Capebel DT 1000mg Tablet is used for:

• Metastatic colorectal cancer: Cancer of the colon or rectum that has spread to other parts of the body.

• Metastatic breast cancer: Used after failure of treatment with paclitaxel and an anthracycline-containing chemotherapy regimen, as prescribed by an oncologist.

Capebel DT 1000mg Tablet contains Capecitabine, which is converted in the body into 5-fluorouracil (5-FU), an active anticancer medicine.

5-FU interferes with the production of DNA and RNA, which cancer cells need to grow and multiply. This slows cancer cell growth and can lead to the death of cancer cells.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins, supplements and herbal products you take. Some medicines can affect how Capecitabine works or increase the risk of side effects.

• Brivudine: Do not take brivudine together with Capecitabine. This interaction can cause severe and potentially fatal toxicity. A suitable interval is required between brivudine and Capecitabine treatment.

• Other Capecitabine-containing medicines: Do not take Capebel DT together with another medicine containing Capecitabine unless specifically prescribed by your doctor. This could result in receiving more Capecitabine than intended.

• Warfarin and other coumarin anticoagulants: Capecitabine can increase the effect of these blood-thinning medicines and may increase the risk of bleeding. Your doctor may monitor your INR or prothrombin time more closely.

• Phenytoin: Capecitabine may increase phenytoin levels and the risk of phenytoin toxicity. Monitoring may be required.

• Allopurinol: Concomitant use should be avoided unless specifically advised by your doctor.

• Folinic acid or folic acid: These may increase the toxicity of Capecitabine in some treatment regimens. Tell your doctor if you take them.

• Store Capebel DT 1000mg Tablet according to the storage instructions provided on the product packaging.

• Keep the tablets in their original packaging and protect them from moisture and direct heat or light.

• Keep the medicine out of the reach and sight of children.

• Do not use the medicine after the expiry date.

Take Capebel DT 1000mg Tablet exactly as prescribed by your oncologist. The dose and treatment schedule depend on the type of cancer, your body size, kidney function and other medicines used with Capecitabine.

Capebel DT is a dispersible tablet. Place the prescribed tablet or tablets in approximately 100 mL of drinking water, allow them to disperse and then drink the resulting solution. The product was developed to allow Capecitabine to be taken as a dispersion in water, which may be useful for people who have difficulty swallowing tablets.

Capecitabine is generally taken with food, within 30 minutes after a meal, according to the prescribed treatment schedule. Do not change the dose or treatment cycle without medical advice.

If you miss a dose, do not take an extra dose to make up for it. Take the next dose at the prescribed time and inform your treatment team.

Capebel DT 1000mg Tablet may cause side effects, although not everyone experiences them.

Common side effects:

• Diarrhoea

• Nausea

• Vomiting

• Abdominal pain

• Mouth sores or stomatitis

• Hand-foot syndrome, causing redness, swelling, pain or peeling of the hands and feet

• Fatigue

• Loss of appetite

• Rash

• Anaemia

• Dizziness

• Dehydration

Serious side effects:

• Severe or persistent diarrhoea, especially with dehydration

• Severe hand-foot syndrome with blistering, peeling or significant pain

• Severe infection or fever associated with low blood cell counts

• Chest pain, irregular heartbeat or other symptoms of serious heart problems

• Severe liver problems, including yellowing of the skin or eyes or dark urine

• Severe allergic reactions, including swelling of the face, lips or throat or difficulty breathing

• Severe skin reactions such as blistering, peeling or widespread skin damage

• Severe toxicity associated with dihydropyrimidine dehydrogenase (DPD) deficiency

Seek prompt medical attention if you develop severe diarrhoea, chest pain, difficulty breathing, significant skin reactions, signs of infection or other severe symptoms.

• Take Capebel DT 1000mg Tablet exactly as prescribed by your oncologist.

• Take the medicine with food and follow the treatment cycle given by your doctor.

• Use the prescribed amount of water when preparing the dispersible tablet and drink the entire solution.

• Do not change the dose or treatment schedule yourself.

• Tell your doctor if you develop severe diarrhoea, vomiting, mouth sores or hand-foot syndrome.

• Your doctor may monitor your blood counts, kidney function and liver function during treatment.

• Tell your doctor if you are taking warfarin, phenytoin, brivudine, allopurinol or other medicines.

• Inform your doctor if you have kidney, liver or heart problems before starting treatment.

• DPD deficiency can increase the risk of severe Capecitabine toxicity. Follow your oncologist's advice regarding pre-treatment testing.

• If you miss a dose, do not take an extra dose. Contact your treatment team if you are unsure what to do.