cannot swallow Sandoz Capecitabine tablets, speak to your healthcare professional.
• Stay under your healthcare professional’s care while taking Sandoz Capecitabine.
• Your healthcare professional might change your dose or stop your treatment if you develop certain side effects.

Usual dose:

The usual dose of Sandoz Capecitabine depends on your body surface size. Your healthcare professional will tell you how much Sandoz Capecitabine to take.

You may need to take a combination of 150 mg and 500 mg tablets. To get the right dose it is very important that you identify the tablets correctly each time you take Sandoz Capecitabine. Taking the wrong tablets could result in an overdose (too much medication) or underdose (too little medication).

Take the tablets twice a day (morning and evening doses) as your healthcare professional prescribed. Do not take more than your prescribed dose, more often or for a longer time than your healthcare professional told you to.

Sandoz Capecitabine is taken in 21-day cycles. This means you take Sandoz Capecitabine for 14 days and then stop taking it for 7 days. It is important to have this rest period. Your healthcare professional will tell you how many cycles of treatment you will need.

For the treatment of colon cancer following complete surgical removal, Sandoz Capecitabine is usually taken for eight 21-day cycles (i.e. for a total of 24 weeks or approximately 6 months).

Overdose:

If you think you, or a person you are caring for, have taken too much Sandoz Capecitabine, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget a dose of Sandoz Capecitabine do not take the missed dose at all. Take your next dose at the usual time and check with your healthcare professional. Do not take double dose.

Possible side effects from using Sandoz Capecitabine?

These are not all the possible side effects you may have when taking Sandoz Capecitabine. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Constipation
• Skin irritation
• Fever
• Pins and needles sensation
• Loss of appetite
• Eye irritation
• Indigestion
• Heartburn
• Hair loss
• Taste altered
• Dizziness
• Nail changes, deformation, or abnormality
• Pain in limb
• Headache
• Trouble sleeping
• Muscle pain

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Talk to your healthcare professional if you experience any diarrhea, vomiting or nausea. Stop taking Sandoz Capecitabine and call your healthcare professional immediately if you notice any of the following additional symptoms in regards to your diarrhea, vomiting or nausea. Your healthcare professional can then adjust Sandoz Capecitabine to a dose that is right for you. This should help to reduce the side effects and stop them from getting worse.

Diarrhea:

• An additional 4 bowel movements a day beyond what is normal or any diarrhea at night
• If you have a colostomy, an increase in loose, watery fluid in your colostomy bag
• An diarrhea together with soreness of the mouth affecting your ability to drink enough fluids

Vomiting:

• Vomiting more than once in 24 hours, especially if you also have diarrhea

Nausea:

• Loss of appetite or eating less food than usual each day.

Side effects may differ when taking Sandoz Capecitabine in combination with docetaxel compared with taking Sandoz Capecitabine alone. In addition to the above side effects listed, increased tears, joint pain, muscle pain, and sore throat can occur. Talk to your healthcare professional for more information on the possible side effects that may occur when taking Sandoz Capecitabine in combination with docetaxel.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep out of reach and sight of children.

Store at room temperature (15-30°C), in the original package.

Special handling using appropriate equipment and disposal procedures, should be taken as Sandoz Capecitabine can be harmful to normal cells of the body. Any unused medicinal product or waster material should be disposed in accordance with the local requirements.

If you want more information about Sandoz Capecitabine:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://health-products.canada.ca/dpd-bdpp/); the manufacturer’s website www.sandoz.ca; or by calling 1-800-361-3062.

Date of Authorization: 2026-04-09