Xeloda 150 mg film-coated tablets, Xeloda 500 mg film-coated tablets
capecitabine
What Xeloda is and what it is used for
Xeloda belongs to a group of medicines called “cytostatics”, which prevent the growth of cancer cells. Xeloda contains capecitabine, which itself is not a cytostatic medicine. Only after the body has absorbed capecitabine is it converted into an active anti-cancer drug (preferably in tumor tissue).
Xeloda is used to treat colon, rectal, stomach, or breast cancer. Xeloda is also used to prevent colon cancer from coming back after a tumor has been surgically removed.
Xeloda can be used either alone or in combination with other medicines.
What you need to know before you take Xeloda
Do not take Xeloda:
- if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must tell your doctor if you know that you are allergic or hypersensitive to this medicine,
- if you have previously had severe reactions to fluoropyrimidine treatment (a group of anti-cancer drugs such as fluorouracil),
- if you are pregnant or breastfeeding,
- if you have severely low levels of white blood cells or platelets ( leukopenia, neutropenia, or thrombocytopenia ),
- if you have severe liver or kidney problems,
- if you know that the enzyme dihydropyrimidine dehydrogenase (DPD) completely lacks activity in you (total DPD deficiency),
- if you are being treated with, or within the last 4 weeks have been treated with brivudine for the treatment of herpes zoster (chicken pox or shingles ).
Warnings and precautions
Talk to your doctor or pharmacist before taking Xeloda
- if you know that the enzyme dihydropyrimidine dehydrogenase (DPD) partially lacks activity in you
- if you have someone in the family who partially lacks activity of, or has a total lack of, the enzyme et dihydropyrimidine dehydrogenase (DPD)
- if you have liver or kidney disease
- if you have or have had heart problems (for example irregular heart rhythm or chest, jaw, or back pain caused by physical exertion and due to problems with blood flow to the heart)
- if you have diseases of the brain (such as cancer that has spread to the brain or nerve damage ( neuropathy ))
- if you have disturbed calcium balance (seen in blood tests)
- if you have diabetes
- if you cannot keep food or water in your body due to severe nausea and vomiting
- if you have diarrhea
- if you are or become dehydrated
- if you have an imbalance of ions in the blood (imbalance of electrolytes, seen in samples)
- if you have had problems with your eyes in the past, you may need extra eye checks
- if you have a severe skin reaction.
DPD shortage
DPD deficiency is a rare congenital condition that is not usually associated with health problems unless you receive certain medications. If you have DPD deficiency and take Xeloda, you may have an increased risk of serious side effects (listed in section 4 Possible side effects ). It is recommended that you be tested for DPD deficiency before starting treatment. If you have no enzyme et activity, you should not take Xeloda. If you have reduced activity of the enzyme (partial deficiency), your doctor may prescribe a lower dose. If you have negative test results for DPD deficiency, serious and life-threatening side effects can still occur.
Children and young people
Xeloda is not indicated for children and adolescents. Do not give Xeloda to children and adolescents.
Other medicines and Xeloda
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is very important because taking more than one drug at the same time can strengthen or weaken the effect of the drugs.
You must not take brivudine (an antiviral medicine used to treat shingles or chickenpox) while you are being treated with capecitabine (including during the rest period when you are not taking any capecitabine tablets).
If you have been taking brivudine, you must wait at least 4 weeks after stopping brivudine before starting treatment with capecitabine. See also the section “Do not take Xeloda”.
You also need to be especially careful if you are taking any of the following:
- medicines for gout (allopurinol),
- blood-thinning medications (coumarin, warfarin ),
- medicines for seizures or tremors ( phenytoin ),
- interferon alpha,
- radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
- medicines used to treat folic acid deficiency.
Xeloda with food and drink
You should take the tablets within 30 minutes after finishing a meal.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not take Xeloda if you are or think you are pregnant.
You should not breastfeed while taking Xeloda and for two weeks after the last dose .
If you are a woman of childbearing potential , you must use effective contraception during treatment with Xeloda and for another 6 months after the last dose .
If you are a male patient and your female partner is fertile , you should use effective contraception during treatment with Xeloda and for an additional 3 months after the last dose .
Driving ability and use of machinery
Xeloda may make you feel dizzy, nauseous or tired after taking it. It is therefore possible that Xeloda can affect your ability to drive or operate machinery.
Xeloda contains excipients
Xeloda contains anhydrous lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Xeloda contains sodium
Xeloda contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Xeloda
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Xeloda should only be prescribed by doctors experienced in the use of anti-cancer drugs.
Your doctor will prescribe the right dose and dosage for you. The Xeloda dose is based on your body surface area. It is calculated based on your height and weight. The normal dose for adults is 1250 mg/m 2 body surface twice a day (morning and evening). Two examples are given here: A person whose body weight is 64 kg and height is 1.64 m has a body surface of 1.7 m 2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg twice a day. A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m 2 and should take 5 tablets of 500 mg twice a day.
Your doctor will tell you what dose you need to take, when to take it and how long you need to take it.
Your doctor may want you to take a combination of 150 mg and 500 mg tablets at each dosing time.
- Take the tablets morning and evening as prescribed by the doctor.
- Take the tablets within 30 minutes after finishing a meal (breakfast and dinner) and swallow them whole with water . Do not crush or split the tablets. If you cannot swallow X eloda tablets whole, talk to your healthcare provider.
- It is important that you take all the medicines prescribed by your doctor.
Xeloda tablets are normally taken for 14 days followed by a 7-day rest period (when no tablets are taken). This 21-day period is a treatment cycle.
In combination with other medicines, the normal dose for adults may be lower than 1250 mg/m 2 body surface, and you may need to take the tablets during a different period of time (eg every day without any rest period).
If you have taken too much Xeloda
If you have taken more Xeloda than you should, contact your doctor as soon as possible before taking the next dose .
You may experience the following side effects if you take much more capecitabine than you should: nausea and vomiting, diarrhea, inflammation or ulcers in the gut or mouth, pain or bleeding from the gut or stomach, or bone marrow depression (decrease in certain types of blood cells ). Tell your doctor right away if you experience any of these symptoms.
If you forget to take Xeloda
Do not take the missed dose . Do not take a double dose to make up for a missed dose . Instead, continue with your prescribed dosage and talk to your doctor.
If you stop taking Xeloda
There are no side effects caused by stopping treatment with capecitabine. If you use coumarin anticoagulants (containing e.g. phenprocoumon), your doctor may need to adjust your dosage of anticoagulants when you stop taking capecitabine.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
STOP taking Xeloda immediately and contact your doctor if any of these symptoms occur:
- Diarrhea: if you have an increase of more than 4 stools each day compared to your normal number of stools per day or diarrhea at night.
- Vomiting: if you vomit more than once in a 24-hour 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-foot syndrome: if you have pain, swelling, redness or tingling in your hands and/or feet.
- Fever: if you have a body temperature of 38ºC or more.
- Infection: if you have signs of infection caused by bacteria or viruses or other organisms .
- Chest pain: if you feel pain from the center of the chest, especially if it comes when you exercise.
- Stevens-Johnson syndrome: if you have a painful red or violet skin rash that spreads and blisters and/or other sores start to appear on the mucous membrane (e.g. mouth and lips), especially if you have previously been sensitive to light, had a respiratory infection (e.g. eg bronchitis ) and/or fever.
- Angioedema: Seek immediate medical attention if you experience any of the following symptoms – you may need emergency medical treatment: swelling, mainly of the face, lips, tongue or throat, which makes it difficult to swallow or breathe, itching and rash. This may be a sign of angioedema .
If these side effects are detected early, they may subside within 2 to 3 days after stopping treatment. If these side effects persist, contact your doctor immediately. Your doctor may ask you to start the treatment again with a lower dose .
If severe stomatitis (sores in your mouth and/or throat), mucositis, diarrhoea, neutropenia (increased risk of infection ) or neurotoxicity occurs during the first treatment cycle, a DPD deficiency may be the cause (see section 2: Warnings and precautions).
Skin reactions on the hands and feet can lead to the loss of fingerprints, which can affect your identification in fingerprint scanning.
In addition to the above, when Xeloda is used alone, very common side effects , which may affect more than 1 in 10 people, are:
- abdominal pain
- skin rash, dry or itchy skin
- fatigue
- loss of appetite ( anorexia )
These side effects can be serious. Therefore, always contact your doctor immediately when you start to feel a side effect. Your doctor may ask you to reduce the dose and/or temporarily stop Xeloda treatment. In this way, the risk of the side effect continuing or worsening is reduced.
Other side effects are:
Common side effects (may affect up to 1 in 10 people) include:
- decreased number of white or red blood cells (seen in samples)
- dehydration, weight loss
- insomnia , depression
- headache, sleepiness, dizziness, abnormal skin sensation (numbness or tingling), taste changes
- eye irritation, increased amount of tears, red eyes ( conjunctivitis )
- inflammation of the veins ( thrombophlebitis )
- shortness of breath, nosebleed, cough, runny nose
- cold sores or other herpes infection
- infection in the lungs or respiratory tract (e.g. pneumonia or bronchitis )
- bleeding from the gut, constipation, pain in the upper abdomen, digestive problems, increased gas in the stomach, dry mouth
- skin rash, hair loss ( alopecia ), skin redness, dry skin, itching , skin discoloration, skin peeling, skin inflammation, nail effects
- pain in joints, extremities , chest or back
- fever, swelling of the extremities , malaise
- problems with liver function (seen in blood tests) and increased amount of bilirubin in the blood (excreted by the liver)
Uncommon side effects (may affect up to 1 in 100 people) include:
- infection in the blood, urinary tract infection, skin infection, infection in the nose and throat, fungal infections (including infection in the mouth), influenza , gastrointestinal catarrh , dental disease
- lumps under the skin (lipoma)
- reduced number of blood cells including platelets , thinned blood (seen in samples)
- allergy
- diabetes , reduced amount of potassium in the blood, malnutrition, elevated blood lipids
- confusional state, panic attacks, depressed mood, decreased libido
- difficulty speaking, impaired memory, loss of ability to coordinate movements, balance problems, fainting, nerve damage ( neuropathy ) and sensory problems
- blurred vision or double vision
- dizziness, earache
- irregular heartbeats and palpitations ( arrhythmia ), chest pain and heart attack (infarction)
- blood clots in the deep veins, high or low blood pressure , hot flushes, cold extremities, purple spots on the skin
- blood clots in the veins of the lung ( pulmonary embolism), collapsed lung, coughing up blood, asthma , shortness of breath on exertion
- intestinal obstruction, accumulation of fluid in the abdomen, inflammation of the small intestine, large intestine, stomach or esophagus, pain in the lower abdomen, abdominal discomfort, heartburn (regurgitation of food from the stomach), bloody stools
- jaundice (yellowing of the skin and eyes)
- sores and blisters on the skin, skin reaction to sunlight, redness of the palms, swelling or pain in the face
- swollen or stiff joints, bone pain, muscle weakness or stiffness
- accumulation of fluid in the kidneys, urinating more often at night, incontinence , blood in the urine, increased creatinine in the blood (signs of impaired kidney function)
- unusual bleeding from the vagina
- swelling ( edema ), chills and stiffness
Rare side effects (may affect up to 1 in 1,000 people) include:
- narrowing or blockage of the tear duct (lacrimalis ductus stenosis)
- liver failure
- inflammation leading to dysfunction or blockage in the secretion of bile (cholestatic hepatitis )
- specific changes on electrocardiogram ( QT prolongation)
- certain types of arrhythmia (including ventricular fibrillation , torsade de pointes , and bradycardia )
- eye inflammation that causes pain in the eyes and possibly vision problems
- inflammation of the skin that produces red, scaly patches due to disease originating from the immune system
- swelling mainly of the face, lips, tongue or throat, itching and rash ( angioedema )
Very rare side effects (may affect up to 1 in 10,000 people) include:
- severe skin reaction such as rash, sores and blisters which may include sores in the mouth, nose, genitals, hands, feet and eyes (red and swollen eyes)
Some of these side effects are more common when capecitabine is used with other medicines to treat cancer. Other side effects seen in these cases are as follows:
Common side effects (may affect up to 1 in 10 people) include:
- reduced amount of sodium , magnesium or calcium in the blood, increased blood sugar
- nerve pain
- ringing or buzzing in the ears ( tinnitus ), hearing loss
- inflammation of the veins
- hiccups, altered voice
- pain or altered/abnormal sensation in the mouth, pain in the jaw
- sweating, night sweats
- muscle cramps
- difficulty urinating, blood or protein in the urine
- bruising or reaction at the injection site (caused by drugs given at the same time as an injection )
How to store Xeloda
Keep this medicine out of the sight and reach of children
Store at a maximum of 30ºC. Store in the original packaging. Moisture sensitive
Use before the expiry date stated on the carton and blister card after Issue. dat. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is capecitabine.Xeloda 150 mg film-coated tablets
Each tablet contains 150 mg capecitabine
- Xeloda 500 mg film-coated tablets
Each tablet contains 500 mg capecitabine - Other ingredients are:
• Tablet core: anhydrous lactose , croscarmellose sodium, hypromellose (3 mPa.s), microcrystalline cellulose, magnesium stearate (see section 2 “Xeloda contains anhydrous lactose and sodium”).
• Tablet coating: hypromellose, titanium dioxide, yellow iron oxide, red iron oxide and talc.
Appearance and package sizes of the medicine
Xeloda 150 mg film-coated tablets
Light peach-colored, biconvex, oblong-shaped film-coated tablets imprinted with “150” on one side and “Xeloda” on the other side.
Each pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Xeloda 500 mg film-coated tablets
Peach colored, biconvex, oblong film-coated tablets imprinted with “500” on one side and “Xeloda” on the other side.
Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany