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CAPECITABINE 500 MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

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Capecitabine Tablets - Pack Insert - Ireland/UK

Circulation No. 1

Capecitabine 150 mg film-coated tablets
Capecitabine 500 mg film-coated tablets

Capecitabine
film-coated tablets

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

Capecitabine
film-coated tablets

xxxxx / xxxxxxxxxx / V003

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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 or
nurse. This includes any possible side effects not listed in this
leaflet.

1. What Capecitabine is and what it is used for
Capecitabine belongs to the group of medicines called "cytostatic
agents", which stop the growth of cancer cells. Capecitabine filmcoated tablets contains 150 mg or 500 mg capecitabine, which itself
is not a cytostatic agent. Only after being absorbed by the body is it
changed into an active anti-cancer agent (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
agents.
2. What you need to know before you take Capecitabine
Do not use 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, or
- 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 or nurse 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 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
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
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 or

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Date: 05 March 2014

- radiotherapy and certain medicines used to treat cancer (folinic
acid, oxaliplatin, bevacizumab).
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 should not take capecitabine if you are pregnant or
think you might be. You should not breast-feed if you are taking
capecitabine. Ask your doctor or pharmacist for advice before taking
any 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 contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking capecitabine.
3. How to take Capecitabine
Always use 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 agents 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.

Version: 05

Font: Times New Roman - 9.5 Pt.

Reason for the Artwork* : Change in Text

Dimension

Artwork No.

Supersedes No. : 7220131854 / KM39A

Prepared By
PDD

: xxxxxxxxxx / xxxxx
Checked By
PDD

: 450 x 210 mm

Approved By
PDD

Production

QA

Approved
Online

Form No.: SOP/PDD/003-03 Rev. 05
D:\Europe\Capecitabine\Ireland + UK\28 Nov 2013\Capecitabine Tab PI - IRL+GBR.CDR

CONFIDENTIAL

I&D RA

QM

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Country RA

* Attached separate sheet if required

• 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.
If you stop taking Capecitabine
There are no side-effects caused by stopping treatment with
capecitabine. In case you are using coumarin anticoagulants (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.
When capecitabine is used alone, the most common side effects
which may affect more than 1 person in 10 are:
• diarrhoea, nausea, vomiting, stomatitis (sores in mouth and
throat) and abdominal pain
• hand-and-foot skin-reaction (palms of the hands or soles of the
feet tingle, become numb, painful, swollen or red), 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.
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.

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Package Leaflet:
Information for the user

Capecitabine Tablets - Pack Insert - Ireland/UK

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.
For UK - You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
For Ireland - Reports may be made by following the links to the
online reporting option accessible from the IMB homepage, or by
completing the downloadable report form also accessible from the
IMB website, which may be completed manually and submitted to
the IMB via freepost, to the following address:
IMB Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie (http://www.imb.ie)
e-mail: imbpharmacovigilance@imb.ie
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 use this medicine after the expiry date which is stated on the
outer pack and labels after EXP. The expiry date refers to the last day
of that month.
This medicinal product does not require any special storage
conditions.
Do not use this medicine if you notice any visible signs of
deterioration.
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 capecitabine.
Each film-coated tablet contains 500 mg capecitabine.
- The other ingredients are:
- Tablet core: Lactose monohydrate, Microcrystalline cellulose
(E460), Hypromellose (E464), Crosscarmellose sodium,
Magnesium stearate (E572)
- Tablet coating: Hypromellose (E464), Titanium dioxide
(E171), Macrogol, Iron oxide red (E172)
What Capecitabine looks like and contents of the pack
Capecitabine 150 mg film-coated tablets
Pink coloured, capsule shaped, biconvex, film coated tablets,
debossed with “150”on one side and plain on other side.
The pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Capecitabine 500 mg film-coated tablets
Pink coloured, capsule shaped, biconvex, film coated tablets,
debossed with “500” on one side and plain on other side.
The pack contains 120 film coated tablets (12 blisters of 10 tablets).
Marketing Authorisation Holder
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF
United Kingdom
Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF
United Kingdom

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA3000
MALTA.

Iceland

This leaflet was last revised in March 2014

Italy
Latvia

This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria
Capecitabin Fresenius Kabi 150 mg Filmtabletten
Capecitabin Fresenius Kabi 500 mg Filmtabletten
Belgium
Capecitabine Fresenius Kabi 150 mg filmomhulde
tabletten
Capecitabine Fresenius Kabi 500 mg filmomhulde
tabletten
Cyprus
Capecitabine Fresenius Kabi 150 mg επικαλυμένα
με λεπτό υμένιο δισκία
Capecitabine Fresenius Kabi 500 mg επικαλυμένα
με λεπτό υμένιο δισκία
Czech
Capecitabine Fresenius Kabi 150 mg potahované
Republic
tablety
Capecitabine Fresenius Kabi 500 mg potahované
tablety
Denmark
Capecitabin Fresenius Kabi
Estonia
Capecitabine Fresenius Kabi 150 mg
Capecitabine Fresenius Kabi 500 mg
Greece
Capecitabine Fresenius Kabi 150 mg επικαλυμμένα
με λεπτό υμένιο δισκία
Capecitabine Fresenius Kabi 500 mg επικαλυμμένα
με λεπτό υμένιο δισκία
Spain
Capecitabina Fresenius Kabi 150 mg comprimidos
recubiertos con película EFG
Capecitabina Fresenius Kabi 500 mg comprimidos
recubiertos con película EFG
Finland
Capecitabin Fresenius Kabi 150 mg
kalvopäällysteinen tabletti
Capecitabin Fresenius Kabi 500 mg
kalvopäällysteinen tabletti
France
Capecitabine Fresenius Kabi 150 mg comprimé
pelliculé
Capecitabine Fresenius Kabi 500 mg comprimé
pelliculé
Hungary
Capecitabine Fresenius Kabi 150 mg filmtabletta
Capecitabine Fresenius Kabi 500 mg filmtabletta
Ireland
Capecitabine 150 mg film-coated tablet
Capecitabine 500 mg film-coated tablet

Lithuania

Malta
The
Netherlands

Norway

Poland
Portugal
Romania

Sweden

Slovenia

Slovak
Republic

United
Kingdom

Or

Black

Date: 05 March 2014

Version: 05

Font: Times New Roman - 9.5 Pt.

Reason for the Artwork* : Change in Text

Dimension

Artwork No.

Supersedes No. : 7220131854 / KM39A

Prepared By
PDD

: xxxxxxxxxx / xxxxx
Checked By
PDD

: 450 x 210 mm

Approved By
PDD

Production

QA

Approved
Online

Form No.: SOP/PDD/003-03 Rev. 05
D:\Europe\Capecitabine\Ireland + UK\28 Nov 2013\Capecitabine Tab PI - IRL+GBR.CDR

CONFIDENTIAL

I&D RA

QM

NA

NA

Capecitabin Fresenius Kabi 150 mg filmuhúðuð
tafla
Capecitabin Fresenius Kabi 500 mg filmuhúðuð
tafla
Capecitabina Fresenius Kabi
Capecitabine Fresenius Kabi 150 mg apvalkotās
tabletes
Capecitabine Fresenius Kabi 500 mg apvalkotās
tabletes
Capecitabine Fresenius Kabi 150 mg plėvele
dengtos tabletės
Capecitabine Fresenius Kabi 500 mg plėvele
dengtos tabletės
Capecitabine 150 mg film-coated tablet
Capecitabine 500 mg film-coated tablet
Capecitabine Fresenius Kabi150 mg filmomhulde
tabletten
Capecitabine Fresenius Kabi500 mg filmomhulde
tabletten
Capecitabin Fresenius Kabi 150 mg filmdrasjerte
tabletter
Capecitabin Fresenius Kabi 500 mg filmdrasjerte
tabletter
Capecitabine Fresenius Kabi
Capecitabina Fresenius Kabi 150 mg
Capecitabina Fresenius Kabi 500 mg
Capecitabina Fresenius Kabi 150 mg comprimate
filmate
Capecitabina Fresenius Kabi500 mg comprimate
filmate
Capecitabin Fresenius Kabi 150 mg, filmdragerade
tabletter
Capecitabin Fresenius Kabi 500 mg, filmdragerade
tabletter
Kapecitabin Fresenius Kabi 150 mg
filmskoobloženetablete
Kapecitabin Fresenius Kabi 500 mg
filmskoobloženetablete
Capecitabine Fresenius Kabi 150 mg filmom
obalené tablety
Capecitabine Fresenius Kabi500 mg filmom
obalené tablety
Capecitabine 150 mg film-coated tablet
Capecitabine 500 mg film-coated tablet
xxxxx / xxxxxxxxxx / V003

• 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.
Other less common and usually mild side-effects which may affect
between 1 and 10 people in 100 have been seen: decreases in the
number of white blood cells or red blood cells, skin rashes, slight hair
loss, weariness, fever, weakness, drowsiness, headache, numbness
or tingling sensations, taste changes, dizziness, sleeplessness,
swelling in the legs, constipation, dehydration, cold sores,
inflammation of the nose and throat, chest infection, depression,
problems with the eyes, inflammation of the veins
(thrombophlebitis), shortness of breath, nose bleeds, cough, runny
nose, bleeding from the gut, heartburn, excess wind, dry mouth, skin
discolouration, nail disorder, pain in the joints, chest or back and loss
of weight.
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.

Circulation No. 1

Country RA

* Attached separate sheet if required

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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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