Skip to Content

UK Edition. Click here for US version.

CAPECITABINE DR. REDDYS 150 MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Capecitabine 150 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 150 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 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 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
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)

medicines for seizures or tremors
(phenytoin)

interferon alpha

radiotherapy and certain medicines
used to treat cancer (folinic acid,
oxaliplatin, bevacizumab, cisplatin,
irinotecan).
Capecitabine with food, drink and alcohol
You should take Capecitabine no later than
30 minutes after meals.
Pregnancy and breast-feeding
Before starting treatment, you must tell your
doctor if you are pregnant, if you think you are
pregnant or if you intend to become pregnant.
You must not take Capecitabine if you are
pregnant or think you might be. You must not
breast-feed 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.

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
medicine 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.
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

Stevens-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.
In addition to the above, when Capcitabine 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)
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)

eye inflammation causing eye pain and
possibly eyesight problems

inflammation of the skin causing red
scaly patches due to an immune system
illness

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, website:
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 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 contain

The active substance is capecitabine.
Each film-coated tablet contains 150 mg
capecitabine.

The other ingredients are:
Tablet core: croscarmellose
sodium, microcrystalline cellulose,
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
Light-peach oval film-coated tablets
embossed with “150” on one side. Of
approximate dimensions 11.4 mm x 5.9 mm.
Capecitabine 150 mg film-coated tablet pack
contains 60 film-coated tablets.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley, East Yorkshire,
HU17 0LD, United Kingdom
Manufacturer
betapharm Arzneimittel GmbH, Kobelweg 95,
86156 Augsburg, Germany
This leaflet was last revised in 06/2014

Expand view ⇕

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.

Hide