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CAPECITABINE ACTAVIS 150MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

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Capecitabine 150mg and 500mg
Film-coated Tablets

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.
• The full name of this medicine is
Capecitabine 150mg and 500mg Filmcoated Tablets but within the leaflet
it will be referred to as Capecitabine
tablets.

Other medicines and Capecitabine
tablets:

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 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 tablets with food and
drink:

What is in this leaflet:
1 What Capecitabine tablets are and
what they are used for
2 What you need to know before you
take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other
information

You should take Capecitabine tablets no later
than 30 minutes after meals.

Pregnancy, breast-feeding and
fertility:

If you are pregnant or breast‑feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor for advice before
taking this medicine. You must not take
Capecitabine tablets if you are pregnant or
think you might be. You must not breast-feed
if you are taking Capecitabine tablets. Ask
your doctor or pharmacist for advice before
taking any medicine.

1 What Capecitabine tablets are and
what they are used for

Driving and using machines:

Capecitabine tablets belong to the group of
medicines called “cytostatic medicines”, which
stop the growth of cancer cells. Capecitabine
tablets contain 150mg or 500mg 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 tablets are prescribed by doctors
for the treatment of colon, rectal, gastric, or
breast cancers. Furthermore, Capecitabine
tablets are prescribed by doctors to prevent
new occurrence of colon cancer after
complete removal of the tumour by surgery.
Capecitabine tablets may be used either alone
or in combination with other medicines.

Capecitabine tablets may make you feel dizzy,
nauseous or tired. It is therefore possible that
Capecitabine tablets could affect your ability
to drive a car or operate machinery.

Capecitabine tablet contains lactose
monohydrate:

If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

3 How to take

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 tablets should only be
prescribed by a doctor experienced in the use
of anticancer medicines.

2 What you need to know before you
take

Capecitabine tablets should be swallowed
with water and within 30 minutes of a meal.

Do not take Capecitabine tablets if
you:

Your doctor will prescribe a dose and
treatment regimen that is right for you. The
dose of Capecitabine tablets is based on your
body surface area. This is calculated from your
height and weight. The recommended dose
for adults is 1250mg/m2 of body surface area
taken two times daily (morning and evening).
Two examples are provided here: A person
whose body weight is 64kg and height is
1.64m has a body surface area of 1.7m2 and
should take 4 tablets of 500mg and 1 tablet
of 150mg two times daily. A person whose
body weight is 80kg and height is 1.80m has a
body surface area of 2.00m2 and should take 5
tablets of 500mg two times daily.

• 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 overreaction to this medicine
• previously have had severe reactions
to fluoropyrimidine therapy (a group of
anticancer medicines such as fluorouracil),
• are pregnant or nursing
• have severely low levels of white cells
or platelets in the blood (leukopenia,
neutropenia or thrombocytopenia),
• have severe liver or kidney problems
• have a known deficiency for the enzyme
dihydropyrimidine dehydrogenase (DPD),
involved in the metabolism of uracil and
thymine, or
• 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.

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.

Warnings and precautions:

Talk to your doctor or pharmacist before
taking Capecitabine tablets if you:
• have liver or kidney diseases
• 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)
• have brain diseases (for example. cancer that
has spread to the brain, or nerve damage
(neuropathy)
• have calcium imbalances (seen in blood
tests)
• have diabetes
• cannot keep food or water in your body
because of severe nausea and vomiting
• have diarrhoea
• are or become dehydrated
• have imbalances of ions in your blood
(electrolyte imbalances, seen in tests)
• have a history of eye problems as you may
need extra monitoring of your eyes
• 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 tablets, you may experience
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).

In combination with other medicines the
recommended dose for adults may be less
than 1250mg/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).
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 150mg and 500mg tablets for
each dose.
• Take the tablets in the combination
prescribed by your doctor for your morning
and evening doses.
• Take the tablets within 30 minutes after the
end of a meal (breakfast and dinner).
• It is important that you take all your
medication as prescribed by your doctor.

If you take more Capecitabine tablets
than you should:

If you take more Capecitabine tablets 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
tablets:

Do not take the missed dose at all and do not
double the next one. Instead, continue your
regular dosing schedule and check with your
doctor.

Children and adolescents

Capecitabine tablets is not indicated in
children and adolescents. Do not give
Capecitabine tablets to children and
adolescents.

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If you stop taking Capecitabine
tablets:

There are no side-effects caused by stopping
treatment with Capecitabine tablets. In
case you are using coumarin anticoagulants
(containing e.g. phenprocoumon), stopping
Capecitabine tablets 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 tablets
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.
• Acute renal failure: low urine output or
no urine output as a consequence of
dehydration.
• 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.
• Hand-and-foot skin-reaction: if you have
pain, swelling, and redness 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 membrane (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.

• jaundice (yellowing of skin and eyes)
• skin ulcer and blister, hives, reaction of the
skin with sunlight, reddening of palms,
swelling or pain of the face
• joint swelling or stiffness, bone pain, facial
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
• kidney failure due to dehydration.
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).

In addition to the above, when Capecitabine
tablets is used alone, very common side
effects, which may affect more than 1 person
in 10 are:
• abdominal pain
• rash, dry or itchy skin
• tiredness
• loss of appetite (anorexia)

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

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 tablets. This will help reduce the
likelihood that the side effect continues or
becomes severe.

By reporting side effects you can help provide
more information on the safety of this
medicine.

5 How to store

Other side effects are:
Common side effects (may affect up to 1 in 10
people) include:
• decreases 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)
• decreases 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
• difficulty in swallowing, 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

Keep this medicine out of the sight and reach
of children.
This medicinal product does not require any
special storage conditions.
Do not use this medicine after the expiry date
which is stated on the outer carton, label and
blister, 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 contains

• The active substance is capecitabine (either
150mg or 500mg per film-coated tablet).
• The other ingredients are:
- Tablet core: lactose monohydrate,
microcrystalline cellulose, hypromellose,
croscarmellose sodium, magnesium
stearate.
- Tablet coating: hypromellose, titanium
dioxide (E171), macrogol 6000, red iron
oxide (E172).

What Capecitabine tablets looks like
and contents of the pack

Pink coloured, capsule shaped, biconvex, film
coated tablets, debossed with “150” on one
side and plain on other side.
Pink coloured, capsule shaped, biconvex, film
coated tablets, debossed with “500” on one
side and plain on other side.
Capecitabine 150mg film-coated tablet pack
contains 60 film-coated tablets.
Capecitabine 500mg film-coated tablet pack
contains 120 film-coated tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Nordic A/S
Ørnegårdsvej 16
2820 Gentofte
Denmark
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
This leaflet was last revised in October 2014.

I f you would like a leaflet with
larger text, please contact
01271 385257.

Continued top of next column
AAAH4211

Actavis, Barnstaple, EX32 8NS, UK

colours/plates:

Capecitabine 150mg and 500mg tablet leaflet - UK
item no:
print proof no:
origination date:
originated by:
approved for print/date

AAAH4211
1
10.11.14

dimensions:

1. Black
150 x 500mm

4.
7 pt

Technical Approval

revised by:

date sent:
Cipla

5.
6.

jh

revision date:

supplier:

3.

pharmacode:
min pt size:

2.

technically app. date:

Non Printing Colours
10.11.14

1.
2.
3.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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