Skip to Content

UK Edition. Click here for US version.

CAPECITABINE ACTAVIS 500MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE / CAPECITABINE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
•  T he full name of this medicine is
Capecitabine 150mg and 500mg Filmcoated Tablets but within the leaflet it will
be referred to as Capecitabine tablets.

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:
•g
 out medicines (allopurinol),
•b
 lood-thinning medicines (coumarin,
warfarin),
• c ertain anti-viral medicines (sorivudine and
brivudine)
•m
 edicines for seizures or tremors (phenytoin)
• interferon alpha
• r adiotherapy and certain medicines used
to treat cancer (folinic acid, oxaliplatin,
bevacizumab, cisplatin, irinotecan),
•m
 edicines used to treat folic acid deficiency.

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 C
 ontents of the pack and other
information

Pregnancy, breast-feeding and fertility:

1  What Capecitabine tablets are and
what they are used for
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.

2 What you need to know before you
take
Do not take Capecitabine tablets if you:

• a re 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
•p
 reviously have had severe reactions
to fluoropyrimidine therapy (a group of
anticancer medicines such as fluorouracil),
• a re pregnant or nursing
•h
 ave severely low levels of white cells
or platelets in the blood (leukopenia,
neutropenia or thrombocytopenia),
•h
 ave severe liver or kidney problems
• k now that you do not have any activity of the
enzyme dihydropyrimidine dehydrogenase
(DPD)
• a re 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 tablets if you:
• k now that you have a partial deficiency in the
activity of the enzyme dihydropyrimidine
dehydrogenase (DPD)
•h
 ave liver or kidney diseases
•h
 ave 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)
•h
 ave brain diseases (for example. cancer that
has spread to the brain, or nerve damage
(neuropathy)
•h
 ave calcium imbalances (seen in blood tests)
•h
 ave diabetes
• c annot keep food or water in your body
because of severe nausea and vomiting
•h
 ave diarrhoea
• a re or become dehydrated
•h
 ave imbalances of ions in your blood
(electrolyte imbalances, seen in tests)
•h
 ave a history of eye problems as you may
need extra monitoring of your eyes
•h
 ave 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 are at an increased
risk of 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 tablets is not indicated in children
and adolescents. Do not give Capecitabine
tablets to children and adolescents.

Other medicines and Capecitabine
tablets:

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Continued top of next column
AAAI8881

Capecitabine tablets with food and
drink:

You should take Capecitabine tablets no later
than 30 minutes after meals.
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. An effective method
of contraception should be used if you are
taking Capecitabine tablets. Ask your doctor
or pharmacist for advice before taking any
medicine.

Driving and using machines:

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.
Capecitabine tablets should be swallowed
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 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.
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
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.
• T ake the tablets in the combination
prescribed by your doctor for your morning
and evening doses.
• T ake the tablets within 30 minutes after the
end of a meal (breakfast and dinner).
• I t is important that you take all your medicine
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 a double dose to make up for a
forgotten tablet. Instead, continue your regular
dosing schedule and check with your doctor.

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.
Continued over page

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 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.
• 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 (e.g. stomatitis, mucosal
inflammation, diarrhoea, neutropenia, and
neurotoxicity).
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
tablets is used alone, very common side effects,
which may affect more than 1 person in 10 are:
• a bdominal pain
• r ash, dry or itchy skin
• t iredness
• 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 tablets. 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:
•d
 ecreases in the number of white blood cells
or red blood cells (seen in tests)
•d
 ehydration, weight loss
• s leeplessness (insomnia), depression
•h
 eadache, sleepiness, dizziness, abnormal
sensation in the skin (numbness or tingling
sensation), taste changes
•e
 ye irritation, increased tears, eye redness
(conjunctivitis)
• inflammation of the veins (thrombophlebitis)
• s hortness of breath, nose bleeds, cough,
runny nose
• c old sores or other herpes infections
• infections of the lungs or respiratory system
(e.g. pneumonia or bronchitis)
•b
 leeding from the gut, constipation, pain in
upper abdomen, indigestion, excess wind, dry
mouth
• s kin rash, hair loss (alopecia), skin reddening,
dry skin, itching (pruritus), skin discolouration,
skin loss, skin inflammation, nail disorder
•p
 ain in the joints, or in the limbs (extremities),
chest or back
• f ever, swelling in the limbs, feeling ill
•p
 roblems 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:
•b
 lood 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)
•d
 ecreases in blood cells including platelets,
thinning of blood (seen in tests)
• a llergy
•d
 iabetes, decrease in blood potassium,
malnutrition, increased blood triglycerides
• c onfusional state, panic attacks, depressed
mood, decreased libido
•d
 ifficulty speaking, impaired memory, loss of
movement coordination, balance disorder,
fainting, nerve damage (neuropathy) and
problems with sensation
•b
 lurred or double vision
• v ertigo, ear pain
• irregular heartbeat and palpitations
(arrhythmias), chest pain and heart attack
(infarction)
•b
 lood clots in the deep veins, high or low
blood pressure, hot flushes, cold limbs
(extremities), purple spots on the skin,
•b
 lood clots in the veins in the lung
(pulmonary embolism), collapsed lung,
coughing up blood, asthma, shortness of
breath on exertion
•d
 ifficulty 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
• j aundice (yellowing of skin and eyes)
• s kin ulcer and blister, hives, reaction of the
skin with sunlight, reddening of palms,
swelling or pain of the face
Continued top of next column
AAAI8881

• 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).
• toxic leukoencephalopathy

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

5 How to store
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 contain

• 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 look 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 Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
This leaflet was last revised in March 2016.

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

Actavis, Barnstaple, EX32 8NS, UK

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