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CAPECITABINE SANDOZ 150 MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

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Package leaflet: Information for the user

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Capecitabine 150 mg Film-coated Tablets
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, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.

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 contains 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 prescribed by doctors 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 nursing.
• if you have severely low levels of white cells or
platelets in the blood (leucopenia, neutropenia or
thrombocytopenia).
• if you have liver or kidney problems.
• if you have a known deficiency for the enzyme
dihydropyrimidine dehydrogenase (DPD), involved in
the metabolism of uracil and thymine.
• 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
• 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.
• have diarrhoea.
• are or become dehydrated.
• have imbalances of ions in your blood (electrolyte
imbalances, seen in tests).

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 experience severe form 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

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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
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) or
• medicines for seizures or tremors (phenytoin)
• interferon alpha

• radiotherapy and certain medicines used to treat
cancer (folinic acid, oxaliplatin, bevacizumab).

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.

Capecitabine contains lactose

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

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.

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

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.
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).
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).
• It is important that you take all your medication as
prescribed by your doctor.

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 and do not double
the next one. Instead, continue your regular dosing
schedule and check with your doctor.

Continued on the next page >>

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.
• 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 or Infection: if you have a temperature of
38°C or greater or other signs of infection.
• Chest pain: if you experience pain localised to the
centre of the chest, especially if it occurs during
exercise.

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.
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:
• 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).

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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
• 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).
Very rare side effects (may affect up to 1 in 10,000
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).

If you are concerned about these or any other
unexpected effect(s), talk to your doctor. If any of the
side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or
pharmacist.

5

How to store Capecitabine

Keep this medicine out of the sight and reach of
children.

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 store above 30ºC.

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 contains

The active substance is capecitabine.

Each Capecitabine 150 mg film-coated tablet contains
150 mg capecitabine.
Each Capecitabine 500 mg film-coated tablet contains
500 mg capecitabine.
The other ingredients are:
• Tablet core: lactose monohydrate, hypromellose,
microcrystalline cellulose, croscarmelose sodium,
magnesium stearate.
• Tablet film-coating: hypromellose, talc, titanium
dioxide (E171), iron oxide red (E172).

What Capecitabine looks like and contents of
the pack

Capecitabine 150 mg film-coated tablets:
Light pink film-coated tablet of modified oval shape (5.5
x 11.0 mm) with the marking “150” on one side.
Capecitabine 500 mg film-coated tablets:
Pink film-coated tablet of modified oval shape (8.4 x
16.0 mm) with the marking “500” on one side.

Capecitabine are packaged in PVC/PVDC Al foil blisters
or alternatively in Al-Al blisters placed into cardboard
boxes containing 28, 30, 50, 56, 60, 80, 84, 90, 100,
110, 112, 120 and 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany.

This leaflet was last revised in 09/2013.

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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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