2. What should I know before I take XELABINE?
Do not take if you have ever had an allergic reaction to XELABINE or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with XELABINE and affect how it works.
4. How do I take XELABINE?
Take your medicine two times each day (morning and evening).
Swallow the tablets whole with a full glass of water. Do not chew the tablets.
5. What should I know while taking XELABINE?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking XELABINE.
If you become pregnant while taking this medicine, tell your doctor immediately.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
|
|
Things you should not do
|
Do not take XELABINE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how XELABINE
affects you.
|
|
Looking after your medicine
|
Keep below 25°C.
Keep your tablets in the pack until it is time to take them.
|
6. Are there any side effects?
Less serious side effects are stomach problems; fatigue; skin problems; fever; headache;
dizziness; hair loss; eye problems; dehydration; sore mouth and throat; breathing
problems; redness or swelling of hands and/or feet; changes in taste; muscle and joint
pain; difficulty in sleeping. Serious side effects are severe diarrhoea; nausea; vomiting;
pain redness and swelling of hand and/or feet; passing little or no urine; breathing
problem; chest pain, irregular heartbeat; confusion; memory loss; blurred vision,
weakness; liver problems, blood in faeces, severe blisters and bleeding on face and
genitals; severe skin reactions. For more information, including what to do if you
have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
capecitabine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking XELABINE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking XELABINE.
Where to find information in this leaflet:
1. Why am I taking XELABINE?
XELABINE contains the active ingredient capecitabine. XELABINE belongs to a group of medicines called anti-neoplastic medicines. Within
this group, XELABINE belongs to a class of medicines called fluoropyrimidine analogues.
The active ingredient, capecitabine, is converted in the body by the liver and cancer
cells to a medicine called 5-fluorouracil (also called 5-FU). It is 5-FU that works
to kill or stop the growth of cancer cells.
XELABINE is used to treat:
cancer of the bowel and rectum (colorectal)
breast cancer
cancer of the stomach and food pipe (oesophagus)
XELABINE may be prescribed alone or in combination with other medicines used to treat
cancer, such as chemotherapy medicines.
Ask your doctor if you have any questions about why XELABINE has been prescribed for
you.
Your doctor may have prescribed it for another reason.
XELABINE is only available with a doctor's prescription.
XELABINE is not addictive.
2. What should I know before I take XELABINE?
Warnings
Do not take XELABINE if:
you are allergic to:
any medicine containing capecitabine
fluorouracil (also called 5-FU), a medicine used to treat cancer
other fluoropyrimidine medicines
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can take this medicine.
have or have had any of the following:
severe kidney disease
known dihydropyrimidine dehydrogenase (DPD) deficiency
you are taking any medicines containing the following:
sorivudine
brivudine
These medicines are usually used to treat viral infections such a shingles, chicken
pox, or cold sores (herpes simplex 1). Taking these medicines at the same time as
XELABINE is potentially fatal.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
have or have had any of the following medical conditions:
heart disease, coronary artery disease
kidney disease
liver disease
are dehydrated. Some signs of dehydration include:
dry skin
dark coloured urine
thirst
weakness or fatigue
loss of appetite
take any medicines for any other condition
If you have not told your doctor about any of the above, tell them before you start
taking XELABINE.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy. Your doctor may
advise you to avoid becoming pregnant while taking this medicine.
Do not breastfeed if you are taking this medicine.
It is not known whether XELABINE and 5-FU pass into breast milk. Your doctor will
discuss with you the risks and benefits involved.
Use in children
Do not give this medicine to a child under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with XELABINE and affect how it works. These include:
warfarin, a medicine used to prevent blood clots and to thin the blood
phenytoin, a medicine used to treat seizures, epilepsy and heart irregularities
leucovorin, also called folinic acid, a medicine used to treat folic acid deficient
anaemias
antacids, medicines used to treat heart burn or indigestion
These medicines may be affected by XELABINE or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect XELABINE.
4. How do I take XELABINE?
How much to take
Take XELABINE exactly as your doctor has told you to.
XELABINE may be given with or without chemotherapy.
Your doctor will tell you how many XELABINE tablets to take each day and how often
to take them. Your doctor will calculate your dose based on your height and weight.
Your doctor may vary your dose depending on the nature of your illness and your response
to XELABINE.
Use in elderly patients:
The same dose is recommended for elderly patients given XELABINE alone.
A lower dose may be given to elderly patients taking XELABINE in combination with
other medicines to treat cancer.
When to take XELABINE
Take your medicine two times each day (morning and evening).
Taking it at the same times each day will have the best effect. It will also help
you remember when to take it.
Take your medicine with food.
You should take XELABINE no later than 30 minutes after food.
When you take XELABINE in combination with chemotherapy, your doctor will advise which
days of your treatment cycle you should take XELABINE.
How to take XELABINE
Swallow the tablets whole with a full glass of water.
Do not chew the tablets.
How long to take XELABINE
Continue taking your medicine for as long as your doctor tells you.
The duration of treatment with XELABINE varies, depending on the nature of your illness
and your individual response to treatment.
Your XELABINE therapy is made up of a series of treatment cycles which usually last
for 21 days. Your doctor will advise you how many cycles of treatment you will have
and whether there are any rest days in the cycle.
In most cases, your treatment cycle will consist of intermittent XELABINE therapy,
where you will take XELABINE for 14 days, followed by a rest period of 7 days. During
the rest period, you will not take any XELABINE.
Alternatively, your treatment cycle may be continuous, which involves 21 days of XELABINE
treatment with no rest period.
If you forget to take XELABINE
Skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much XELABINE
If you think that you or anyone else has taken too much XELABINE, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Some signs of an overdose may include nausea, vomiting, diarrhoea or gastrointestinal
irritation and bleeding.
5. What should I know while taking XELABINE?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking XELABINE.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
XELABINE.
If you become pregnant while taking XELABINE, tell your doctor immediately.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you develop:
diarrhoea (more than 4 bowel movements each day)
nausea (feeling like you want to vomit) and it has affected your appetite significantly
vomiting, and vomit more than once in a 24-hour period
redness or swelling of your hands and/or feet that affects your normal activities,
also called hand-foot syndrome
pain, redness, swelling, sores or ulcers in the mouth
XELABINE can sometimes cause the above problems in some people. Your doctor may stop
your treatment and treat these issues before starting you on XELABINE again.
Remind any doctor, dentist or pharmacist you visit that you are taking XELABINE.
Things you should not do
Do not take XELABINE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Things to be careful of
Ensure that you remain well hydrated by drinking adequate amounts of water each day.
Driving or using taking machines
Be careful before you drive or use any machines or tools until you know how XELABINE
affects you.
Looking after your medicine
Keep below 25°C.
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a- half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take XELABINE or it is out of date, take it to any pharmacy
for safe disposal.
Do not take XELABINE after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking XELABINE.
XELABINE helps most people with cancer, but it may have unwanted side effects in a
few people.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Less serious side effects
Serious side effects
These side effects may differ when taking XELABINE in combination with a chemotherapy
medicine.
Ask your doctor for possible side effects that may be caused by taking XELABINE with
a chemotherapy medicine.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What XELABINE contains
|
Active ingredient
(main ingredient)
|
capecitabine 500 mg
|
|
Other ingredients
(inactive ingredients)
|
croscarmellose sodium
hypromellose
iron oxide red
iron oxide yellow
lactose
magnesium stearate
microcrystalline cellulose
purified talc
purified water
titanium dioxide
|
|
Potential allergens
|
sugars as lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What XELABINE looks like
XELABINE tablets are peach coloured, oblong shaped, biconvex, film-coated tablets,
debossed with "500" on one side, and plain on the other side (AUST R 213045).
XELABINE tablets are available in blister packs of 120 tablets.
Who distributes XELABINE
Sponsor
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2025.
XELABINE_cmi\Dec25/00