Capecitabine 500 mg Film-Coated Tablets

Capecitabine

Capecitabine belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine tablets contain 500 mg capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).

Capecitabine is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.

Capecitabine may be used either alone or in combination with other medicines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Capecitabine should only be prescribed by a doctor experienced in the use of anti-cancer medicines.

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Capecitabine is based on your body surface area. This is calculated from your height and weight.

The usual dose for adults is 1250 mg/m² of body surface area taken two times daily (morning and evening).

Two examples are provided here:

• a person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m² and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily
• a person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m² and should take 5 tablets of 500 mg two times daily.

Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.

Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.

• Take the tablets morning and evening as prescribed by your doctor.
  • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water. Do not crush or cut tablets. If you cannot swallow Capecitabine tablets whole, tell your healthcare provider.
• It is important that you take all your medicine as prescribed by your doctor.

Capecitabine tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken). This 21 day period is one treatment cycle.

In combination with other medicines the usual dose for adults may be less than 1250 mg/m² of body surface area, and you may need to take the tablets over a different time period (e.g. every day, with no rest period).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Capecitabine immediately and contact your doctor if any of these symptoms occur:

• diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night
• vomiting: if you vomit more than once in a 24-hour time period
• nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual
• stomatitis: if you have pain, redness, swelling or sores in your mouth and/or throat
• hand-and-foot skin-reaction: if you have pain, swelling, redness or tingling of hands and/or feet
• fever: if you have a temperature of 38°C or greater
• infection: if you experience signs of infection caused by bacteria or virus, or other organisms
• chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise
• Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (bronchitis) and/or fever
• Angioedema: Seek medical attention straight away if you notice any of the following symptoms - you may need urgent medical treatment: swelling mainly of the face, lips, tongue or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of angioedema.

If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. If these side effects continue, however, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

If severe stomatitis (sores in your mouth and/or throat), mucosal inflammation, diarrhoea, neutropenia (increased risk for infections), or neurotoxicity occurs during the first cycle of treatment, a DPD deficiency may be involved (see Section 2: Warning and precautions).

Hand and foot skin-reaction can lead to loss of fingerprints, which could impact your identification by fingerprint scan.

In addition to the above, when Capecitabine is used alone, very common side effects, which may affect more than 1 in 10 people are:

• abdominal pain
• rash, dry or itchy skin
• tiredness
• loss of appetite (anorexia).

These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect. Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine. This will help reduce the likelihood that the side effect continues or becomes severe.

Other side effects are:

Common side effects (may affect up to 1 in 10 people) include:

• decreases in the number of white blood cells or red blood cells (seen in tests)
• dehydration, weight loss
• sleeplessness (insomnia), depression
• headache, sleepiness, dizziness, abnormal sensation in the skin (numbness or tingling sensation), taste changes
• eye irritation, increased tears, eye redness (conjunctivitis)
• inflammation of the veins (thrombophlebitis)
• shortness of breath, nose bleeds, cough, runny nose
• cold sores or other herpes infections
• infections of the lungs or respiratory system (e.g. pneumonia or bronchitis)
• bleeding from the gut, constipation, pain in upper abdomen, indigestion, excess wind, dry mouth
• skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration, skin loss, skin inflammation, nail disorder
• pain in the joints, or in the limbs (extremities), chest or back
• fever, swelling in the limbs, feeling ill
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver).

Uncommon side effects (may affect up to 1 in 100 people) include:

• blood infection, urinary tract infection, infection of the skin, infections in the nose and throat, fungal infections (including those of the mouth), influenza, gastroenteritis, tooth abscess
• lumps under the skin (lipoma)
• decreases in blood cells including platelets, thinning of blood (seen in tests)
• allergy
• diabetes, decrease in blood potassium, malnutrition, increased blood triglycerides
• confusional state, panic attacks, depressed mood, decreased libido
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder, fainting, nerve damage (neuropathy) and problems with sensation
• blurred or double vision
• vertigo, ear pain
• irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
• blood clots in the deep veins, high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin
• blood clots in the veins in the lung (pulmonary embolism), collapsed lung, coughing up blood, asthma, shortness of breath on exertion
• bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort, heartburn (reflux of food from the stomach), blood in the stool
• jaundice (yellowing of skin and eyes)
• skin ulcer and blister, reaction of the skin with sunlight, reddening of palms, swelling or pain of the face
• joint swelling or stiffness, bone pain, muscle weakness or stiffness
• fluid collection in the kidneys, increased frequency of urination during the night, incontinence, blood in the urine, increase in blood creatinine (sign of kidney dysfunction)
• unusual bleeding from the vagina
• swelling (oedema), chills and rigours.

Rare side effects (may affect up to 1 in 1,000 people) include:

• narrowing or blockage of tear duct (lacrimal duct stenosis)
• liver failure
• inflammation leading to dysfunction or obstruction in bile secretion (cholestatic hepatitis)
• specific changes in the electrocardiogram (QT prolongation)
• certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
• eye inflammation causing eye pain and possibly eyesight problems
• inflammation of the skin causing red scaly patches due to an immune system illness.
• swelling mainly of the face, lip, tongue or throat, itching and rashes (angioedema)

Very rare side effects (may affect up to 1 in 10,000 people) include:

• severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes).

Some of these side effects are more common when Capecitabine is used with other medicines for the treatment of cancer. Other side effects seen in this setting are the following:

Common side effects (may affect up to 1 in 10 people) include:

• decrease in blood sodium, magnesium or calcium, increase in blood sugar
• nerve pain
• ringing or buzzing in the ears (tinnitus), loss of hearing
• vein inflammation
• hiccups, change in voice
• pain or altered/abnormal sensation in the mouth, pain in the jaw
• sweating, night sweats
• muscle spasm
• difficulty in urination, blood or protein in the urine
• bruising or reaction at the injection site (caused by medicines given by injection at the same time).

Rare side effects (may affect up to 1 in 1,000 people) include:

• acute renal failure secondary to dehydration

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.