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CAPECITABINE MYLAN 500 MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

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Package leaflet: Information for the patient

Capecitabine 500 mg
Film-coated Tablets
(capecitabine)

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

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
film-coated tablets contain 500 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:

• if you are allergic to capecitabine or any of
the other ingredients of this medicine (listed
in section 6). You must inform your doctor
if you know that you have an allergy or
over-reaction to this medicine
• if you previously have had severe reactions
to fluoropyrimidine therapy (a group of
anticancer medicines such as fluorouracil),
• if you are pregnant or breast-feeding
• if you have severely low levels of white
cells or platelets in the blood (leucopenia,
neutropenia or thrombocytopenia)
• if you have severe liver or kidney problems,
• if you know that you do not have any
activity of the enzyme dihydropyrimidine
dehydrogenase (DPD)
• if you are being treated now or have been
treated in the last 4 weeks with brivudine,
sorivudine or similar classes of substance as
part of herpes zoster (chickenpox or shingles)
therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Capecitabine:
• if you know that you have a partial
deficiency in the activity of the enzyme
dihydropyrimidine dehydrogenase (DPD)
• if you have liver or kidney diseases
• if you have or had heart problems (for
example an irregular heartbeat or pains to the
chest, jaw and back brought on by physical
effort and due to problems with the blood
flow to the heart)
• if you have brain diseases (for example, cancer
that has spread to the brain, or nerve damage
(neuropathy))
• if you have calcium imbalances (seen in
blood tests)
• if you have diabetes
• if you cannot keep food or water in your body
because of severe nausea and vomiting
• if you have diarrhoea
• if you are (or become) dehydrated
• if you have imbalances of ions in your blood
(electrolyte imbalances, seen in tests)
• if you have a history of eye problems as you
may need extra monitoring of your eyes
• if you have a severe skin reaction.
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 may be more likely to
experience sudden and 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

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This is extremely important, as

Description Capecitabine_500 mg_120
Component Type Leaflet
Affiliate Item Code 1164003
Superceded Affiliate Item Code 950515
TrackWise PR No. 1164003
MA No. PL 04569/1425
Packing Site/Printer

Remedica Ltd
(Limassol - CY)

Supplier Code TBC

taking more than one medicine at the same
time can strengthen or weaken the effect of the
medicines.
You need to be particularly careful if you are
taking any of the following:
• gout medicines (allopurinol)
• blood-thinning medicines (coumarin, warfarin)
• certain anti-viral medicines (sorivudine and
brivudine)
• 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.

Capecitabine with food

You should take Capecitabine no later than
30 minutes after meals (see section 3 below).

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
machines.

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 recommended 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.
• 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 whole with water
• 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
recommended 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:
• 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

Date: 26 Jul 17

Pharma Code N/A

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Colours

Vendor Job No. 487069
Trackwise Proof No. 3
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Client Market United Kingdom

Non-Print
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Time: 12:36
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1/2

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Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

• Stomatitis: if you have pain, redness, swelling
or sores in your mouth and/or throat
• 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 membranes (e.g. mouth and
lips), in particular if you had before light
sensitivity, infections of the respiratory system
(e.g. bronchitis) and/or fever.
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 Capecitabine is
used alone, very common side effects, which
may affect more than 1 in 10 people are:
• abdominal pain
• rash, dry or itchy skin
• tiredness
• 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 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:
• decrease 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 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)
• decrease in blood cells including platelets,
thinning of blood (seen in tests)
• allergy
• 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 side effects (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
• 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 arrhythmia (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,
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 at: www.mhra.gov.uk/yellowcard.
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 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. C
 ontents of the pack and other
information
What Capecitabine contains

The active substance is capecitabine. Each
film-coated tablet contains 500 mg capecitabine.
The other ingredients are:
• Tablet core: Croscarmellose sodium, cellulose,
microcrystalline, hypromellose, silica colloidal
anhydrous, magnesium stearate
• Tablet coating: Hypromellose, titanium dioxide
(E171), talc, macrogol 400, red iron oxide
(E172), yellow iron oxide (E172).

What Capecitabine looks like and contents
of the pack
Peach, oblong, capsule-shaped, film-coated
tablets marked with “500” on one side, of
approximate dimensions 17.1 mm x 8.1 mm.

Capecitabine 500 mg film-coated tablets are
available in different pack sizes:
Blister packs of 120 film-coated tablets.
Unit dose blister packs of 120x1 film-coated
tablets.
Not all pack sizes/types may be marketed.

Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
UK.

Manufacturer

Remedica Ltd.,
Aharnon Street,
Limassol Industrial Estate,
3056 Limassol,
Cyprus.
This leaflet was last revised in 08/2017.

1164003

Description Capecitabine_500 mg_120
Component Type Leaflet
Affiliate Item Code 1164003
Superceded Affiliate Item Code 950515
TrackWise PR No. 1164003
MA No. PL 04569/1425
Packing Site/Printer

Remedica Ltd
(Limassol - CY)

Supplier Code TBC

Date: 26 Jul 17

Pharma Code N/A

No. of colours

SAP No. N/A

Colours

Vendor Job No. 487069
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom

Non-Print
Colours

1

Time: 12:36
Page Count

2/2

Black
Keyline

Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
157 x 490 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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