POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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: PL08553/0516.
Capecitabine Dr. Reddys 150 mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Capecitabine 150 mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
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
1. WHAT CAPECITABINE IS AND WHAT IT IS USED FOR
Capecitabine belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine tablets contain 150 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE
Do not take Capecitabine
Warnings and precautions
Talk to your doctor or pharmacist before taking Capecitabine
DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines. If you have an unrecognised DPD deficiency and take Capecitabine, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects. Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects).
Children and adolescents
Capecitabine is not indicated in children and adolescents. Do not give Capecitabine to children and adolescents.
Other medicines and Capecitabine
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 medicine for the 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 stopping brivudine before starting to take capecitabine. See also section “Do not take Capecitabine”.
Also, you need to be particularly careful if you are taking any of the following:
Capecitabine with food and drink
You should take Capecitabine no later than 30 minutes after meals.
Pregnancy and breast-feeding
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.
Driving and using machines
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 machinery.
3. HOW TO TAKE CAPECITABINE
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:
Your doctor will tell you what dose you need to take, when to take it and for how long you nee d to take it.
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.
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 take more Capecitabine than you should
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.
If you forget to take Capecitabine
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.
If you stop taking Capecitabine
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.
4. POSSIBLE SIDE EFFECTS
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.
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 Capcitabine 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:
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 the Yellow Card Scheme website: 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.
5. HOW TO STORE CAPECITABINE
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 label 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Capecitabine tablets contain
What Capecitabine looks like and contents of the pack
Light-peach oval film-coated tablets embossed with “150” on one side. Of approximate dimensions 11.4 mm x 5.9 mm.
Capecitabine 150 mg film-coated tablet pack contains 60 film-coated tablets.
Marketing Authorisation Holder
This leaflet was last revised in 07/2019.
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