Document: Capecitabine Orion tablet ENG PL change

• Capecitabine Orion film-coated tablet PL
• Capecitabine Orion tablet ENG PL

---

Packageleaflet:Informationfortheuser

Capecitabine Orion150 mgfilm-coatedtablets

Capecitabine Orion500 mgfilm-coatedtablets

capecitabine

Readallofthisleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontains importantinformationforyou.

• 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.

Whatisinthisleaflet

1. WhatCapecitabine Orionisandwhatitisusedfor

2. WhatyouneedtoknowbeforeyoutakeCapecitabine Orion

3. HowtotakeCapecitabine Orion

4. Possiblesideeffects

5. HowtostoreCapecitabine Orion

6. Contentsofthepackandotherinformation

1. WhatCapecitabine Orionisandwhatitisusedfor

Capecitabine Orionbelongstothegroupofmedicinescalled“cytostaticmedicines”,whichstopthegrowthof cancercells.Capecitabine Orioncontains150 mgor 500 mg capecitabine,whichitselfisnotacytostaticmedicine.Onlyafter beingabsorbedby thebodyisitchangedintoanactiveanti-cancermedicine(moreintumourtissue thaninnormaltissue).

Capecitabine Orionisusedinthetreatmentofcolon,rectal,gastric,orbreastcancers.

Furthermore,Capecitabine Orionisusedtopreventnewoccurrenceofcoloncanceraftercompleteremovalofthe tumourby surgery.

Capecitabine Orionmaybeusedeitheraloneorincombinationwithothermedicines.

2. WhatyouneedtoknowbeforeyoutakeCapecitabine Orion

DonottakeCapecitabine Orion:

• 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 nursing

• if you have severely low levels of white cells or platelets in the blood (leukopenia, neutropenia or thrombocytopenia)

• if you have severe liver or kidney problems

• if you have a known deficiency for the enzyme dihydropyrimidine dehydrogenase (DPD)

involvedinthemetabolismofuracilandthymine,or

Warningsandprecautions

TalktoyourdoctororpharmacistbeforetakingCapecitabine Orion

• 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.

DPDdeficiency:DPDdeficiencyisarareconditionpresentatbirththatisnotusuallyassociatedwith healthproblemsunlessyoureceivecertainmedicines.IfyouhaveanunrecognisedDPDdeficiency and takeCapecitabine Orion,youmayexperiencesevereformsofthesideeffectslistedundersection 4Possible sideeffects.Contactyourdoctorimmediatelyifyouareconcernedaboutanyofthesideeffectsorif younoticeanyadditionalsideeffectsnotlistedintheleaflet(seesection 4Possiblesideeffects).

Childrenandadolescents

Capecitabine Orionisnotindicatedinchildrenandadolescents.DonotgiveCapecitabine Oriontochildrenandadolescents.

OthermedicinesandCapecitabine Orion

Beforestartingtreatment,tellyourdoctororpharmacistifyouaretaking,haverecentlytakenormight takeanyothermedicines.Thisisextremelyimportant,astakingmorethanonemedicineat thesame timecanstrengthenorweakentheeffectofthemedicines.Youneedtobeparticularlycarefulifyou aretakinganyofthefollowing:

• gout medicines (allopurinol)

• blood-thinning medicines (coumarin, warfarin)

• certain anti-viral medicines (sorivudine and brivudine)

• medicines for seizures or tremors (phenytoin)

• interferon alpha, or

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

• medicines used to treat folic acid deficiency.

Capecitabine Orionwithfood,drinkandalcohol

YoushouldtakeCapecitabine Orionnolaterthan30 minutesaftermeals.

Pregnancyandbreast-feeding

Beforestartingtreatment,youmusttellyourdoctorifyouarepregnant,ifyouthinkyouarepregnant orifyouintendtobecomepregnant.YoumustnottakeCapecitabine Orionif youarepregnantorthinkyoumight be.Youmustnotbreast-feedifyouaretakingCapecitabine Orion.Askyourdoctororpharmacistforadvice beforetakingthismedicine.

Drivingandusingmachines

Capecitabine Orionmaymakeyoufeeldizzy,nauseousortired.ItisthereforepossiblethatCapecitabine Orioncouldaffect yourabilitytodriveacaroroperatemachinery.

Capecitabine Orioncontainsanhydrouslactose

Ifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,contactyourdoctor beforetakingthismedicine.

3. HowtotakeCapecitabine Orion

Alwaystakethismedicineexactlyasyourdoctororpharmacisthastoldyou.Checkwithyourdoctor orpharmacistifyouarenotsure. Capecitabine Orionshouldonlybeprescribedbyadoctorexperiencedintheuseofanticancermedicines. Capecitabine Oriontabletsshouldbeswallowedwholewithwaterandwithin30 minutesofameal.

Yourdoctorwillprescribeadoseandtreatmentregimenthatisrightforyou.ThedoseofCapecitabine Orionis basedonyourbodysurfacearea.Thisis calculatedfromyourheightandweight.Theusualdosefor adultsis1,250 mg/m²ofbodysurfaceareatakentwotimesdaily(morningandevening).Two examplesareprovidedhere:Apersonwhosebodyweightis64 kgandheightis1.64 mhasabody surfaceareaof1.7 m²andshouldtake4 tabletsof500 mgand1 tabletof150 mgtwotimesdaily.A personwhosebodyweightis80 kgandheightis1.80 mhasabodysurfaceareaof2.00 m²andshould take5 tabletsof500 mgtwotimesdaily.

Capecitabine Oriontabletsareusuallytakenfor14 daysfollowedby a7‑dayrestperiod(whennotabletsare taken).This21‑dayperiodisonetreatmentcycle.

Incombinationwithothermedicinestheusualdoseforadultsmaybelessthan1,250 mg/m²ofbody surfacearea,andyoumayneedtotakethetabletsoveradifferenttimeperiod(e.g.everyday,withno restperiod).

Yourdoctorwilltellyouwhatdoseyouneedtotake,whentotakeitandforhowlongyouneedto takeit.

Yourdoctormaywantyoutotakeacombinationof150 mgand500 mgtabletsforeachdose.

• 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).

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

IfyoutakemoreCapecitabine Orionthanyoushould

IfyoutakemoreCapecitabine Orionthanyoushould,contactyourdoctorassoonaspossiblebeforetakingthe nextdose.

Youmightgetthefollowingsideeffectsifyoutakealotmorecapecitabinethanyoushould:feeling orbeingsick,diarrhoea,inflammationorulcerationofthegutormouth,painorbleedingfromthe intestineorstomach,orbonemarrowdepression(reductionincertainkindsofbloodcells).Tellyour doctorimmediatelyifyouexperienceanyofthesesymptoms.

IfyouforgettotakeCapecitabine Orion

Donottakethemisseddoseatallanddonotdoublethenextone.Instead,continueyourregular dosingscheduleandcheckwithyourdoctor.

IfyoustoptakingCapecitabine Orion

Therearenosideeffectscausedbystoppingtreatmentwithcapecitabine.Incaseyouareusing coumarinanticoagulants(containinge.g.phenprocoumon),stoppingcapecitabinemightrequirethat yourdoctoradjustsyouranticoagulantdose.

Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.

4. Possiblesideeffects

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.

STOPtakingCapecitabine Orionimmediatelyandcontactyourdoctorifanyofthesesymptomsoccur:

• 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.

Ifcaughtearly,thesesideeffectsusuallyimprovewithin2to3 daysaftertreatmentdiscontinuation.If thesesideeffectscontinue,however,contactyourdoctorimmediately.Yourdoctormayinstructyou torestarttreatmentatalowerdose.

Inadditiontotheabove,whenCapecitabine Orionisusedalone,verycommonsideeffects,whichmayaffect morethan1 personin 10,are:

• abdominal pain

• rash, dry or itchy skin

• tiredness

• loss of appetite (anorexia).

Thesesideeffectscanbecomesevere;therefore,itisimportantthatyoualwayscontactyourdoctor immediatelywhenyoustarttoexperienceasideeffect.Yourdoctormayinstructyoutodecreasethe doseand/ortemporarilydiscontinuetreatmentwithCapecitabine Orion.Thiswillhelpreducethelikelihoodthat thesideeffectcontinuesorbecomessevere.

Othersideeffectsare:

Commonsideeffects(mayaffectupto 1in10 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).

Uncommonsideeffects(mayaffectupto 1in100 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.

Someofthesesideeffectsaremorecommonwhencapecitabineisusedwithothermedicinesforthe treatmentofcancer.Otherside effectsseeninthissettingarethefollowing:

Commonsideeffects(mayaffectupto1 in10 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).

Raresideeffects(mayaffectupto1 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

Veryraresideeffects(mayaffectupto1 in 10,000 people)include:

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. HowtostoreCapecitabine Orion

Keepthismedicineoutofthesightandreachofchildren.

DonotusethismedicineaftertheexpirydatewhichisstatedontheoutercartonandlabelafterEXP.

Theexpirydatereferstothelastdayofthatmonth.

For Aluminium-aluminium blisters

This medicinal product does not require any special storage conditions.

For PVC/PVdC/aluminium blisters

Do not store above 30°C.

Donotthrowawayanymedicinesviawastewateror householdwaste.Askyourpharmacisthowto throwawaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6. Contentsofthepackandotherinformation

WhatCapecitabine Orioncontains

• The active substance is capecitabine (150 mg or 500 mg per film-coated tablet).

• The other ingredients are:

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

• Tablet coating: hypromellose, talc, titanium dioxide (E171), yellow and red iron oxide (E172).

WhatCapecitabine Orionlookslikeandcontentsofthepack

150 mg tablets

Light peach‑coloured, oblong shaped, biconvex, film‑coated tablets of 11.4 mm in length and 5.3 mm in width, debossed with ‘150’ on one side and plain on other side.

Pack sizes: 10 film‑coated tablets per blister, in pack sizes of 30, 60 or 120 film‑coated tablets.

500 mg tablets

Peach‑coloured, oblong‑shaped, biconvex, film‑coated tablets of 15.9 mm in length and 8.4 mm in width, debossed with ‘500’ on one side and plain on other side.

Pack sizes: 10 film‑coated tablets per blister, in pack sizes of 30, 60 or 120 film‑coated tablets.

Not all pack sizes may be marketed.

MarketingAuthorisationHolderandManufacturer

<[To be completed nationally]>

Thisleafletwaslastrevised17 July 2014