qanastek/EMEA-V3 huggingface dataset:
5-FU is further catabolised by the enzyme dihydropyrimidine dehydrogenase (DPD) to the much less toxic dihydro-5-fluorouracil (FUH2).
5- FU jkompli jiġi kkatabolizzat mill- enżima dihydropyrimidine dehydrogenase (DPD) għal dihydro- 5- fluorouracil (FUH2) li huwa ħafna inqas tossiku.
Phase I studies evaluating the effect of Xeloda on the pharmacokinetics of either docetaxel or paclitaxel and vice versa showed no effect by Xeloda on the pharmacokinetics of docetaxel or paclitaxel (Cmax and AUC) and no effect by docetaxel or paclitaxel on the pharmacokinetics of 5’ -DFUR
Studji ta ’ fażi I biex jivvalutaw l- effett ta ’ Xeloda fuq il- farmakokinetika ta ’ docetaxel jew ta ’ paclitaxel u viċeversa ma wrew l- ebda effett minn Xeloda fuq il- farmakokinetika ta ’ docetaxel jew ta ’ paclitaxel (Cmax u AUC) u l- ebda effett minn docetaxel jew paclitaxel fuq il - farmakokinetika ta ’ 5 ’ - DFUR.
Pharmacokinetics in special populations:
46 Farmakokinetiċi f’ popolazzjonijiet speċjali:
Gender, presence or absence of liver metastasis at baseline, Karnofsky Performance Status, total bilirubin, serum albumin, ASAT and ALAT had no statistically significant effect on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.
Is- sess, il- preżenza jew in- nuqqas ta ’ metastasi fil- fwied fil- linja bażi, Karnofsky Performance Status, bilirubin totali, albumina fis- serum, ASAT u ALAT ma kellhom l - ebda effett statistikament sinifikattiv fuq il- farmakokinetika ta ’ 5 '- DFUR, 5- FU u FBAL.
Patients with hepatic impairment due to liver metastases:
Pazjenti b ’ indeboliment tal- fwied minħabba metastasi fil- fwied:
44 Patients with renal impairment:
Pazjenti b’ indeboliment tal- kliewi:
5.3 Preclinical safety data
5. 3 Studju ta ’ qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina
PR- and QT-interval prolongation) was detectable in cynomolgus monkeys after intravenous administration (100 mg/ kg) but not after repeated oral dosing (1379 mg/ m2/ day).
Tossiċità kardjovaskulari (eż. titwil ta ’ l- intervall tal- QT u PR) setgħet tiġi osservata f’ xadini cynomolgus wara l- għoti fil- vini (100 mg/ kg) iżda mhux wara dożi ripetuti mill- ħalq (1379 mg/ m2/ kuljum).
Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/ HPRT gene mutation assay).
47 Capecitabine ma kienx mutaġeniku in vitro għall- batterji (test ta ’ Ames) jew għal ċelluli mammiferi (analiżi ta ’ tibdil fil- ġeni tal- ħamster Ċiniż V79/ HPRT).
45 Tablet coating: hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172), talc.
Il- kisja tal- pillola: hypromellose, titanium dioxide (E171), iron oxide isfar u aħmar (E172), talc.
120 film-coated tablets (12 blisters of 10 tablets)
120 pilloli miksija b’ rita (12- il folja ta ’ 10 pilloli)
EU/ 1/ 00/ 163/ 002
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 00/ 163/ 002
46 ANNEX II
49 ANNESS II
48 ANNEX III
51 ANNESS III
Xeloda 150 mg film-coated tablets Capecitabine
Xeloda 150 mg pilloli miksija b’ rita Capecitabine
Each film-coated tablet contains 150 mg capecitabine.
Kull pillola miksija b’ rita fiha 150 mg capecitabine.
Also contains anhydrous lactose, colourants titanium dioxide (E171), yellow and red iron oxide (E172), and other constituents.
Fiha wkoll anhydrous lactose, sustanzi koloranti, titanium dioxide (E171), iron oxide isfar u aħmar (E172), u sustanzi mhux attiva oħra.
60 film-coated tablets
60 pillola miksija b’ rita
Oral use Read the package leaflet before use
Użu orali Aqra l- fuljett fil- pakkett qabel l- użu
Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, Ir- Renju Unit
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Xeloda 500 mg film-coated tablets Capecitabine
Xeloda 500 mg pilloli miksija b’ rita Capecitabine
Each film-coated tablet contains 500 mg capecitabine.
Kull pillola miksija b’ rita fiha 500 mg capecitabine.
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BATCH NUMBER
NUMRU TAL- LOT
57 PACKAGE LEAFLET:
60 FULJETT TA ’ TAGĦRIF:
Xeloda 150 mg film-coated tablets capecitabine
Xeloda 150 mg pilloli miksija b’ rita capecitabine
What Xeloda is and what it is used for 2.
X’ inhu Xeloda u għalxiex jintuża 2.
Before you take Xeloda 3.
Qabel ma tieħu Xeloda 3.
How to take Xeloda 4.
Kif għandek tieħu Xeloda 4.
How to store Xeloda 6.
Kif taħżen Xeloda 6.
WHAT XELODA IS AND WHAT IT IS USED FOR
X’ INHU XELODA U GĦALXIEX JINTUŻA
Xeloda belongs to the group of medicines called "cytostatic agents", which stop the growth of cancer cells.
Xeloda jappartieni għall- grupp ta ’ mediċini msejħa "aġenti ċitostatiċi", li jwaqqfu l- iżvilupp taċ- ċelluli tal- kanċer.
Xeloda contains 150 mg capecitabine, which itself is not a cytostatic agent.
Xeloda fih 150 mg capecitabine, li huwa nnifsu mhuwiex aġent ċitostatiku.
Only after being absorbed by the body is it changed into an active anti-cancer agent (more in tumour tissue than in normal tissue).
Huwa biss wara li jiġi assorbit mill- ġisem li jinbidel f’ aġent attiv kontra l- kanċer (aktar f’ tessut tat- tumur milli f’ tessut normali).
Xeloda is prescribed by doctors for the treatment of colon, rectal, gastric, or breast cancers.
Xeloda jingħata bir- riċetta tat- tobba għall- kura ta ’ kanċer tal- kolon, tar- rektum, ta ’ l- istonku jew tas - sider.
Furthermore, Xeloda is prescribed by doctors to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Barra dan, Xeloda jġi preskritt mit- tobba biex jipprevjeni okkorrenza ġdida ta ’ kanċer tal- kolon wara t - tneħħija kollha tat- tumur permezz ta ’ kirurġija.
Xeloda may be used either alone or in combination with other agents.
Xeloda jista ’ jintuża waħdu jew f’ taħlita ma ’ sustanzi oħra.
BEFORE YOU TAKE XELODA
QABEL MA TIEĦU XELODA
Do not take Xeloda:
Tieħux Xeloda:
- if you are allergic (hypersensitive) to capecitabine or any of the other ingredients of Xeloda.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva għal capecitabine jew sustanzi oħra ta ’
You must inform your doctor if you know that you have an allergy or over-reaction to Xeloda,
Għandek tgħarraf lit- tabib tiegħek jekk taf li għandek allerġija jew sensittività eċċessiva għal Xeloda, jekk inti tqila jew qed tredda ’,
- if you are pregnant or nursing,
-
- if you have blood disorders,
- jekk għandek mard tad- demm,
- if you have liver ailments or kidney problems,
- jekk għandek mard tal- fwied jew problemi tal- kliewi,
- if you have a known deficiency for the enzyme dihydropyrimidine dehydrogenase (DPD), or
- jekk taf li għandek defiċjenza ta ’ l- enżima dihydropyrimidine dehydrogenase (DPD), jew
- if you are being treated now or have been treated in the last 4 weeks with brivudine, sorivudine
- jekk qed tiġi kkurat issa jew kont ikkurat fl- aħħar 4 ġimgħat b’ brivudine, sorivudine jew
or similar classes of substance as part of herpes zoster (chickenpox or shingles) therapy.
klassijiet simili ta ’ sustanzi bħala parti minn terapija għal herpes zoster (ġidri r- riħ jew ħruq ta ’ Sant’ Antnin).
Take special care with Xeloda:
61 Oqgħod attent ħafna b’ Xeloda:
Before treatment with Xeloda, make sure your doctor knows if you
Qabel kura b’ Xeloda, kun żgur li t- tabib tiegħek ikun jaf jekk int
- have liver or kidney diseases
- għandek mard tal- fwied jew tal- kliewi
- have or had other illnesses, such as heart problems or chest pain
- għandek jew kellek mard ieħor, bħall- problemi tal- qalb jew uġigħ fis- sider
- have brain diseases
- għandek mard tal- moħħ
- have calcium imbalances
- għandek żbilanċ fil- kalċju
- have diabetes
- għandek id- dijabete
Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Qabel il- bidu tal- kura, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Dan huwa importanti ħafna, għax it- teħid ta ’ aktar minn mediċina waħda fl- istess ħin jista ’ jsaħħaħ jew idgħajjef l- effett tal- mediċini.
You need to be particularly careful if you are taking any of the following: • gout medicines (allopurinol), • blood-thinning medicines (coumarin, warfarin), • certain anti-viral medicines (sorivudine and brivudine) or • medicines for seizures or tremors (phenytoin).
Hemm bżonn li toqgħod attent b’ mod speċjali jekk inti qed tieħu xi wieħed minn dawn li ġejjin: • mediċini għall- gotta (allopurinol), • mediċini biex traqqaq id- demm (coumarin, warfarin), • ċerti mediċini antivirali (sorivudine u brivudine) jew • mediċini għall- aċċessjonijiet jew għar- rogħda (phenytoin).
Taking Xeloda with food and drink:
Meta tieħu Xeloda ma ’ l- ikel u x- xorb:
You should take Xeloda no later than 30 minutes after meals.
Għandek tieħu Xeloda mhux aktar tard minn 30 minuta wara l- ikel.
Pregnancy and breast-feeding Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant.
Tqala u Treddigħ Qabel tibda l- kura, għandek għid lit- tabib tiegħek jekk inti tqila, jekk taħseb li inti tqila jew jekk għandek il- ħsieb li toħroġ tqila.
You should not take Xeloda if you are pregnant or think you might be.
M’ għandekx tieħu Xeloda jekk inti tqila jew taħseb li inti tqila.
You should not breast-feed if you are taking Xeloda.
M’ għandekx tredda ’ jekk qed tieħdu Xeloda.
Xeloda may make you feel dizzy, nauseous or tired.
Xeloda jista ’ jġiegħlek tħossok sturdut, imqalla ’ jew għajjien.
It is therefore possible that Xeloda could affect your ability to drive a car or operate machinery.
Għalhekk huwa possibbli li Xeloda jista ’ jaffettwa l- abilità tiegħek li ssuq karrozza jew li tħaddem magni.
Important information about some of the ingredients of Xeloda:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Xeloda:
This medicinal product contains anhydrous lactose as an excipient.
Dan il- prodott mediċinali fih anhydrous lactose bħala sustanza mhux attiva.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xeloda.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel tieħu Xeloda.
HOW TO TAKE XELODA
KIF GĦANDEK TIEĦU XELODA
Xeloda tablets should be swallowed with water.
Il- pilloli Xeloda għandhom jinbelgħu ma ’ l- ilma.
Your doctor will prescribe a dose and treatment regimen that is right for you.
It- tabib tiegħek se jippreskrivilek doża u kors ta ’ kura li huwa adattat għalik.
The dose of Xeloda is based on your body surface area.
Id- doża ta ’ Xeloda hija bbażata fuq l- erja tas- superfiċje tal- ġisem tiegħek.
This is calculated from your height and weight.
Din hija kkalkulata mit- tul u l- piż tiegħek.
Two examples are provided here:
Id- doża tas- soltu għall- adulti hija ta ’ 1250 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem meħuda darbtejn kuljum (filgħodu u filgħaxija).
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.
Żewġ eżempji huma pprovuti hawnhekk: persuna li għandha piż tal- ġisem ta ’ 64 kg u tul ta ’ 1. 64 m għandha erja tas- superfiċje tal- ġisem ta ’ 1. 7 m2 u għandha tieħu 4 pilloli ta ’ 500 mg u pillola ta ’ 150 mg darbtejn kuljum.
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.
Persuna li għandha piż tal- ġisem ta ’ 80 kg u tul ta ’ 1. 80 m għandha erja tas- superfiċje tal- ġisem ta ’ 2. 00 m2 u għandha tieħu 5 pilloli ta ’ 500 mg darbtejn kuljum.
Xeloda tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Normalment, pilloli Xeloda jittieħdu għal 14- il ġurnata segwit minn perjodu ta ’ waqfien ta ’ sebat ijiem (fejn ma jittieħdux pilloli).
This 21 day period is one treatment cycle.
Dan il- perjodu ta ’ 21 ġurnata huwa ċiklu wieħed ta ’ kura.
In combination with other agents 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).
F’ taħlita ma ’ sustanzi oħra id- doża tas- soltu għall- aduti tista ’ tkun inqas minn 1250 mg/ m2 ta ’ erja tas - superfiċje tal- ġisem, u jista ’ jkollok bżonn tieħu l- pilloli fuq perjodu ta ’ ħin differenti (e. ż. kujum, mingħajr perjodu ta ’ waqfien).
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
62 It- tabib tiegħek jgħidlek x’ doża għandek bżonn tieħu, meta trid teħodha u għal kemm għandek bżonn teħodha.
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose. • Take the tablets in the combination prescribed by your doctor for your morning and evening doses. • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner). • It is important that you take all your medication as prescribed by your doctor.
It- tabib tiegħek jista ’ jagħtik parir biex tieħu taħlita ta ’ pilloli ta ’ 150 mg u ta ’ 500 mg għal kull doża. • Ħu l- pilloli fit- taħlita preskritta mit- tabib tiegħek għad- dożi tiegħek ta ’ filgħodu u ta ’ filgħaxija. • Ħu l- pilloli fi żmien 30 minuta wara li tispiċċa l- ikel (kolazzjon u pranzu). • Huwa importanti li tieħu l- medikazzjoni kollha tiegħek kif preskritt mit- tabib tiegħek.
59 If you take more Xeloda than you should, contact your doctor before taking the next dose.
Jekk tieħu aktar Xeloda milli suppost, kellem lit- tabib tiegħek qabel tieħu d- doża ta ’ wara.
If you forget to take Xeloda: do not take the missed dose at all and do not double the next one.
Jekk tinsa tieħu Xeloda: tieħux id- doża li insejt tieħu u tirduppjax id- doża ta ’ wara.
Instead, continue your regular dosing schedule and check with your doctor.
Minflok, kompli ħu d- dożi regolari tiegħek skond l- skeda u ħu l- parir tat- tabib tiegħek.
If you stop taking Xeloda:
Jekk tieqaf tieħu Xeloda:
There are no side-effects caused by stopping treatment with Xeloda.
M’ hemm l- ebda effetti sekondarji kkawżati minn waqfien tal- kura b’ Xeloda.
In case you are using coumarin anticoagulants (e. g.
F’ każ li inti qed tuża antikoagulanti coumarin (eż.
Marcumar), stopping Xeloda might require that your doctor adjusts your anticoagulant dose.
Marcumar®), il- waqfien ta ’ Xeloda jista ’ jirrekjiedi li t- tabib tiegħek ibiddel id- doża tal- antikoagulanti tiegħek.
Like all medicines, Xeloda can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xeloda jista’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects of Xeloda which may affect more than 1 person in 10 are: • diarrhoea, nausea, vomiting, stomatitis (sores in mouth and throat) and abdominal pain • hand-and-foot skin-reaction (palms of the hands or soles of the feet tingle, become numb, painful, swollen or red), rash, dry or itchy skin • tiredness • loss of appetite (anorexia)
L- aktar effetti sekondarji komuni ta ’ Xeloda li jistgħu jaffettwaw aktar minn persuna minn kull 10 huma: • dijarea, tqallih, rimettar, stomatite (ulċeri fil- ħalq u fil- grieżem) u uġigħ addominali • reazzjoni tal- ġilda ta ’ l- idejn u tas- saqajn - (il- pala ta ’ l- idejn jew il- qiegħ tas- saqajn inemnmu, imtarrxa, juġgħu, jintefħu jew jiħmaru), raxx, ġilda xotta jew ħakk tal- ġilda • għeja • telf. ta ’ l- aptit (anoreksja)
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.
Dawn l- effetti sekondarji jistgħu jsiru severi; għalhekk, huwa importanti li dejjem tikkuntattja lit - tabib tiegħek minnufih meta tibda tħoss xi effett sekondarju.
Your doctor may instruct you to decrease the dose and/ or temporarily discontinue treatment with Xeloda.
It- tabib tiegħek jista ’ jagħtik struzzjonijiet biex tnaqqas id- doża u/ jew twaqqaf il- kura b’ Xeloda temporanjament.
This will help reduce the likelihood that the side effect continues or becomes severe.
Dan jgħin biex tnaqqas il- probabbilità li l- effett sekondarju jkompli jew isir sever.
STOP taking Xeloda 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. • Hand-and-foot skin-reaction: if you have pain, swelling, and redness of hands and/ or feet • Fever or Infection: if you have a temperature of 38°C or greater, or other signs of infection. • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
IEQAF milli tieħu Xeloda minnufih u ikkuntattja lit- tabib tiegħek jekk iseħħ xi wieħed minn dawn is - sintomi jseħħu: • Dijarea: jekk ikollok żieda ta ’ 4 episodji jew aktar ta ’ ppurgar meta mqabbel man- numru ta ’ episodji ta ’ ppurgar normali tiegħek kuljum jew xi dijarrea matul il- lejl. • Rimettar: jekk int tirremetti aktar minn darba f’ perijodu ta ’ 24 siegħa. • Tqallih: jekk int titlef l- aptit, u l- ammont ta ’ ikel li tiekol kuljum huwa ħafna inqas minn dak tas- soltu. • Stomatite: jekk ikollok uġigħ, ħmura, nefħa jew ulċeri f’ ħalqek. • Reazzjoni tal- ġilda ta ’ l- idejn u tas- saqajn: jekk ikollok uġigħ, nefħa, u ħmura ta ’ l- idejn u/ jew tas- saqajn • Deni jew Infezzjoni: jekk ikollok temperatura ta ’ 38°C jew iżjed, jew sinjali oħra ta ’ infezzjoni. • Uġigħ fis- sider: jekk tħoss uġigħ lokalizzat fiċ- ċentru tas- sider, speċjalement jekk iseħħ waqt l - eserċizzju.
If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation.
Jekk tilqagħlhom kmieni, dawn l- effetti sekondarji s- soltu jitjiebu fi żmien jumejn sa tlett ijiem wara l - interruzzjoni tal- kura.
If these side effects continue, however, contact your doctor immediately.
Madankollu, jekk dawn l- effetti sekondarji jkomplu, ikkuntattja lit- tabib tiegħek minnufih.
Your doctor may instruct you to restart treatment at a lower dose.
It- tabib tiegħek jista ’ jagħtik struzzjonijiet biex terġa ’ tibda l- kura b’ doża mnaqqsa.
Other less common and usually mild side-effects which may affect between 1 and 10 people in 100 have been seen: decreases in the number of white blood cells or red blood cells, skin rashes, slight hair loss, weariness, fever, weakness, drowsiness, headache, numbness or tingling sensations, taste changes, dizziness, sleeplessness, swelling in the legs, constipation, dehydration, cold sores, inflammation of the nose and throat, chest infection, depression, problems with the eyes, inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose, bleeding from the gut, heartburn, excess wind, dry mouth, skin discolouration, nail disorder, pain in the joints, chest or back and loss of weight.
63 Effetti sekondarji inqas komuni u ġeneralment ħfief li jistgħu jaffettwaw bejn persuna u 10 minn kull 100 ġew innutati: tnaqqis fin- numru ta ’ ċelluli bojod tad- demm jew ċelluli ħomor tad- demm, raxx tal - ġilda, telf ħafif ta ’ xagħar, għeja, deni, debbulizza, ħedla, uġigħ ta ’ ras, tirżiħ jew sensazzjoni ta ’ tnemnim, tibdil fit- togħma, sturdament, nuqqas ta ’ rqad, nefħa fir- riġlejn, stitikezza, deidratazzjoni, feriti tar- riħ, infjammazzjoni ta ’ l- imnieħer u l- ħalq, infezzjoni fis- sider, depressjoni, problemi fl - għajnejn, infjammazzjoni tal- vini (tromboflebite), qtugħ ta ’ nifs, fsada mill- imnieħer, sogħla, mnieħer iqattar, fsada mill- musrana, ħruq ta ’ stonku, gass żejjed, ħalq xott, telf ta ’ kulur fil- ġilda, problema fid - dwiefer, uġigħ fil- ġogi, sider jew dahar u telf ta ’ piż.
60 If you are concerned about these or any other unexpected effect(s), talk to your doctor.
Jekk int inkwetat dwar dawn jew xi effett( i) oħra mhux mistennija, kellem lit- tabib tiegħek.
HOW TO STORE XELODA
KIF TAĦŻEN XELODA
Do not use Xeloda after the expiry date which is stated on the outer pack and label.
Tużax Xeloda wara d- data ta ’ skadenza li tidher fuq il- pakkett ta ’ barra u t- tikketta.
What Xeloda contains
X’ fih Xeloda:
- The active substance is capecitabine (150 mg per film-coated tablet).
- Is- sustanza attiva hi capecitabine (150 mg f’ kull pillola miksija b’ rita).
Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
Qalba tal- pillola: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172), talc.
Kisja tal- pillola: titanium dioxide (E171), iron oxide isfar u aħmar (E172), talc.
What Xeloda looks like and contents of the pack
Id- Dehra ta ’ Xeloda u l- kontenuti tal- pakkett:
Xeloda 150 mg film-coated tablet pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Pakkett ta ’ Xeloda 150 mg pilloli miksija b’ rita fiħ 60 pillola miksija b’ rita (6 folji ta ’ 10 pilloli).
Manufacturer:
64 Manifattur:
1 D-79639 Grenzach-Wyhlen Germany
1 D- 79639 Grenzach- Wyhlen Il- Ġermanja.
Slovenská republika Roche Slovensko, s. r. o.
Slovenská republika Ísland Roche Slovensko, s. r. o.
Italia Roche S. p. A.
65 Suomi/ Finland Italia Roche Oy Roche S. p. A.
Xeloda 500 mg film-coated tablets capecitabine
Xeloda 500 mg pilloli miksija b’ rita capecitabine
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett qabel tibda tieħu din il- mediċina.
- Keep this leaflet.
- Żomm dan fuljett.
What Xeloda is and what it is used for 2.
X’ inhi Xeloda u għalxiex jintuża 2.
Before you take Xeloda 3.
Qabel tieħu Xeloda 3.
Further Information
Aktar Tagħrif
Xeloda contains 500 mg capecitabine, which itself is not a cytostatic agent.
Xeloda fih 500 mg capecitabine, li huwa nnifsu mhuwiex aġent ċitostatiku.
Furthermore, Xeloda is prescribed by doctors to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Barra dan, Xeloda jġi preskritt mit- tobba biex jipprevjeni okkorrenza ġdida ta ’ kanċer tal- kolon wara t- tneħħija kollha tat- tumur permezz ta ’ kirurġija.
You must inform your doctor if you know that you have an allergy or over-reaction to Xeloda,
Għandek tgħarraf lit- tabib tiegħek jekk taf li għandek allerġija jew sensittività eċċessiva għal Xeloda,
- if you are pregnant or nursing,
- jekk inti tqila jew qed tredda ’,
Take special care with Xeloda:
67 Oqgħod attent ħafna b’ Xeloda:
Before treatment with Xeloda, make sure your doctor knows if you
Qabel kura b’ Xeloda, kun żgur li t- tabib tiegħek jkun jaf jekk int
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
68 It- tabib tiegħek jgħidlek x’ doża għandek bżonn tieħu, meta trid teħodha u għal kemm għandek bżonn teħodha.
65 If you take more Xeloda than you should, contact your doctor before taking the next dose.
Jekk tieħu aktar Xeloda milli suppost, kellem lit- tabib tiegħek qabel tieħu d- doża ta ’ wara.
Like all medicines, Xeloda can cause side effects, although not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Bħal kull mediċina oħra, Xeloda jista’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
STOP taking Xeloda 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. • Hand-and-foot skin-reaction: if you have pain, swelling, and redness of hands and/ or feet. • Fever or Infection: if you have a temperature of 38°C or greater, or other signs of infection. • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
IEQAF milli tieħu Xeloda minnufih u ikkuntattja lit- tabib tiegħek jekk iseħħ xi wieħed minn dawn is - sintomi jseħħu: • Dijarea: jekk ikollok żieda ta ’ 4 episodji jew aktar ta ’ ppurgar meta mqabbel man- numru ta ’ episodji ta ’ ppurgar normali tiegħek kuljum jew xi dijarrea matul il- lejl. • Rimettar: jekk int tirremetti aktar minn darba f’ perijodu ta ’ 24 siegħa. • Tqallih: jekk int titlef l- aptit, u l- ammont ta ’ ikel li tiekol kuljum huwa ħafna inqas minn dak tas- soltu. • Stomatite: jekk ikollok uġigħ, ħmura, nefħa jew ulċeri f’ ħalqek. • Reazzjoni tal- ġilda ta ’ l- idejn u tas- saqajn: jekk ikollok uġigħ, nefħa, u ħmura ta ’ l- idejn u/ jew tas- saqajn • Deni jew Infezzjoni: jekk ikollok temperatura ta ’ 38°C jew iżjed, jew sinjali oħra ta ’ infezzjoni. • Uġigħ fis- sider: jekk tħoss uġigħ lokalizzat fiċ- ċentru tas- sider, speċjalement jekk iseħħ waqt l - eserċizzju.
Other less common and usually mild side-effects which may affect between 1 person and 10 people in 100 have been seen: decreases in the number of white blood cells or red blood cells, skin rashes, slight hair loss, weariness, fever, weakness, drowsiness, headache, numbness or tingling sensations, taste changes, dizziness, sleeplessness, swelling in the legs, constipation, dehydration, cold sores, inflammation of the nose and throat, chest infection, depression, problems with the eyes, inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose, bleeding from the gut, heartburn, excess wind, dry mouth, skin discolouration, nail disorder, pain in the joints, chest or back and loss of weight.
69 Effetti sekondarji inqas komuni u ġeneralment ħfief li jistgħu jaffettwaw bejn persuna u 10 minn kull 100 ġew innutati: tnaqqis fin- numru ta ’ ċelluli bojod tad- demm jew ċelluli ħomor tad- demm, raxx tal - ġilda, telf ħafif ta ’ xagħar, għeja, deni, debbulizza, ħedla, uġigħ ta ’ ras, tirżiħ jew sensazzjoni ta ’ tnemnim, tibdil fit- togħma, sturdament, nuqqas ta ’ rqad, nefħa fir- riġlejn, stitikezza, deidratazzjoni, feriti tar- riħ, infjammazzjoni ta ’ l- imnieħer u l- ħalq, infezzjoni fis- sider, depressjoni, problemi fl - għajnejn, infjammazzjoni tal- vini (tromboflebite), qtugħ ta ’ nifs, fsada mill- imnieħer, sogħla, mnieħer iqattar, fsada mill- musrana, ħruq ta ’ stonku, gass żejjed, ħalq xott, telf ta ’ kulur fil- ġilda, problema fid - dwiefer, uġigħ fil- ġogi, sider jew dahar u telf ta ’ piż.
66 If you are concerned about these or any other unexpected effect(s), talk to your doctor.
Jekk int inkwetat dwar dawn jew xi effett( i) oħra mhux mistennija, kellem lit- tabib tiegħek.
Keep out of the reach and sight of children
Żommu fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal.
- The active substance is capecitabine (500 mg per film-coated tablet).
- Is- sustanza attiva hi capecitabine (500 mg f’ kull pillola miksija b’ rita).
Xeloda 500 mg film-coated tablet pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Pakkett ta ’ Xeloda 500 mg pilloli miksija b’ rita fiħ 120 pillola miksija b’ rita (12- il folja ta ’ 10 pilloli).
Manufacturer:
70 Manifattur:
Malta (See United Kingdom)
Malta (See/ ara United Kingdom)
Italia Roche S. p. A.
71 Suomi/ Finland Italia Roche Oy Roche S. p. A.
This leaflet was last approved in {MM/ YYYY}
Din fuljett kienet approvat l- aħħar fi {XX/ SSSS}
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex wasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is Xenical?
X' inhu Xenical?
Xenical is a medicine containing the active substance orlistat.
Xenical huwa mediċina li fiha s- sustanza attiva orlistat.
It is available as turquoise capsules (120 mg).
Huwa disponibbli bħala kapsuli turkważ (120 mg).
What is Xenical used for?
Għal xiex jintuża Xenical?
Xenical is used together with dieting for the treatment of obese (very overweight) patients with a body mass index (BMI) greater than or equal to 30 kg per square metre, or overweight patients (BMI greater than or equal to 28 kg/ m2) who are at risk of illness because of their weight.
Xenical jintuża flimkien ma 'dieta għat- trattament ta' pazjenti bil- problema tal- obeżità (piż eċċessiv ħafna) b' indiċi ta 'massa tal- ġisem (BMI) ogħla minn jew ugwali għal 30 kg/ m², jew ta' pazjenti b' piż eċċessiv (BMI ogħla minn jew ugwali għal 28 kg/ m²) li għandhom riskju li jimirdu minħabba l- piż tagħhom.
How is Xenical used?
Kif jintuża Xenical?
Xenical is given as one capsule taken with water just before, during, or up to one hour after each main meal.
Xenical jingħata f' doża ta 'kapsula waħda mal- ilma eżattament qabel, matul, jew sa siegħa wara kull ikla prinċipali.
If a meal is missed or contains no fat, Xenical should not be taken.
Jekk tinqabeż ikla jew jekk l- ikel ma jkunx fih xaħam, Xenical ma għandux jittieħed.
The patient should be on a diet in which about 30% of the calories come from fat, and which is rich in fruit and vegetables.
Il- pazjent għandu jkun fuq dieta li jkun fiha ħafna frott u ħaxix, li fiha, it- 30% tal- kaloriji jiġu mix - xaħam.
Treatment with Xenical should be stopped after 12 weeks if patients have been unable to lose at least 5% of their body weight since the start of treatment.
It- trattament b' Xenical għandu jitwaqqaf wara 12- il ġimgħa jekk il- pazjenti ma jkunux tilfu tal- inqas 5% tal- piż tal- ġisem tagħhom mill- bidu tat- trattament.
How does Xenical work?
Kif jaħdem Xenical?
The active ingredient in Xenical, orlistat, is an anti-obesity medicine, which does not affect appetite.
Is- sustanza attiva fi Xenical, orlistat, hija mediċina kontra l- obeżità, li ma tolqotx l- aptit.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested.
L- imblukkar ta 'dawn l - enzimi jimpedixxi il- metaboliżmu ta' xi xaħmijiet tad- dieta, u dan jippermetti li madwar 30% tax - xaħam li jkun ittiekel waqt l- ikel jgħaddi mill- imsaren mingħajr ma jiġi ddiġerut.
The body cannot use this dietary fat for energy or convert it into fat tissue.
Il- ġisem ma jistax juża dan ix- xaħam li ġej mill- ikel biex jipproduċi l- enerġija jew jaqilbu f' tessut tax- xaħam.
How has Xenical been studied?
Kif ġie studjat Xenical?
The effects of Xenical were first tested in experimental models before being studied in humans.
L- effetti ta 'Xenical ġew l- ewwel ittestjati f' mudelli sperimentali qabel ma ġew studjati fuq il- bniedem.
Xenical has been studied in seven main studies involving over 3,000 overweight or obese patients.
Xenical ġie studjat f' seba 'studji prinċipali li involvew 3, 000 pazjent b' piż żejjed jew bil- problema tal - obeżità.
The studies lasted from one to two years and compared three different doses of Xenical with placebo (a dummy treatment), in combination with dieting.
L- istudji damu għaddejjin minn sena sa sentejn u qabblu tliet dożaġġi differenti ta 'Xenical ma' plaċebo (trattament finta), flimkien ma 'dieta.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Studju addizzjonali itwal li involva aktar minn 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In all studies, the main measure of effectiveness was the change in weight.
3, 000 pazjent bil- problema tal- obeżità qabbel l- effetti ta 'Xenical u l- plaċebo fuq perjodu ta' erba 'snin, flimkien ma' dieta u eżerċizzju fiżiku.
What benefit has Xenical shown during the studies?
Liema benefiċċju wera Xenical matul l- istudji mwettqa?
Xenical was more effective than placebo in producing a reduction in weight.
Xenical kien aktar effikaċi meta mqabbel mal- plaċebo biex jiddetermina tnaqqis tal- piż.
When the results from all seven shorter studies were taken together, patients taking 120 mg Xenical three times a day had an average fall of 6.1 kg in body weight after a year, compared with 2.6 kg in those taking placebo.
Meta r - riżultati mis- seba 'studji iqsar tqiesu flimkien, il- pazjenti ttrattati bi Xenical f' dożi ta' 120 mg, tliet darbiet kuljum, wara sena, kellhom tnaqqis medju tal- piż ta '6. 1 kg tal- piż tal- ġisem, meta mqabbel ma' 2. 6 kg tal- pazjenti ttrattati bil- plaċebo.
The proportion of patients losing 10% or more of their body weight was 20% in the patients taking this dose of Xenical and 8% in those taking placebo.
Il- perċentwal ta 'pazjenti li tilfu 10% jew aktar tal- piż tal - ġisem tagħhom kien 20% fil- pazjenti ttrattati b' din id- doża ta' Xenical u 8% f' dawk ittrattati bil - plaċebo.
At the end of the four-year study, 21% of the patients treated with Xenical had lost more than 10% of their body weight, compared with 10% of the patients who received placebo.
Fit- tmiem tal- istudju ta 'erba' snin, 21% tal- pazjenti ttrattati bi Xenical tilfu aktar minn 10% tal- piż tal- ġisem tagħhom, meta mqabbel ma '10% tal- pazjenti ttrattati bil- plaċebo.
What is the risk associated with Xenical?
X' inhuma r- riskji assoċjati ma 'Xenical?
The most common side effects with Xenical (seen in more than 1 patient in 10) are influenza (flu), hypoglycaemia (low blood sugar levels), headache, upper respiratory infection (colds), oily spotting from the rectum, abdominal (tummy) pain or discomfort, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty or oily stools, flatulence (gas), liquid stools, oily evacuation (faeces) and increased defecation.
L- effetti sekondarji l- aktar komuni bi Xenical (li dehru f' aktar minn pazjent 1 minn kull 10) huma l - influwenza, ipogliċemija (livelli baxxi ta 'zokkor fid- demm), uġigħ ta' ras, infezzjoni fil- parti ta 'fuq ta' l- apparat respiratorju (irjiħat), qtar żejtni mir- rektum, uġigħ jew skonfort addominali (ta 'żaqq), flatulenza (gass) flimkien ma' ħruġ ta 'feċi, urġenza biex jitbattlu l- imsaren, feċi li jidhru xaħmin jew żejtnin, flatulenza (gass), feċi maħlula, evakwazzjoni (feċi) żejtnija u żieda fl- ammont ta' feċi.
These symptoms generally occur at the beginning of treatment, and go away after some time.
Normalment, dawn is- sintomi jseħħu fil- bidu tat- trattament, u jgħaddu wara xi ftit taż- żmien.
For the full description of all side effects reported with Xenical, see the Package Leaflet.
Għal deskrizzjoni sħiħa tal- effetti sekondarji rrappurtati bi Xenical, ara l- Fuljett ta 'Tagħrif.
Xenical should not be used in people who may be hypersensitive (allergic) to orlistat or any of the other ingredients.
Xenical ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal orlistat jew għal xi sustanza oħra tiegħu.
It should also not be used in people with a long-term malabsorption disease (where nutrients from the food are not easily absorbed during digestion), with cholestasis (a liver disorder) or who are breast-feeding.
Ma għandux jintuża f' persuni li jbatu mill- marda tal- assorbiment ħażin fuq perjodu ta 'żmien twil (fejn in- nutrijenti li jinsabu fl- ikel mhumiex assorbiti faċilment matul id - diġestjoni), mill- kolestażi (disturb epatiku) jew li qegħdin ireddgħu.
Why has Xenical been approved?
Għaliex ġie approvat Xenical?
The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical’ s benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/ m2, or overweight patients (BMI ≥ 28 kg/ m2) with associated risk factors.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Xenical huma ogħla mir- riskji tiegħu flimkien ma' dieta moderatament ipokalorika għat- trattament ta 'pazjenti bil- problema tal- obeżità b' BMI ogħla minn jew ugwali għal 30 kg/ m2, jew ta' pazjenti b' piż eċċessiv (BMI ≥ 28 kg/ m2) b' fatturi ta 'riskju assoċjati.
The Committee recommended that Xenical be given marketing authorisation.
Il- Kumitat irrakkomanda li Xenical jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Xenical:
Aktar tagħrif dwar Xenical:
The European Commission granted a marketing authorisation valid throughout the European Union for Xenical to Roche Registration Limited on 29 July 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Xenical lil Roche Registration Limited fid- 29 ta 'Lulju 1998.
The marketing authorisation was renewed on 29 July 2003 and on 29 July 2008.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet mġedda fid- 29 ta 'Lulju 2003 u fid- 29 ta' Lulju 2008.
The full EPAR for Xenical can be found here.
L- EPAR sħiħ għal Xenical jista 'jiġi kkonsultat hawn.
Xenical 120 mg hard capsules
Xenical 120 mg kapsuli iebsa.
Each hard capsule contains 120 mg orlistat.
Kull kapsula iebsa fiha 120 mg orlistat.
The capsule has a turquoise cap and turquoise body bearing the imprint of “ ROCHE XENICAL 120”.
Il- kapsula hija ta ’ lewn turkważ b ’ “ ROCHE XENICAL 120 ” stampat fuqha u għandha għatu ta ’ lewn turkważ.
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/ m², or overweight patients (BMI > 28 kg/ m²) with associated risk factors.
Xenical huwa ndikat flimkien ma ’ dieta ta ’ kaloriji kemmxejn baxxi għall- kura ta ’ pazjenti ħoxnin iżżejjed b’ indiċi tal- massa tal- ġisem (BMI) aktar minn, jew daqs 30 kg/ m², jew għall- pazjenti b’ piż żejjed (BMI > 28 kg/ m²) li għandhom ukoll fatturi ta ’ riskju assoċjati magħhom.
Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.
Il- kura b’ orlistat għandha titwaqqaf wara 12- il ġimgħa jekk il- pazjenti ma jkunx irnexxielhom inaqqsu mill- inqas 5% mill- piż tal- ġisem kif imkejjel fil- bidu tat- terapija.
Adults The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal.
Adulti Id- doża rakkomandata ta ’ orlistat hi kapsula ta ’ 120 mg waħda li tittieħed ma ’ l- ilma immedjatament qabel, waqt jew sa siegħa wara kull ikla prinċipali.
If a meal is missed or contains no fat, the dose of orlistat should be omitted.
Jekk tinqabeż xi ikla jew fil- każ ta ’ ikla bla ebda xaħam, id- doża ta ’ orlistat m’ għandhiex tittieħed.
The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat.
Il- pazjent irid ikun fuq dieta ta ’ nutriment bilanċjat u b’ kaloriji kemmxejn baxxi li jkun fiha madwar 30% tal- kaloriji minn xaħmijiet.
It is recommended that the diet should be rich in fruit and vegetables.
Huwa rakkomandat li d- dieta għandha tinkludi ħafna frott u ħaxix.
The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
L - ammont ta ’ xaħmijiet, karboidrati u proteini kkunsmati kuljum għandu jitqassam fuq tliet ikliet prinċipali.
Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.
Dożi ta ’ orlistat aktar minn 120 mg tliet darbiet kuljum ma wrew l- ebda benefiċċju żejjed.
The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing.
L- effett ta ’ orlistat jirriżulta f’ żieda ta ’ xaħam fil- purgar sa minn 24 sa 48 siegħa wara li tittieħed id - doża.
Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Kif titwaqqaf it- terapija, il- kontenut ta ’ xaħam fil- purgar normalment jerġa ’ lura għal- livelli ta ’ qabel il- kura fi żmien 48 sa 72 siegħa.
Special populations The effect of orlistat in patients with hepatic and/ or renal impairment, children and elderly patients has not been studied.
Popolazzjonijiet speċjali L- effett ta ’ orlistat f’ pazjenti b’ indeboliment tal- fwied u/ jew renali, tfal u pazjenti anzjani ma ġiex studjat.
There is no relevant indication for use of Xenical in children.
M’ hemmx indikazzjoni rilevanti għall- użu ta ’ Xenical fit- tfal.
- Chronic malabsorption syndrome.
- Sindrome kronika ta ’ assorbiment ħażin.
- Cholestasis.
- Kolestasi
- Breast-feeding.
- Treddigħ.
In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients.
Fi provi kliniċi, it- tnaqqis fil- piż tal- ġisem bil- kura b’ orlistat kien inqas f’ pazjenti b’ dijabete tat- tip II milli f’ pazjenti li mhumiex dijabetiċi.
Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat.
Meta jkun qed jittieħed orlistat, kura bi prodotti mediċinali antidijabetiċi għandu mnejn ikollha bżonn tiġi monitorjata mill- qrib.
Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).
L- għoti ta ’ orlistat flimkien ma ’ ciclosporin mhux rakkomandat (ara sezzjoni 4. 5).
Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
Il- pazjenti għandhom jingħataw parir biex joqogħdu fuq ir- rakkomandazzjonijiet li jingħataw dwar id - dieta (ara sezzjoni 4. 2).
The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e. g. in a 2000 kcal/ day diet, > 30% of calories from fat equates to > 67 g of fat).
Il- possibiltà ta ’ esperjenza ta ’ reazzjonijiet avversi gastro- intestinali (ara sezzjoni 4. 8) tista ’ tiżdied meta orlistat jittieħed flimkien ma ’ dieta b’ kontenut għoli ta ’ xaħam (e. ż f’ dieta ta ’ 2000 kkal/ kuljum, > 30% ta ’ kaloriji mix- xaħam ifissru > 67 g ta ’ xaħam).
The daily intake of fat should be distributed over three main meals.
Il- konsum ta ’ xaħam kuljum għandu jitqassam fuq tliet ikliet prinċipali.
If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.
Jekk orlistat jittieħed ma ’ ikla b’ ħafna xaħam, il- possibiltà ta ’ reazzjonijiet gastro- intestinali avversi tista ’ tiżdied.
Cases of rectal bleeding have been reported with Xenical.
Ġew rappurtati każijiet ta ’ fsada mir- rektum b’ Xenical.
Prescribers should investigate further in case of severe and/ or persistent symptoms.
Dawk li jippreskrivu l- mediċina għandhom ikomplu jinvestigaw f’ każ ta ’ sintomi severi u/ jew persistenti.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).
L- użu ta ’ metodu kontraċettiv addizzjonali huwa rakkomandat biex jipprevjeni l- possibiltà li kontraċezzjoni orali ma taħdimx, li tista ’ isseħħ f’ każ ta ’ dijarea severa (ara sezzjoni 4. 5)
Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants (see section 4.5 and 4.8).
Parametri tal- koagulazzjoni għandhom jiġu sorveljati f’ pazjenti kkurati fl- istess waqt b’ sustanzi kontra l- koagulazzjoni tad- demm (ara sezzjoni 4. 5 u 4. 8).
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy in patients with underlying chronic kidney disease and/ or volume depletion (see section 4.8).
F’ pazjenti b’ mard kroniku tal- kliewi eżistenti u/ jew tnaqqis fil- volum, l- użu ta ’ orlistat jista ’ jkun assoċjat ma ’ iperoxalurja u nefropatija kkawżata minn oxalate (ara sezzjoni 4. 8).
Rare occurrence of hypothyroidism and/ or reduced control of hypothyroidism may occur.
Jista ’ jkun hemm l- okkorrenza rari ta ’ ipotirojdiżmu u/ jew kontroll imnaqqas ta ’ ipotirojdiżmu.
The mechanism, although not proven, may involve a decreased absorption of iodine salts and/ or levothyroxine (see section 4.5).
Il - mekkanżimu, għalkemm mhux ipprovat, jista ’ jinvolvi assorbiment imnaqqas ta ’ mluħa ta ’ iodine u/ jew ta ’ levothyroxine (ara sezzjoni 4. 5).
Antiepileptics patient:
Pazjenti li jieħdu mediċini kontra l- epilessija:
Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions (see section 4.5).
Orlistat jista ’ jikkawża żbilanċ fil- kura kontra l - konvulżjonijiet billi jnaqqas l- assorbiment ta ’ mediċini kontra l- epilessija u b’ hekk iwassal għall - konvulżjonijiet (ara sezzjoni 4. 5)
Ciclosporin A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly.
Ciclosporin Kien osservat tnaqqis fil- livelli ta ’ ciclosporin fil- plażma fi studju dwar l- interazzjoni bejn mediċina u oħra u kien ukoll rappurtat f’ diversi każijiet meta orlistat ingħata fl- istess waqt.
This can lead to a decrease of immunosuppressive efficacy.
Dan jista ’ jwassal għal tnaqqis ta ’ effikaċja immunosoppressiva.
Therefore the combination is not recommended (see section 4.4).
Għalhekk it- taħlita mhijiex rakkomandata (ara sezzjoni 4. 4).
However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients.
Madankollu, jekk dan l- użu fl- istess waqt ma jistax jiġi evitat, għandu jsir monitoraġġ aktar frekwenti tal- livelli ta ’ ciclosporin fid- demm kemm wara li jibda ’ jinagħta orlistat kif ukoll malli jitwaqqaf orlistat f’ pazjenti kkurati b’ ciclosporin.
Ciclosporin blood levels should be monitored until stabilised.
Il- livelli ta ’ ciclosporin fid- demm għandhom ikunu monitorjati sakemm dawn jiġu stabbilizzati.
Acarbose In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.
3 Fin- nuqqas ta ’ studji farmakokinetiċi dwar l- interazzjonijiet, l- għoti ta ’ orlistat flimkien ma ’ acarbose għandu jiġi evitat.
Oral anticoagulants When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Sustanzi kontra il- koagulazzjoni li jittieħdu mill- ħalq Meta warfarin jew xi sustanzi oħra kontra l- koagulazzjoni jingħataw flimkien ma ’ orlistat, il- valuri ta ’ proporzjon normalizzat internazzjonali (INR) għandhom jiġu monitorjati (ara sezzjoni 4. 4).
Fat soluble vitamins Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Vitamini li jinħallu fix- xaħam Kura b’ orlistat għandu mnejn iddgħajjef l- assorbiment ta ’ vitamini li jinħallu fix- xaħam (A, D, E u K).
In order to ensure
Fi studji kliniċi l- biċċa l- kbira tal- pazjenti li jkunu fuq kura b’ orlistat għal erba ’ snin sħaħ kellhom livelli ta ’ vitamini A, D, E u K u ta ’ beta- carotene li baqgħu fil- firxa normali.
3 adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered.
Biex ikun żgurat nutriment adegwat, pazjenti fuq dieta għall- kontroll tal- piż għandhom jingħataw il- parir li jsegwu dieta b’ ħafna frott u ħaxix u jista ’ jiġi kkunsidrat l- użu ta ’ suppliment ta ’ multivitamini.
If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of orlistat or at bedtime.
Jekk ikun rakkomandat suppliment ta ’ multivitamini, dan għandu jittieħed mill- inqas sagħtejn wara l- għoti ta ’ orlistat jew qabel l- irqad.
Amiodarone A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly.
Amiodarone F’ numru limitat ta ’ voluntiera f’ saħħithom li ħadu orlistat fl- istess waqt, kien osservat tnaqqis ħafif fil - livelli tal- plażma ta ’ amiodarone, meta ingħata bħala doża waħda.
In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases.
F’ pazjenti li jkunu qed jirċievu kura b’ amiodarone, ir- rilevanza klinika ta ’ dan l- effett għad mhix magħrufa iżda f’ xi każijiet tista ’ ssir klinikament rilevanti.