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CAPECITABINE DEXCEL 500MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

3.04.14

Irina

Capecitabine 500 mg
Dexcel Pharma

Black
157mmx322mm

9pt
157x322

Capecitabine 500mg film-coated tablets
capecitabine
Read all of this leaflet carefully before you start taking adolescents. Do not give Capecitabine 500mg, to children
this medicine because it contains important information and adolescents.
for you.
Other medicines and Capecitabine 500mg tablets
• Keep this leaflet. You may need to read it again.
Before starting treatment, tell your doctor or pharmacist if
• If you have any further questions, ask your doctor or you are taking, have recently taken or might take any other
pharmacist.
medicines. This is extremely important, as taking more than
• This medicine has been prescribed for you only. Do not one medicine at the same time can strengthen or weaken the
pass it on to others. It may harm them, even if their signs effect of the medicines. You need to be particularly careful if
of illness are the same as yours.
you are taking any of the following:
• If you get any side effects, talk to your doctor or pharmacist. • gout medicines (allopurinol),
This includes any possible side effects not listed in this • blood-thinning medicines (coumarin, warfarin),
leaflet.
• certain anti-viral medicines (sorivudine and brivudine),
What is in this leaflet
• medicines for seizures or tremors (phenytoin),
1. What Capecitabine 500mg tablets are and what they are • interferon alpha or
used for
• radiotherapy and certain medicines used to treat cancer
2. What you need to know before you take Capecitabine
(folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan)
500mg tablets
• medicines used to treat folic acid deficiency.
3. How to take Capecitabine 500mg tablets
Capecitabine 500mg tablets with food, drink and alcohol
4. Possible side effects
You should take Capecitabine 500mg tablets no later than
5. How to store Capecitabine 500mg tablets
30 minutes after meals.
6. Contents of the pack and other information
Pregnancy and breast-feeding
1. What Capecitabine 500mg tablets are and what they Before starting treatment, you must tell your doctor if you are
are used for
pregnant, if you think you are pregnant or if you intend to
Capecitabine 500mg tablets belongs to the group of medicines become pregnant. You must not take Capecitabine 500mg
called "cytostatic medicines", which stop the growth of tablets if you are pregnant or think you might be. You must
cancer cells. Capecitabine 500mg tablets contains 500 mg not breast-feed if you are taking Capecitabine 500mg tablets.
capecitabine, which itself is not a cytostatic medicine. Only Ask your doctor or pharmacist for advice before taking this
after being absorbed by the body is it changed into an active medicine.
anti-cancer medicine (more in tumour tissue than in normal
Driving and using machines
tissue).
Capecitabine 500mg tablets may make you feel dizzy,
Capecitabine 500mg tablets is used in the treatment of colon, nauseous or tired. It is therefore possible that Capecitabine
rectal, gastric, or breast cancers. Furthermore, Capecitabine 500mg tablets could affect your ability to drive a car or operate
500mg tablets is used to prevent new occurrence of colon machinery.
cancer after complete removal of the tumour by surgery.
Capecitabine 500mg tablets may be used either alone or in 3. How to take Capecitabine 500mg tablets
Always take this medicine exactly as your doctor or pharmacist
combination with other medicines.
has told you. Check with your doctor or pharmacist if you
2. What you need to know before you take Capecitabine are not sure.
500mg tablets
Capecitabine 500mg should only be prescribed by a doctor
Do not take Capecitabine 500mg tablets:
• if you are allergic to capecitabine or any of the other experienced in the use of anticancer medicines. Capecitabine
ingredients of this medicine (listed in section 6). You must 500mg tablets should be swallowed whole with water and
tell your doctor if you know that you have an allergy or within 30 minutes of a meal.
over-reaction to this medicine,
Your doctor will prescribe a dose and treatment regimen that
• if you previously have had severe reactions to is right for you. The dose of Capecitabine 500mg tablets is
fluoropyrimidine therapy (a group of anticancer medicines based on your body surface area. This is calculated from
such as fluorouracil),
your height and weight. The usual dose for adults is 1250
• if you are pregnant or breastfeeding,
mg/m2 of body surface area taken two times daily (morning
• if you have severely low levels of white cells or platelets in and evening). Two examples are provided here: A person
the blood (leucopenia, neutropenia or thrombocytopenia), whose body weight is 64 kg and height is 1.64 m has a body
• if you have severe liver or kidney problems,
surface area of 1.7 m2 and should take 4 tablets of 500 mg
• if you have a known deficiency for the enzyme and 1 tablet of 150 mg two times daily. A person whose body
dihydropyrimidine dehydrogenase (DPD) involved in the weight is 80 kg and height is 1.80 m has a body surface area
metabolism of uracil and thymine, or
of 2.00 m2 and should take 5 tablets of 500 mg two times daily.
• if you are being treated now or have been treated in the
last 4 weeks with brivudine, sorivudine or similar classes Capecitabine 500mg tablets are usually taken for 14 days
of substance as part of herpes zoster (chickenpox or followed by a 7 day rest period (when no tablets are taken).
This 21 day period is one treatment cycle.
shingles) therapy.
In combination with other medicines the usual dose for adults
Warnings and precautions
2
Talk to your doctor or pharmacist before taking Capecitabine may be less than 1250 mg/m of body surface area, and you
may need to take the tablets over a different time period (e.g.
500mg tablets:
every day, with no rest period).
• if you have liver or kidney diseases
• if you have or had heart problems (for example, an irregular Your doctor will tell you what dose you need to take, when
heartbeat or pains to the chest, jaw and back brought to take it and for how long you need to take it.
on by physical effort and due to problems with the blood Your doctor may want you to take a combination of 150 mg
flow to the heart)
and 500 mg tablets for each dose.
• if you have brain diseases (for example, cancer that has • Take the tablets morning and evening as prescribed
spread to the brain, or nerve damage (neuropathy)
by your doctor.
• if you have calcium imbalances (seen in blood tests)
• Take the tablets within 30 minutes after the end of a
• if you have diabetes
meal (breakfast and dinner).
• if you cannot keep food or water in your body because of • It is important that you take all your medicine as prescribed
severe nausea and vomiting
by your doctor.
• if you have diarrhoea
If you take more Capecitabine 500mg tablets
• if you are or become dehydrated
• if you have imbalances of ions in your blood (electrolyte If you take more Capecitabine 500mg than you should, contact
your doctor as soon as possible before taking the next dose.
imbalances, seen in tests)
• if you have a history of eye problems as you may need You might get the following side effects if you take a lot more
capecitabine than you should: feeling or being sick, diarrhoea,
extra monitoring of your eyes
inflammation or ulceration of the gut or mouth, pain or bleeding
• if you have a severe skin reaction
from the intestine or stomach, or bone marrow depression
DPD deficiency: DPD deficiency is a rare condition present at (reduction in certain kinds of blood cells). Tell your
birth that is not usually associated with health problems unless doctor immediately if you experience any of these symptoms.
you receive certain medicines. If you have an unrecognised
DPD deficiency and take Capecitabine 500mg you may If you forget to take Capecitabine 500mg tablets
experience severe forms of the side effects listed under section Do not take the missed dose at all and do not double the
4 Possible side effects. Contact your doctor immediately if next one. Instead, continue your regular dosing schedule
you are concerned about any of the side effects or if you and check with your doctor.
notice any additional side effects not listed in the leaflet (see If you stop taking Capecitabine 500mg tablets
There are no side effects caused by stopping treatment with
section 4 Possible side effects).
capecitabine. In case you are using coumarin anticoagulants
Children and adolescents
Capecitabine 500mg is not indicated in children and (containing e.g. phenprocoumon), stopping capecitabine might
require that your doctor adjusts your anticoagulant dose.

9pt
157x322
Black
157mmx322mm

Irina

3.04.14

Capecitabine 500 mg
Dexcel Pharma

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 500mg 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.
• 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 (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 Capecitabine 500mg 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 500 mg. 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
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, 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 effect, you can help provide more information
on the safety of this medicine.
5. How to store Capecitabine 500mg tablets
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 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 500mg tablets contains
• The active substance is capecitabine. Each film-coated
tablet contains 500 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 500mg tablets looks like and contents
of the pack
Peach, oblong capsule-shaped, film-coated tablets embossed
with “500” on one side. Of approximate dimensions
17.1 mm x 8.1 mm.
Capecitabine 500 mg film-coated tablet pack contains 120
film-coated tablets.
Marketing Authorisation Holder: Dexcel®-Pharma Ltd.,
7 Sopwith Way, Drayton Fields Industrial Estate, Daventry,
Northamptonshire, NN11 8PB, United Kingdom.
Manufacturer: Remedica Ltd., Aharnon Street, Limassol
Industrial Estate, 3056 Limassol, Cyprus.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany: Capecitabine Dexcel 500mg, Filmtabletten
UK:
Capecitabine Dexcel 500mg Film-coated Tablets
This leaflet was last revised in April 2014.
V-1045

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