qanastek/EMEA-V3 huggingface dataset:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance (see section 4.8).
Reazzjonijiet serji tal- ġilda, uħud minnhom fatali, inkluż dermatite esfoljattiva, is- sindrome ta ’ Stevens - Johnson, u nekroliżi epidermali tossika, ġew irrapportati fuq bażi rari ħafna f’ assoċjazzjoni ma ’ l- użu ta ’ NSAIDs u xi inibituri selettivi ta ’ COX- 2 matul sorveljanza ta ’ wara t- tqegħid fis- suq (ara sezzjoni 4. 8).
Patients appear to be at highest risk for these reactions early in the course of therapy with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Il - pazjenti jidhru li jkunu fl- akbar riskju għal dawn ir- reazzjonijiet kmieni fil- kors tal- kura bil- feġġa tar - reazzjoni sseħħ, fil- maġġoranza tal- każijiet, fl- ewwel xahar tal- kura.
Some selective COX- 2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Xi inibituri selettivi ta ’ COX- 2 ġew assoċjati ma ’ żieda fir- reazzjonijiet tal- ġilda f’ pazjenti bi storja ta ’ xi allerġija għal mediċina.
Etoricoxib may mask fever and other signs of inflammation.
Etoricoxib jista ’ jaħbi d- deni u sinjali oħrajn ta ’ infjammazzjoni.
The use of etoricoxib, as with any medicinal product known to inhibit cyclooxygenase / prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.6, 5.1, and 5.3).
L- użu ta ’ etoricoxib, bħal b’ kull prodott mediċinali ieħor magħruf li jinibixxi sinteżi ta ’ cyclooxygenase / prostaglandin, mhuwiex rakkomandat f’ nisa li jkunu qegħdin jipprovaw ikollhom it- tfal (ara sezzjonijiet 4. 6, 5. 1, u 5. 3).
< Etoricoxib > tablets contain lactose.
Il- pilloli ta ’ < Etoricoxib > fihom il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- glucose, Lapp lactase deficiency jew assorbiment ħażin ta ’ glucose- galactose ma għandhomx jieħdu din il- mediċina.
17 4.5 Interaction with other medicinal products and other forms of interaction
17 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l - effett farmaċewtiku tal- prodott
Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed (see section 4.4).
Għalhekk, il- pazjenti li jirċievu antikoagulanti orali għandhom jiġu mmonitorjati mill- qrib għall - prothrombin time INR tagħhom, b’ mod partikolari fl- ewwel ftit jiem meta tkun inbdiet il- kura b’ etoricoxib jew meta din tinbidel (ara sezzjoni 4. 4).
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Il- pazjenti għandhom jiġu idratati b’ mod adegwat u għandha tingħata kunsiderazzjoni għall- monitoraġġ tal- funzjoni renali wara l- bidu ta ’ terapija konkomittanti, u perjodikament minn hemm ’ il quddiem.
Although this interaction has not been studied with etoricoxib, coadministration of cyclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of cyclosporin or tacrolimus.
Għalkemm din l- interazzjoni ma ġietx studjata ma ’ etoricoxib, l- għoti fl- istess ħin ta ’ cyclosporin jew tacrolimus ma ’ kwalunkwe NSAID jista ’ jirriżulta f’ żieda fl- effett nefrotossiku ta ’ cyclosporin jew tacrolimus.
If necessary, monitor blood lithium closely and adjust the lithium dosage while the combination is being taken and when the NSAID is withdrawn.
Jekk ikun hemm bżonn, immonitorja l- litju tad- demm mill- qrib u aġġusta d- dożaġġ tal- litju waqt li l- kombinazzjoni tkun qiegħda tittieħed u waqt li jkun irtirat l- NSAID.
Methotrexate:
Methotrexate:
Etoricoxib at 60 and 90 mg had no effect on methotrexate plasma concentrations or renal clearance.
Etoricoxib f’ 60 u 90 mg ma kellu ebda effett fuq il- konċentrazzjonijiet tal- plasma jew fuq it - tneħħija mill- kliewi ta ’ methotrexate.
In one study, etoricoxib 120 mg had no effect, but in the other study, etoricoxib 120 mg increased methotrexate plasma concentrations by 28% and reduced renal clearance of methotrexate by 13%.
Fi studju wieħed, etoricoxib 120 mg ma kellu ebda effett, iżda fi studju ieħor, etoricoxib 120 mg żied il- konċentrazzjonijiet ta ’ plasma ta ’ methotrexate bi 28% u naqqas it - tneħħija mill- kliewi ta ’ methotrexate bi 13%.
An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e. g., venous thrombo-embolic events in women at risk).
Żieda fl -
18 Hormone Replacement Therapy (HRT):
18 espożizzjoni ta ’ EE tista ’ żżid l- inċidenza ta ’ episodji avversi assoċjati ma ’ kontraċettivi orali (eż. episodji trombo- emboliċi venużi f’ nisa li jkunu f’ riskju).
Administration of etoricoxib 120 mg with hormone replacement therapy consisting of conjugated estrogens (0.625 mg PREMARINTM) for 28 days, increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%), and 17-β -estradiol (22%).
L- għoti ta ’ etoricoxib 120 mg b’ terapija ta ’ sostituzzjoni ta ’ l- ormoni magħmula minn estroġeni konjugati (0. 625 mg PREMARINTM) għal 28 jum, naqqas l- AUC0- 24hr fl - istat fiss medju ta ’ estrone mhux konjugat (41%), equilin (76%), u 17- β- estradiol (22%).
These increases in estrogenic concentration should be taken into consideration when selecting post-menopausal hormone therapy for use with etoricoxib because the increase in oestrogen exposure might increase the risk of adverse events associated with HRT.
Dawn iż- żidiet fil- konċentrazzjoni estroġenika għandhom jiġu kkunsidrati meta tintagħżel terapija ta ’ l - ormoni ta ’ wara l- menopawża għal użu ma ’ etoricoxib minħabba li ż- żieda fl- espożizzjoni għall- oestroġenu tista ’ żżid ir- riskju ta ’ l- episodji avversi assoċjati ma ’ HRT.
Etoricoxib 120 mg administered once daily for 10 days to healthy volunteers did not alter the steady-state plasma AUC0-24hr or renal elimination of digoxin.
Etoricoxib 120 mg mogħti darba kuljum għal 10 ijiem lil voluntiera b’ saħħithom ma biddilx l - AUC0- 24hr tal- plasma fi stat fiss jew l- eliminazzjoni renali tad- digoxin.
While knowledge about effects of multiple sulfotransferases is presently limited and the clinical consequences for many drugs are still being examined, it may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases (e. g., oral salbutamol and minoxidil).
Filwaqt li fil- preżent, it- tagħrif dwar l- effetti ta ’ sulfotransferases multipli huwa limitat u l- konsegwenzi kliniċi għal bosta mediċini għad iridu jiġu eżaminati, jista ’ jkun prudenti li tiġi eżerċitata l- kawtela meta etoricoxib jingħata fl- istess ħin ma ’ mediċini oħrajn metabolizzati primarjament minn sulfotransferases umani (eż. salbutamol u minoxidil orali).
Effects of other drugs on the pharmacokinetics of etoricoxib
Effetti ta ’ mediċini oħrajn fuq il- farmakokinetiċi ta 'etoricoxib
In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can catalyse the main metabolic pathway, but their quantitative roles have not been studied in vivo.
Studji in vitro jindikaw li CYP2D6, CYP2C9, CYP1A2 u CYP2C19 ukoll jistgħu jikkatalizzaw il- mogħdija metabolika prinċipali, iżda l- irwoli kwantitattivi tagħhom ma ġewx studjati in vivo.
This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin.
Din l- interazzjoni tista ’ tirriżulta fir - rikorrenza tas- sintomi meta etoricoxib jingħata ma ’ rifampicin.
While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended (see section 4.2).
Filwaqt li din l- informazzjoni tista ’ tissuġġerixxi żieda fid- doża, dożi ta ’ etoricoxib ikbar minn dawk elenkati għal kull indikazzjoni ma ġewx studjati f’ kombinazzjoni ma ’ rifampicin u għalhekk mhumiex rakkomandati (ara sezzjoni 4. 2).
4.6 Pregnancy and lactation
19 4. 6 Tqala u Treddigħ
19 The use of etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.
L- użu ta ’ etoricoxib, bħal kull mediċina oħra magħrufa li tinibixxi COX- 2, mhuwiex rakkomandat f’ nisa li qegħdin jipprovaw ikollhom it- tfal.
In a clinical study for acute gouty arthritis, patients were treated with etoricoxib 120 mg once daily for eight days.
Fi studju kliniku għal artrite tal- gotta akuta, il- pazjenti ġew ikkurati b’ etoricoxib 120 mg darba kuljum għal tmint ijiem.
The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
Il- profil ta ’ l- esperjenza avversa f’ dan l- istudju kien ġeneralment simili għal dak irrapportat fl - OA, RA u studji dwar l- uġigħ kroniku fil- parti t’ isfel tad- dahar.
The safety data and details from this program are presented in section 5.1.
It- tagħrif tas- sigurtà u dettalji minn dan il- programm huma ppreżentati fis- sezzjoni 5. 1.
Very rare: hypersensitivity reactions, including angioedema, anaphylactic/ anaphylactoid reactions including shock.
Mhux komuni: gastroenterite, infezzjoni respiratorja fil- parti ta ’ fuq, infezzjoni fil- passaġġ awrinarju.
Metabolism and nutrition disorders:
Disturbi fis- sistema immunitarja:
Common: oedema/ fluid retention Uncommon: appetite increase or decrease, weight gain.
Rari ħafna: reazzjonijiet ta ’ sensittività eċċessiva, inkluż anġjoedema, reazzjonijiet anafilattiċi/ anafilaktojde inkluż xokk.
20 Psychiatric disorders:
20 Disturbi fil- metaboliżmu u n- nutrizzjoni:
Uncommon: anxiety, depression, mental acuity decreased.
Komuni: edema/ żamma ta ’ fluwidu Mhux komuni: żieda jew tnaqqis fl- aptit, żieda fil- piż
Very rare: hypertensive crisis.
Rari ħafna: kriżi ipertensiva.
Uncommon: proteinuria.
Mhux komuni: bugħawwiġ/ spażmi muskolari, uġigħ/ ebusija muskuloskeletali.
* Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
* Fuq il- bażi ta ’ provi kliniċi fuq perjodu ta ’ żmien twil ikkontrollati bi plaċebo u kkontrollati b’ mod attiv, inibituri COX- 2 selettivi ġew assoċjati ma ’ riskju miżjud ta ’ episodji arterjali trombotiċi, inkluż infart mijokardijaku u puplesija.
The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Iż- żieda fir- riskju assolut għal tali episodji mhijex mistennija li taqbeż 1% fis- sena abbażi ta ’ dejta eżistenti (mhux komuni).
21 General disorders and administration site conditions:
21 Disturbi fil- kliewi u fis- sistema urinarja:
Common: asthenia/ fatigue, flu-like disease.
Mhux komuni: proteinurja.
Uncommon: chest pain.
Rari ħafna: insuffiċjenza renali, inkluż indeboliment tal- kliewi, normalment riversibbli malli titwaqqaf il - kura (ara sezzjoni 4. 4).
Investigations:
Mhux komuni: uġigħ fis- sider.
Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.
Mhux komuni: żieda fin- nitroġenu fl- urea tad- demm, żieda fil- creatine phosphokinase, tnaqqis ematokritiku, tnaqqis fl- emoglobina, iperkalamija, tnaqqis fil- lewkoċiti, tnaqqis fil- pjastrini, żieda fil- kreatinina tas- serum, żieda fl- aċidu uriku.
In the event of overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Fil- każ ta ’ doża eċċessiva, jagħmel sens li jintużaw miżuri ta ’ appoġġ normali, eż. tneħħija ta ’ materjal li ma jkunx ġie assorbit mill- passaġġ GI, użu ta ’ monitoraġġ kliniku, u introduzzjoni ta ’ terapija ta ’ appoġġ, jekk ikun hemm bżonn.
Across clinical pharmacology studies ,< Etoricoxib > produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Tul studji farmakoloġiċi kliniċi, < Etoricoxib > ipproduċa inibizzjoni dipendenti fuq id- doża ta ’ COX- 2 mingħajr inibizzjoni ta ’ COX- 1 f’ dożi ta ’ mhux aktar minn 150 mg kuljum.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
COX- 2 hija l- isoformi ta ’ l- enzima li ntweriet li tiġi indotta minn stimuli pro - infjammatorji u ġiet postulata bħala li hija primarjament responsabbli għas- sinteżi ta ’ medjaturi prostanojde ta ’ l- uġigħ, infjammazzjoni u deni.
COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
22 ductus arteriosus, regolazzjoni tal- funzjoni renali, u funzjonijiet tas- sistema nervuża ċentrali (induzzjoni ta ’ deni, perċezzjoni ta ’ uġigħ u funzjonament konoxxittiv).
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
COX- 2 ġiet identifikata fit- tessut madwar ulċeri gastriċi fil- bniedem iżda r- relevanza tagħha għall- fejqan mill- ulċeri għadha ma ġietx stabbilita.
22 In patients with osteoarthritis (OA), etoricoxib 60 mg once daily provided significant improvements in pain and patient assessments of disease status.
F’ pazjenti b’ osteoartrite (OA), etoricoxib 60 mg darba kuljum ta titjib sinjifikanti fil- valutazzjonijiet ta ’ l - istatus tal- marda fir- rigward ta ’ l- uġigħ u tal- pazjent.
Pain relief was observed as early as four hours after initiation of treatment.
Is- serħan mill- uġigħ ġie osservat sa wara erba ’ sigħat mill- bidu tal - kura.
In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provided significant improvements in spine pain, inflammation, stiffness and function.
F’ pazjenti b’ ankylosing spondylitis, etoricoxib 90 mg darba kuljum ta titjib sinjifikanti fl- uġigħ ta ’ l- ispina, infjammazzjoni, ebusija u funzjoni.
The clinical benefit of etoricoxib was observed as early as the second day of therapy after initiation of treatment and was maintained throughout the 52-week treatment period.
Il- benefiċċju kliniku ta ’ etoricoxib ġie osservat sa mit- tieni jum wara l - bidu tal- kura u dan inżamm tul il- perjodu ta ’ 52 ġimgħa kollu.
In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing.
Fi studji mfasslin speċifikament sabiex ikejlu l- bidu ta ’ azzjoni ta ’ etoricoxib, il- bidu ta ’ l- azzjoni seħħ sa minn wara 24 minuta wara d- doża.
The EDGE study included 7111 OA patients treated with a dose of etoricoxib 90 mg daily (1.5 times the dose recommended for OA) or diclofenac 150 mg daily for a mean period of 9.1 months (maximum 16.6 months, median 11.4 months).
L- istudju EDGE nkluda 7111- il pazjent OA ikkurati b’ doża ta ’ etoricoxib 90 mg kuljum (1. 5 drabi d- doża rakkomandata għall- OA) jew diclofenac 150 mg kuljum għal perjodu medju ta ’ 9. 1 xhur (massimu 16. 6 xahar, medjan ta ’ 11. 4 xahar).
Overall Safety:
23 Sigurtà Ġenerali:
There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events.
Ma kien hemm ebda differenza sinjifikanti bejn etoricoxib u diclofenac fir- rata ta ’ episodji trombotiċi kardjovaskulari.
The incidence
Episodji gastrointestinali u epatiċi avversi ġew osservati b’ mod ferm aktar frekwenti b’ diclofenac milli b’ etoricoxib.
23 of adverse experiences in EDGE and EDGE II and of adverse experiences considered serious or resulting in discontinuation in the MEDAL study was higher with etoricoxib than diclofenac.
L- inċidenza ta ’ esperjenzi avversi f’ EDGE u EDGE II u ta ’ esperjenzi avversi meqjusin serji jew li jirriżultaw fi twaqqif ta ’ l- istudju MEDAL kienu ogħla b’ etoricoxib milli b’ diclofenac.
The rate of confirmed thrombotic cardiovascular serious adverse events (consisting of cardiac, cerebrovascular, and peripheral vascular events) was comparable between etoricoxib and diclofenac, and data are summarized in the table below.
Ir- rata ta ’ l- episodji avversi serji kardjovaskulari trombotiċi (li jikkonsistu minn episodji kardijaċi, ċerebrovaskulari u episodji vaskulari periferali) kienet komporabbli bejn etoricoxib u diclofenac, u t- tagħrif huwa mogħti fil- qosor fit- tabella t’ hawn taħt.
There were no statistically significant differences in thrombotic event rates between etoricoxib and diclofenac across all subgroups analyzed including patient categories across a range of baseline cardiovascular risk.
Ma kien hemm ebda differenza statistikament sinjifikanti fir - rati ta ’ episodji trombotiċi bejn etoricoxib u diclofenac fis- subgruppi kollha analizzati nkluż kategoriji ta ’ pazjenti tul firxa ta ’ riskji kardjovaskulari tal- linja bażi.
0.71 (0.61, 0.82) 0.69 (0.61, 0.78)
1. 05 (0. 93, 1. 19)
0.78 (0.68, 0.90) 0.70 (0.62, 0.79)
Per- protokoll 0. 71 (0. 61, 0. 82) Intenzjoni għall - 0. 69 (0. 61, 0. 78) kura Episodji Ċerebrovaskulari Kkonfermati
0.90 (0.74, 1.10) 0.99 (0.84, 1.17)
0. 78 (0. 68, 0. 90) 0. 70 (0. 62, 0. 79)
Confirmed Cerebrovascular Events
0. 90 (0. 74, 1. 10) 0. 99 (0. 84, 1. 17)
Per-protocol Intent-to-treat
Per- protokoll 0. 34 (0. 28, 0. 42) Intenzjoni għall - 0. 33 (0. 28, 0. 39) kura Episodji Vaskulari Periferali Kkonfermati
0.32 (0.25, 0.40) 0.29 (0.24, 0.35)
0. 32 (0. 25, 0. 40) 0. 29 (0. 24, 0. 35)
1.08 (0.80, 1.46) 1.12 (0.87, 1.44)
1. 08 (0. 80, 1. 46) 1. 12 (0. 87, 1. 44)
Per-protocol Intent-to-treat †
Per- protokoll 0. 20 (0. 15, 0. 27) Intenzjoni għall - 0. 24 (0. 20, 0. 30) kura †
CV mortality, as well as overall mortality, was similar between the etoricoxib and diclofenac treatment groups.
24 Il- mortalità CV, kif ukoll il- mortalità in ġenerali, kienet simili bejn il- grupp bil- kura b’ etoricoxib u dak bil - kura b’ diclofenac
Approximately 50% of patients enrolled in the MEDAL study had a history of hypertension at baseline.
Bejn wieħed u ieħor 50% tal- pazjenti rreġistrati fl- istudju MEDAL kellhom storja ta ’ pressjoni għolja fil - linja bażi.
The incidence of congestive heart failure adverse events (discontinuations and serious events) occurred at similar rates on etoricoxib 60 mg compared to diclofenac 150 mg but was higher for etoricoxib 90 mg compared to diclofenac 150 mg (statistically significant for 90 mg etoricoxib vs.
L- inċidenza ta ’ episodji avversi ta ’ kollass konġestiv tal- qalb (twaqqif u episodji serji) seħħew f’ rati simili fuq etoricoxib 60 mg meta mqabbel ma ’ diclofenac 150 mg iżda kienet ogħla għal etoricoxib 90 mg meta mqabbel ma ’ diclofenac 150 mg (statistikament sinjifikanti għal 90 mg etoricoxib vs.
The incidence of confirmed congestive heart failure adverse events (events that were serious and resulted in hospitalisation or a visit to an emergency department) was non-significantly higher with etoricoxib than diclofenac 150 mg, and this
L - inċidenza ta ’ episodji avversi ta ’ kollass konġestiv tal- qalb ikkonfermati (episodji li kienu serji u rriżultaw f’ kura l- isptar jew fi żjara f’ dipartiment ta ’ l- emerġenza) kienet ogħla iżda mhux b’ mod sinjifikanti b’ etoricoxib milli b’ diclofenac 150 mg, u dan l- effett kien dipendenti fuq id- doża.
In the individual MEDAL Program studies, for etoricoxib (60 mg or 90 mg), the absolute incidence of discontinuation in any treatment group was up to 2.6% for hypertension, up to 1.9% for edema, and up to 1.1% for congestive heart failure, with higher rates of discontinuation observed with etoricoxib 90 mg than etoricoxib 60 mg.
Fl- istudji tal- Programm MEDAL individwali, għal etoricoxib (60 mg jew 90 mg), l- inċidenza assoluta ta ’ waqfien fi kwalunkwe grupp ta ’ kura kien sa 2. 6% għal pressjoni għolja, sa 1. 9% għal edema, u sa 1. 1% għal kollass konġestiv tal- qalb, b’ rati ogħla ta ’ waqfien osservati b’ etoricoxib 90 mg milli b’ etoricoxib 60 mg.
The subset of overall upper GI events considered complicated included perforations, obstructions, and complicated bleeding; the subset of upper GI events considered uncomplicated included uncomplicated bleeds and uncomplicated ulcers.
Is- subsett ta ’ l- episodji GI ta ’ fuq ġenerali meqjusin bħala kkumplikati kien jinkludi perforazzjonijiet, ostruzzjonijiet u fsada kkomplikata; is- subsett ta 'episodji GI ta' fuq meqjusin bħala mhux ikkumplikati inkludew fsada mhux ikkumplikata u ulċeri mhux ikkumplikati.
For the subset of upper GI hemorrhage events (complicated and uncomplicated combined), there was no significant difference between etoricoxib and diclofenac.
Għas- subsett ta ’ episodji ta ’ emorraġija GI ta ’ fuq (ikkumplikati u mhux ikkumplikati flimkien), ma kien hemm ebda differenza sinjifikanti bejn etoricoxib u diclofenac.
MEDAL Program Hepatic Safety Results:
25 Ir- Riżultati tas- Sigurtà Epatika tal- Programm MEDAL:
However, most hepatic adverse experiences in the MEDAL Program were non-serious.
Madankollu, ħafna mill- esperjenzi avversi epatiċi fil- Programm MEDAL ma kinux serji.
There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥ 60 mg, placebo, or non- naproxen NSAIDs.
Ma kien hemm ebda differenza kbira fir- rata ta ’ episodji kardjovaskulari trombotiċi serji kkonfermati bejn pazjenti li rċevew etoricoxib ≥60 mg, plaċebo, jew NSAIDs mhux naproxen.
Selective COX-2 inhibitors reduce the formation of systemic (and therefore
Id- differenza fl- attività kontra l- pjastrini bejn xi NSAIDs li jinibixxu COX- 1 u inibituri COX- 2 selettivi tista ’ tkun ta ’ sinjifikat klinikali f’ pazjenti f’ riskju ta ’ episodji trombo- emboliċi.
25 possibly endothelial) prostacyclin without affecting platelet thromboxane.
Inibituri COX- 2 selettivi jnaqqsu l- formazzjoni ta ’ prostacyclin sistemiku (u għalhekk possibbilment endoteljali) mingħajr ma jaffettwaw it- thromboxane tal - pjastrini.
Additional Gastrointestinal Safety Data In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Tagħrif Addizzjonali dwar is- Sigurtà Gastrointestinali F’ żewġ studji ta ’ endoskopija double- blind ta ’ 12- il ġimgħa, l- inċidenza kumulattiva ta ’ ulċerazzjoni gastroduwodenali kienet ferm inqas fil- pazjenti kkurati b’ etoricoxib 120 mg darba kuljum milli f’ pazjenti kkurati jew b’ naproxen 500 mg darbtejn kuljum jew b’ ibuprofen 800 mg tliet darbiet kuljum.
Renal Function Study in the Elderly A randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of 15 days of treatment of etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) and placebo on urinary sodium excretion, blood pressure, and other renal function parameters in subjects 60 to 85 years of age on a 200-mEq/ day sodium diet.
L- Istudju dwar il- Funzjoni Renali fl- Anzjani Studju bi grupp parallel, ikkontrollat bi plaċebo, double- blind, randomizzat evalwa l- effetti ta '15- il jum ta ’ kura ta ’ etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) u plaċebo fuq it- tneħħija ma ’ l - awrina tas- sodju, pressjoni tad- demm, u parametric oħrajn tal- funzjoni renali f’ suġġetti ta ’ bejn 60 u 85 sena fuq dieta ta ’ sodju ta ’ 200- mEq/ kuljum.
Etoricoxib, celecoxib, and naproxen had similar effects on urinary sodium excretion over the 2 weeks of treatment.
Etoricoxib, celecoxib, u naproxen kellhom effetti simili fuq it - tneħħija tas- sodju ma ’ l- awrina fuq iż- 2 ġimgħat tal- kura.
Metabolism Etoricoxib is extensively metabolised with < 1% of a dose recovered in urine as the parent drug.
26 Metaboliżmu Etoricoxib huwa metabolizzat b’ mod estensiv b ’ < 1% tad- doża rkuprata fl- awrina bħala l- mediċina prinċipali.
These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors.
Dawn il- metaboliti prinċipali jew ma juru ebda attività li titkejjel jew huma biss attivi b’ mod debboli bħala inibituri ta ’ COX- 2.
Elimination Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Eliminazzjoni Wara għoti ta ’ doża ġol- vini radju- tikkettjata ta ’ 25 mg waħdanija ta ’ etoricoxib lil suġġetti b’ saħħithom, 70% tar- radju- attività ġiet irkuprata fl- awrina u 20% fil- feċi, l- aktar bħala metabolite.
26 Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion.
L- eliminazzjoni ta ’ etoricoxib isseħħ kważi esklussivament permezz ta ’ metaboliżmu segwit minn tneħħija mill- kliewi.
Etoricoxib was not carcinogenic in mice.
Etoricoxib ma kienx karċinoġeniku fil - ġrieden.
Rats developed hepatocellular and thyroid follicular cell adenomas at > 2-times the daily human dose [90 mg] based on systemic exposure when dosed daily for approximately two years.
Il- firien żviluppaw adenomi epatoċellulari u taċ- ċelloli follikulari tat- tirojde bi kważi > darbtejn id - doża umana ta ’ kuljum [90 mg] abbażi ta ’ espożizzjoni sistemika meta ddożati kuljum għal madwar sentejn.
Hepatocellular and thyroid follicular cell adenomas observed in rats are considered to be a consequence of rat-specific mechanism related to hepatic CYP enzyme induction.
27 konsegwenza ta ’ mekkaniżmu speċifiku għall- firien relatat ma ’ induzzjoni ta ’ enzim CYP tal- fwied.
Etoricoxib has not been shown to cause hepatic CYP3A enzyme induction in humans.
Etoricoxib ma ntweriex li jikkawża induzzjoni ta ’ enzim CYP3A epatiku fil- bniedem.
In the 14-week toxicity study etoricoxib caused gastrointestinal ulcers at exposures greater than those seen in man at the therapeutic dose.
Fl- istudju ta ’ 14- il ġimgħa, etoricoxib ikkawża ulċeri gastrointestinali f’ espożizjonijiet ogħla minn dawk li dehru fuq il- bniedem fid- doża terapewtika.
In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
Fl- istudju tat- tossiċità ta ’ 53 ġimgħa u ta ’ 106 ġimgħa, ulċeri gastrointestinali dehru wkoll f’ espożizzjonijiet komparabbli ma ’ dawk li dehru fil- bniedem fid- doża terapewtika.
In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg).
Fil - fniek, żieda relatata mal- kura f’ malformazzjonijiet kardjovaskulari ġiet osservata f’ livelli ta ’ espożizzjoni taħt l- espożizzjoni klinika fid- doża umana ta ’ kuljum (90 mg).
However no treatment-related external or skeletal foetal malformations were observed.
Madankollu, ebda malformazzjoni fetali esterna jew skeletali relatata mal- kura ma ġiet osservata.
In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
F’ firien u fniek, kien hemm żieda dipendenti fuq id- doża f’ telf ta 'wara l- impjantazzjoni f' espożizzjonijiet ikbar minn jew daqs 1. 5 drabi l- espożizzjoni umana (ara sezzjonijiet 4. 3 u 4. 6).
27 Etoricoxib is excreted in the milk of lactating rats at concentrations approximately two-fold those in plasma.
Etoricoxib jitneħħa fil- ħalib ta ’ firien li jreddgħu f’ konċentrazzjonijiet ta ’ madwar darbtejn dawk fil- plasma.
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali għall- ħażna
No special requirements.
Ebda rekwiżit speċjali.
29 LABELLING
29 TIKKETTA
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MIEGĦU
< Etoricoxib containing medicinal products (see Annex 1) > 30 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 60 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 90 mg film-coated tablets < Etoricoxib containing medicinal products (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 30 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 60 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 90 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 120 mg pilloli miksijin b’ rita [Ara l- Anness I – Għandha timtela fuq livell nazzjonali]
60 mg – 90 mg -120mg 2 Film coated tablets 5 Film-coated tablets 7 Film-coated tablets 10 Film-coated tablets 14 Film-coated tablets 20 Film-coated tablets 28 Film-coated tablets 30 Film-coated tablets 50 Film-coated tablets 84 Film-coated tablets 98 Film-coated tablets 100 Film-coated tablets 50 Film-coated tablets (unit dose) 100 Film-coated tablets (unit dose) 30 Film-coated tablets (HDPE bottles) 90 Film-coated tablets (HDPE bottles)
60 mg – 90 mg - 120mg 2 Pilloli miksijin b’ rita 5 Pilloli miksijin b’ rita 7 Pilloli miksijin b’ rita 10 Pilloli miksijin b’ rita 14- il Pillola miksija b’ rita 20 Pillola miksija b’ rita 28 Pillola miksija b’ rita 30 Pillola miksija b’ rita 50 Pillola miksija b’ rita 84 Pillola miksija b’ rita 98 Pillola miksija b’ rita 100 Pillola miksija b’ rita 50 Pillola miksija b’ rita (doża singola) 100 Pillola miksija b’ rita (doża singola) 30 Pillola miksija b’ rita (Fliexken HDPE) 90 Pillola miksija b’ rita (Fliexken HDPE)
GENERAL CLASSIFICATION FOR SUPPLY 32 [To be completed nationally]
[Għandha timtela fuq livell nazzjonali]
< Etoricoxib containing medicinal products (see Annex 1) > 30 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 60 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 90 mg film-coated tablets < Etoricoxib containing medicinal products (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 30 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 60 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 90 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 120 mg pilloli miksijin b’ rita [Ara Anness I – Li għandha timtela fuq livell nazzjonali]
< Etoricoxib containing medicinal products (see Annex 1) > 60 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 90 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
ARCOXIA (ara l- Anness 1) 60 mg pilloli miksijin b’ rita ARCOXIA (ara l- Anness 1) 90 mg pilloli miksijin b’ rita ARCOXIA (ara l- Anness 1) 120 mg pilloli miksijin b’ rita
35 PACKAGE LEAFLET
35 FULJETT TA ’ TAGĦRIF
< Etoricoxib containing medicinal products (see Annex I) > 30 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex I) > 60 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex I) > 90 mg film-coated tablets < Etoricoxib containing medicinal products (see Annex I) > 120 mg film-coated tablets
Prodotti mediċinali li fihom Etoricoxib (ara l- Anness I) 30 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness I) 60 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness I) 90 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness I) 120 mg pilloli miksijin b’ rita
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
Din il- mediċina ġiet mogħtija lilek.
What< Etoricoxib > is and what it is used for 2.
X’ inhu < Etoricoxib > u għalxiex jintuża 2.
Before you take< Etoricoxib > 3.
Qabel ma tieħu < Etoricoxib > 3.
How to take< Etoricoxib > 4.
Kif għandek tieħu < Etoricoxib > 4.
How to store< Etoricoxib > 6.
Kif taħżen < Etoricoxib > 6.
WHAT< Etoricoxib > IS AND WHAT IT IS USED FOR
X' INHU < Etoricoxib > U GĦALXIEX JINTUŻA
• < Etoricoxib > is one of a group of medicines called selective COX-2 inhibitors.
Etoricoxib huwa wieħed minn grupp ta ’ mediċini msejħa inibituri selettivi COX- 2.
These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • < Etoricoxib > helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Etoricoxib jgħin biex inaqqas l- uġigħ u n- nefħa (infjammazzjoni) fil- ġogi u l- muskoli ta ’ persuni li jbatu bl- osteoartrite, l- artrite rewmatojde, ankylosing spondylitis u l- gotta.
It results from the gradual breakdown of cartilage that cushions the ends of the bones.
Din tirriżulta mill- kollass gradwali tal- qarquċa li tipproteġi t- truf ta ’ l - għadam.
Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints.
Il- gotta hija marda ta ’ attakki għal għarrieda u rikorrenti ta 'infjammazzjoni li ġġib uġigħ kbir u ħmura fil - ġogi.
BEFORE YOU TAKE< Etoricoxib >
QABEL TIEĦU < Etoricoxib >
Do not take< Etoricoxib >: • if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of < Etoricoxib > (see Further information, section 6) • if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4) • if you have a current stomach ulcer or bleeding in your stomach or intestines • if you have serious liver disease • if you have serious kidney disease • if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and breast feeding’) • if you are under 16 years of age • if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis • if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including mini- stroke, transient ischaemic attack or TIA).
Tiħux < Etoricoxib >: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal etoricoxib jew għal xi sustanza oħra ta ’ < Etoricoxib > (ara Aktar tagħrif, sezzjoni 6) • jekk inti allerġiku għal mediċini anti- infjammatorji mhux sterojdi (NSAIDs), inkluż aspirina u inibituri COX- 2 (ara Effetti Sekondarji Possibbli, sezzjoni 4) • jekk bħalissa għandek ulċera fl- istonku jew fsada fl- intestini jew fl- istonku tiegħek • jekk għandek marda serja fil- fwied • jekk għandek marda serja fil- kliewi • jekk inti tqila jew taħseb li tista ’ tkun tqila jew inkella qegħda tredda ’ (ara ‘ Tqala u treddigħ ’) • jekk inti għandek inqas minn 16- il sena • jekk għandek marda infjammatorja ta 'l- imsaren, bħall- Marda ta ’ Crohn, Kolite Ulċerattiva jew Kolite • jekk it- tabib tiegħek ikun iddijanjostika problemi tal- qalb inkluż kollass tal- qalb (tipi moderati jew severi), anġina (uġigħ fis- sider) jew jekk kellek attakk tal- qalb, kirurġija tal- bypass, marda arterjali periferali (ċirkolazzjoni batuta fir- riġlejn jew fis- saqajn minħabba arterji dojoq jew imblokkati), jew kwalunkwe tip ta' puplesija (inkluż mini- puplesija, attakk iskemiku temporanju jew TIA).
Take special care with< Etoricoxib > < Etoricoxib > may not be suitable for you, or you may need to be monitored regularly while taking it if any of the following apply to you:
Oqgħod attent ħafna b '< Etoricoxib > Etoricoxib jista ’ ma jkunx tajjeb għalik, jew jista' jkun hemm bżonn li inti tkun immonitorjat regolarment meta tkun qed tieħdu jekk xi punt minn dawn li ġejjin japplika għalik:
These can increase your risk of heart disease.
• Għandek storja ta ’ fsada fl- istonku jew ta ’ ulċeri. • Jekk inti de- idrat, per eżempju minn attakk ta ’ rimettar jew dijarrea. • Għandek nefħa minħabba żamma ta ’ fluwidi. • Għandek storja ta ’ kollass tal- qalb, attack tal- qalb jew xi forma oħra ta ’ mard tal- qalb. • Għandek storja ta ’ puplesija jew ta ’ mini puplesija. • Għandek storja ta ’ pressjoni għolja tad- demm. < Etoricoxib > jista ’ jżid il- pressjoni tad- demm f’ xi nies, b’ mod speċjali f’ dożi għoljin, u t- tabib tiegħek ikun irid jara l- pressjoni tad- demm tiegħek minn żmien għal żmien. • Għandek xi storja ta ’ mard tal- fwied jew tal- kliewi. • Qed tiġi kkurat/ a għal infezzjoni. < Etoricoxib > jista ’ jaħbi deni, li huwa sinjal ta ’ infezzjoni. • Inti mara li tixtieq tinqabad tqila. • Inti anzjan/ a (jiġifieri għandek aktar minn 65 sena). • Għandek id- dijabete, kolesterol għoli, jew tpejjep Dawn jistgħu jżidu r- riskju ta ’ mard tal- qalb tiegħek.
If you are not sure if any of the above apply to you, talk to your doctor before taking< Etoricoxib > to see if this medicine is suitable for you.
Jekk m’ intix ċert jekk xi punt minn dawn t’ hawn fuq japplikax għalik, kellem lit- tabib tiegħek qabel tieħu Etoricoxib biex tara jekk din il- mediċina hijiex tajba għalik.
< Etoricoxib > works equally well in older and younger adult patients.
Etoricoxib jaħdem tajjeb kemm fuq pazjenti anzjani kif ukoll fuq pazjenti adulti iżgħar fl- età.
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.
38 Meta tuża medicini oħra Jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
38 In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking< Etoricoxib >:
B’ mod partikolari, jekk qed tieħu xi mediċini minn dawn li ġejjin, it- tabib tiegħek ikun irid jimmonitorjak sabiex jara li l- mediċini tiegħek qegħdin jaħdmu sew, ladarba tibda tieħu < Etoricoxib >:
• medicines that thin your blood (anticoagulants), such as warfarin • rifampicin (an antibiotic) • methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis) • medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan • lithium (a medicine used to treat some types of depression) • diuretics (water tablets) • ciclosporin or tacrolimus (drugs used for suppressing the immune system) • digoxin (a medicine for heart failure and irregular heart rhythm) • minoxidil (a drug used to treat high blood pressure) • salbutamol tablets or oral solution (a medicine for asthma) • birth control pills • hormone replacement therapy • aspirin, the risk of stomach ulcers is greater if you take< Etoricoxib > with aspirin. - < Etoricoxib > can be taken with low-dose aspirin.
• mediċini li jraqqu d- demm tiegħek (antikoagulanti), bħall- warfarina • rifampicin (antibijotiku) • methotrexate (mediċina użata għat- trażżin tas- sistema immunitarja, u spiss użata f’ artrite rewmatojde) • mediċini użati biex jgħinu jikkontrollaw pressjoni tad- demm għolja u indeboliment tal- qalb imsejħin inibituri ACE u imblokkaturi ta ’ riċetturi angiotensin, eżempji jinkludu enalapril u ramipril, u losartan u valsartan • litju (mediċina użata sabiex tikkura xi tipi ta ’ dipressjoni) • dijuretiċi (pilloli ta ’ l- ilma) • ciclosporin jew tacrolimus (mediċini użati għat- trażżin tas- sistema immunitarja) • digoxin (mediċina għall- kollass tal- qalb u għal ritmu irregolari tal- qalb) • minoxidil (mediċina wżata biex tikkura pressjoni tad- demm għolja) • pilloli salbutamol jew soluzzjoni orali (mediċina għall- ażżma) • pilloli ta ’ kontroll tat- twelid • terapija ta ’ sostituzzjoni ta ’ l- ormoni • aspirina, ir- riskju ta ’ ulċeri fl- istonku huwa ikbar jekk tieħu < Etoricoxib > ma ’ l- aspirina.
If you are currently taking low-dose aspirin to prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor -do not take high dose aspirin or other anti-inflammatory medicines while taking< Etoricoxib >
baxxa biex timpedixxi attakki tal- qalb jew puplesija, ma għandekx tieqaf tieħu aspirina sakemm tkellem lit- tabib tiegħek
Pregnancy and breast-feeding< Etoricoxib > tablets must not be taken during pregnancy.
Tqala u treddigħ Il- pilloli ta ’ < Etoricoxib > ma għandhomx jintużaw waqt tqala.
If you become pregnant, stop taking the tablets and consult your doctor.
Jekk toħroġ tqila, waqqaf il- pilloli u kellem lit- tabib tiegħek.
It is not known if< Etoricoxib > is excreted in human milk.
Mhuwiex magħruf jekk < Etoricoxib > joħroġx fil- ħalib uman.
If you are breast-feeding, or planning to breast- feed, consult your doctor before taking< Etoricoxib >.
Jekk qegħda tredda ’, jew jekk qegħda tippjana li tredda ’, ikkonsulta mat- tabib tiegħek qabel tieħu < Etoricoxib >.
If you are using< Etoricoxib >, you must not breast- feed.
Jekk qegħda tuża < Etoricoxib >, ma għandekx tredda ’.
Driving and using machines Dizziness and sleepiness have been reported in some patients taking< Etoricoxib >.
Sewqan u tħaddim ta ’ magni Sturdament u ħedla ġew irrapportati f’ xi pazjenti li kienu qegħdin jieħdu < Etoricoxib >.
Important information about some of the ingredients of< Etoricoxib > < Etoricoxib > contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta '< Etoricoxib > Etoricoxib fih lactose.
HOW TO TAKE< Etoricoxib >
KIF TIEĦU < Etoricoxib >
Always take< Etoricoxib > exactly as your doctor has told you.
Dejjem għandek tieħu < Etoricoxib > eżatt kif jgħidlek it- tabib tiegħek.
< Etoricoxib > Tablets should not be taken by children or adolescents under 16 years of age.
Il- Pilloli ta ’ < Etoricoxib > ma għandhomx jittieħdu mit- tfal jew mill- adoloxxenti li għandhom inqas minn 16- il sena.
Take< Etoricoxib > Tablets by mouth once a day. < Etoricoxib > can be taken with or without food.
Ħu l- Pilloli ta ’ < Etoricoxib > mill- ħalq darba kuljum. < Etoricoxib > jista ’ jittieħed bi jew mingħajr ikel.
Do not take more than the recommended dose for your condition.
39 Tiħux aktar mid- doża rakkomandata għall- kundizzjoni tiegħek.
Your doctor will want to discuss your treatment from time to time.
It- tabib tiegħek ikun irid jiddiskuti l- kura tiegħek minn żmien għall- ieħor.
It is important that you use the lowest dose that controls your pain and you should not take< Etoricoxib > for longer than necessary.
Huwa importanti li tuża l- iżgħar doża li tikkontrolla l- uġigħ tiegħek u ma għandekx tieħu < Etoricoxib > għal perjodu ta 'żmien itwali milli jkun hemm bżonn.
39 Osteoarthritis The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Osteoartrite Id- doża rakkomandata hija 30 mg darba kuljum, miżjuda għal massimu ta ’ 60 mg darba kuljum jekk ikun hemm bżonn.
If you take more< Etoricoxib > than you should You should never take more tablets than the doctor recommends.
Jekk tuża aktar < Etoricoxib > milli suppost Qatt ma għandek tieħu iktar pilloli milli jgħidlek it- tabib.
If you do take too many< Etoricoxib > tablets, you should seek medical attention immediately.
Jekk tieħu wisq Pilloli < Etoricoxib >, għandek tmur tfittex attenzjoni medika minnufih.
If you forget to take< Etoricoxib > It is important to take< Etoricoxib > as your doctor has prescribed.
Jekk tinsa tieħu < Etoricoxib > Dejjem għandek tieħu < Etoricoxib > skond il- parir tat- tabib.
Like all medicines ,< Etoricoxib > can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, < Etoricoxib > jista ’ jkollu effetti mhux mixtieqa, għalkemm ma jidhrux fuq kulħadd.
If you develop any of these signs you should stop< Etoricoxib > and talk to your doctor immediately: • shortness of breath, chest pains, or ankle swelling appear or if they get worse • yellowing of the skin and eyes (jaundice) – these are signs of liver problems • severe or continual stomach pain or your stools become black • an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing
Jekk tiżviluppa kwalunkwe sinjal minn dawn, għandek tieqaf tieħu < Etoricoxib > u għandek tkellem lit- tabib tiegħek minnufih: • jekk tesperjenza qtugħ ta ’ nifs, uġigħ fis- sider, jew nefħa fl- għekiesi jew jekk dawn imorru għall - agħar • il- ġilda u l- għajnejn jisfaru (suffejra) – dawn huma sinjali ta ’ problemi fil- fwied • uġigħ sever jew kontinwu fl- istonku jew jekk l- ippurgar tiegħek isir iswed • reazzjoni allerġika – li tista ’ tinkludi problem ital- ġilda bħal ulċeri jew infafet, jew nefħa tal- wiċċ, xofftejn, ilsien, jew gerżuma li tista ’ tikkawża diffikultà fit- teħid tan- nifs
The following side effects can occur during treatment with< Etoricoxib >:
L- effetti sekondarji li ġejjin jistgħu jseħħu matul trattament b ’ < Etoricoxib >:
Common (occurring in greater than 1 out of 100 and less than 1 out of 10 people) Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind, nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn, changes in blood tests related to your liver, swelling of the legs and/ or feet due to fluid retention (oedema), increased blood pressure, palpitations, bruising.
Komuni (li jseħħu f’ aktar minn persuna 1 minn kull 100 u f’ inqas minn persuna 1 minn kull 10)
Uncommon (occurring in greater than 1 out of 1000 and less than 1 out of 100 people) Stomach or bowel bloating, chest pain, heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection, high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers, taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable bowel syndrome, inflammation of the esophagus, blurred vision, eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight gain, muscle cramp/ spasm, muscle pain/ stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety, depression, 40 decreases in mental sharpness, breathlessness, cough, swelling of the face, flushing, skin rash or itchy skin, urinary tract infection.
Mhux komuni (li jseħħu f’ aktar minn persuna 1 minn kull 1000 u f’ inqas minn persuna 1 minn kull 100) Nefħa fl- istonku jew fl- imsaren, uġigħ fis- sider, kollass tal- qalb, attakk tal- qalb, puplesija, puplesija ħafifa (attakk iskemiku temporanju), rittmu tal- qalb anormali (fibrillazzjoni atrijali), infezzjoni fil- parti respiratorja ta ’ fuq, livelli għoljin ta ’ potassju f’ demmek, tibdil fit- testijiet tad- demm u ta ’ l- awrina relatat mal- kliewi tiegħek, tibdil fil- mod kif jaħdmu l- imsaren inkluż stitikezza, ħalq xott, ulċeri tal- ħalq, tibdil fit- togħma, gastroenterite, gastrite, ulċera fl- istonku, tħossok ma tiflaħx (rimettar), is- sindrome ta ’ l- imsaren irritabbli, infjammazjoni ta ’ l- esofagu, viżta mċajpra, irritazzjoni u ħmura ta ’ l- għajn, fsada fl- imnieħer, ċempil fil - widnejn, vertiġini, żieda jew tnaqqis fl- aptit, żieda fil- piż, bugħawwiġ/ spażmi fil- muskoli, uġigħ/ ebusija fil - muskoli, inabilità biex torqod, ħedla, tirżih jew tagħrix, ansjetà, dipressjoni, tnaqqis fil- prontezza mentali, nuqqas ta 'nifs, sogħla, nefħa tal- wiċċ, ħmura fil- wiċċ, raxx tal- ġilda jew ħakk fil- ġilda, infezzjoni fil - passaġġ urinarju.