How does it work?

Xeloda tablets contain capecitabine, which is a type ofchemotherapy medicine for cancer known as a 'cytotoxic antimetabolite'. It istaken 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 severalcompounds within the body that are called enzymes. The enzyme responsible forthe final step is found mostly in tumour tissues (although it is also found inother tissues in the body). This means that higher concentrations of the active5-FU are produced within the tumour tissues, rather than other healthy areas ofthe body. The medicine is said to be 'targeted' against the cancerous cells.

Cancers form when cells within the body multiply abnormally anduncontrollably. These cells spread, destroying nearby tissues. 5-FU works bystopping the cancer cells from multiplying. It does this by inhibiting theproduction of the cells' genetic material, DNA and RNA. Both DNA and RNA areneeded for growth and multiplication of cells. 5-FU causes a deficiency of DNAand RNA in the cancer cells, and this causes the cells to grow in an unbalancedway, resulting in the death of the cells.

5-FU can also affect normal, healthy cells, particularly thosethat multiply quickly, such as blood cells. However, because the capecitabineis mostly converted to 5-FU only in the cancer cells, it means that sideeffects on normal healthy cells are less with this medicine than withtraditional 'non-targeted' 5-FU given via a drip.

The most important side effect is on the bone marrow where bloodcells are made. 5-FU can decrease the production of blood cells, leaving peoplesusceptible to infection. Regular blood tests are therefore needed to monitorlevels of blood cells.

What is it used for?

• Cancer of the large bowel and rectum that has spread to other parts of the body (metastatic colorectal cancer).
• To improve survival following surgery for stage III colon cancer.
• Advanced stomach cancer (in combination with platinum-based chemotherapy).
• Breast cancer that is locally advanced or has spread to other areas of the body (metastatic breast cancer).

For breast cancer, capecitabine is used as second-line treatmentwhen previous chemotherapy has been unsuccessful. It is used either incombination with another anti-cancer medicine called docetaxol, (when previouschemotherapy included an anthracycline medicine), or on its own (when previouschemotherapy included a taxane and an anthracycline, or where furtheranthracycline treatment is not indicated).

Warning!

• Xeloda tablets should be swallowed with water within 30 minutes after a meal.
• This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activites, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.
• Chemotherapy medicines can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• 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 an increase of more than 4 bowel movements compared to your normal 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; if you have a temperature of 38°C or greater or any other signs of infection; or if you get chest pain, especially if it occurs during exercise.
• This medicine may be harmful to an unborn child. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished. Seek medical advice from your doctor.
• Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.
• The safety and efficacy of this medicine in children and adolescents under 18 years of age has not been established.

Use with caution in

• Decreased kidney function.
• Decreased liver function.
• Diabetes mellitus.
• Disease affecting the brain or nervous system.
• History of heart disease.
• History of angina.
• History of coronary artery disease.
• History of irregular heart beats (arrhythmias).
• Imbalance of salt concentrations in the blood (electrolyte imbalance).
• High levels of calcium in the blood (hypercalcaemia).
• Low levels of calcium in the blood (hypocalcaemia).
• People over 60 years of age.
• Severe diarrhoea.
• Hand-foot skin reaction (hand-foot syndrome).

Not to be used in

• Deficiency of an enzyme in the body called dihydropyrimidine dehydrogenase (DPD).
• Allergy to fluorouracil.
• History of severe and unexpected reactions to fluoropyrimidine therapy such as fluorouracil.
• Severely decreased kidney function.
• Severely decreased liver function.
• Severely decreased number of platelets in the blood (thrombocytopenia).
• 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).
• Pregnancy.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Xeloda tablets contain lactose).

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

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

• This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished. Seek medical advice from your doctor.
• It is not known if 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.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

• Painful redness, swelling, blistering or ulceration of the palms and soles (hand-foot syndrome or palmar-plantar erythrodysesthesia).
• Disturbances of the gut such as diarrhoea, nausea, vomiting, constipation or abdominal pain.
• Inflammation of the lining of the mouth (stomatitis).
• Fatigue.
• Weakness or loss of strength (asthenia).
• Loss of appetite.
• Skin reactions such as rash, itching, dry skin, red skin.
• Hair loss (alopecia).
• Fever (pyrexia).
• Headache.
• Dizziness.
• Pins and needles sensations (paraesthesia).
• Change in taste.
• Watery eyes.
• Swollen ankles due to fluid retention.
• Difficulty in breathing (dyspnoea).
• Dehydration.
• Decreased production of blood cells by the bone marrow (bone marrow suppression).
• Pain in the muscles or joints.
• Chest pain (angina).

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

This medicine may increase the blood level of blood thinning(anticoagulant) medicines such as warfarin and phenprocoumon, and this mayincrease the risk of bleeding. People taking this medicine with anticoagulantsshould have their blood clotting time (INR) monitored.

This medicine may increase blood levels of phenytoin. Peopletaking this medicine with phenytoin should have their phenytoin blood levelmonitored.

The maximum tolerated dose of this medicine is lower if folinicacid or interferon alfa is taken at the same time.

Allopurinol may decrease the effectiveness of this medicine andshould be avoided.

This medicine must not be administered with sorivudine orbrivudine.

Chemotherapy decreases the body's immune response. This meansthat vaccines may be less effective if given during treatment, and livevaccines may cause serious infections. Live vaccines include: measles, mumps,rubella, MMR, oral polio, oral typhoid and yellow fever. If live vaccines areneeded they should be postponed until at least six months after finishingchemotherapy.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain capecitabine as the active ingredient.