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XELCIP 500 MG FILM-COATED TABLETS

Active substance(s): CAPECITABINE

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Package Leaflet: Information for
the user
XELCIP 150 mg film-coated
tablets
XELCIP 500 mg film-coated
tablets
capecitabine

− gout medicines (allopurinol),
− blood-thinning medicines (coumarin, warfarin),
− certain anti-viral medicines (sorivudine and
brivudine) or
− medicines for seizures or tremors (phenytoin).
Taking XELCIP with food and drink:
You should take XELCIP no later than 30
minutes after meals.
Pregnancy, breast-feeding and fertility :
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 XELCIP if you are pregnant
or think you might be. You should not breast-feed
if you are taking XELCIP. Ask your doctor or
pharmacist for advice before taking any
medicine.
Driving and using machines:
XELCIP may make you feel dizzy, nauseous or
tired. It is therefore possible that XELCIP could
affect your ability to drive a car or operate
machinery.
Important information about some of the
ingredients of XELCIP:
This medicinal product contains lactose monohydrate as an excipient. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking
XELCIP

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.
Do not pass it on to others. It may harm them,
even
if their symptoms are the same as yours.
- 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.
In this leaflet:
1. What XELCIP is and what it is used for
2. Before you take XELCIP
3. How to take XELCIP
4. Possible side effects
5. How to store XELCIP
6. Further Information

3. How to take XELCIP

1. What XELCIP is and what it is used
for

XELCIP should be swallowed with water.
Your doctor will prescribe a dose and treatment
regimen that is right for you. The dose of
XELCIP 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.
XELCIP 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 in the combination prescribed
by your doctor for your morning and evening
doses.
• 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 XELCIP than you should,
contact your doctor before taking the next dose.
If you forget to take XELCIP: 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 XELCIP:
There are no side-effects caused by stopping
treatment with XELCIP. In case you are using
coumarin anticoagulants (e.g. Marcumar),
stopping XELCIP might require that your doctor
adjusts your anticoagulant dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

XELCIP belongs to the group of medicines
called "cytostatic agents", which stop the growth
of cancer cells. XELCIP contains 150 mg / 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).
XELCIP is prescribed by doctors for the
treatment of colon, rectal, gastric, or breast
cancers. Furthermore, XELCIP is prescribed by
doctors to prevent new occurrence of colon
cancer after complete removal of the tumour by
surgery.
XELCIP may be used either alone or in
combination with other agents.

2. What you need to know before you
take XELCIP
Do not take XELCIP:
- if you are allergic (hypersensitive) to capecitabine or any of the other ingredients of
XELCIP. You must inform your doctor if you
know that you have an allergy or over-reaction
to Xelcip tablet.
- if you are pregnant or nursing,
- if you have blood disorders,
- if you have liver ailments or kidney problems,
- if you have a known deficiency for the
enzyme dihydropyrimidine dehydrogenase
(DPD), 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.
Take special care with XELCIP:
Before treatment with XELCIP, make sure your
doctor knows if you
- have liver or kidney diseases
- have or had other illnesses, such as heart
problems or chest pain
- have brain diseases
- have calcium imbalances
- have diabetes
Taking other medicines:
Before starting treatment, please tell your doctor
or pharmacist if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription. 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:

4. Possible side effects
Like all medicines, XELCIP can cause side
effects, although not everybody gets them.
XXXXX

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UK

UK

more information on the safety of this medicine.

5. How to store XELCIP
Keep this medicine out of the sight and reach of
children.
Store in original pack.
Do not use XELCIP after the expiry date which is
stated on the outer carton , label and blister , after
EXP :
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information
What XELCIP contains
- The active substance is capecitabine (150 mg
per film-coated tablet).
- The active substance is capecitabine (500 mg
per film-coated tablet).
- The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose
6 cps, croscarmellose sodium, magnesium
stearate, hypromellose 15 cps (E464), titanium
dioxide (E171), red iron oxide (E172) and
macrogol
What Xelcip tablet looks like and contents of
the pack
Xelcip 150 mg
Pink colored, capsule shaped, biconvex, film
coated tablets, debossed with “150”on one side
and plain on other side.
Xelcip 500 mg
Pink colored, capsule shaped, biconvex, film
coated tablets, debossed with “500” on one side
and plain on other side.
For 150 mg : Carton containing blister
(PVC/PVDC film and aluminium foil) of 10, 60
tablets.
For 500 mg : Carton containing blister
(PVC/PVDC film and aluminium foil) of 4, 120
tablets.
Not all pack sizes may be marketed
Marketing authorization holder
Cipla UK Ltd.,
The Old Post House, Heath Road,
Weybridge, Surrey, KT13 8TS,
United Kingdom
Manufacturer
S & D Pharma, CZ, spol. s.r.o.
Registered office of the company: Písnická
22/546, 142 00 Prague 4, Czech Republic
Place of manufacture: Theodor 28, 273 08 Pchery
(PHARMOS a.s. facility), Czech Republic
Imedica S.A.
Sos, Bucuresti-Ploiesti, 141D, 013686, Sector 1,
Bucuresti, Romania
Cipla (EU) Limited,
4th Floor, 1 Kingdom Street, London, W2 6BY,
United Kingdom
This leaflet was last updated in 01/2015

XXXXX

STOP taking XELCIP 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.
• 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.
In addition to the above, when XELCIP is used
alone, very common side effects, which may
affect more than 1in 10 people 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 XELCIP. 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
• 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.
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

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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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