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.

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

-    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

1. What XELCIP is and what it is used for

3. How to take XELCIP

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 capecit-abine 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:

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.

4. Possible side effects

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

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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

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: Pisnicka 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,

4^th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom

This leaflet was last updated in 01/2015

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