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CAPECITABINE GLENMARK 500 MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

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Capecitabine 500 mg film-coated tablets
Capecitabine

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. W
 hat 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 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. W
 hat 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 breastfeeding,
- 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 for
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
dehydrogenanse (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 are at an
increased risk of acure early-onset of 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)
- medicines used to treat folic acid deficiency

Capecitabine with food and drink
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.

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.

Contraception/Females and males
An effective method of contraception should be
used during the treatment.
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.

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)

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

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.

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.

Other side effects are:

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

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)

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
Although there are no side effects caused by
stopping treatment with capecitabine, you should
not stop taking these tablets or change the dose,
unless your doctor has told you to. If you are
taking coumarin anticoagulants (containing
e.g. phenprocoumon), your doctor will need to
check your dose of this medicine and change it if
necessary when you stop taking capecitabine.
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 24hour 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.

Front Side

DUMMY
92640

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).

- 
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.
- 
DPD Deficiency: if you have a known DPD
deficiency, you are at an increased risk of
acute early onset of toxicity and severe, lifethreatening, or fatal adverse reactions caused
by Capecitabine Glenmark (e.g. stomatitis,
mucosal inflammation, diarrhea, neutropenia and
neurotoxicity).

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
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 or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via Yellow Card Scheme:
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.
Aluminium-aluminium blister
The medicinal product does not require any special
storage condition.
PVC/PVdc-Aluminium blister
Do not store above 30°C.
Do not use this medicine after the expiry date which
is stated on the outer carton and label 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 contains
The active substance is capecitabine
Each film-coated tablet contains 150 mg of
capecitabine.
Each film-coated tablet contains 500 mg of
capecitabine.
The other ingredients are:
• Tablet core: anhydrous lactose, croscarmellose
sodium, hypromellose, microcrystalline
cellulose, magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide
(E171), yellow and red iron oxide (E172), talc.
What Capecitabine looks like and contents of the
pack
Capecitabine 150 mg film-coated tablet is a light
peach coloured, oblong shaped, biconvex, filmcoated, debossed with “150” on one side and plain
on other side.
Capecitabine 500 mg film-coated tablet is a peach
coloured, oblong shaped, biconvex, film-coated,
debossed with “500” on one side and plain on other
side.
Capecitabine is available in the following pack
sizes:
Blisters of aluminium/aluminium or PVC/PVdC/
Aluminium, in packs of 30, 60 or 120 film-coated
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited, Laxmi
House, 2B Draycott Avenue Kenton, Middlesex,
HA3 0BU, United Kingdom
Manufacturer
Accord Healthcare Limited, 319 Pinner Road,
Harrow, HA1 4HF, United Kingdom
Glenmark Pharmaceuticals s.r.o., Hvězdova
1716/2b, 140 78 Prague, Czech Republic with
release site Fibichova 143, 566 17 Vysoké Mýto,
Czech Republic
Pharmacare Premium Ltd., Hal Far Industrial Estate
Birzebbugia, BBG 3000, Malta
The medicinal product is authorized in the
Member States of the EEA under the following
names:
Name of member state: Name of medicinal product
BG: Capecitabine 150 mg/
500 mg Film-coated Tablets
CZ: Capecitabine 150 mg/
500 mg potahované tablety
HU: Capecitabine 150 mg/
500 mg Film tabletta
PL: Capecitabine
RO: Capecitabina Glenmark
150 mg/500 mg
comprimate filmate
SK: Capecitabine 150 mg/
500 mg Filmom obalené
tablety
UK: Capecitabine 150 mg/
500 mg film-coated tablets
This leaflet was last revised in 01/2016
INP001
10 00000 0 000000

Back Side

CUG Number

INP001

PIL Size

170 x 550 mm (Front/Back side) (Text area 145 x 540 mm)

Approved by

Packing Development

Prepare Date

09/05/12

Die Punch Line (Cutting edge)
Text Area (Text must be in dotted area only)
Note: Pharmacode must be in BLACK(Not in Bitmap).
10 0000 0 00000 / CUG number over internal code must be print in actual Packing Material.

DUMMY
92640

Capecitabine 150 mg film-coated tablets

DUMMY
92640

Package leaflet: Information for the user

PRODUCT:

Amends:

Capecitabine 150 mg and
500mg film-coated tablets
UK

Cutter Guide
Black

Times New Roman ALL 9.5 pts
body copy (min)

12-1-16

Internal proof approval
Signed (digitally)

gc

GM364

Artwork Signoff(digitally):

13-7-15
Leaflet (PIL)
170X550 mm

Approval:

6

Y

Indesign CS 5

External proof approval
Signed (digitally)

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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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