qanastek/EMEA-V3 huggingface dataset:
Oral use Read the package leaflet before use
Aqra l- fuljett ta 'tagħrif qabel l- użu
numbers 1 to 14 numbers 1 to 28 sun as symbol moon as symbol
numru 1 sa 14 numru 1 sa 28 simbolu tax- xemx simbolu tal- qamar
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 14 x 1 mg and 28 x 1 mg varenicline film-coated tablets, Heat Sealed Card
Pakkett Folji ta '14 x 1 mg u 28 x 1 mg varenicline pilloli miksijin b' rita, Kartuna Issiġillata bis- Sħana
Maintenance pack Heat sealed card pack containing either 2 blister packs of 14 x 0.5 mg varenicline film-coated tablets or 2 blister packs of 28 x 0.5 mg varenicline film-coated tablets– inner and outer labelling
Pakkett ta 'manteniment Pakkett tal- kartun issiġillat bis- sħana li fih jew żewġ pakketti ta' folji ta '14 x 0. 5 mg varenicline pilloli miksijin b' rita jew 2 pakketti ta' folji ta '28 x 0. 5 mg varenicline pilloli miksijin b' rita - tikketta ta' ġewwa u ta 'barra
CHAMPIX 0.5 mg film-coated tablets Varenicline
Champix 0. 5 mg pilloli miksijin b' rita Varenicline
Each tablet contains 0.5 mg varenicline (as tartrate).
Kull pillola fiha 0. 5 mg varenicline (bħala tartrat).
Oral use Read the package leaflet before use
Jittieħed mill- ħalq Aqra l- fuljett ta 'tagħrif qabel l- użu
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline film-coated tablets, Heat Sealed Card
Pakkett Folji ta '14 x 0. 5 mg u 28 x 0. 5 mg varenicline pilloli miksijin b' rita, Kartuna Issiġillata bis - Sħana
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Treatment initiation pack Carton pack with 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets
Pakkett għall- bidu tal- kura Pakkett tal- kartun li fih pakkett folji ta '11 x 0. 5 mg varenicline pilloli miksijin b' rita u pakkett folji ta' 14 x 1 mg varenicline pilloli miksijin b' rita
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 11 x 0.5 mg varenicline film-coated tablets
Pakkett Folji ta '11 x 0. 5 mg varenicline pilloli miksijin b' rita
CHAMPIX 0.5 mg Varenicline
Champix 0. 5 mg Varenicline
sun as symbol moon as symbol
simbolu tax- xemx simbolu tal- qamar
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 14 x 1 mg varenicline film-coated tablets
Pakkett Folji ta '14 x 1 mg varenicline pilloli miksijin b' rita
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Maintenance pack Carton Pack containing 2 blister packs of 14 x 1 mg varenicline film-coated tablets or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 8 blister packs of 14 x 1 mg varenicline film-coated tablets
Pakkett ta 'manteniment Pakkett tal- Kartun li fih jew 2 folji ta' 14 x 1 mg varenicline pilloli miksijin b' rita jew 4 folji ta '14 x 1 mg varenicline pilloli miksijin b' rita jew 8 folji ta' 14 x 1 mg varenicline pilloli miksijin b' rita.
28 Film-coated tablets 56 Film-coated tablets 112 Film-coated tablets
28 pillola miksijin b' rita 56 pillola miksijin b' rita 112 pillola miksijin b' rita
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Pakkett fi flixkun tal- politin ta 'densita' għolja (HDPE) għal 56 x 1 mgvarenicline pilloli miksijin b' rita
56 Film-coated tablets
56 pillola miksijin b' rita
48 PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING
50 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
High-density polyethylene (HDPE) bottle label for 56 x 1 mg varenicline film-coated tablets
Tikketta għall- flixkun tal- politin ta 'densita' għolja (HDPE) għal 56 x 1 mg varenicline pilloli miksijin b' rita
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Pakkett fi flixkun tal- politin ta 'densita' għolja (HDPE) għal 56 x 0. 5 mg varenicline pilloli miksijin b' rita
52 PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING
54 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
High-density polyethylene (HDPE) bottle label for 56 x 0.5 mg varenicline film-coated tablets
Tikketta għall- flixkun tal- politin ta 'densita' għolja (HDPD) għal 56 x 0. 5 mg varenicline pilloli miksijin b' rita
55 PACKAGE LEAFLET:
57 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA CHAMPIX 0. 5 mg pilloli miksijin b' rita CHAMPIX 1 mg pilloli miksijin b' rita
Varenicline
Varenicline
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What CHAMPIX is and what it is used for 2.
X' inhu CHAMPIX u għalxiex jintuża 2.
Before you take CHAMPIX 3.
Qabel ma tieħu CHAMPIX 3.
How to take CHAMPIX 4.
Kif għandek tieħu CHAMPIX 4.
How to store CHAMPIX 6.
Kif taħżen CHAMPIX 6.
WHAT CHAMPIX IS AND WHAT IT IS USED FOR
X' INHU CHAMPIX U GĦALXIEX JINTUŻA
CHAMPIX is a a non-nicotine medicine which is used to help you stop smoking.
CHAMPIX hu mediċina mingħajr nikotina li tintuża biex tgħinek taqta 't- tipjip.
CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking.
CHAMPIX jista 'jgħinek biex ittaffi x- xenqa u s- sintomi ta' l- irtirar assoċjati mal- waqfien mit- tipjip.
Although you are not recommended to smoke after your quit date, CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment.
Għalkemm huwa rrakkomandat li ma tpejjipx wara d- data tat- twaqqif mit- tipjip, CHAMPIX jista 'jnaqqas ukoll il- pjaċir tas- sigarretti jekk inti tpejjep waqt il- kura.
(The quit date is the day in the second week of treatment when you will stop smoking, see Section 3.)
(Id- data tat- twaqqif mit- tipjip hija waqt it- tieni ġimgħa tal- kura, meta se taqta ’ is- sigaretti).
BEFORE YOU TAKE CHAMPIX
QABEL MA TIEĦU CHAMPIX
Do not take CHAMPIX
Tiħux CHAMPIX
- If you are allergic (hypersensitive) to varenicline tartrate or any of the other ingredients of
- jekk int allerġiku/ a (sensittiv/ a żżejjed) għal varenicline tartrate jew xi sustanzi oħra ta '
Take special care with CHAMPIX
Oqgħod attent ħafna b' CHAMPIX
Taking other medicines 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 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
The effects of stopping smoking The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other drugs work.
L- effetti ta 'waqfien mit- tipjip L- effetti tal- bidliet fil- ġisem tiegħek b' riżultat tal- waqfien mit- tipjip, bi jew mingħajr kura b' CHAMPIX, jistgħu jbiddlu l- mod kif jaħdmu mediċini oħra.
Therefore, in some cases an adjustment of the dose
Għalhekk, f' ċerti każijiet jista 'jkun meħtieġ aġġustament fid- doża.
Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes).
Eżempji jinkludu theophylline (mediċina għall- kura ta 'problemi tan - nifs), warfarin (mediċina biex tnaqqas it- tagħqid tad- demm), u l- insulina (mediċina biex tikkura d - dijabete).
If in doubt, you should consult your doctor or pharmacist.
F' każ ta 'dubju, inti għandek tikkonsulta mat- tabib jew ma' l- ispiżjar tiegħek.
For some people stopping smoking, with or without treatment, has been associated with an increased risk of experiencing feelings such as depression and anxiety and can be associated with a worsening of psychiatric illness.
58 Għal ċerti nies il- waqfien mit- tipjip, waqt kura jew le, kien assoċjat ma 'riskju akbar li jħossu sensazzjonijiet bħal depressjoni u ansjeta' u jista ’ jiġri li mard psikjatriku jmur għall- agħar..
If you have a history of psychiatric illness you should discuss this with your doctor or pharmacist.
Għandek tkiddiskuti mat- tabib jew ma ’ l- ispiżjar tiegħek jekk għandek qatt kellek mard psikjatriku.
Depressed mood may appear during smoking cessation with or without treatment.
Il- waqfien mit- tipjip jista ’ jwassal għal burdata ta ’ dwejjaq.
Depression, rarely including suicidal thoughts and suicide attempt, has been reported in patients undergoing a smoking cessation attempt.
Ġiet rappurtata dipressjoni, li rarament tinkludi ideat ta ’ suwiċidju u attentat ta ’ suwiċidju f’ pazjenti li jkunu qed jippruvaw jieqfu jpejpu.
These feelings have also been reported while attempting to quit smoking with Champix.
Dawn is- sintomi ġew rapurtati wkoll f’ pazjenti li jkunu qed jippruvaw jieqfu jpejpu b ’ Champix.
You may temporarily experience increased irritability, urge to smoke, depression and/ or sleep disturbances when you stop taking CHAMPIX.
Meta twaqqaf CHAMPIX inti tista 'tesperjenza temporanjament żieda fl- irritabilita', impuls biex tpejjep, depressjoni u/ jew disturbi ta 'l- irqad.
Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
It- tabib tiegħek jista 'jiddeċiedi li jbaxxi b' mod gradwali d- doża tiegħek ta' CHAMPIX fit- tmiem tal- kura.
Effect of CHAMPIX on other drugs CHAMPIX is not expected to affect the way other drugs work.
L- effett ta 'CHAMPIX fuq mediċini oħrajn CHAMPIX mhux mistenni li jaffettwa l- mod kif jaħdmu mediċini oħra.
Effect of other drugs on CHAMPIX Due to the way in which varenicline tartrate is removed from the body, it is not expected that other drugs will affect the way in which CHAMPIX works.
Effett ta 'mediċini oħra fuq CHAMPIX Minħabba l- mod kif varenicline tartrate jiġi eliminat mill- ġisem, mhux mistenni li mediċini oħra jaffettwaw il- mod kif jaħdem CHAMPIX.
Use of CHAMPIX with other therapies for smoking cessation The safety and benefits of taking CHAMPIX in combination with other medicines for stopping smoking have not been studied.
Użu ta 'CHAMPIX ma' terapiji oħra għal waqfien mit- tipjip Is- sigurta 'u l- benefiċċji li tieħu CHAMPIX ma' mediċini oħra għal waqfien mit- tipjip ma ġewx studjati.
CHAMPIX in combination with other smoking cessation therapies is therefore not recommended.
It- teħid ta 'CHAMPIX ma' terapiji oħrajn għal waqfien mit- tipjip għalhekk mhuwiex rakkomandat.
CHAMPIX is not recommended for use in children or adolescents below 18 years.
CHAMPIX mhux rakkomandat għall- użu fit- tfal jew l- adoloxxenti ta 'taħt it- 18- il sena.
Taking CHAMPIX with food and drink
Meta tieħu CHAMPIX ma ’ l- ikel u max- xorb
You should not take CHAMPIX while you are pregnant.
M' għandekx tieħu CHAMPIX meta tkun tqila.
Talk to your doctor if you are intending to become pregnant.
Tkellem mat- tabib tiegħek jekk qed tippjana li tinqabad tqila.
If you want to start treatment with CHAMPIX, your treatment should be timed so that you have completed the course before becoming pregnant.
Jekk trid tibda kura b' CHAMPIX, il - kura tiegħek għandha tkun iffissata b' mod li tkun lestejt il- kors qabel ma tinqabad tqila.
Although it was not studied, CHAMPIX may pass into breast milk.
Għalkemm ma ġiex studjat, CHAMPIX jista 'jgħaddi ġol- ħalib tas- sider.
You should ask your doctor or pharmacist for advice before taking CHAMPIX.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu CHAMPIX.
CHAMPIX may produce dizziness and sleepiness.
CHAMPIX jista 'jikkawża sturdament u ngħas.
You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Issuqx, tħaddimx makkinarju kumpless jew tinvolvi ruħek f' attivitajiet oħra li jistgħu jkunu perikolużi sakemm tkun taf jekk din il- mediċina taffettwax il - ħila tiegħek biex twettaq dawn l- attivitajiet.
HOW TO TAKE CHAMPIX
KIF GĦANDEK TIEĦU CHAMPIX
You are more likely to stop smoking if you are motivated to stop.
Għandek ċans akbar li tieqaf tpejjep jekk tkun motivat/ a biex tieqaf.
Your doctor and pharmacist can provide advice, support and sources of further information to help ensure your attempt to stop smoking is successful.
It- tabib u l- ispiżjar tiegħek jistgħu jipprovdu parir, appoġġ u sorsi ta 'aktar informazzjoni biex jiġi żgurat li t- tentattiv tiegħek li taqta' t- tipjip jirnexxi.
Always take CHAMPIX exactly as your doctor has told you.
59 Dejjem għandek tieħu CHAMPIX eżatt kif qallek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma 'l- ispiżjar tiegħek jekk ikollok xi dubju.
Before starting your course of CHAMPIX you should decide on a date in the second week of treatment (between day 8 and day 14) when you will stop smoking.
Qabel ma tibda l- kors tiegħek ta 'CHAMPIX inti għandek tiddeċiedi data fit- tieni ġimgħa tal- kura (bejn jum 8 u jum 14) meta se tieqaf tpejjep.
You should write this date on the pack as a reminder.
Inti għandek tikteb din id- data fuq il- pakkett bħala tfakkira.
The usual dose for adults which you should follow from Day 1 is described in the following table:
Id- doża normali għall- adulti li inti għandek issegwi minn Jum 1 hija deskritta fit- tabella li ġejja:
Week 1 Day 1 - 3
Jum 1 - 3
Dose From day 1 to day 3, you should take one white CHAMPIX 0.5 mg film-coated tablet once a day.
Minn jum 1 sa jum 3, inti għandek tieħu CHAMPIX 0. 5 mg pillola bajda miksija b' rita darba kuljum.
Day 4 - 7
Jum 4 - 7
From day 4 to day 7, you should take one white CHAMPIX 0.5 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Minn jum 4 sa jum 7, inti għandek tieħu pillola CHAMPIX 0. 5 mg pillola bajda miksija b' rita darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl- istess ħin kuljum.
Week 2 Day 8 – 14
It- 2ni ġimgħa Jum 8 - 14
From day 8 to day 14, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Minn jum 8 sa jum 14, inti għandek tieħu CHAMPIX 1 mg pillola blu ċara miksija b' rita darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl- istess ħin kuljum.
Weeks 3 - 12 Day 15 - end of treatment
It- 3et - 12- il ġimgħa Jum 15 - tmiem tal- kura
From day 15 until the end of treatment, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Minn jum 15 sat- tmiem tal- kura, inti għandek tieħu CHAMPIX 1 mg pillola blu ċara miksija b' rita darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
Should you experience adverse effects that you cannot tolerate your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice daily.
F' każ li tesperjenza xi effetti avversi li ma tkunx tista 'tittollerahom, it- tabib tiegħek jista' jiddeċiedi li jnaqqas id- doża tiegħek b' mod temporanju jew permanenti għal 0. 5 mg darbtejn kuljum.
After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice daily.
Wara 12- il ġimgħa ta 'kura, jekk tkun waqaft tpejjep, it- tabib tiegħek jista' jirrakkomanda 12- il ġimgħa oħra ta 'kura b' CHAMPIX 1 mg pilloli miksijin b' rita darbtejn kuljum.
In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment.
Fit- terapija għal waqfien mit- tipjip, ir- riskju ta 'rikaduta għat- tipjip jista' jkun għoli fil- perjodu immedjatament wara t- tmiem tal- kura.
If you have problems with your kidneys, you should speak to your doctor before taking CHAMPIX.
Jekk għandek problemi bil- kliewi, inti għandek titkellem mat- tabib tiegħek qabel ma tieħu CHAMPIX.
You may need a lower dose.
Jista 'jkollok bżonn doża aktar baxxa.
If you take more CHAMPIX than you should
Jekk tieħu CHAMPIX aktar milli suppost
If you accidentally take more CHAMPIX than your doctor prescribed, you must seek medical advice or go to the nearest hospital casualty department immediately.
Jekk aċċidentalment tieħu aktar CHAMPIX milli ordnalek it- tabib tiegħek, inti għandek tfittex parir mediku jew tmur fid- dipartiment ta 'l- emerġenza ta' l- eqreb sptar immedjatament.
Take your box of tablets with you.
Ħu l- kaxxa tal - pilloli miegħek.
58 If you forget to take CHAMPIX
60 Jekk tinsa tieħu CHAMPIX
Do not take a double dose to make up for a forgotten tablet.
Tiħux doża doppja biex tpatti għall- pillola li nsejt.
It is important that you take CHAMPIX regularly at the same time each day.
Importanti li tieħu CHAMPIX b' mod regolari fl - istess ħin kuljum.
If you forget to take a dose, take it as soon as you remember.
Jekk tinsa tieħu doża, ħudha malli tiftakar.
If it is almost time for your next dose, do not take the tablet that you have missed.
Jekk ikun wasal il- ħin għad- doża li jmiss, tiħux il- pillola li tkun insejt.
If you stop taking CHAMPIX
Jekk tieqaf tieħu CHAMPIX
It has been shown in clinical trials that taking all doses of your medicine at the appropriate times and for the recommended duration of treatment described above will increase your chances of stopping smoking.
Fil- provi kliniċi ntwera li t- teħid tad- dożi kollha tal- mediċina tiegħek fil- ħinijiet korretti u għall - perjodu rakkomandat ta 'kura deskritt fuq iżid iċ- ċansijiet tiegħek li taqta' t- tipjip.
Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CHAMPIX, according to the instructions described in the table above.
Għalhekk, sakemm it- tabib tiegħek ma jgħidlekx biex twaqqaf il- kura, huwa importanti li tkompli tieħu CHAMPIX, skond l- istruzzjonijiet deskritti fit- tabella ta 'hawn fuq.
Giving up smoking with or without treatment can cause various symptoms.
Il- waqfien mit- tipjip bi jew mingħajr kura jista 'jikkawża diversi sintomi.
These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
Dawn jistgħu jinkludu bidliet fil- burdata (bħal tħossok depress/ a, irritabbli, frustrat/ a jew ansjuż/ a), nuqqas ta 'rqad, diffikulta' biex tikkonċentra, tnaqqis fit- taħbit tal- qalb u żieda fl- aptit jew żieda fil- piż.
Like all medicines, CHAMPIX can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CHAMPIX jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
- Very common side effects which may affect more than 1 person in 10 are listed below:
għaxra (10) huma elenkati hawn isfel:
Headache, difficulty sleeping, abnormal dreams Nausea
Uġigħ ta 'ras, diffikulta' biex torqod, ħolm abnormali o Dardir o
side effects which may affect more than 1 person in 100 are listed below:
Effetti sekondarji komuni li jistgħu jaffettwaw aktar minn persuna waħda (1) minn kull mija (100) huma elenkati hawn isfel:
Increased appetite, changes in the way things taste, dry mouth Sleepiness, tiredness, dizziness Vomiting, constipation, diarrhoea, feeling bloated, stomach discomfort, indigestion, flatulence
Żieda fl- aptit, tibdil fil- mod li jtiegħmu l- affarijiet, ħalq xott o Ngħas, għeja, sturdament o Rimettar, stitikezza, dijarea, tħossok mifqugħ, diqa fl- istonku, indiġestjoni, gass fl - o istonku
- Uncommon side effects which may affect more than 1 person in 1, 000 are listed below:
Effetti sekondarji mhux komuni li jistgħu jaffettwaw aktar minn persuna waħda (1) minn kull elf (1000) huma elenkati hawn isfel:
Chest infection, discomfort or pain, inflammation of the sinuses, Fever, feeling cold, feeling weak or unwell, viral infection, shortness of breath, cough, hoarseness, throat pain and irritation, congested sinuses, runny nose, snoring
Infjammazzjoni tas- sider, diqa jew uġigħ, infjammazzjoni tas- sinus o Deni, sensazzjoni ta 'kesħa, sensazzjoni ta' indeboliment jew malesseri, infezzjoni virali, o qtugħ ta 'nifs, sogħla, ħanqa, uġigħ u irritazzjoni tal- gerżuma, sinus miżdudin, mnieħer iqattar, nħir Telf ta' l- aptit, sensazzjoni ta 'għatx, żieda fil- piż o Sensazzjoni ta' paniku, diffikulta 'biex taħseb, tibdil fil- burdata o Tregħid, diffikulta' bil- koordinazzjoni, diffikulta 'bid- diskors, sensittivita' anqas għall - o mess, tensjoni akbar fil- muskoli, irrekwitezza Disturbi fir- ritmu tal- qalb, pressjoni tad- demm aktar għolja, żieda fir- ritmu tal- qalb o Disturb tal- vista, tidnis tal- boċċa ta 'l- għajn, uġigħ fl- għajnejn, pupilli mwessgħin, o mijopija, sensittivita' għad- dawl, għajnejn idemmgħu Żarżir fil- widnejn o Rimettar bid- demm, irritazzjoni u ħruq fl- istonku, uġigħ addominali, purgar abnormali, o purgar bid- demm, tifwiq, ulċeri fil- ħalq, uġigħ fil- ħniek, ilsien miksi
Loss of appetite, feeling thirsty, increased weight Feeling of panic, difficulty thinking, mood swings Tremor, difficulty with coordination, difficulty with speech, less sensitive to touch, increased muscle tension, restlessness,
61 Raxx tal- ġilda, ċista, infezzjoni fungali, taħmir tal- ġilda, ħakk, akne, żieda fl- għaraq o Uġigħ fil- ħajt tas- sider u l- kustilji, ġogi ebsin, spażmi fil- muskoli o Glukożju fl- awrina, volum u frekwenza akbar ta 'l- awrina o Fluss mestrwali akbar, tnixxija vaġinali, tibdil fl- impulsi jew fil- prestazzjoni sesswali o
- There have been reports of heart attack, depression, suicidal thoughts and hypersensitivity
- Kienu rrapurtati każijiet ta ’ attakki tal- qalb, ta’ depressjoni u ta ’ ħsibijiet ta’ suwiċidju u
reactions (such as swollen face or tongue) in patients attempting to quit smoking with CHAMPIX.
reazzjonijiet ta ’ sensittivita ’ eċċessiva (bħal nefħa fil- wiċċ jew fl- ilsien) f’ pazjenti li ppruvaw jieqfu jpejpu b ’ CHAMPIX.
If you are taking Champix and develop agitation, depressed mood, changes in behaviour or suicidal thoughts you should stop your treatment and contact your doctor immediately.
Jekk qed tieħu Champix u ssir aġitat, tiżviluppa burdati dipressivi, bdil fl- atteġjamenti u jkollok ħsibijiet dwar suwiċidju, għandek twaqqaf it- trattament u tkellem immedjatament lit- tabib tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CHAMPIX
KIF TAĦŻEN CHAMPIX
Do not use CHAMPIX after the expiry date which is stated on the card packaging or carton.
Tużax CHAMPIX wara d- data ta 'skadenza li tidher fuq il- pakkett tal- kartun jew fuq il- kaxxa.
This medicine does not require any special storage conditions.
Din il- mediċina ma teħtieġx kondizzjonijiet ta 'ħażna speċjali.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m' għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri għandhom jgħinu għal protezzjoni ta 'l- ambjent.
What CHAMPIX contains
X' fih CHAMPIX
- The active substance is 0.5 mg varenicline and 1 mg varenicline respectively
- Is- sustanza attiva hi 0. 5 mg varenicline u 1 mg varenicline rispettivament
Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, Colloidal Anhydrous Magnesium Stearate
Qalba tal- Pillola - CHAMPIX 0. 5 mg u 1 mg pilloli miksijin b' rita Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, colloidal anhydrous Magnesium Stearate
Tablet film coating - CHAMPIX 0.5 mg film-coated tablets Hypromellose Titanium dioxide (E171) Macrogols Triacetin
Rita tal- pillola - CHAMPIX 0. 5 mg pilloli miksijin b' rita Hypromellose Titanium Dioxide (E171) Macrogols Triacetin
Tablet film coating - CHAMPIX 1 mg film-coated tablets Hypromellose Titanium dioxide (E171) Macrogols Indigo Carmine Aluminium Lake (E132) Triacetin
62 Hypromellose Titanium Dioxide (E171) Macrogols Indigo Carmine Aluminium Lake E132 Triacetin
What CHAMPIX 0.5 mg and 1 mg film-coated tablets look like and contents of the pack
Id- dehra ta 'CHAMPIX 0. 5 mg u 1 mg pilloli miksijin b' rita u l- kontenut tal- pakkett
- CHAMPIX 0.5 mg film-coated tablets are white, film-coated, modified capsular shaped tablets,
- CHAMPIX 0. 5 mg pilloli miksijin b' rita huma pilloli bojod, miksijin b' rita, forma ta 'kapsula
marked “ Pfizer” and “ CHX 0.5”
modifikata, immarkati “ Pfizer ” u “ CHX 0. 5 ”
- CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped
- CHAMPIX 1 mg pilloli miksijin b' rita huma pilloli blu ċari, miksijin b' rita, forma ta 'kapsula
tablets, marked “ Pfizer” and “ CHX 1.0”
modifikata, immarkati “ Pfizer ” u “ CHX 1. 0 ”
CHAMPIX is available in the following pack presentations:
CHAMPIX hu disponibbli fil- pakkett li ġejjin:
- A treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-
- Pakkett għall- bidu tal- kura li fih 2 folji; folja trasparenti ta '11 x CHAMPIX 0. 5 mg pilloli
coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
miksijin b' rita u folja trasparenti ta '14 x CHAMPIX 1 mg pilloli miksijin b' rita f' pakkett tal - kartun.
- A treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and
- Pakkett għall- bidu tal- kura li fih 2 folji; folja trasparenti ta ’ 11 x CHAMPIX 0. 5 mg u 14 x
14 x 1 mg film-coated tablets and 1 clear blister of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
1 mg pilloli miksija b’ rita u folja trasparenti ta ’ 28 x CHAMPIX 1 mg pilloli miksija b’ rita f’ pakkett tal- kartun.
- A follow-on (maintenance) pack containing 2 clear blisters of 14 x CHAMPIX 1 mg film-
- Pakkett ta 'kontinwazzjoni (manteniment) li fih 2 folji trasparenti ta' 14 x CHAMPIX 1 mg
coated tablets in card packaging.
pilloli miksijin b' rita f' pakkett tal- kartun.
- A follow-on (maintenance) pack containing 2 clear blisters of 28 x CHAMPIX 1 mg film-
- Pakkett ta 'kontinwazzjoni (manteniment) li fih 2 folji trasparenti ta' 28 x CHAMPIX 1 mg
- A follow-on (maintenance) pack containing 2 clear blisters of 14 x CHAMPIX 0.5 mg film-
- Pakkett ta 'kontinwazzjoni (manteniment) li fih 2 folji trasparenti ta' 14 x CHAMPIX 0. 5 mg
- A follow-on (maintenance) pack containing 2 clear blisters of 28 x CHAMPIX 0.5 mg film-
- Pakkett ta 'kontinwazzjoni (manteniment) li fih 2 folji trasparenti ta' 28 x CHAMPIX 0. 5 mg
coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
miksijin b' rita u folja trasparenti ta '14 x CHAMPIX 1 mg pilloli miksijin b' rita f' kaxxa.
coated tablets in a carton.
pilloli miksijin b' rita f' kaxxa.
- A follow-on (maintenance) pack containing 4 clear blisters of 14 x CHAMPIX 1 mg film-
- Pakkett ta 'kontinwazzjoni (manteniment) li fih 4 folji trasparenti ta' 14 x CHAMPIX 1 mg
- A follow-on (maintenance) pack containing 8 clear blisters of 14 x CHAMPIX 1 mg film-
- Pakkett ta 'kontinwazzjoni (manteniment) li fih 8 folji trasparenti ta' 14 x CHAMPIX 1 mg
- A sealed blue white HDPE bottle pack, with a child resistant screw cap, in a carton, containing
- Flixkun HDPE ta 'lewn abjad kaħlani ssiġillat, b' tapp bil- kamin reżistenti għat- tfal, f' kaxxa, li
56 x CHAMPIX 1 mg film-coated tablets.
fih 56 x CHAMPIX 1 mg pilloli miksijin b' rita.
56 x CHAMPIX 0.5 mg film-coated tablets.
fih 56 x CHAMPIX 0. 5 mg pilloli miksijin b' rita.
Marketing Authorisation Holder
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq
Manufacturer
63 Manifattur
35 D-89257 Illertissen Germany
35 D- 89257 Illertissen Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq.
This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar fi.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Tagħrif dettaljat dwar din il- mediċina huwa disponibbli fuq il- website ta 'l- Aġenzija Ewropea għall - Mediċini (EMEA): http: // www. emea. europea. eu /
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use
Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq
bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE) without outer carton
Flixkun (HDPE) Flixkun (HDPE) Flixkun (HDPE) Flixkun (HDPE) mingħajr il- kartuna ta ’ barra
24 tablets 100 tablets (2 x 50) 180 tablets 180 tablets
24 pillola 100 pillola (2 X 50) 180 pillola 180 pillola
Cholestagel 625 mg film-coated tablets
Cholestagel 625 mg pilloli miksijin b’ rita
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITATTIVA W KWANTITATTIVA
Each tablet contains 625 mg colesevelam (as hydrochloride).
Kull pillola fiha 625 mg colesevelam (bħala hydrochloride).
Film-coated tablet (tablet).
Pillola miksija b’ rita (pillola).
Off-white, capsule-shaped film-coated tablets imprinted with “ Cholestagel” on one side.
Pilloli off- wajt, miksijin b’ rita, forma ta ’ kapsula, li għandhom stampat Cholestagel fuq naħa waħda.
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.
Cholestagel mogħti flimkien ma ’ inibitur ta ’ 3- hydroxy- 3- methyl- glutaryl- coenzyme A (HMG - CoA) reductase (statin) jintuża bħala terapija aġġuntiva mad- dieta biex jipprovdi tnaqqis addizzjonali fil- livelli tal - kolesterol b’ lipoproteina ta ’ densità baxxa (LDL- C) f’ pazjenti adulti li għandhom iperkolesterolimja li mhix ikkontrollata b’ mod adekwat permezz ta ’ statin waħdu.
Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.
Cholestagel waħdu jintuża bħala terapija aġġuntiva mad- dieta għat- tnaqqis ta ’ livell għoli ta ’ total- kolesterol u LDL- C f‘ pazjenti adulti li għandhom iperkolesterolimja primarja iżolata, f’ każi fejn statin mhux meqjus li jgħodd għalihom jew li mhux ittolerat sewwa.
Posology Combination therapy
Pożoloġija Terapija Flimkien ma ’ mediċini oħra
The recommended dose of Cholestagel is 4 to 6 tablets per day.
Id- doża rrakkomandata ta ’ Cholestagel hi bejn 4 sa 6 pilloli kuljum.
The maximum recommended dose is 3 tablets taken twice per day with meals or 6 tablets taken once per day with a meal.
Id- doża massima rrakkomandata hi ta ’ 3 pilloli darbtejn kuljum ma ’ l- ikel jew 6 pilloli meħuda darba kuljum ma ’ l - ikla.
Clinical trials have shown that Cholestagel and atorvastatin, lovastatin or simvastatin can be co-administered or dosed apart.
Il- provi kliniċi wrew li Cholestagel u atorvastatin, lovastatin jew simvastatin jistgħu jingħataw flimkien jew waħidhom.
Monotherapy The recommended starting dose of Cholestagel is 3 tablets taken twice per day with meals or 6 tablets once per day with a meal.
Monoterapija Id- doża rrakkomandata tal- bidu ta ’ Cholestagel hi ta ’ 3 pilloli li jittieħdu darbtejn kuljum ma ’ l- ikel jew 6 pilloli darba kuljum ma ’ l- ikla.
The maximum recommended dose is 7 tablets per day.
Id- doża massima rrakkomandata hi 7 pilloli kuljum.
During therapy, the cholesterol-lowering diet should be continued, and serum total-C, LDL-C and triglyceride levels should be determined periodically during treatment to confirm favourable initial and adequate long-term responses.
Matul terapija, id- dieta li tnaqqas il- kolesterol għandha titkompla, u l- livelli ta ’ serum total- C, LDL- C u triglycerides għandhom jiġu stabbiliti perjodikament matul il- kura biex jiġu kkonfermati r- risponsi favorevoli inizjali u adegwati fit- tul.
When a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be administered at least four hours after the concomitant medication in order to minimize the risk of reduced absorption of the concomitant medication (see section 4.5).
Meta ma tkunx tista ’ tiġi eskluża interazzjoni tal- mediċina ma ’ prodott mediċinali li jintuża fl - istess ħin, Cholestagel għandu jingħata mill- inqas erba ’ sigħat wara li tittieħed il- mediċina fl- istess ħin biex jiġi jitnaqqas ir- riskju ta ’ tnaqqis fl - assorbiment tal- mediċina użata fl- istess ħin (ara sezzjoni 4. 5).
Elderly population There is no need for dose adjustment when Cholestagel is administered to elderly patients.
2 Popolazzjoni anzjana M’ hemmx bżonn ta ’ aġġustament fid- doża meta Cholestagel jingħata lill- pazjenti anzjani.
2 Paediatric population The safety and efficacy of Cholestagel have not been established in children and adolescent patients; therefore, the use of Cholestagel in these patient populations is not recommended.
Popolazzjoni pedjatrika Is- sigurtà u l- effikaċja ta ’ Cholestagel ma ġewx stabbiliti f’ pazjenti tfal u adolexxenti; għalhekk, l- użu ta Cholestagel f’ dawn il popolazzjinijet tal pazjenti mhux irrakkomandat.
Method of administration Cholestagel tablets should be taken orally with a meal and liquid.
Kif jingħata Il- pilloli Cholestagel għandhom jittieħdu mill- ħalq ma ’ l- ikel u max- xorb.
• Hypersensitivity to the active substance or to any of the excipients • Bowel or biliary obstruction
• Sensittivita ’ eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi • Imsaren jew kanali biljari imblukkati
4.4 Special warnings and special precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
Prior to initiating therapy with Cholestagel, if secondary causes of hypercholesterolaemia (i. e., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease) are considered, these should be diagnosed and properly treated.
Qabel ma tibda t- terapija b’ Cholestagel, jekk il- kawżi sekondarji ta ’ l- iperkolesterolimja (i. e., diabetes mellitus li mhix ikkontrollata tajjeb, ipotirojdiżmu, sindromu nefrotiku, disproteinimji, mard li jinvolvi sadd fil- fwied, terapija oħra farmakoloġika, alkoħoliżmu) huma kkunsidrati, dawn għandhom ikunu ddijanjostikati u kkurati kif suppost.
For patients on ciclosporin starting or stopping Cholestagel or patients on Cholestagel with a need to start ciclosporin:
Għal pazjenti li qed jieħdu ciclosporin li ser jibdew jew iwaqqfu Cholestagel, jew pazjenti li qed jieħdu Cholestagel li jeħtieġu jibdew ciclosporin:
Cholestagel reduces the bioavailability of ciclosporin (see also section 4.5).
Cholestagel inaqqas il- bijodisponibilità ta ’ ciclosporin (ara wkoll sezzjoni 4. 5).
Patients starting on ciclosporin already taking Cholestagel should have their ciclosporin blood concentrations monitored as normal and their dose adjusted as normal.
Pazjenti li ser jibdew ciclosporin u li diġà qed jieħdu Cholestagel, għandu jkollhom il- konċentrazzjonijiet ta ’ ciclosporin fid- demm tagħhom immonitorjati bħas- soltu u d- doża tagħhom aġġustata bħas- soltu.
Patients starting on Cholestagel already taking ciclosporin should have their blood concentrations monitored prior to combination therapy and frequently monitored immediately starting co-therapy with the ciclosporin dose adjusted accordingly.
Pazjenti li ser jibdew jieħdu Cholestagel u li diġà qed jieħdu ciclosporin, għandu jkollhom il- konċentrazzjonijiet tad- demm tagħhom immonitorjati qabel it- terapija kombinata u għandhom ikunu mmonitorjati b’ mod frekwenti immedjatament malli jibdew il- ko- terapija, u d- doża ta ’ ciclosporin għandha tkun aġġustata kif suppost.
It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations.
Wieħed għandu jinnota li t- twaqqif tat- terapija b’ Cholestagel jirriżulta f’ żieda fil- konċentrazzjonijiet ta ’ ciclosporin fid- demm.
Therefore, patients taking both ciclosporin and Cholestagel should have their blood concentrations monitored prior to and frequently after when Cholestagel therapy is stopped with their ciclosporin dose adjusted accordingly.
Għalhekk, il- pazjenti li jkunu qed jieħdu kemm ciclosporin kif ukoll Cholestagel għandu jkollhom il- konċentrazzjonijiet tad- demm tagħhom immonitorjati qabel, u mmonitorjati b’ mod frekwenti wara li t- terapija b’ Cholestagel titwaqqaf, u d- doża tagħhom ta ’ ciclosporin għandha tkun aġġustata kif suppost.
Caution should be exercised when treating patients with triglyceride levels greater than 3.4 mmol/ L due to the triglyceride increasing effect with Cholestagel.
Wieħed għandu joqgħod attent meta jkun qed jikkura pazjenti li għandhom il- livelli tat- trigliċeridi ta ’ aktar minn 3. 4 mmol/ L minħabba l- effett ogħla tat- trigliċeridi ma ’ Cholestagel.
Safety and efficacy are not established for patients with triglyceride levels greater than 3.4 mmol/ L, since such patients were excluded from the clinical studies.
Is- sigurtà u l- effikaċja mhumiex stabbiliti għall- pazjenti li għandhom livelli tat- trigliċeridi ta ’ aktar minn 3. 4 mmol/ L, għax dawn il- pazjenti tħallew barra mill- istudji kliniċi.
The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.
Is- sigurtà u l- effikaċja ta ’ Cholestagel f’ pazjenti li jbatu mill- disfaġja, li jsibuha bi tqila biex jibilgħu, problemi serji fil- motilità gastrointestinali, mard ta ’ infjamazzjoni fl- imsaren, insuffiċjenza tal- fwied, jew operazzjoni kbira tas- sistema gastrointestinali, ma ġewx stabbiliti.
Consequently, caution should be exercised when Cholestagel is used in patients with these disorders.
Għalhekk, wieħed għandu joqgħod attent meta Cholestagel jingħata lill- pazjenti li għandhom dawn il- problemi.
Cholestagel can induce or worsen present constipation.
Cholestagel jista ’ jikkawża l- istitikezza jew iġagħalha tmur għall- agħar.
The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.
Ir- riskju ta ’ l- istitikezza għandu aktar ikun meqjus fil- każ ta ’ pazjenti li jbatu minn mard koronjaru tal- qalb u angina pectoris.
Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants, like Cholestagel, have been shown to reduce absorption of vitamin K and therefore interfere with warfarin’ s anticoagulant effect (see also section 4.5).
3 It- terapija kontra l- koaġulazzjoni tad- demm għandha tkun monitorjata sewwa f’ pazjenti li qed jingħataw warfarin jew prodotti simili, għax hemm x’ juri li s- sekwestranti ta ’ l- aċidu tal- bili, bħal Cholestagel, inaqqsu l- assorbiment tal- vitamina K u għalhekk jfixxklu l- effett kontra l- koaġulazzjoni tad- demm ta ’ warfarin (ara wkoll sezzjoni 4. 5).
Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously.
Cholestagel jista ’ jaffettwa l- bijodisponibilità tal- pillola kontraċettiva orali meta jingħata fl- istess ħin.
It is important to ensure that Cholestagel is administered at least 4 hours after the oral contraceptive pill to minimise the risk of any interaction (see also section 4.5).
Hu importanti li tiżgura li Cholestagel jingħata mill- inqas 4 sigħat wara l- pillola kontraċettiva orali biex timminimizza r- riskju ta ’ kwalunkwe interazzjoni (ara wkoll sezzjoni 4. 5).
In general Cholestagel may affect the bioavailability of other medicinal products.
B’ mod ġenerali Cholestagel għandu mnejn jaffettwa l- bijodisponibiltà ta ’ prodotti mediċinali oħra.
Therefore when a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be
Għalhekk meta ma tistax tkun eskluża interazzjoni mediċinali ma ’ prodott mediċinali li jingħata fl- istess ħin, Cholestagel għandu jingħata ta ’ l- anqas erba ’ sigħat wara li tittieħed l- mediċina li tingħata fl- istess ħin biex jitnaqqas ir- riskju ta ’ tnaqqis fl- assorbiment tal- mediċina użata fl- istess ħin.
When administering medicinal products for which alterations in blood levels could have a clinically significant effect on safety or efficacy, physicians should consider monitoring serum levels or effects.
Meta jingħataw prodotti mediċinali fejn it- tibdil tal- livelli tad- demm jista ’ jkollu effetti klinikali sinifikanti fuq is- sigurtà u l- effikaċja, it- tobba għandhom iqisu jekk għandhomx jimmonitorjaw il- livelli fis- serum jew l- effetti.
Interaction studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott, saru biss fuq l- adulti.
In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin.
Skond studju ta ’ interazzjoni f’ voluntiera b’ saħħithom, Cholestagel ma kellu l- ebda effett fuq il- bijodisponibiltà ta ’ digoxin, metoprolol, quinidine, valproic acid, u warfarin.
Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
Cholestagel naqqas Cmax u l- AUC ta ’ verapamil, li jintreħa bil- mod, b’ madwar 31% u 11%, rispettivament.
Since there is a high degree of variability in the bioavailability of verapamil, the clinical significance of this finding is unclear.
Peress li hemm livell għoli ta ’ varjabilità fuq il- bijodisponibilità ta ’ verapamil, is- sinifikat kliniku ta ’ dan l- istudju mhux ċar.
There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin.
Kien hemm rapporti rari ħafna ta ’ tnaqqis fil- livelli ta ’ phenytoin f’ pazjenti li rċivew Cholestagel mogħti ma ’ phenytoin.
Anticoagulant therapy Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect.
Terapija kontra l- koagulazzjoni Terapija ta ’ kontra l- koaġulazzjoni tad- demm għandha tkun monitorjata bir- reqqa f’ pazjenti li qed jirċievu warfarin jew prodotti simili, għax hemm x’ juri li s- sekwestranti ta ’ l- aċidu tal- bili jnaqqsu l- assorbiment tal- vitamina K u għalhekk ifixxklu l- effett kontra l- koaġulazzjoni tad- demm ta ’ warfarin.
Specific clinical interaction studies with colesevelam and vitamin K have not been performed.
Ma sarux studji speċifiċi ta ’ interazzjoni klinika bejn colesevelam u vitamina K.
Levothyroxine In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour.
Levothyroxine Fi studju dwar l- interazzjoni f’ voluntiera b’ saħħithom, Cholestagel naqqas l- AUC u s- Cmax ta ’ levothyroxine meta ngħata fl- istess ħin jew wara siegħa.
No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
Ma kienet osservata l- ebda interazzjoni meta Cholestagel ingħata mill- inqas erba ’ sigħat wara levothyroxine.
Oral contraceptive pill In an interaction study in healthy volunteers, Cholestagel reduced the Cmax of norethindrone as well as the AUC and Cmax of ethinylestradiol when administered simultaneously with the oral contraceptive pill.
Pillola kontraċettiva orali Fi studju dwar l- interazzjoni f’ voluntiera b’ saħħithom, Cholestagel naqqas is- Cmax ta ’ norethindrone kif ukoll l- AUC u s- Cmax ta ’ ethinylestradiol meta ngħata fl- istess ħin mal- pillola kontraċettiva orali.
This interaction was also observed when Cholestagel was administered one hour after the oral contraceptive pill.
Din l- interazzjoni kienet osservata wkoll meta Cholestagel ngħata siegħa wara l- pillola kontraċettiva orali.
However no interaction was observed when Cholestagel was administered four hours after the oral contraceptive pill.
Madankollu l- ebda interazzjoni ma kienet osservata meta Cholestagel ingħata erba ’ sigħat wara l- pillola kontraċettiva orali.
Ciclosporin In an interaction study in healthy volunteers, co-administration of Cholestagel and ciclosporin significantly reduced the AUC0-inf and Cmax of ciclosporin by 34% by 44%, respectively.
Ciclosporin Fi studju dwar l- interazzjoni f’ voluntiera b’ saħħithom, l- għoti flimkien ta ’ Cholestagel u ciclosporin naqqas b’ mod sinifikanti l- AUC0- inf u s- Cmax ta ’ ciclosporin b’ 34% u 44%,
In addition, based on theoretical grounds Cholestagel should be administered at least 4 hours after ciclosporin in order to further minimise the risks related to the concomitant administration of ciclosporin and Cholestagel.
Għalhekk, għandu jingħata parir biex il- konċentrazjonijiet ta ’ ciclosporin fid- demm jiġu mmonitorjati mill- qrib (ara wkoll sezzjoni 4. 4).
Furthermore, Cholestagel should always be administered at the same times consistently since the timing of intake of Cholestagel and ciclosporin could theoretically influence the degree of reduced bioavailability of ciclosporin.
Flimkien ma ’ dan, ibbażat fuq raġunijiet teoretiċi, Cholestagel għandu jingħata mill- inqas 4 sigħat wara ciclosporin sabiex jitnaqqsu aktar ir- riskji marbuta mal- għoti fl- istess ħin ta ’ ciclosporin u Cholestagel.
Statins When Cholestagel was co-administered with statins in clinical studies, an expected add-on LDL-C lowering effect was observed, and no unexpected effects were observed.
Statins Meta Cholestagel ingħata ma ’ statins fi studji kliniċi, kien hemm effett miżjud fit- tnaqqis ta ’ LDL- C li kien mistenni, u ma kien hemm l- ebda effetti mhux mistennija.
Interaction studies with colesevelam in combination with pravastatin, rosuvastatin, or high dose HMG-CoA reductase inhibitors have not been performed.
Ma saru l- ebda studji ta ’ interazzjoni b’ colesevelam flimkien ma ’ pravastatin, rosuvastatin, jew doża għolja ta ’ inibituri ta ’ HMG- CoA reductase.
Antidiabetic agents Co-administration of Cholestagel and glyburide (also known as glibenclamide) caused a decrease in the AUC0-inf and Cmax of glyburide by 32% and 47%, respectively.
Mediċini kontra d- dijabete L- għoti flimkien ta ’ Cholestagel u glyburide (magħruf ukoll bħala glibenclamide) ikkawża tnaqqis fl- AUC0- inf u s- Cmax ta ’ glyburide bi 32% u 47%, rispettivament.
No interaction was observed when Cholestagel was administered four hours after glyburide.
Ma kienet osservata l- ebda interazzjoni meta Cholestagel ingħata erba ’ sigħat wara glyburide.
4 Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown.
Ir- rilevanza klinika ta ’ dan il- fatt mhijiex magħrufa.
No interaction was observed when Cholestagel was administered one hour after repaglinide.
Ma kienet osservata l- ebda interazzjoni meta Cholestagel ingħata siegħa wara repaglinide.
No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
Ma kienet osservata l- ebda interazzjoni meta Cholestagel u pioglitazone ingħataw fl- istess ħin f’ voluntiera b’ saħħithom.