How does it work?

This medicine contains capecitabine, which is an anti-cancer medicine known as a 'cytotoxic antimetabolite'. It is taken by mouth and is converted inside cancer cells to 5-fluorouracil (5-FU), the active form of the medicine. The conversion of capecitabine to 5-FU is carried out by several compounds within the body that are called enzymes. The enzyme responsible for the final step is found mostly in tumour tissues (although it is also found in other tissues in the body). This means that higher concentrations of the active 5-FU are produced within the tumour tissues, rather than other healthy areas of the body. The medicine is said to be targeted against the cancerous cells. Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. 5-FU works by stopping the cancer cells from multiplying. It does this by inhibiting the production of the cells' genetic material, DNA and RNA. Both DNA and RNA are needed for growth and multiplication of cells. 5-FU causes a deficiency of DNA and RNA in the cancer cells, and this causes the cells to grow in an unbalanced way, resulting in the death of the cells. 5-FU can also affect normal, healthy cells, particularly those that multiply quickly, such as blood cells. However, because the capecitabine is mostly converted to 5-FU only in the cancer cells, it means that side effects on normal healthy cells are less with this medicine than with traditional 'non-targeted' 5-FU given via a drip. The most important side effect is on the bone marrow where blood cells are made. 5-FU can decrease the production of blood cells, leaving people susceptible to infection. Regular blood tests are therefore needed to monitor levels of blood cells. Capecitabine is used to treat colorectal cancer that has spread to other areas of the body, and breast cancer that is locally advanced or has spread to other areas of the body. For breast cancer, capecitabine is used as second-line treatment when previous chemotherapy has been unsuccessful. It is used either in combination with another anti-cancer medicine called docetaxol, (when previous chemotherapy included an anthracycline medicine), or on its own (when previous chemotherapy included a taxane and an anthracycline, or where further anthracycline treatment is not indicated).

What is it used for?

Breast cancer that is locally-advanced or has spread to other areas of the body

Cancer of the large bowel and rectum that has spread to other parts of the body

Warning!

This medicine may cause fatigue and dizziness. If affected, caution is required when driving or operating machinery due to the possible reduction in physical and/or mental ability.

The safety and efficacy of this medicine in children and adolescents under 18 years of age has not been established.

The tablets should be swallowed with water within 30 minutes after a meal.

Side effects from this medicine can become severe, so it is important that you always contact your doctor immediately if you start to experience a side effect. Your doctor may instruct you to decrease the dose and/or temporarily stop taking this medicine.

Stop taking this medicine immediately and contact your doctor if any of the following symptoms occur: if you have more than 4 bowel movements each day or any diarrhoea at night; if you vomit more than once in a 24-hour time period; if you lose your appetite, and the amount of food you eat each day is much less than usual; if you have pain, redness, swelling or sores in your mouth; if you have pain, swelling, and redness of your hands and/or feet; or if you have a temperature of 38°C or greater, or other signs of infection.

Use with caution in

Current or previous coronary artery disease

Decreased kidney function

Decreased liver function

Diabetes mellitus

Disease affecting the brain or nervous system

Hand-foot skin reaction (hand-foot syndrome).

High levels of calcium in the blood (hypercalcaemia)

History of angina

History of heart disease

History of irregular heart beats (arrhythmias)

Imbalance of salt concentrations in the blood (electrolyte imbalance)

Low levels of calcium in the blood (hypocalcaemia)

People over 60 years of age

Severe diarrhoea

Not to be used in

Breastfeeding

Deficiency of an enzyme in the body called dihydropyrimidine dehydrogenase (DPD)

History of severe and unexpected reactions to fluoropyrimidine therapy such as fluorouracil

Pregnancy

Severely decreased kidney function

Severely decreased liver function

Severely decreased number of platelets in the blood

Severely decreased number of white blood cells in the blood (leucopenia)

Severely decreased numbers of a type of white blood cell (neutrophil) in the blood (neutropenia)

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Seek medical advice from your doctor.

It is not known whether this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.

Label warnings

Take this medication with or after food.

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