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Package leaflet: Information for the user

Tificape 150 mg film-coated tablets Tificape 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.

What is in this leaflet:

1.    What Tificape is and what it is used for

2.    What you need to know before you take Tificape

3.    How to take Tificape

4.    Possible side effects

5.    How to store Tificape

6.    Contents of pack and other information

1. What Tificape is and what it is used for

Tificape belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells. Tificape 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).

Tificape is prescribed by doctors for the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Tificape is prescribed by doctors to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.

Tificape may be used either alone or in combination with other agents. ¹

-    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

Before treatment with Tificape, 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

Other medicines and Tificape

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:

•    gout medicines (allopurinol),

•    blood-thinning medicines (coumarin, warfarin),

•    certain anti-viral medicines (sorivudine and brivudine) or

•    medicines for seizures or tremors (phenytoin).

Tificape with food, drink and alcohol

You should take Tificape 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 Tificape if you are pregnant or think you might be. You should not breast-feed if you are taking Tificape. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Tificape may make you feel dizzy, nauseous or tired. It is therefore possible that Tificape could affect your ability to drive a car or operate machinery.

Tificape 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 medicinal product.

3. How to take Tificape

Tificape tablets should be swallowed with water.

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Tificape is based on your body surface area. This is calculated from your height and weight. The usual dose for adults is 1250 mg/m¹ 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 m¹ 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 m¹ and should take 5 tablets of 500 mg two times daily.

Tificape 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 Tificape than you should, contact your doctor before taking the next dose.

If you forget to take Tificape

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 Tificape

There are no side-effects caused by stopping treatment with Tificape. In case you are using coumarin anticoagulants (e.g. Marcumar), stopping Tificape 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 Tificape 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 Tificape. This will help reduce the likelihood that the side effect continues or becomes severe.

STOP taking Tificape 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.

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.

5. How to store Tificape

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the outer carton, label and blister, after EXP.

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 Tificape 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:

-    Tablet core: lactose monohydrate, microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate.

-    Tablet coating: hypromellose, titanium dioxide (E171), macrogol 6000, red iron oxide (E172).

What Tificape looks like and contents of the pack

Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with “150”/ “500” on one side and plain on other side.

Tificape 150 mg film-coated tablet pack contains 60 film-coated tablets. Tificape 500 mg film-coated tablet pack contains 120 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

ALFRED E. TIEFENBACHER (GmbH & Co.KG)

Van-der-Smissen-Str. 1 22767 Hamburg Germany

Manufacturers:

Aegis Ltd.

17, Athinon Street, Ergates 2643 Lefkosia Cyprus or

APL Swift Services (Malta) Ltd.

HF26

Hal Far Industrial Estate Hal Far

Birzebbugia BBG 3000

Malta

or

Pharmacare Premium Ltd HHF 003

Hal Far Industrial Estate

Birzebbugia

Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Tificape 150 mg/500 mg comprimes pellicules/filmomhulde

tabletten/Filmtabletten

Tificape 150 mg/500 mg Filmtabletten

Tificape 150 mg/500 mg comprimidos recubiertos con pelicula

Tificape 150 mg/500 mg comprimes pellicules

Tificape

This leaflet was last revised in 04/2012

1

What you need to know before you take Tificape Do not take Tificape

-    if you are allergic to Capecitabine, flourouracil 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 capecitabine or to flouropyrimide therapy,

-    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