InfoCons Consumer Protection informs you – Capecitabine Teva – Package Leaflet

Before anything else

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.

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

Capecitabine Teva belon gs 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 no t 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) (complete DPD deficiency) ,
• if you are being treated now or have been treated in the last 4 weeks with bri vudine as part of herpes zoster (chickenpox or shingles) therapy.

43 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 a family member who has partial or complete deficiency 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 t o 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 monitor ing of your eyes
• if you have a severe skin reaction .

DPD deficiency: DPD deficiency is a genetic condition that is not usually associated with health problems unless you receive certain medicines. If you have DPD deficiency and take Capecitabine Teva, you are at an increased risk of severe side effects (listed under section 4 Possible side effects). It is recommended to test you for DPD deficiency before start of treatment. If you h ave no activity of the enzyme you should not take Capecitabine Teva. If you have a reduced enzyme activity (partial deficiency) your doctor might prescribe a reduced dose. If you have negative test results for DPD deficiency, severe and life-threatening si de effects may still occur.

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 must not take brivudine (an anti- viral medicines for treatment of shingles or chickenpox) at the same time as capecitabine treatment (including during any rest periods when you are not taking any capecitabine tablets).

If you have taken brivudine you must wait for at least 4 weeks after stoping brivudine before starting to take capecitabine. See also section “Do not take Capecitabine Teva”.

Also, y ou need to be particularly careful if you are taking any of the following:

• gout medicines (allopurinol),
• blood-thinning medicines (coumarin, warfarin),
• 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 44 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 o r 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 and for 2 weeks after the last dose.

If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine Teva and for 6 months after the last dose.

If you are a male patient and your female partner could become pregnant, you should use effective contraception durin g treatment with Capecitabine Teva and for 3 months after the last dose .

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 .

Capecitabine Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film -coated tablet, that is to say essentially “sodium -free”.

💊 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 y ou 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/m 2 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 d octor 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 doc tor.
• Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water. Do not crush or cut tablets. If you cannot swallow Capecitabine Teva tablets whole, tell your healthcare provider.
• 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/m 2 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).

45 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 ulcerati on 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 treat ment 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, as k 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 tem perature 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 s-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) .
• Angioedema: seek medical attention straight away if you notice any of the following symptoms
• you may need urgent medical treatment: swelling mainly of the face, lips, tongue or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of angioedema.

If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation. If these side effects continue, however, contact your doct or immediately. Your doctor may instruct you to restart treatment at a lower dose.

46 If severe stomatitis (sores in your mouth and/or throat), mucosal inflammation, diarrhoea, neutropenia (increased risk for infections), or neurotoxicity occurs during the first cycle of treatment a DPD deficiency may be involved (please see section 2: “Warnings and precautions)”.

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

In addition to the above, w hen 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 eff ect 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 f unction (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, funga l 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 47 • 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 dysfunc tion)
• unusual bleeding from the vagina
• swelling (oedema), chills and rigors Rare side- effects (may affect up to 1 in 1 ,000 people) include:
• angioedema (swelling mainly of the face, lip, tongue or throat, itching and rashes) 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.

Store below 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 capecitabine.

Capecitabine Teva 500 mg film -coated tablets Each film -coated tablet contains 500 mg capecitabine.

• The other ingredients are:

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

Tablet coating: macrogol 400, hypromellose, titanium diox ide (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 “50 0” 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 49 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel : +32 38207373 Lietuva UAB Teva Baltics Tel: +370 52660203 България Тева Фарма ЕАД Тел.: +359 24899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien 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 L-Irlanda Τel: + 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 915359180 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 TEVA HELLAS A.E.

Ελλάδα Τηλ: +30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67 323666

This leaflet was last revised in

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

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Capecitabine Teva (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/12/761).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.