Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ecansya

Document Subject

Generated Narrative: MedicinalProductDefinition mpefa7f0457f33e21d0516b1da0af6e176

identifier: http://ema.europa.eu/identifier/30 film-coated tablets: EU/1/12/763/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ecansya 150 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-efa7f0457f33e21d0516b1da0af6e176

identifier: http://ema.europa.eu/identifier/30 film-coated tablets: EU/1/12/763/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ecansya

Attesters

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

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.

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.

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.

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.

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.

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: Tablet core Lactose, croscarmellose sodium, hypromellose (E-5), microcrystalline cellulose, magnesium stearate. Film-coating Ecansya 150 mg film-coated tablets Hypromellose (6cps), titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc. Ecansya 300 mg film-coated tablets Hypromellose (6cps), titanium dioxide (E171), talc. Ecansya 500 mg film-coated tablets Hypromellose (6cps), titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc. See section 2 "Ecansya contains lactose". 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, or 120 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0 Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: