Ecansya (previously Capecitabine Krka) - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ecansya 150 mg film-coated tablets

Ecansya 300 mg film-coated tablets

Ecansya 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 Ecansya is and what it is used for

• 2. What you need to know before you take Ecansya

• 3. How to take Ecansya

• 4. Possible side effects

• 5. How to store Ecansya

• 6. Contents of the pack and other information

1. What Ecansya is and what it is used for

Ecansya belongs to the group of medicines called „cytostatic medicines“, which stop the growth of cancer cells. Ecansya 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).

Ecansya is used in the treatment of colon, rectal, gastric, or breast cancers.

Furthermore, Ecansya is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.

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

2. What you need to know before you take Ecansya

Do not take Ecansya

• – 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 brivudine as part of

herpes zoster (chickenpox or shingles) therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ecansya

• – 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 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 genetic condition that is not usually associated with health problems unless you receive certain medicines. If you have DPD deficiency and take Ecansya, 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 have no activity of the enzyme you should not take Ecansya. 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 side effects may still occur.

Children and adolescents

Ecansya is not indicated in children and adolescents. Do not give Ecansya to children and adolescents.

Other medicines and Ecansya

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 medicine for the 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 stopping brivudine before starting to take capecitabine. See also section „Do not take Ecansya“.

Also, you 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),

• – interferon alpha,

• – radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,

cisplatin, irinotecan),

• – medicines used to treat folic acid deficiency.

Ecansya with food and drink

You should take Ecansya 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 Ecansya if you are pregnant or think you might be.

You must not breast-feed if you are taking Ecansya 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 Ecansya 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 during treatment with Ecansya and for 3 months after the last dose.

Driving and using machines

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

Ecansya 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 Ecansya

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 Ecansya 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, 300 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. Do not crush or cut tablets. If you cannot swallow Ecansya tablets whole, tell your healthcare provider.

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

Ecansya 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 Ecansya than you should

If you take more Ecansya 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 Ecansya

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 Ecansya

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 Ecansya 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.

• - Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and

blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.

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 Ecansya (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 doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

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: Warning 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, when Ecansya 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 Ecansya. 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

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, 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 Ecansya

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.

For Aluminium-aluminium blisters

This medicine does not require any special storage conditions.

For PVC/PVdC-aluminium blisters

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ecansya contains

• – The active substance is capecitabine. Each film-coated tablet contains 150 mg, 300 mg or

500 mg capecitabine.

• – The other ingredients (excipients) are:

What Ecansya looks like and contents of the pack

Ecansya 150 mg film-coated tablets (tablets) are light peach coloured, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with „150“ on one side and plain on other side.

Ecansya 300 mg film-coated tablets (tablets) are white to off white, oblong shaped, biconvex tablets of

14.6 mm in length and 6.7 mm in width, debossed with „300“ on one side and plain on other side.

Ecansya 500 mg film-coated tablets (tablets) are peach coloured, oblong shaped, biconvex tablets of 15.9 mm in length and 8.4 mm in width, debossed with „500“ on one side and plain on other side.

Ecansya is available in blisters (Aluminium-aluminium or PVC/PVdC-aluminium) containing 30, 60 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

Pharmacare Premium Limited, HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

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

Belgie/Belgiqu­e/Belgien KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 Ebnrapua KPKA Bbnrapua EOOfl, Ten.: + 359 (02) 962 34 50 Česká republika KRKA ČR, s.r.o. Tel: + 420 (0) 221 115 150 Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Deutschland

Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27 40 Luxembourg/Lu­xemburg KRKA Belgium, SA. Tel/Tel: + 32 (0) 487 50 73 62 (BE) Magyarorszag KRKA Magyarorszag Kereskedelmi Kft. Tel.: + 36 (1) 355 8490 Malta E. J. Busuttil Ltd. Tel: + 356 21 445 885 Nederland

KRKA Belgium, SA.

Tel: + 32 (0) 487 50 73 62 (BE)

Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Österreich

KRKA Pharma GmbH, Wien

Tel: + 43 (0)1 66 24 300

Polska

KRKA-POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500

Portugal

KRKA Farmacéutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

Romania

KRKA Romania S.R.L., Bucharest

Tel: + 4 021 310 66 05

Slovenija

KRKA, d.d., Novo mesto

Tel: + 386 (0) 1 47 51 100

Slovenská republika

KRKA Slovensko, s.r.o.

Tel: + 421 (0) 2 571 04 501

Suomi/Finland

KRKA Finland Oy

Puh/Tel: + 358 20 754 5330

Sverige

KRKA Sverige AB

Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom (Northern Ireland)

Consilient Health Limited

Tel: + 353 (0)1 2057760

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

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