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CAPECITABINE DR REDDYS 500MG FILM COATED TABLETS

Active substance(s): CAPECITABINE

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Package Leaflet: Information for the User
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 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 anticancer 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 anti-cancer
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 severe 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
• 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 experience severe forms of the
side effects listed in 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,
including medicines obtained without a prescription.
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 with food and drink

You should take Capecitabine 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 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 breastfeed if you are taking Capecitabine. Ask your doctor or
pharmacist for advice before taking this medicine.

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 tablets contain lactose

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

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 in the 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 medicine as
prescribed by your doctor.

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.

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 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
membrane (e.g. mouth and lips), in particular if you
had before light sensitivity, infections of the
respiratory system (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.
In addition to the above, when Capecitabine 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).
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).
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).
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.
• acute renal failure secondary 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.

Reporting of side effects

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report any side effects
directly via the Yellow Card Scheme, website:
https://yellowcard.mhra.gov.uk/. 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



The active substance is capecitabine (500 mg per
film-coated tablet).
The other ingredients are:
- Tablet core: lactose, anhydrous;
croscarmellose sodium; hypromellose (6 cPs);
cellulose, microcrystalline; magnesium
stearate.
- Tablet coating: hypromellose; titanium dioxide
(E 171); yellow and red iron oxide (E 172), talc.

What Capecitabine tablets look like and
contents of the pack

Peach colour film-coated tablet of biconvex, oblong
shape (16.00 mm x 8.50 mm) with ‘500’ debossed on
one side and ‘RDY’ on the other side.
Each pack contains 28 or 120 film-coated tablets.

Marketing Authorisation Holder and
Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 08/2014

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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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