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Capecitabine SUN (capecitabine) – Package leaflet - L01BC06

Updated on site: 05-Oct-2017

Medication nameCapecitabine SUN
ATC CodeL01BC06
Substancecapecitabine
ManufacturerSun Pharmaceutical Industries Europe B.V.

Package leaflet: Information for the user

Capecitabine SUN 150 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. See section 4.

What is in this leaflet

1.What Capecitabine SUN is and what it is used for authorised

2.What you need to know before you take Capecitabine SUN

3.How to take Capecitabine SUN

4.Possible side effects

5.How to store Capecitabine SUN

6.Contents of the pack and other information

 

longer

1. What Capecitabine SUN is and what it is used for

no

 

Capecitabine SUN belongs to the group of medicines called "cytostatic agents", which stop the growth

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

of cancer cells. Capecitabine SUN contains capecitabine, which itself is not a cytostatic agent. Only after being absorbed by the body isproductit changed in o an active anti-cancer agent (more in tumour tissue than in normal tissue).

removal of the tumourMedicinalby surgery.

Capecitabine SUN may be used either alone or in combination with other medicines.

2. What you need to know before you take Capecitabine SUN

Do not take Capecitabine SUN

-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.

Warnings and precautions

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).

Children and adolescents

 

authorised

 

 

Capecitabine SUN is not indicated in children and adolescents. Do not give Capecitabine SUN to

children and adolescents.

longer

 

Other medicines and Capecitabine SUN

 

 

 

Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might

take any other medicines, including medicines obtainedno

without a prescription. This is extremely

-gout medicines (allopurinol)product

-blood-thinning medicines (coumarin, warfarin)

-certain anti-viral medicines (sorivudine and brivudine)

-medicines forMedicinalseizures or tremors (phenytoin)

-a medicine to treat ca cer (interferon alpha)

-radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinot can)

-medicines used to treat folic acid deficiency.

Capecitabine SUN with food and drink

You should take Capecitabine SUN 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 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.

Driving and using machines

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.

Capecitabine SUN contains anhydrous lactose

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.

3. How to take Capecitabine SUN

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 7 day rest period (when no

tablets are taken). This 21 day period is one treatment cycle.

authorised

 

In combination with other medicines the usual dose for adults may be less than 1250 mg/m2

of body

longer

 

 

surface area, and you may need to take the tablets over a different time period (e.g. every day, with no

rest period).

no

 

 

 

product

Your doctor will tell you what dose you need ake, 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.

You might get the followingMedicinalside effects if you take a lot more capecitabine than you should: feeling

-

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.

If you take more Cap citabine SUN than you should

Contact your doctor as soon as possible before taking the next dose.

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 SUN

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 SUN

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.

4. Possible side effects

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

STOP taking Capecitabine SUN 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 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.

authorised

-

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 respirato y system (e.g. bronchitis) and/or fever.

If caught early, these side effects usually improve within 2 to 3 d ys after stopping treatment. If these

side effects continue, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

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:

no

 

-

abdominal pain

product

 

-

loss of appetite (anorexia).

 

-

rash, dry or itchy skin

 

 

-

tiredness

 

 

longer

likelihood that the side effe t continues or becomes severe. Other side effects are:

These side effects can become severe; therefore, it is important that you always contact your doctor immediately whenMedicinalyou start to experience a side effect. Your doctor may instruct you to decrease the dose and/or temporarily disco tinue treatment with Capecitabine SUN. This will help reduce the

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, hotauthorisedflushes, 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, inflamma ion of the small or large intestine, the stomach or the oesophagus, pain in the lower bdomen, 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 su light, reddening of palms, swelling or pain of the face

-joint swelling or stiffness, bone pain, muscle weakness or stiffness

-fluid collection in the kidneys, increased frequency of urination during the night, incontinence,longerno

Some of these side effects are moreproductcommon when capecitabine is used with other medicines for the

 

blood in the urine, increase in blood rea inine (sign of kidney dysfunction)

-

unusual bleeding from the vagina

-

swelling (oedema), chills and rigors.

 

 

Medicinal

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 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)

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

-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).

5. How to store Capecitabine SUN

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.

 

authorised

 

longer

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 informati

no

What Capecitabine SUN contains

-

 

 

product

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).

 

-

Medicinal

 

 

Tablet coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate,

macrogol nd ferric oxide yellow and red (E172).

What Capecitabine SUN looks like and contents of the pack

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).

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/България/Česká republika/

Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/

Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/

Malta/Nederland/Norge/Österreich/Polska/Portugal/ România/Slovenija/Slovenská republika/Suomi/Finland/Sverige

Sun Pharmaceutical Industries Europe B.V. 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

Deutschland

Sun Pharmaceuticals Germany GmbH Kandelstrasse 7

79199 Kirchzarten Deutschland

España

Sun Pharmaceuticals Spain S.L.U. C/Bobinadora 1-5 Planta 1a Local 13 Mataro, 08302

Barcelona España

tel. +34 93 798 02 85

France

 

Sun Pharmaceuticals France

product

34, Rue Jean Mermoz

 

78600 Maisons Laffitte

 

France

 

tel. +33 1 39 62 10 24

 

tel. +39 02 33 49 07Medicinal93

 

Italia

 

Sun Pharmaceuticals Italia S.R.L.

 

Via Luigi Rizzo, 8

 

I-20151 – Milano

 

Italia

 

 

longer

authorised

no

 

 

 

United Kingdom

Sun Pharmaceuticals UK Limited 4100 Park Approach

Thorpe Park Leeds LS15 8GB

United Kingdom

tel. +44 (0) 113 397 08 70

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

Capecitabine SUN 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. See section 4.

What is in this leaflet

1.What Capecitabine SUN is and what it is used for authorised

2.What you need to know before you take Capecitabine SUN

3.How to take Capecitabine SUN

4.Possible side effects

5.How to store Capecitabine SUN

6.Contents of the pack and other information

 

longer

1. What Capecitabine SUN is and what it is used for

no

 

Capecitabine SUN belongs to the group of medicines called "cytostatic agents", which stop the growth

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

of cancer cells. Capecitabine SUN contains capecitabine, which itself is not a cytostatic agent. Only after being absorbed by the body isproductit changed in o an active anti-cancer agent (more in tumour tissue than in normal tissue).

removal of the tumourMedicinalby surgery.

Capecitabine SUN may be used either alone or in combination with other medicines.

2. What you need to know before you take Capecitabine SUN

Do not take Capecitabine SUN

-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.

Warnings and precautions

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).

Children and adolescents

 

authorised

 

 

Capecitabine SUN is not indicated in children and adolescents. Do not give Capecitabine SUN to

children and adolescents.

longer

 

Other medicines and Capecitabine SUN

 

 

 

Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might

take any other medicines, including medicines obtainedno

without a prescription. This is extremely

-gout medicines (allopurinol)product

-blood-thinning medicines (coumarin, warfarin)

-certain anti-viral medicines (sorivudine and brivudine)

-medicines forMedicinalseizures or tremors (phenytoin)

-a medicine to treat ca cer (interferon alpha)

-radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab, cisplatin, irinot can)

-medicines used to treat folic acid deficiency.

Capecitabine SUN with food and drink

You should take Capecitabine SUN 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 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.

Driving and using machines

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.

Capecitabine SUN contains anhydrous lactose

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.

3. How to take Capecitabine SUN

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 7 day rest period (when no

tablets are taken). This 21 day period is one treatment cycle.

authorised

 

In combination with other medicines the usual dose for adults may be less than 1250 mg/m2

of body

longer

 

 

surface area, and you may need to take the tablets over a different time period (e.g. every day, with no

rest period).

no

 

 

 

product

Your doctor will tell you what dose you need ake, 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.

You might get the followingMedicinalside effects if you take a lot more capecitabine than you should: feeling

-

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.

If you take more Cap citabine SUN than you should

Contact your doctor as soon as possible before taking the next dose.

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 SUN

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 SUN

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.

4. Possible side effects

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

STOP taking Capecitabine SUN 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 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.

authorised

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 respirato y system (e.g. bronchitis) and/or fever.

If caught early, these side effects usually improve within 2 to 3 d ys after stopping treatment. If these

side effects continue, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

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:

no

 

-

abdominal pain

product

 

-

loss of appetite (anorexia).

 

-

rash, dry or itchy skin

 

 

-

tiredness

 

 

longer

likelihood that the side effe t continues or becomes severe. Other side effects are:

These side effects can become severe; therefore, it is important that you always contact your doctor immediately whenMedicinalyou start to experience a side effect. Your doctor may instruct you to decrease the dose and/or temporarily disco tinue treatment with Capecitabine SUN. This will help reduce the

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, hotauthorisedflushes, 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, inflamma ion of the small or large intestine, the stomach or the oesophagus, pain in the lower bdomen, 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 su light, reddening of palms, swelling or pain of the face

-joint swelling or stiffness, bone pain, muscle weakness or stiffness

-fluid collection in the kidneys, increased frequency of urination during the night, incontinence,longerno

Some of these side effects are moreproductcommon when capecitabine is used with other medicines for the

 

blood in the urine, increase in blood rea inine (sign of kidney dysfunction)

-

unusual bleeding from the vagina

-

swelling (oedema), chills and rigors.

 

 

Medicinal

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 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)

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

-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).

5. How to store Capecitabine SUN

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.

 

authorised

 

 

 

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 informati

longer

 

 

no

 

 

-The active substance is capecitabine.productEach film-coated tablet contains 500 mg of capecitabine.

-The other ingredients are:

-Tablet core: talc (E553b), anhydrous lactose, croscarmellose sodium (E468), hypromellose (E464), cellulose microcrystalline (E460), magnesium stearate (E572).

-TabletMedicinalcoating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol and ferric oxide yellow and red (E172).’500’

Each pack contains 120 film-coated tablets (12 blisters of 10 tablets).

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/Latvija/Lietuva/Luxembourg/Luxemb urg/Magyarország/

Malta/Nederland/Norge/Österreich/Polska/Portugal/ România/Slovenija/Slovenská republika/Suomi/Finland/Sverige

Sun Pharmaceutical Industries Europe B.V. 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

Deutschland

Sun Pharmaceuticals Germany GmbH Kandelstrasse 7

79199 Kirchzarten Deutschland

España

Sun Pharmaceuticals Spain S.L.U. C/Bobinadora 1-5 Planta 1a Local 13 Mataro, 08302

Barcelona España

tel. +34 93 798 02 85

France

 

Sun Pharmaceuticals France

product

34, Rue Jean Mermoz

 

78600 Maisons Laffitte

 

France

 

tel. +33 1 39 62 10 24

 

tel. +39 02 33 49 07Medicinal93

 

Italia

 

Sun Pharmaceuticals Italia S.R.L.

 

Via Luigi Rizzo, 8

 

I-20151 – Milano

 

Italia

 

 

longer

authorised

no

 

 

 

United Kingdom

Sun Pharmaceuticals UK Limited 4100 Park Approach

Thorpe Park Leeds LS15 8GB

United Kingdom

tel. +44 (0) 113 397 08 70

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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