Capecitabine Polpharma 500mg Filmomhulde tabletten

Capecitabine belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells. Capecitabine contains 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 prescribed by doctors for the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine is prescribed by doctors 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.

Do not take Capecitabine:

• if you are allergic (hypersensitive) to capecitabine or any of the other ingredients of this medicine. You must inform your doctor if you know that you have an allergy or over - reaction to Capecitabine,
• if you are pregnant or breast-feeding,
• 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

Warnings and precautions

Before treatment with Capecitabine, 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 capecitabine

Module 1.3.1

Page 2 of 6

Capecitabine Film-coated Tablets

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. T his 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).

Capecitabine with food, drink and alcohol

You should take Capecitabine 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 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 machines. Do not drive if you feel dizzy, nauseous or tired after taking this medicine.

Capecitabine contains

This medicinal product contains anhydrous lactose as an excipient. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Capecitabine.

Capecitabine tablets should be swallowed with water.

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 of 500 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 n eed to take it.

Your doctor may want you to take a combination of 150 mg, 300mg & 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 medicine as prescribed by your doctor.

If you take more Capecitabine than you should

Contact your doctor 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

Module 1.3.1 Page 3 of 6

Capecitabine Film-coated Tablets

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, 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.

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.
• Vomiting: if you vomit more than once in a 24-hour time period.
• Nausea: if you lose your appetite, and the amount of food y ou 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, constipatio n, 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.

Module 1.3.1

Page 4 of 6

Capecitabine Film-coated Tablets

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

Aluminium/aluminium blisters

This medicinal product does not require any special storage conditions.

PVC/PVdC/Aluminium blisters

Do not store above 30°C

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

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment

What Capecitabine contains

The active substance is capecitabine

Each film-coated tablet contains 150 mg of capecitabine

Each film-coated tablet contains 500 mg of capecitabine

• The other ingredients are:
  • Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
  • Tablet coating: hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172), talc.

What Capecitabine Polpharma looks like and contents of the pack

Capecitabine Polpharma 150mg film-coated tablet is a light peach coloured, oblong shaped,

biconvex, film-coated tablet of approximately 11.4 mm in length and 5.3 mm in width debossed with “150” on one side and plain on other side.

Capecitabine Polpharma 500mg film-coated tablet is a peach coloured, oblong shaped, biconvex, film-coated tablet of approximately 15.9 mm in length and 8.4 mm in width debossed with “500”

on one side and plain on other side

Capecitabine Polpharma is available in blister packs (Aluminium- Aluminium & PVC/PVdC - Aluminium) containing 30, 60 or 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmaceutical Works Polpharma SA

19, Pelplińska Street, 83-200 Starogard Gdański

Poland

Manufacturer

Accord Healthcare Limited,

Sage house, 319 Pinner road, Harrow, Middlesex, HA1 4HF, United Kingdom or

Pharmacare Premium Limited,

HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta or

Pharmaceutical Works Polpharma SA

19 Pelplińska Street, 83-200 Starogard Gdański, Poland

Module 1.3.1

Page 5 of 6

Capecitabine Film-coated Tablets

The medicinal product is authorized in the Member States of the EEA under the following names:

Name of member state	:	Name of medicinal product
PL	:	Capecitabine Polpharma
RO	:	Capecitabina Medana 150mg/500mg comprimate filmate
NL	:	Capecitabine Polpharma 150mg/500mg filmomhulde tabletten

Capecitabine Polpharma 150mg Filmomhulde tabletten: RVG 110021 Capecitabine Polpharma 500mg Filmomhulde tabletten: RVG 110022

This leaflet was last revised in July 2012

Module 1.3.1

Page 6 of 6