The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0195.
Capecitabine 150, 500 mg film-coated tablets
Capecitabine 150 mg film-coated tablets
Capecitabine 500 mg film-coated tablets
1. What Capecitabine is and what it is used for
2. What you need to know before you take Capecitabine
3. How to take Capecitabine
4. Possible side effects
5. How to store Capecitabine
6. Contents of the pack and other information
Capecitabine belongs to the group of medicines called “cytostatic medicines”, which stop the growth of cancer cells. Capecitabine contains capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body it is 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.
Talk to your doctor or pharmacist before taking Capecitabine
DPD deficiency: DPD deficiency is a genetic condition that is not usually associated with health problems unless you receive certain medicines. If you have DPD deficiency and take Capecitabine, you are at an increased risk of severe side effects (listed under section 4 Possible side effects). It is recommended to test you for DPD deficiency before start of treatment. If you have no activity of the enzyme you should not take Capecitabine. If you have a reduced enzyme activity (partial deficiency) your doctor might prescribe a reduced dose. If you have negative test results for DPD deficiency, severe and life-threatening side effects may still occur.
Capecitabine is not indicated in children and adolescents. Do not give Capecitabine to children and adolescents.
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
You must not take brivudine (an anti-viral medicines for treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).
If you have taken brivudine you must wait for at least 4 weeks after stoping brivudine before starting to take capecitabine. See also section “Do not take Capecitabine Glenmark”.
Also, you need to be particularly careful if you are taking any of the following:
You should take Capecitabine no later than 30 minutes after meals.
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 taking this medicine. You must not take Capecitabine if you are pregnant or think you might be.
You must not breast-feed if you are taking Capecitabine and for 2 weeks after the last dose.
If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine and for 6 months after the last dose.
If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Capecitabine and for 3 months after the last dose.
Capecitabine may make you feel dizzy, nauseous or tired. It is therefore possible that Capecitabine could affect your ability to drive a car or operate machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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 anticancer 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.
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 take more Capecitabine 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.
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.
Although there are no side effects caused by stopping treatment with capecitabine, you should not stop taking these tablets or change the dose, unless your doctor has told you to. If you are taking coumarin anticoagulants (containing e.g. phenprocoumon), your doctor will need to check your dose of this medicine and change it if necessary when you stop taking capecitabine.
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:
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 fingerprint, 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:
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:
Uncommon side effects (may affect up to 1 in 100 people) include:
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:
Rare side effects (may affect up to 1 in 1,000 people) include:
Very rare side effects (may affect up to 1 in 10,000 people) include:
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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
The medicinal product does not require any special storage condition.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the outer carton and label 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.
The active substance is capecitabine
Each film-coated tablet contains 150 mg of capecitabine.
Each film-coated tablet contains 500 mg of capecitabine.
The other ingredients are:
Capecitabine 150 mg film-coated tablet is a light peach coloured, oblong shaped, biconvex, film-coated, debossed with “150” on one side and plain on other side.
Capecitabine 500 mg film-coated tablet is a peach coloured, oblong shaped, biconvex, film-coated, debossed with “500” on one side and plain on other side.
Capecitabine is available in the following pack sizes:
Blisters of aluminium/aluminium or PVC/PVdC/Aluminium, in packs of 30, 60 or 120 film-coated tablets
Not all pack sizes may be marketed.
with release site
This leaflet was last revised in 05/2022