Capecitabine SUN
capecitabine
capecitabine
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 Capecitabine SUN is and what it is used for
What you need to know before you take Capecitabine SUN
How to take Capecitabine SUN
Possible side effects
How to store Capecitabine SUN
Contents of the pack and other information
Medicinal product no longer authorised
Capecitabine SUN belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells. Capecitabine SUN 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 SUN is used in the treatment of colon, rectal, gastric, or breast cancers.
Furthermore, Capecitabine SUN is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Capecitabine SUN may be used either alone or in combination with other medicines.
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 to capecitabine.
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 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.
Talk to your doctor before taking Capecitabine SUN, if you
have liver or kidney diseases
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)
have brain diseases (for example. cancer that has spread to the brain), or nerve damage (neuropathy)
have calcium imbalances (seen 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 Capecitabine SUN, 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).
Capecitabine SUN is not indicated in children and adolescents. Do not give Capecitabine SUN to
children and adolescents.
Medicinal product no longer authorised
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might
take 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)
medicines for seizures or tremors (phenytoin)
a medicine to treat cancer (interferon alpha)
radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan)
medicines used to treat folic acid deficiency.
You should take Capecitabine SUN no later than 30 minutes after meals.
Before starting treatment, you must tell your doctor if you are pregnant, if you think you may be pregnant or if you intend to become pregnant. You must not take Capecitabine SUN if you are
pregnant or think you might be.
Effective contraceptive precautions must be taken by patients who are taking Capecitabine SUN. You must not breast-feed if you are taking Capecitabine SUN.
Ask your doctor or pharmacist for advice before taking any medicine.
Capecitabine SUN may make you feel dizzy, nauseous or tired. It is therefore possible that
Capecitabine SUN 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.
This medicine contains anhydrous lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
Always take 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 SUN 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 SUN 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 SUN 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.
Medicinal product no longer authorised
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.
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose.
Take the tablets in the 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 medicines as prescribed by your doctor.
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.
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.
There are no side-effects caused by stopping treatment with Capecitabine SUN. In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping Capecitabine SUN 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.
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.
If caught early, these side effects usually improve within 2 to 3 days after stopping treatment. If these side effects continue, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.
Medicinal product no longer authorised
In addition to the above, when Capecitabine SUN is used alone, very common side effects which may affect more than 1 person in 10 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 Capecitabine SUN. 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
Medicinal product no longer authorised
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 capecitabine 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.
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).
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 thenationalreporting systemlistedinAppendixV*. By reporting side effects you can help provide more information on the
safety of this medicine.
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 carton and blister after EXP. Do not store above 25°C.
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.
Medicinal product no longer authorised
The active substance is capecitabine. Each film-coated tablet contains 150 mg of capecitabine.
The other ingredients are:
Tablet core: talc (E553b), anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), cellulose microcrystalline (E460), magnesium stearate (E572).
Tablet coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol and ferric oxide yellow and red (E172).
Capecitabine SUN 150 mg are light peach coloured, oval, biconvex, film-coated tablet debossed with
‘150’ on one side and plain on other side.
Each pack contains 60 film-coated tablets (6 blisters of 10 tablets).
2132 JH Hoofddorp The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
L-Olanda/Nederland/Nederland/Niederlande/Holandia/Países Baixos/ Olanda/Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501
Sun Pharmaceuticals Germany GmbH
Kandelstrasse 7
79199 Kirchzarten Deutschland
tel. +49 (0) 7661 90 91 58-0
Sun Pharmaceuticals Spain S.L.U.
C/Bobinadora 1-5 Planta 1a Local 13
Mataro, 08302 Barcelona España
tel. +34 93 798 02 85
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Sun Pharmaceuticals France
34, Rue Jean Mermoz 78600 Maisons Laffitte France
tel. +33 1 39 62 10 24
Sun Pharmaceuticals Italia S.R.L.
Via Luigi Rizzo, 8 I-20151 – Milano Italia
tel. +39 02 33 49 07 93
Sun Pharmaceuticals UK Limited
4100 Park Approach Thorpe Park
Leeds
LS15 8GB
United Kingdom
tel. +44 (0) 113 397 08 70