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XELCIP 150 MG FILM- COATED TABLETS

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Package Leaflet: Information for the user
Xelcip 150 mg film-coated tablets
Xelcip 500 mg film-coated tablets
capecitabine
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.
What is 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. Contents of the pack and other information

1. What Xelcip is and what it is used for
Xelcip belongs to the group of medicines called "cytostatic agents",
which stop the growth of cancer cells. Xelcip 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).
Xelcip is used in the treatment of colon, rectal, gastric, or breast
cancers. Furthermore, Xelcip is used 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
medicines.

2. What you need to know before you take Xelcip

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3. How to take Xelcip
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Xelcip should only be prescribed by a doctor experienced in the use of
anticancer medicines.
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 recommended 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.
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) and swallow whole with water.
- It is important that you take all your medicine as prescribed by your
doctor.
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 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.
If you take more Xelcip than you should
If you take more Xelcip 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 Xelcip
Do not take the missed dose Do not take a double dose to make up for a
forgotten dose. 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 (containing e.g. phenprocoumon), stopping Xelcip 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.
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 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.
- DPD deficiency: if you have a known DPD deficiency, you are at an
increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Capecitabine tablets (e.g.
stomatitis, mucosal inflammation, diarrhoea, neutropenia, and
neurotoxicity).
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Xelcip 150 mg and 500 mg
film-coated tablets

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Xelcip 150 mg and 500 mg
film-coated tablets

Do not take Xelcip:
- if you are allergic (hypersensitive) 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 breast-feeding,
- if you have severely low levels of white cells or platelets in the
blood (leucopenia, neutropenia or thrombocytopenia),
- if you have liver or kidney problems,
- if you know that you do not have any activity of 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 Xelcip, if you
- know that you have a partial deficiency in the activity of the enzyme
dihydropyrimidine dehydrogenase (DPD)
- have liver or kidney diseases
- have or had heart problems (for example an irregular heartbeat or
pain to the chest jaw and back brought on by physical effort and due
to problems with the blood flow to the heart)
- have brain diseases (for example cancer that has spread to the brain,
or nerve damage (neuropathy)
- have calcium imbalances (see in blood tests)
- have diabetes
- cannot keep food or water in your body because of severe nausea
and vomiting
- have diarrhoea
- are or become dehydrated
- have imbalances of ions in your blood (electrolyte imbalances, seen
in tests)
- have a history of eye problems as you may need extra monitoring of
your eyes
- 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 Xelcip, you are at an increased risk of acute early onset of severe
forms of the side effects listed in 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
Xelcip is not indicated in children and adolescents. Do not give Xelcip
to children and adolescents.
Other medicines and Xelcip:
Before starting treatment, please tell your doctor or pharmacist if you
are taking or 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
- radiotherapy and certain medicines used to treat cancer (folinic acid,
oxaliplatin, bevacizumab, cisplatin, irinotecan),
- medicines used to treat folic acid deficiency.
Taking Xelcip with food and drink:
You should take Xelcip no later than 30 minutes after meals.
Pregnancy, breast-feeding and fertility :
If you are pregnant or breast-feeding, think you may be pregnant or are

planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. You must not take Xelcip if you are
pregnant or think you might be. You should not breast-feed if you are
taking Xelcip.
An effective method of contraception should be used if you are taking
Xelcip.
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
machines.
Xelcip 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 medicine.

UK

Date: 28-12-2016

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. 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 Xelcip
Keep this medicine out of the sight and reach of Children.
Store in original pack
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 Xelcip contains
- The active substance is capecitabine
o Xelcip 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of capecitabine.
o Xelcip 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of capecitabine.
- 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), macrogol
What Xelcip tablet looks like and contents of the pack
Xelcip 150 mg film-coated tablets are pink colored, capsule shaped,
biconvex, film coated tablets, debossed with “150”on one side and
plain on other side.
Xelcip 500 mg film-coated tablets are 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 and Manufacturer
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
Cipla Europe NV
Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in Month of variation approval

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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.
Hand and foot skin-reaction can lead to loss of fingerprint, which could
impact your identification by fingerprint scan.
In addition to the above, when Xelcip is used alone, very common side
effects, which may affect more than 1 in 10 people 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 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 (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 Xelcip 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

UK

Date: 28-12-2016

Expand Transcript

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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