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Capecitabine Teva (capecitabine) – Package leaflet - L01BC06

Updated on site: 05-Oct-2017

Medication nameCapecitabine Teva
ATC CodeL01BC06
Substancecapecitabine
ManufacturerTeva Pharma B.V.

Package leaflet: Information for the user

Capecitabine Teva 150 mg film-coated tablets Capecitabine Teva 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 Teva is and what it is used for

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

3.How to take Capecitabine Teva

4.Possible side effects

5.How to store Capecitabine Teva

6.Contents of the pack and other information

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

Capecitabine Teva belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells. Capecitabine Teva contains capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body is it changed into an active anti-cancer medicine (more in tumour tissue than in normal tissue).

Capecitabine Teva is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine Teva is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.

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

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

Do not take Capecitabine Teva

-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 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 know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD),

-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 before taking Capecitabine Teva

-if you know that you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)

-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 cannot keep food or water in your body because of severe nausea and vomiting

-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

-if you 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, you are at an increased risk of acute early-onset of 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 Teva

Before starting treatment, 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),

-medicines for seizures or tremors (phenytoin),

-certain medicines used to treat various cancers or virus infection (interferon alpha),

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

-medicines used to treat folic acid deficiency.

Capecitabine Teva with food and drink

You should take Capecitabine Teva no later than 30 minutes after meals.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must not take Capecitabine Teva if you are pregnant or think you might be. You must not breast-feed if you are taking Capecitabine Teva.

Driving and using machines

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

Capecitabine Teva contains 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 Teva

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.

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Capecitabine Teva 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.

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) and swallow whole with water.

-It is important that you take all your medicine as prescribed by your doctor.

Capecitabine Teva 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 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).

If you take more Capecitabine Teva than you should

If you take more Capecitabine Teva 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 Teva

Do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose. Instead, continue your regular dosing schedule and check with your doctor.

If you stop taking Capecitabine Teva

There are no side effects caused by stopping treatment with capecitabine. In case you are using coumarin anticoagulants (containing 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.

STOP taking Capecitabine Teva 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.

Stevens-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.

DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Capecitabine Teva (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).

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.

Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan.

In addition to the above, when capecitabine is used alone, very common side effects which may affect more than 1 in 10 people 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 Teva. 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

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)

Reporting of side effects

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. 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.

5.How to store Capecitabine Teva

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. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package to protect from moisture.

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 Teva contains

-The active substance is capecitabine.

-Capecitabine Teva 150 mg film-coated tablets

Each film-coated tablet contains 150 mg of capecitabine.

-Capecitabine Teva 500 mg film-coated tablets

Each film-coated tablet contains 500 mg of capecitabine.

-The other ingredients are:

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

-Tablet coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Capecitabine Teva looks like and contents of the pack

Capecitabine Teva 150 mg film-coated tablets

Oval biconvex light peach film-coated tablets with inscription “C” on one side and “150” on the other side.

The tablets are available in blisters containing 10 film-coated tablets. Each pack contains 60 tablets.

Capecitabine Teva 500 mg film-coated tablets

Oval biconvex light peach film-coated tablets with inscription “C” on one side and “500” on the other side.

The tablets are available in blisters containing 10 film-coated tablets. Each pack contains 120 tablets.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770

Opava-Komarov

Czech Republic

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Merckle GmbH

Ludwig Merckle Str. 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z.o.o ul. Mogilska 80,

31-546 Krakow Poland

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./A.G.

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

Teva Pharma Belgium N.V./S.A./A.G.,

Teл: +359 2 489 95 82

Belgique/Belgien

 

Tél: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 6400

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland, L-Irlanda

Tlf: +45 44 98 55 11

Τel: +353 51 321740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: +49 731 402 08

Tel: +31 (0) 800 0228400

Eesti

Norge

Teva Eesti esindus UAB Sicor Biotech

Teva Norway AS

Eesti filiaal

Tlf: +47 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 970070

España

Polska

Teva Pharma, S.L.U

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +34 91 387 32 80

Tel.: +48 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +33 1 55 91 7800

Tel: +351 214 767 550

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +40 21 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 (0) 51 321 740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

ratiopharm Oy, Finnland

Teva Pharmaceuticals Slovakia s.r.o.

Sími: +358 20 180 5900

Tel: +421 2 5726 7911

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +39 0289 17981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε., Ελλάδα

Teva Sweden AB

Τηλ: +30 210 72 79 099

Tel: +46 42 12 11 00

Latvija

United Kingdom

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 323 666

Tel: +44 1977 628 500

This leaflet was last revised in

 

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

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