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What Xeloda is and what it is used for
Capecitabine Accord belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Accord contains 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 Accord is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine Accord is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Capecitabine Accord may be used either alone or in combination with other medicines.
How to take Xeloda
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 Accord should only be prescribed by a doctor experienced in the use of anticancer
Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of
Capecitabine Accord 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 m
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
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 them whole with water.
• It is important that you take all your medicine as prescribed by your doctor. Capecitabine Accord 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 1250mg/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 take more Capecitabine Accord than you should If you take more Capecitabine Accord than you should, contact your doctor as soon as possible before taking the next dose. You might get the following side effects if you take a lot more capecitabine than you should, feeling or being sick, diarrhoea, inflammation or ulceration of the gut or mouth, pain or bleeding from the intestine or stomach, or bone marrow depression (reduction in certain kinds of blood cells). Tell your doctor immediately if you experience any of these symptoms. If you forget to take Capecitabine Accord Do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose.Instead, continue your regular dosing schedule and check with your doctor. 4 If you stop taking Capecitabine Accord There are no side-effects caused by stopping treatment with capecitabine. In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Capecitabine Accord immediately and contact your doctor if any of these symptoms
• 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.
• 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 (e.g. bronchitis) and/or fever.
• DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Capecitabine Accord (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity). If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. Ifthese side effects continue, contact your doctor immediately. Your doctor may instruct youto restart treatment at a lower dose. Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan. In addition to the above, whencapecitabine is used alone, the very common side effects which may affect more than 1 in 10 people are:
• abdominal pain
• rash, dry or itchy skin
• 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 thedose and/or temporarily discontinue treatment with Capecitabine Accord. This will help reduce the likelihood thatthe side effect continues or becomes severe
Other side effects are: 5
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 tract 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)
• 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 rigors 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 sideeffects (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 6
• 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:
• 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 arrhythmias (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
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).
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Xeloda
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. For Aluminium-aluminium blisters This medicine does not require any special storage conditions. For PVC/PVdC-aluminium blisters (perforated unit dose) Do not store above 30°C. 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
2 to 3 weeks on average
The average shipping time is 2 to 3 weeks in North America and 4 to 6 weeks internationally. We offer free shipping on all orders shipped to North America. Shipping is a flat rate of $20.00 for all other countries.
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