Capecitabine Teva

Package leaflet: Information for the user

Capecitabine Teva 150 mg film-coated tablets, 500 mg film-coated tablets

capecitabine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 taking 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 a group of medicines called "cytostatic agents", which block the growth of tumour cells. Capecitabine Teva contains capecitabine, which is not itself a cytostatic medicine. Only after being absorbed by the body is it converted into an active anticancer medicine (to a greater extent in tumour tissues than in normal tissues).
Capecitabine Teva is used in the treatment of cancers of the colon, rectum, stomach or breast.
Capecitabine Teva is used to prevent recurrence of colon cancer after complete surgical removal of the tumour.
Capecitabine Teva may be used alone or in combination with other medicines.

2. What you should know before taking Capecitabine Teva

Do not take Capecitabine Teva

• if you are allergic to capecitabine or to any of the other ingredients of this medicine (listed in section 6). You must inform your doctor if you know you are allergic or have had excessive reactions to this medicine,
• if you have previously experienced severe reactions to treatment with fluoropyrimidines (a group of anticancer drugs such as fluorouracil),
• if you are pregnant or breastfeeding,
• if you have significantly low levels of white blood cells or platelets in your blood (leukopenia, neutropenia, thrombocytopenia),
• if you suffer from serious liver or kidney problems,
• if you have no activity of the enzyme dihydropyrimidine dehydrogenase (DPD) (complete absence of DPD activity),
• if you are currently being treated or have been treated in the last 4 weeks with brivudine for herpes zoster (shingles or varicella).

Warnings and precautions
Talk to your doctor or pharmacist before taking Capecitabine Teva

• if you have a partial deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you have a family member with partial or complete deficiency in the activity of the enzyme dihydropyrimidine dehydrogenase (DPD)
• if you suffer from liver or kidney disorders
• if you have or have had heart problems (for example, irregular heartbeat or chest, jaw and back pain triggered by physical exertion due to problems with blood flow to the heart)
• if you suffer from brain disorders (for example, cancer that has spread to the brain, or nerve damage (neuropathy))
• if you suffer from calcium imbalances (detectable through blood tests)
• if you suffer from diabetes
• if you are unable to retain food or fluids due to severe nausea and vomiting
• if you suffer from diarrhea
• if you are dehydrated or become dehydrated
• if you suffer from imbalances in blood ions (electrolyte imbalances, detectable through blood tests)
• if you have experienced eye problems, as you may require additional eye monitoring
• if you develop a severe skin reaction.

Dihydropyrimidine dehydrogenase (DPD) deficiency: DPD deficiency is a genetic condition that
generally does not cause health problems unless certain medications are taken. If you have DPD
deficiency and take Capecitabine Teva, you are at higher risk of developing severe adverse reactions
(listed in section 4 Possible side effects). Testing for DPD deficiency is recommended before starting
treatment. Do not take Capecitabine Teva if you have no enzyme activity. If you have reduced enzyme
activity (partial deficiency), your doctor may prescribe you a lower dose. Even if DPD deficiency test
results are negative, severe or potentially life-threatening adverse reactions may still occur.
Inform your doctor immediately if any of the side effects concern you, or if you notice any other side
effects not listed in this leaflet (see section 4 Possible side effects).
Children and adolescents
Capecitabine Teva is not indicated for the treatment of children and adolescents. Do not administer
Capecitabine Teva to children and adolescents.
Other medicines and Capecitabine Teva
Before starting treatment, inform your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. This is extremely important, as taking multiple medicines together may
increase or reduce their effects.
You must not take brivudine (an antiviral medicine used to treat shingles or varicella) at the same
time as capecitabine treatment (including during treatment breaks when no capecitabine tablets are
being taken).
If you have taken brivudine, you must wait at least 4 weeks after stopping it before starting
capecitabine treatment. See also section “Do not take Capecitabine Teva”.
Additionally, you need to be particularly careful if you are taking any of the following medicines at the
same time:

• medicines for gout (allopurinol),
• medicines that thin the blood (coumarin, warfarin),
• medicines for treating seizures or tremors (phenytoin),
• certain medicines used to treat various types of cancer or viral infections (interferon alfa),
• radiotherapy and certain medicines used to treat cancer (folic 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 a meal.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
You must not take Capecitabine Teva if you are definitely or possibly pregnant.
You must not breastfeed during treatment with Capecitabine Teva and for 2 weeks after the last dose.
If you are a woman of childbearing potential, you must use effective contraception during treatment with
Capecitabine Teva and for 6 months after the last dose.
If you are a male patient and your partner is a woman of childbearing potential, you must use effective
contraception during treatment with Capecitabine Teva and for 3 months after the last dose.
Driving and using machines
Capecitabine Teva may cause dizziness, nausea or fatigue. Therefore, Capecitabine Teva may affect your
ability to drive or operate machinery.
Capecitabine Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
Capecitabine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Capecitabine Teva

Take this medicine exactly as prescribed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Capecitabine must only be prescribed by a physician experienced in the use of anticancer medicines.
Your doctor will prescribe the dosage and treatment schedule appropriate for you. The dose of Capecitabine
Teva is based on your body surface area, which is calculated from your height and weight.
The usual dose for adults is 1,250 mg/m² of body surface area, taken twice daily (morning and evening).
Two examples are provided below: a person weighing 64 kg and 1.64 m tall has a body surface area of 1.7 m² and
should take 4 tablets of 500 mg and 1 tablet of 150 mg twice daily. A person weighing 80 kg and 1.80 m tall has a body surface area of 2.00 m² and
should take 5 tablets of 500 mg twice daily.
Your doctor will tell you the exact dose to take, when to take it, and for how long.
Your doctor may prescribe a combination of 150 mg and 500 mg tablets for each dose.

• Take the tablets in the morning and in the evening, as prescribed by your doctor.
• Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow them whole with water. Do not crush or cut the tablets. If you are unable to swallow Capecitabine Teva tablets whole, inform your healthcare provider.
• It is important to take all your medicines exactly as prescribed by your doctor.

Capecitabine Teva tablets are generally taken for 14 days, followed by a 7-day rest period (during which the tablets are not taken). These 21 days constitute one treatment cycle.
When used in combination with other medicines, the usual adult dose may be lower than 1,250 mg/m² of body surface area, and you may be required to take the tablets for a different duration (e.g., daily, without any rest period).

If you take more Capecitabine Teva than you should
If you take more Capecitabine Teva than prescribed, contact your doctor as soon as possible before taking the next dose.
If you take much more capecitabine than prescribed, you may experience the following adverse effects: nausea or vomiting, diarrhoea, inflammation or ulceration of the intestine or mouth, pain or bleeding from the intestine or stomach, or bone marrow suppression (reduction in certain types of blood cells). Contact your doctor immediately if you experience any of these symptoms.

If you forget to take Capecitabine Teva
Do not take the missed dose. Do not take a double dose to make up for the forgotten dose. Instead, continue with your regular dosing schedule and contact your doctor.

If you stop taking Capecitabine Teva
Stopping treatment with capecitabine does not cause adverse effects. However, if you are taking coumarin anticoagulants (e.g., phenprocoumon), stopping capecitabine treatment may require your doctor to adjust the dose of your anticoagulant.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking Capecitabine Teva immediately and contact your doctor if you experience any of the
following symptoms:

• Diarrhoea: if you have 4 or more bowel movements per day than usual, or have nocturnal diarrhoea.
• Vomiting: if you vomit more than once within 24 hours.
• Nausea: if you lose your appetite and the amount of food you eat in a day is much less than normal.
• Stomatitis: if you have pain, redness, swelling or ulcers in your mouth and/or throat.
• Hand-foot reaction: if you have pain, swelling, redness or tingling in your hands and/or feet.
• Fever: if your body temperature is equal to or greater than 38°C.
• Infection: if you show signs of infection caused by bacteria, viruses, or other organisms.
• Chest pain: if you feel pain in the centre of your chest, especially if it occurs during physical activity.
• Stevens-Johnson syndrome: if you develop a painful red or purplish rash that spreads and forms blisters and/or other lesions starting around mucous membranes (e.g. mouth and lips), particularly if you previously had light sensitivity, respiratory tract infections (e.g. bronchitis) and/or fever.
• DPD deficiency: if you have a known DPD deficiency, you are at higher risk of acute and early onset of toxicity and serious, potentially fatal or life-threatening adverse reactions due to

Capecitabine Teva (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia and
neurotoxicity).

• Angioedema: if you notice any of the following symptoms, seek immediate medical help as urgent treatment may be needed: swelling mainly affecting face, lips, tongue or throat causing difficulty in swallowing or breathing, itching sensation and skin rashes. This could be a sign of angioedema.

If detected early, these side effects usually improve within 2–3 days after stopping the medicine. However, if side effects persist, contact your doctor immediately. Your doctor may advise you to restart the medicine at a lower dose.
If severe stomatitis (ulcers in the mouth and/or throat), mucosal inflammation, diarrhoea, neutropenia (increased risk of infections), or neurotoxicity occur during the first treatment cycle, this may be due to DPD deficiency (see section 2: Warnings and precautions).
The hand-foot syndrome may lead to loss of fingerprints, which could affect your identification using fingerprint scanners.

In addition to those listed above, when capecitabine is used alone, very common side effects that may affect more than 1 in 10 people are:

• abdominal pain
• skin rash, dry or itchy skin
• fatigue
• loss of appetite (anorexia)

These side effects can become severe; therefore, it is important that you always contact your doctor immediately if you experience any side effect. Your doctor may instruct you to reduce the dose and/or temporarily stop treatment with Capecitabine Teva.
This will help reduce the likelihood of the side effect persisting or becoming a serious adverse reaction.

Other side effects include:
Common side effects (may affect up to 1 in 10 people) include:

• decreased white or red blood cell count (seen in blood tests)
• dehydration, weight loss
• sleep disturbance (insomnia), depression
• headache, drowsiness, dizziness, abnormal skin sensations (numbness or tingling), taste alterations
• eye irritation, increased tearing, eye redness (conjunctivitis)
• inflammation of veins (thrombophlebitis)
• shortness of breath, nosebleeds, cough, common cold
• cold sores or other herpes infections
• lung or respiratory tract infections (e.g. pneumonia or bronchitis)
• intestinal bleeding, constipation, upper abdominal pain, indigestion, flatulence, dry mouth
• skin rashes, hair loss (alopecia), skin redness, dry skin, itching, skin colour changes, skin peeling, skin inflammation, nail changes
• joint pain, limb pain (extremities), chest pain or backache
• fever, swelling of limbs, feeling unwell
• liver function problems (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, skin infections, nose and throat infections, fungal infections (including in the mouth), influenza, gastroenteritis, dental abscess
• lumps under the skin (lipoma)
• decreased blood cells, including platelets, increased blood fluidity (seen in laboratory tests)
• allergies
• diabetes, decreased potassium in blood, malnutrition, increased blood triglycerides
• confusion, panic attacks, depressed mood, decreased libido
• difficulty speaking, memory impairment, lack of coordination in movements, balance disorders, fainting, nerve damage (neuropathy) and sensory perception problems
• blurred or double vision
• dizziness, ear pain
• irregular heartbeat and palpitations (arrhythmias), chest pain and heart attack (infarction)
• blood clots in deep veins (deep vein thrombosis), high or low blood pressure, hot flushes, cold limbs (extremities), purple spots on the skin
• blood clots in lung veins (pulmonary embolism), lung collapse, coughing up blood, asthma, exertional dyspnoea
• intestinal obstruction, fluid accumulation in the abdomen, inflammation of the small or large intestine, stomach or oesophagus, lower abdominal pain, abdominal disorders, heartburn (reflux of food from stomach), blood in stools
• jaundice (yellowing of skin and eyes)
• skin ulcers and blisters, sun-sensitive skin reactions, redness of palms, facial swelling or pain
• joint swelling or stiffness, bone pain, muscle weakness or stiffness
• fluid accumulation in kidneys, increased frequency of urination at night, incontinence, blood in urine, increased blood creatinine (a sign of kidney dysfunction)
• unusual vaginal bleeding
• swelling (oedema), chills and stiffness

Rare side effects (may affect up to 1 in 1,000 people) include:

• angioedema (swelling mainly affecting face, lips, tongue or throat, itching sensation and skin rashes)

Some of these side effects are more common when capecitabine is used together with other cancer
treatment medicines. Other side effects reported include:
Common side effects (may affect up to 1 in 10 people) include:

• decreased sodium, magnesium or calcium in blood, increased blood sugar
• nerve pain
• ringing or buzzing in the ears (tinnitus), hearing loss
• inflammation of veins
• hiccups, voice changes
• pain or altered/abnormal sensation in the mouth, jaw pain
• sweating, night sweats
• muscle spasms
• difficulty urinating, blood or protein in urine
• bruising or injection site reaction (caused by injected medicines administered at the same time)

Rare side effects (may affect up to 1 in 1,000 people) include:

• narrowing or blockage of the tear duct (lacrimal duct stenosis)
• liver failure
• inflammation causing dysfunction or obstruction of bile secretion (cholestatic hepatitis)
• specific changes in the electrocardiogram (prolongation of the QT interval)
• certain types of arrhythmia (including ventricular fibrillation, torsades de pointes, and bradycardia)
• inflammatory eye conditions causing eye pain and potential vision problems
• skin inflammation leading to red, peeling patches due to an immune system disorder

Very rare side effects (may affect up to 1 in 10,000 people) include:

• severe skin reactions such as rash, ulceration and blistering, which may involve ulcers in the mouth, nose, genitals, hands, feet and eyes (eye redness and swelling).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex 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 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 packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents 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 components are:
  Tablet core: lactose, microcrystalline cellulose, hypromellose, sodium croscarmellose, magnesium stearate.
  Tablet coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the Appearance of Capecitabine Teva and Contents of the Pack
Capecitabine Teva 150 mg film-coated tablets
Light peach-coloured, oval, biconvex film-coated tablets, marked with "C" on one side and "150" on the other.
The tablets are available in blisters containing 10 film-coated tablets. Each pack contains 60 tablets.

Capecitabine Teva 500 mg film-coated tablets
Light peach-coloured, oval, biconvex film-coated tablets, marked with "C" on one side and "500" on the other.
The tablets are available in blisters containing 10 film-coated tablets. Each pack contains 120 tablets.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България (Bulgaria)
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS A.E.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος (Cyprus)
TEVA HELLAS A.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.