Document: leaflet MAH GENERIC_PL 18727-0026 change

• leaflet MAH GENERIC_PL 18727-0026
• leaflet MAH GENERIC_PL 20117-0207

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Capecitabine Tablets - Pack Insert - Ireland/UK

Package Leaflet: Information for the user

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

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.

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

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 film-coated 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

- 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 of500 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.

•    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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Capecitabine Tablets - Pack Insert - Ireland/UK

•    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 ofhands 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.

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 ofthat 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

Or

^Black    Date: 05 March 2014 Version: 05    Font: Times New Roman - 9.5 Pt.

Reason for the Artwork* : Change in Text					Dimension : 450 x 210 mm
Artwork No. : xxxxxxxxxx / xxxxx					Supersedes No.: 7220131854 / KM39A
Prepared By PDD	Checked By PDD	Approved By
		PDD	Production	QA	I&D RA	QM	Country RA
			Approved Online		NA	NA

Form No.: SOP/PDD/003-03 Rev. 05    CONFIDENTIAL    * Attached separate sheet if required

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