qanastek/EMEA-V3 huggingface dataset:
Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
L- età ma kellhiex impatt klinikament sinifikanti fuq il- farmakokinetika ta ’ sitagliptin ibbażat fuq analiżi farmakokinetika ta ’ popolazzjoni ta ’ dejta Fażi I u Fażi II.
Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Suġġetti anzjani (65 sa 80 sena) kellhom konċentrazzjonijiet ta ’ sitagliptin fil - plażma madwar 19% aktar għoljin meta mqabbla ma ’ suġġetti iżgħar.
Paediatric No studies with sitagliptin have been performed in paediatric patients.
It- tfal Ma sar l- ebda studju b’ sitagliptin f’ pazjenti pedjatriċi.
Other patient characteristics No dose adjustment is necessary based on gender, race, or body mass index (BMI).
Karatteristiċi ta ’ pazjenti oħrajn L- ebda aġġustament fid- doża ma huwa meħtieġ abbażi tas- sess, razza, jew indiċi tal- piż (BMI).
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a 13 composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Dawn il- karatteristiċi ma kellhom l- ebda effett klinikament sinifikanti fuq il- farmakokinetika ta ’ sitagliptin abbażi ta ’ analiżi ta ’ dejta farmakokinetika mħallta ta ’ Fażi I u fuq analiżi farmakokinetika ta ’ popolazzjoni ta ’ dejta ta ’ Fażi I u Fażi II.
Metformin Absorption After an oral dose of metformin, tmax is reached in 2.5 h.
Metformin Assorbiment Wara doża orali ta ’ metformin, tmax jintlaħaq f’ 2. 5 sigħat.
Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Il- bijodisponibbiltà assoluta ta ’ pillola ta ’ 500 mg metformin hija madwar 50- 60% f’ suġġetti b’ saħħithom.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Wara doża orali, il- frazzjoni mhux assorbita rkuprata mill- purgar kienet 20- 30%.
After oral administration, metformin absorption is saturable and incomplete.
Wara għoti orali, assorbiment ta ’ metformin jieqaf malajr u mhux komplut.
It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Wieħed jassumi li l - farmakokinetika ta ’ assorbiment ta ’ metformin mhix linejari.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ ml.
Fid- dożi u skedi ta ’ l- iddożar tas- soltu ta ’ metformin, konċentrazzjonijiet ta ’ stat fiss fil- plażma jintlaħqu fi żmien 24- 48 siegħa u huma ġeneralment inqas minn 1 µg/ ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ ml, even at maximum doses.
Fi provi kliniċi kkontrollati, livelli massimi ta ’ metformin fil- plażma (Cmax) ma qabżux 4 µg/ ml, anke f’ dożi massimi.
Food decreases the extent and slightly delays the absorption of metformin.
L- ikel inaqqas il- kwantita ’ u jittardja xi ftit l- assorbiment ta ’ metformin.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Wara l- għoti ta ’ doża ta ’ 850 mg, kienet osservata konċentrazzjoni massima fil- plażma ta ’ 40% inqas, tnaqqis ta ’ 25% fl- AUC u 35 min titwil fil- ħin għal konċentrazzjoni massima fil- plażma.
The clinical relevance of this decrease is unknown.
Ir- relevanza klinika ta ’ dan it- tnaqqis mhijiex magħrufa.
Distribution Plasma protein binding is negligible.
Distribuzzjoni L- irbit ma ’ proteini fil- plażma huwa negliġibbli.
Metformin partitions into erythrocytes.
Metformin jinqasam għal ġol- eritroċiti.
The blood peak is lower than the plasma peak and appears at approximately the same time.
Il- massimu fid- demm huwa aktar baxx mill- massimu fil- plażma u jidher bejn wieħed u ieħor fl- istess ħin.
The red blood cells most likely represent a secondary compartment of distribution.
Iċ - ċelloli tad- demm ħomor x’ aktarx jirrappreżentaw kompartiment sekondarju ta ’ distribuzzjoni.
The mean Vd ranged between 63 – 276 l.
Il- Vd medju jvarja bejn 63 – 276 l.
Metabolism Metformin is excreted unchanged in the urine.
Metaboliżmu Metformin huwa eliminat mhux mibdul fl- awrina.
No metabolites have been identified in humans.
L- ebda metaboliti ma ġew identifikati fil- bnedmin.
Elimination Renal clearance of metformin is > 400 ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Eliminazzjoni Ir- rata ta ’ eliminazzjoni ta ’ metformin mill- kliewi hija ta ’ > 400 ml/ min, li tindika li metformin huwa eliminat permezz ta ’ filtrazzjoni glomerulari u tnixxija tubulari.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h.
Wara doża orali, il- half life ta ’ l - eliminazzjoni terminali apparenti hija madwar 6. 5 sigħat.
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Meta l- funzjoni tal- kliewi hija anqas min - normal, ir- rata ta ’ eliminazzjoni mill- kliewi tonqos skond il- kreatinin u għalhekk il- half- life ta ’ l - eliminazzjoni titwal, li twassal għal żidiet fil- livelli ta ’ metformin fil- plażma.
5.3 Preclinical safety data
14 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No animal studies have been conducted with Efficib.
Ma sar l- ebda studju fl- annimali b’ Efficib.
In 16-week studies in which dogs were treated with either metformin alone or a combination of metformin and sitagliptin, no additional toxicity was observed from the combination.
Fi studji ta ’ 16- il ġimgħa li fihom il- klieb ġew ittrattati jew b’ metformin waħdu jew b’ kombinazzjoni ta ’ metformin u sitagliptin, ebda tossiċità addizzjonali ma ġiet osservata mill- kombinazzjoni.
The NOEL in these studies was observed at exposures to sitagliptin of approximately 6 times the human exposure and to metformin of approximately 2.5 times the human exposure.
Il- NOEL f’ dawn l- istudji ġie osservat f’ espożizzjonijiet għal sitagliptin ta ’ madwar 6 darbiet l- espożizzjoni umana u għal metformin ta ’ madwar 2. 5 drabi l- espożizzjoni umana.
The following data are findings in studies performed with sitagliptin or metformin individually.
It- tagħrif li ġej huwa ta ’ riżultati fi studji magħmula bi sitagliptin jew metformin individwalment.
Sitagliptin Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Sitagliptin Tossiċitajiet tal- kliewi u tal- fwied kienu osservati f’ annimali gerriema f’ valuri ta ’ esponiment sistemiku ta ’ 58 darba l- livell ta ’ esponiment tal- bniedem, waqt li livell bla effett instab fi 19- il darba l- livell ta ’ esponiment tal- bniedem.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no- effect level for this finding was 58-fold based on the 14-week rat study.
Anormalitajiet fis- snien ta ’ quddiem kienu osservati f’ firien f’ livelli ta ’ esponiment ta ’ 67 darba l- livell ta ’ esponiment sistemiku; il- livell ta ’ bla effett għal din is - sejba kien ta ’ 58 darba, ibbażat fuq studju ta ’ 14- il ġimgħa fil- firien.
The relevance of these findings for humans is unknown.
Ir- relevanza ta ’ dawn is- sejbiet għall- bnedmin mhijiex magħrufa.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Sinjali fiżiċi ta ’ qasir żmien relatati mal- kura, xi wħud minnhom jissuġġerixxu tossiċità newrali, bħalma huma teħid ta ’ nifs b’ ħalq miftuħ, tnixxija ta’ saliva, emesi ta ’ ragħwa bajda, atassja, tregħid, tnaqqis fl- attività, u/ jew qagħda mħattba kienu osservati fi klieb f’ livelli ta ’ esponiment ta ’ madwar 23 darba l- livell ta ’ esponiment kliniku.
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times
Barra minn hekk, deġenerazzjoni minn żgħira għal żgħira ħafna tal- muskolu skeletrali kienet ukoll osservata taħt il- mikroskopju f’ dożi li jirriżultaw f’ esponiment sistemiku ta ’ madwar 23 darba l- livell ta ’ esponiment fil- bniedem.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Livell ta ’ bla effett għal dawn is- sejbiet instab f’ esponiment ta ’ 6 darbiet il- livell ta ’ esponiment kliniku.
Sitagliptin has not been demonstrated to be genotoxic in preclinical studies.
Sitagliptin ma ntweriex li huwa ġenotossiku fi studji ta ’ qabel l- użu kliniku.
Sitagliptin was not carcinogenic in mice.
Sitagliptin ma kienx karċinoġeniku fil- ġrieden.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Fil- firien, kien hemm żieda fl- inċidenza ta ’ adenomi u karċinomi tal- fwied fil- livelli ta ’ esponiment sistemiku ta ’ 58 darba l- livell ta ’ esponiment fil- bniedem.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Minħabba li t - tossiċità fil- fwied ntweriet li tikkorrispondi ma ’ induzzjoni ta ’ neoplejżja tal- fwied fil- firien, din iż - żieda fl- inċidenza ta ’ tumuri tal- fwied fil- firien x’ aktarx kienet sekondarja għal tossiċità kronika tal - fwied f’ din id- doża għolja.
Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Minħabba l- marġini għoli ta ’ sigurtà (19- il darba f’ dan il- livell bla effett), dawn it- tibdiliet neoplastiċi mhumiex ikkunsidrati relevanti għas- sitwazzjoni fil- bnedmin.
No treatment related effects on fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
L- ebda effett relatat mal- kura ma kien osservat fuq il- fertilità f’ firien irġiel u nisa li ngħataw sitagliptin qabel jew matul it- tgħammir.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Fl- istudju ta ’ żvilupp ta ’ qabel/ ta ’ wara t- twelid magħmul fil- firien, sitagliptin ma wera l- ebda effett avvers.
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Studji ta ’ tossiċità riproduttiva wrew żieda żgħira fl- inċidenza ta ’ malformazzjonijiet tal- kustilji fetali (nuqqas, ipoplastiċi u kustilji mmewwġin) relatati mad- doża, fil- wild ta ’ firien f’ livelli ta ’ esponiment sistemiku aktar minn 29 darba l- livelli ta ’ esponiment fil- bniedem.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Minħabba l- marġini għoljin ta ’ sigurtà, dawn is- sejbiet ma jissuġġerixxux riskju relevanti għar- riproduzzjoni fil- bniedem.
Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/ plasma ratio:
Sitagliptin jitfaċċa f’ ammonti konsiderevoli ġol- ħalib ta ’ firien li jkunu qegħdin ireddgħu (proporzjon ħalib/ plażma:
Metformin Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Metformin Dejta ta ’ qabel l- użu kliniku għal metformin ma turi l- ebda riskju speċjali għal bnedmin abbażi tal - farmakoloġija ta ’ sigurtà, tossiċità ta ’ doża ripetuta, ġenotossiċità, potenzjal karċinoġenetiku, tossiċità għar- riproduzzjoni.
Tablet core: microcrystalline cellulose (E460) povidone K29/ 32 (E1201) sodium lauril sulfate sodium stearyl fumarate
Qalba tal- pillola: microcrystalline cellulose (E460) povidone K29/ 32 (E1201) sodium lauril sulfate sodium stearyl fumarate
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
Kisja tar- rita: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
24 months.
24 xahar.
Do not store above 30°C.
Taħżinx f’ temperatura ogħla minn 30°C.
Opaque blisters (PVC/ PE/ PVDC and aluminum).
Folji opaki (PVC/ PE/ PVDC u aluminju).
Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets.
Pakketti ta ’ 14, 28, 56, 112, 168, 196 pillola miksija b’ rita, pakketti multipli li fihom 196 (2 pakketti ta ’ 98) pillola miksija b’ rita.
Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakkett ta ’ 50 x 1 pilloli miksijin b’ rita f’ folji pperforati b’ doża singola.
Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir- Renju Unit
16 July 2008
16 ta ’ Lulju 2008
Efficib 50 mg/ 1000 mg film-coated tablets
Efficib 50 mg/ 1000 mg pilloli miksijin b’ rita
Each tablet contains 50 mg of sitagliptin (as phosphate monohydrate) and 1,000 mg of metformin hydrochloride.
Kull pillola fiha 50 mg ta ’ sitagliptin (bħala phosphate monohydrate) u 1000 mg ta ’ metformin hydrochloride.
Capsule-shaped, red film-coated tablet with “ 577” debossed on one side.
Pillola ħamra miksija b’ rita, forma ta ’ kapsula b ’ “ 577 ” imnaqqxa fuq naħa waħda.
17 For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
18 Għal dożi differenti ta ’ metformin, Efficib jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1000 mg metformin hydrochloride.
18 risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia.
L- inċidenza ta ’ aċidożi lattika tista ’ u għandha titnaqqas ukoll bl- għarfien ta ’ fatturi ta ’ riskju oħrajn bħalma huma dijabete ikkontrollata ħażin, ketożi, sawm fit- tul, teħid eċċessiv ta ’ alkoħol, indeboliment epatiku u kwalunkwe kundizzjoni assoċjata ma ’ ipoksja.
19 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Efficib who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
20 Bidla fl- istat kliniku ta ’ pazjenti b’ dijabete tip 2 li diġà kienu kkontrollati Pazjent b’ dijabete tip 2 li diġà kien ikkontrollat sewwa fuq Efficib li jiżviluppa anormalitajiet tal - laboratorju jew mard kliniku (speċjalment mard vag u mard mhux ċar biżżejjed) għandu jiġi evalwat minnufih għal evidenza ta ’ ketoaċidożi jew aċidożi lattika.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
21 Għaldaqstant, mhumiex mistennija interazzjonijiet b’ mod sinifikanti b’ impedituri p- glycoprotein oħrajn.
20 In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Studji in vitro indikaw li l- enzima primarja responsabbli għall- metaboliżmu limitat ta ’ sitagliptin hija CYP3A4, b’ kontribuzzjoni minn CYP2C8.
21 4.8 Undesirable effects
22 4. 8 Effetti mhux mixtieqa
2 In this 24-week placebo-controlled study of sitagliptin 100 mg once daily added to ongoing combination treatment with glimepiride and metformin, the overall incidence of adverse reactions considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment
23 sitagliptin li seħħew f’ eċċess (> 0. 2% u differenza > pazjent 1) ta ’ dak f’ pazjenti li kienu qegħdin jirċievu mediċina sulphonylurea huma kif ġejjin: nuqqas t’ aptit (Disturbi ta ’ metaboliżmu u nutriment; frekwenza mhux komuni) u tnaqqis fil- piż (Investigazzjonijiet; frekwenza mhux komuni).
22 with glimepiride and metformin was 18.1% compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1%.
2 F’ dan l- istudju kkontrollat bi plaċebo ta ’ 24 ġimgħa ta ’ sitagliptin 100 mg darba kuljum miżjud ma ’ kura ta ’ kombinazzjoni ta ’ glimepiride u metformin li kompliet, l- inċidenza totali ta ’ reazzjonijiet avversi kkunsidrati bħala relatati mal- mediċina f’ pazjenti kkurati biż- żieda ta ’ sitagliptin mal- kura li tkun għadha qegħda tittieħed bi glimepiride u metformin kienet ta ’ 18. 1% meta mqabbla ma ’ kura biż- żieda ta ’ plaċebo mal- kura li tkun għadha qegħda tittieħed bi glimepiride u metformin li kienet 7. 1%.
23 Adverse reaction
Disturbi gastro- intestinali sintomi gastrointestinalia
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
25 Fil- każ li tittieħed doża eċċessiva, huwa raġonevoli li tuża l- miżuri ta ’ appoġġ tas- soltu, eż., tneħħija ta ’ materjal mhux assorbit mill- istonku u l- imsaren, tuża sorveljanza klinika (inkluż l- użu ta ’ elettrokardjogramma), u tistitwixxi terapija ta ’ appoġġ jekk meħtieġa.
24 Sitagliptin Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Sitagliptin Sitagliptin phosphate huwa impeditur attiv li jittieħed mill- ħalq, qawwi, ferm selettiv ta ’ l- enzim dipeptidyl peptidase 4 (DPP- 4) għall- kura ta ’ dijabete tip 2.
25 Table 3:
Tabella 3:
Metformin may act via three mechanisms:
27 Metformin jista ’ jaħdem permezz ta ’ tliet mekkaniżmi:
- by delaying intestinal glucose absorption
- billi jittardja l- assorbiment ta ’ zokkor intestinali.
26 The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
L- istudju prospettiv randomizzat (UKPDS) stabbilixxa l- benefiċċju ta ’ tul ta ’ żmien fuq kontroll intensiv ta ’ zokkor fid- demm f’ dijabete tip 2.
Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
28 Metaboliżmu Sitagliptin huwa primarjament eliminat mhux mibdul fl- awrina, u l- metaboliżmu huwa passaġġ minuri.
27 Elimination Following administration of an oral [14C]sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
Eliminazzjoni Wara għoti ta ’ doża [14C] sitagliptin orali lil suġġetti b’ saħħithom, madwar 100% tar- radjuattività kienet eliminata fl- ippurgar (13%) jew l- awrina (87%) fi żmien ġimgħa mid- dożaġġ.
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a 28 composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Dawn il- karatteristiċi ma kellhom l- ebda effett klinikament sinifikanti fuq il- farmakokinetika ta ’ sitagliptin abbażi ta ’ analiżi ta ’ dejta farmakokinetika mħallta ta ’ Fażi I u fuq analiżi farmakokinetika ta ’ popolazzjoni ta ’ dejta ta ’ Fażi I u Fażi II.
5.3 Preclinical safety data
30 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
30 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets.
Pakketti ta ’ 14, 28, 56, 112, 168 168, 196 pillola miksija b’ rita, pakketti multipli li fihom 196 (2 pakketti ta ’ 98) pillola miksija b’ rita.
31 ANNEX II
33 ANNESS II
Via Complutense 140 ES-28805 Alcala de Henares - Madrid Spain
Via Complutense 140 ES- 28805 Alcala de Henares - Madrid Spanja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 4 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni Għat- Tqegħid Fis- Suq, tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Ġestjoni tar- Riskji Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqu fil- verżjoni 1. 1 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ppreżentat fil- Modulu 1. 8. 2. ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u għal kwalunkwe aġġornament sussegwenti tal- RMP miftiehem minn CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linjagwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin tar- Rapport Perijodiku ta ’ Aġġornament dwar is- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) • Fuq talba ta ’ l- EMEA
33 ANNEX III
35 ANNESS III
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Efficib 50 mg/ 850 mg film-coated tablets
Pakkett ta ’ barra għal pilloli miksijin b’ rita Efficib 50 mg/ 850 mg
Efficib 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Pilloli miksijin b’ rita Efficib 50 mg/ 850 mg sitagliptin/ metformin hydrochloride
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 196 film-coated tablets Multi-pack containing 196 (2 packs of 98) film-coated tablets 50 x 1 film-coated tablets
14- il pillola miksijin b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 112- il pillola miksija b’ rita 168 pillola miksija b’ rita 196 pillola miksija b’ rita Pakkett multiplu li fih 196 (2 packs of 98) pillola miksija b’ rita 50 x 1 pillola miksija b’ rita
SPECIAL STORAGE CONDITIONS
KONDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN
36 Do not store above 30°C.
38 Taħżinx f’ temperatura ogħla minn 30°C.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
EU/ 1/ 08/ 457/ 001 14 film-coated tablets EU/ 1/ 08/ 457/ 002 28 film-coated tablets EU/ 1/ 08/ 457/ 003 56 film-coated tablets EU/ 1/ 08/ 457/ 004 112 film-coated tablets EU/ 1/ 08/ 457/ 005 168 film-coated tablets EU/ 1/ 08/ 457/ 006 196 film-coated tablets EU/ 1/ 08/ 457/ 007 50 x 1 film-coated tablets EU/ 1/ 08/ 457/ 015 196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 457/ 001 14- il pillola miksija b’ rita EU/ 1/ 08/ 457/ 002 28 pillola miksija b’ rita EU/ 1/ 08/ 457/ 003 56 pillola miksija b’ rita EU/ 1/ 08/ 457/ 004 112- il pillola miksija b’ rita EU/ 1/ 08/ 457/ 005 168 pillola miksija b’ rita EU/ 1/ 08/ 457/ 006 196 pillola miksija b’ rita EU/ 1/ 08/ 457/ 007 50 x 1 pillola miksija b’ rita EU/ 1/ 08/ 457/ 015 196 (2 x 98) pillola miksija b’ rita
37 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without blue box - 50 mg/ 850 mg film- coated tablets
Pakketti multipli ta ’ 196 (2 pakketti ta ’ 98 pillola miksija b’ rita) – mingħajr kaxxa blu għal Efficib - 50 mg/ 850 mg pillola miksija b’ rita
Efficib 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Efficib 50 mg/ 850 mg pillola miksija b’ rita sitagliptin/ metformin hydrochloride
Component of a multi-pack comprising 2 packs, each containing 98 film-coated tablets.
Komponenti ta ’ pakkett multiplu magħmul minn 2 pakketti, kull wieħed fih 98 pillola miksija b’ rita.
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI
Blister for Efficib 50 mg/ 850 mg film-coated tablets
Folji għal pilloli miksijin b’ rita Efficib 50 mg/ 850 mg
Efficib 50 mg/ 850 mg tablets sitagliptin/ metformin HCl
Pilloli Efficib 50 mg/ 850 mg sitagliptin/ metformin hydrochloride
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for Efficib 50 mg/ 1,000 mg film-coated tablets
Pakkett ta ’ barra għal pilloli miksijin b’ rita Efficib 50 mg/ 1000 mg
Efficib 50 mg/ 1,000 mg film-coated tablets sitagliptin/ metformin hydrochloride
Pilloli miksijin b’ rita Efficib 50 mg/ 1000 mg sitagliptin/ metformin hydrochloride
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA)
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 196 film-coated tablets Multi-pack containing 196 (2 packs of 98) film-coated tablets 50 x 1 film-coated tablets
14- il pillola miksijin b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 112- il pillola miksija b’ rita 168 pillola miksija b’ rita 196 - il pillola miksija b’ rita Pakkett multiplu li fih 196 (2 pakketti ta ’ 98) pillola miksija b’ rita 50 x 1 pillola miksija b’ rita
41 Do not store above 30°C.
43 Taħżinx f’ temperatura ogħla minn 30°C.
EU/ 1/ 08/ 457/ 008 14 film-coated tablets EU/ 1/ 08/ 457/ 009 28 film-coated tablets EU/ 1/ 08/ 457/ 010 56 film-coated tablets EU/ 1/ 08/ 457/ 011 112 film-coated tablets EU/ 1/ 08/ 457/ 012 168 film-coated tablets EU/ 1/ 08/ 457/ 013 196 film-coated tablets EU/ 1/ 08/ 457/ 014 50 x 1 film-coated tablets EU/ 1/ 08/ 457/ 016196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 457/ 008 14- il pillola miksija b’ rita EU/ 1/ 08/ 457/ 009 28 pillola miksija b’ rita EU/ 1/ 08/ 457/ 010 56 pillola miksija b’ rita EU/ 1/ 08/ 457/ 011 112- il pillola miksija b’ rita EU/ 1/ 08/ 457/ 012 168 pillola miksija b’ rita EU/ 1/ 08/ 457/ 013 196 pillola miksija b’ rita EU/ 1/ 08/ 457/ 014 50 x 1 pillola miksija b’ rita EU/ 1/ 08/ 457/ 016 196 (2 x 98) pillola miksija b’ rita
42 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without bleu box - 50 mg/ 1,000 mg film- coated tablets
Pakketti multipli ta ’ 196 (2 pakketti ta ’ 98 pillola miksija b’ rita) – mingħajr kaxxa blu għal Efficib - 50 mg/ 1, 000 mg pilloli miksijin b’ rita
Efficib 50 mg/ 1,000 mg film-coated tablets sitagliptin/ metformin hydrochloride
Efficib 50 mg/ 1, 000 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
Each tablet contains 50 mg of sitagliptin (as phosphate monohydrate) and 1,000 mg of metformin hydrochloride.
Kull pillola fiha 50 mg ta ’ sitagliptin (bħala phosphate monohydrate) u 1, 000 mg ta ’ metformin hydrochloride.
Component of a multi-pack comprising 2 packs, each containing 98 film-coated tablets.
Komponenti ta ’ pakkett multiplu magħmulin minn 2 pakketti, li kull wieħed fih 98 pillola miksija b’ rita.
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI
Blister for Efficib 50 mg/ 1,000 mg film-coated tablets
Folja għal pilloli miksijin b’ rita Efficib 50 mg/ 1000 mg
Efficib 50 mg/ 1,000 mg tablets sitagliptin/ metformin HCl
Pilloli Efficib 50 mg/ 1000 mg sitagliptin/ metformin hydrochloride
46 PACKAGE LEAFLET:
48 FULJETT TA ’ TAGĦRIF:
Efficib 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Efficib 50 mg/ 850 mg pilloli miksijin b’ rita sitagliptin/ metformin hydrochloride
What Efficib is and what it is used for 2.
X’ inhu Efficib u għalxiex jintuża 2.
Before you take Efficib 3.
Qabel ma tieħu Efficib 3.
How to take Efficib 4.
Kif għandek tieħu Efficib 4.
How to store Efficib 6.
Kif taħżen Efficib 6.
WHAT EFFICIB IS AND WHAT IT IS USED FOR
X’ INHU EFFICIB U GĦALXIEX JINTUŻA
The name of your tablet is Efficib.
L- isem tal- pillola tiegħek hija Efficib.
It contains two different medicines called sitagliptin and metformin. • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) • metformin belongs to a class of medicines called biguanides.
Fiha żewġ mediċini differenti msejħin sitagliptin u metformin. • sitagliptin jappartieni għall- klassi ta ’ mediċini msejħin impedituri DPP- 4 (impedituri dipeptidyl peptidase- 4) • metformin jappartieni għall- klassi ta ’ mediċini msejħin biguanides.
They work together to control blood sugar levels in patients with a form of diabetes called ‘ type 2 diabetes mellitus’.
Huma jaħdmu flimkien biex jikkontrollaw livelli ta ’ zokkor fid- demm f’ pazjenti b’ forma ta ’ dijabete msejħa ‘ dijabete mellitus tip 2 ’.
Efficib helps to improve the levels of insulin after a meal and lowers the amount of sugar made by your body.
Efficib jgħin biex itejjeb il- livelli ta ’ insulina wara ikla u jbaxxi l - ammont ta ’ zokkor magħmul minn ġismek.
Along with diet and exercise, this medicine helps lower your blood sugar.
Flimkien ma ’ dieta u eżerċizzju, din il- mediċina tgħin biex tbaxxi z- zokkor f’ demmek.
Efficib can be used alone or with another medicine for diabetes called a sulphonylurea.
Efficib jista ’ jintuża waħdu jew flimkien ma ’ mediċina oħra għad- dijabete msejħa sulphonylurea.
What is type 2 diabetes?
X’ inhi dijabete tip 2?
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
Dijabete tip 2 tisejjaħ ukoll dijabete mellitus mhux dipendenti fuq l- insulina, jew NIDDM.
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Dijabete tip 2 hija kondizzjoni fejn il- ġisem ma jagħmilx biżżejjed insulina, u l- insulina li jipproduċi ma taħdimx daqshekk tajjeb kif suppost.
Your body can also make too much sugar.
Ġismek jista ’ wkoll jagħmel iżżejjed zokkor.
When this happens, sugar (glucose) builds up in the blood.
Meta jiġri dan, iz- zokkor (glucose) jakkumula fid- demm.
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Dan jista ’ jwassal għal problemi mediċi serji bħal mard tal- qalb, mard tal- kliewi, għama, u amputazzjoni.
BEFORE YOU TAKE EFFICIB
QABEL MA TIEĦU EFFICIB
Do not take Efficib:
Tiħux Efficib:
- if you are allergic (hypersensitive) to sitagliptin or metformin or any of the other ingredients of
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal sitagliptin jew metformin jew għal
Efficib (listed in section 6)
sustanzi oħra ta ’ Efficib (elenkati f’ sezzjoni 6)
- if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or
- jekk għandek ketoaċidożi dijabetika (kumplikazzjoni ta ’ dijabete b’ telf fil- piż, dardir jew
vomiting) or have had a diabetic coma
rimettar) jew jekk għandek koma dijabetika
- if you have problems with your kidneys
- jekk għandek problemi bil- kliewi tiegħek
- if you have a severe infection or are dehydrated
- jekk għandek infezzjoni severa jew inti deidratat
You will need to stop
- jekk sejjer tieħu raġġi- X fejn ikun hemm bżonn tkun injettat bi speċi ta ’ kulur għal kuntrast.
taking Efficib at the time of the X-ray and for a few days after
Trid tieqaf tieħu Efficib fil- ħin tar- raġġi- X u għal ftit jiem wara
- if you have recently had a heart attack or have severe circulatory problems, such as ‘ shock’ or
- jekk riċentement kellek attakk tal- qalb jew għandek problemi severi taċ- ċirkulazzjoni, bħalma
breathing difficulties
huwa ‘ xokk ’ jew diffikulta biex tieħu n- nifs
- if you have liver problems
- jekk għandek problemi tal- fwied
- if you drink alcohol to excess (either every day or only from time to time)
- jekk tixrob ħafna alkoħol (jew kuljum jew minn żmien għal żmien biss)
- if you are breast-feeding
- jekk qegħda tredda ’
Do not take Efficib if any of the above apply to you.
Tiħux Efficib jekk xi problema minn dawn tapplikaw għalik.
If you are not sure, talk to your doctor or pharmacist before taking Efficib.
Jekk m’ intix ċert, kellem lit- tabib jew l - ispiżjar tiegħek qabel tieħu Efficib.
Take special care with Efficib Check with your doctor or pharmacist before taking your medicine:
Oqgħod attent ħafna b’ Efficib Iċċekkja mat- tabib jew l- ispiżjar tiegħek qabel tieħu l- mediċina tiegħek:
This is sometimes called insulin-dependent diabetes
- jekk għandek dijabete tip 1, jiġifieri jkun hemm bżonn l- insulina.
- if you experience some of the following symptoms: feeling cold or uncomfortable, severe
- jekk ikollok xi wħud mis- sintomi li ġejjin: tħossok kiesaħ jew skomdu, ikollok dardir jew
nausea or vomiting, abdominal pain, unexplained weight loss, muscular cramps, or rapid breathing.
remettar severi, uġigħ addominali, telf ta ’ piż bla spjegazzjoni, bugħawwiġ, jew tieħu n- nifs mgħaġġel.
Metformin hydrochloride, one of the ingredients in Efficib, can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death.
Metformin hydrochloride, wieħed mis- sustanzi f’ Efficib, jista ’ jikkaġuna effett sekondarju rari iżda serju msejjaħ aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fid- demm) li tista ’ tkun ta ’ periklu.
Lactic acidosis is a medical emergency and must be treated in a hospital.
L- aċidożi lattika hija emerġenza medika u għandha tiġi kkurata fi sptar.
If you experience some of the symptoms of lactic acidosis stop taking Efficib and consult a doctor immediately
Jekk tesperjenza xi wħud mis- sintomi ta ’ aċidożi lattika ieqaf milli tieħu Efficib u fittex parir ta ’ tabib minnufih
- During treatment with Efficib, your doctor will check your kidney function at least once a year
- Waqt kura b’ Efficib, it- tabib tiegħek sejjer jiċċekkja l- funzjoni tal- kliewi tiegħek ta ’ l- anqas
and more frequently if you are elderly or if your kidney function is borderline or at risk of worsening
darba f’ sena jew aktar spiss jekk inti anzjan jew il- funzjoni tal- kliewi tiegħek mhix sodisfaċenti jew f’ riskju li tmur għall- agħar
- if you have or have had an allergic reaction to sitagliptin, metformin, or Efficib
- Jekk għandek jew kellek reazzjoni alleġika għal sitagliptin, metformin, jew Efficib
- if you are taking a sulphonylurea, a diabetes medicine, together with Efficib, as you may
- Jekk barra Efficib qiegħed tieħu wkoll sulphonylurea, mediċina ta ’ kontra d- dijabete, flimkien
experience low blood sugar levels (hypoglycaemia).
ma ’ Efficib, għaliex jista ’ jkollok livelli ta ’ zokkor fid- demm baxxi (ipogliċemija).
Your doctor may reduce the dose of your sulphonylurea
It- tabib tiegħek jista ’ jnaqqas id- doża ta ’ sulphonylurea li tkun qed tieħu
- if you are going to have an operation under general, spinal or epidural anaesthetic.
- Jekk għandek bżonn operazzjoni taħt loppju ġenerali, anesteżija spinali jew epidurali.
You may
Inti
need to stop taking Efficib for a couple of days before and after the procedure
jeħtieġ li tieqaf tieħu Efficib għal xi jiem qabel u wara l- proċedura
- if you are under 18 years of age
- Jekk inti taħt l- età ta ’ 18- il sena
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Efficib.
Jekk m’ intix ċert jekk waħda minn dawn ta ’ hawn fuq japplikaw għalik, kellem lit- tabib jew lill - ispiżjar tiegħek qabel tieħu Efficib.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra.
This includes medicines obtained without a prescription, including herbal medicines.
Dawn jinkludu mediċini miksubin mingħajr riċetta, inklużi mediċini erbali.
The following medicines are particularly important: • medicines used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids) • specific medicines for the treatment of high blood pressure (ACE inhibitors) • medicines which increase urine production (diuretics) • specific medicines for the treatment of bronchial asthma (β -sympathomimetics) • iodinated contrast agents or alcohol-containing medicines.
Il- mediċini li ġejjin huma partikolarment importanti: • mediċini wżati biex jikkuraw mard li jinvolvi infjammazzjoni, bħal ażma u artrite (kortikosterojdi) • mediċini speċifiċi għall- kura ta ’ pressjoni għolja tad- demm (impedituri ACE) • mediċini li jżidu l- produzzjoni ta ’ l- awrina (dijuretiċi) • mediċini speċifiċi għall- kura ta ’ ażma fil- bronki (simpatomimetiċi- β) • mediċini ta ’ kuntrast li fihom il- jodju jew mediċini li fihom l- alkoħol.
Taking Efficib with food and drink Take Efficib with meals to lower your chance of an upset stomach.
Meta tieħu Efficib ma ’ l- ikel u max- xorb Ħu Efficib ma ’ l- ikel biex tnaqqas iċ- ċans ta ’ taqliba ta ’ l- istonku
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should talk to their doctor before taking Efficib.
Tqala u Treddigħ Nisa li huma tqal jew li qed jippjanaw li joħorġu tqal għandhom ikellmu lit- tabib tagħhom qabel ma jieħdu Efficib.
You should not use Efficib during pregnancy.
M’ għandekx tieħu Efficib waqt it- tqala.
48 Metformin passes into human milk in small amounts.
Metformin jgħaddi fil- ħalib tal- omm f’ ammonti żgħar.
It is not known whether sitagliptin passes into human milk.
Mhuwiex magħruf jekk sitagliptin jgħaddix għal ġol- ħalib tal- bniedem.
It is not known if Efficib passes into human breast milk.
Mhuwiex magħruf jekk sitagliptin jgħaddix għal ġol- ħalib tas- sider tal - bniedem.
You must not use Efficib if you are breast-feeding or plan to breast-feed.
M’ għandekx tieħu Efficib jekk qegħda tredda ’ jew qegħda tippjana li tredda ’.
Driving and using machines No studies on the effects of Efficib on the ability to drive or to use machines have been performed.
50 Sewqan u tħaddim ta ’ magni Ma sar ebda studju fuq l- effetti ta ’ Efficib fuq il- ħila tiegħek biex issuq jew tħaddem magni.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported with sitagliptin.
Madankollu, waqt is- sewqan jew tħaddim ta ’ magni, żomm f’ moħħok li ġew irrapportati sturdament u ħedla b’ sitagliptin.
Taking Efficib in combination with medicines called sulphonylureas can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
It- teħid ta ’ Efficib f’ kumbinazzjoni ma ’ mediċini msejħin sulphonylureas jista ’ jikkaġuna ipogliċemija, li tista ’ taffettwa l- ħila tiegħek li ssuq u tuża magni jew taħdem f’ post li mhux sod biżżejjed.
HOW TO TAKE EFFICIB
KIF GĦANDEK TIEĦU EFFICIB
Always take Efficib exactly as your doctor has told you.
Dejjem ħu Efficib eżattament kif qallek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Għandek tiċċekkja mat- tabib jew ma ’ l - ispiżjar tiegħek jekk m’ intix ċert.
• Efficib should be taken:
• Efficib għandu jittieħed:
twice daily by mouth with meals to lower your chance of an upset stomach.
darbtejn kuljum mill- ħalq ma ’ l- ikel biex inaqqas iċ- ċans li jkollok taqlib fl- istonku.
• Your doctor may need to increase your dose to control your blood sugar.
• It- tabib tiegħek jista ’ jkollu bżonn li jżidlek id- doża biex jikkontrollalek iz- zokkor fid- demm
• Continue to take Efficib as long as your doctor prescribes it so you can continue to help control your blood sugar.
• Kompli ħu Efficib sakemm jibqa ’ jiktibulek fuq ir- riċetta t- tabib tiegħek sabiex inti tibqa ’ tgħin tikkontrolla z- zokkor fid- demm.
You should continue your diet during treatment with Efficib and take care that your carbohydrate intake is equally distributed over the day.
Għandek tkompli d- dieta waqt kura b’ Efficib u tagħmel mezz li tqassam il- karboidrati ugwalment matul il- jum.
If you are overweight continue your energy-restricted diet as instructed.
Jekk għandek piż eċċessiv kompli d- dieta tiegħek billi tillimita l- ammont ta ’ kaloriji, hekk kif għallmuk.
Efficib alone is unlikely to cause abnormally low blood sugar (hypoglycaemia).
Efficib waħdu mhuwiex mistenni li jikkawża livelli ta ’ zokkor fid- demm baxxi ħafna (ipogliċemija).
When Efficib is used with a sulphonylurea medicine, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea.
Meta Efficib jintuża ma ’ mediċina tat- tip sulphonylurea, jista ’ jseħħ livell baxx ta ’ zokkor fid- demm u t- tabib tiegħek jista ’ jnaqqas id- doża ta ’ sulphonylurea li tkun qed tieħu.
Sometimes you may need to stop taking your medicine for a short time.
Xi drabi jkun jeħtieġlek li twaqqaf il- mediċina għal żmien qasir.
Talk to your doctor for instructions if you:
Kellem lit- tabib tiegħek għal struzzjonijiet jekk inti:
• have a condition that may be associated with dehydration (large loss of body fluids) such as being sick with severe vomiting, diarrhoea or fever, or if you drink fluids a lot less than normal • plan to have surgery • are due to get an injection of dye or contrast agent as part of an X-ray
• għandek kundizzjoni li tista ’ tkun assoċjata ma ’ deidratazzjoni (telf kbir ta ’ fluwidi tal- ġisem) bħalma huwa remettar persistenti, dijarea jew deni qawwi, jew jekk tixrob fluwidi anqas minn normal • qed tippjana li jkollok operazzjoni • ikollok bżonn injezzjoni ta ’ kulur jew mediċina ta ’ kuntrast bħala parti mir- raġġi- X
If you take more Efficib than you should If you take more than the prescribed dosage of Efficib, contact your doctor immediately.
Jekk tieħu Efficib aktar milli suppost Jekk tieħu aktar Efficib mid- dożaġġ miktub fir- riċetta, ikkuntattja lit- tabib tiegħek minnufih.
If you forget to take Efficib If you miss a dose, take it as soon as you remember.
Jekk tinsa tieħu Efficib Jekk tinsa tieħu doża, ħudha mill- aktar fis malli tiftakar.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Jekk ma tiftakarx qabel ma jkun il- waqt għad - doża li jmissek, aqbeż id- doża minsija u mur lura għall- iskeda regolari tiegħek.
Do not take a double dose of Efficib.
Tiħux doża doppja ta ’ Efficib.
Like all medicines, Efficib may cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Efficib jista ’ jkollu effetti sekondarji, għalkemm mhux kulħadd ikollu.
Very rarely patients taking metformin (one of the active substances of Efficib) have experienced a serious condition called lactic acidosis (too much lactic acid in your blood).
Rari ħafna, pazjenti li jkunu qegħdin jieħdu metformin (wieħed mis- sustanzi attivi ta ’ Efficib) ikollhom kundizzjoni serja msejħa aċidożi lattika (wisq aċidu lattiku fid- demm).
This is more common in people whose kidneys are not working properly.
Din hija iktar komuni fin- nies li l- kliewi tagħhom ma jkunux qegħdin jaħdmu sew.
Stop taking Efficib and see a doctor straight away if you notice any of the following symptoms: • feeling sick (nausea) or being sick (vomiting), abdominal pain, muscular cramps, unexplained weight loss, rapid breathing, and feeling cold or uncomfortable.
Waqqaf Efficib u ara tabib minnufih jekk tara xi sintomi minn dawn li ġejjin: • ikollok dardir jew tirremetti, jew ikollok uġigħ ta ’ żaqq, bugħawwieġ, telf ta ’ piż mhux mistenni, nifs mgħaġġel u tħoss tkexkix ta ’ bard jew skumdità.
Very common side effects (likely to occur in more than 1 per 10 patients).
Effetti sekondarji komuni ħafna (x’ aktarx iseħħu f’ aktar minn pazjent 1 minn kull 10).
Common side effects (likely to occur in less than 1 per 10 but more than 1 per 100 patients).
Effetti sekondarji komuni (x’ aktarx iseħħu f’ anqas minn pazjent 1 minn kull 10 iżda f’ aktar minn pazjent 1 minn kull 100).
Uncommon side effects (likely to occur in less than 1 per 100 but more than 1 per 1,000 patients).
Effetti sekondarji mhux komuni (x’ aktarx iseħħu f’ anqas minn pazjent 1 minn kull 100 iżda f’ aktar minn pazjent 1 minn kull 1000).
Rare side effects (likely to occur in less than 1 per 1,000 but more than 1 per 10,000).
Effetti sekondarji rari (x’ aktarx iseħħu f’ anqas minn pazjent 1 minn kull 1000 iżda f’ aktar minn pazjent 1 minn kull 10, 000).
Very rare side effects (likely to occur in less than 1 per 10,000).
Effetti sekondarji rari ħafna (x’ aktarx iseħħu f’ anqas minn 1 kull 10, 000).
Some patients taking metformin have experienced the following side effects after starting sitagliptin:
Xi pazjenti li kienu qegħdin jieħdu metformin esperjenzaw l- effetti sekondarji li ġejjin wara li bdew sitagliptin:
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness
Komuni: dardir Mhux komuni: telf fil- piż, nuqqas t’ aptit, uġigħ ta ’ żaqq, dijarea, zokkor baxx fid- demm, ngħas
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Xi pazjenti ħassew dwejjaq fl- istonku meta bdew kombinazzjoni ta ’ sitagliptin u metformin flimkien.
Some patients have experienced the following side effects while taking Efficib with a sulphonylurea:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu Efficib ma ’ sulphonylurea:
Very common: low blood sugar Common: constipation
Komuni ħafna: livell baxx ta ’ zokkor fid- demm Komuni: stitikezza
Some patients have experienced the following side effects while taking sitagliptin alone:
Xi pazjenti kellhom l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu sitagliptin waħdu:
In addition, some patients have reported the following side effects while taking sitagliptin:
Komuni: zokkor fid- demm baxx, uġigħ ta ’ ras Mhux komuni: sturdament, stitikezza Xi pazjenti kellhom ukoll l- effetti sekondarji li ġejjin waqt li kienu qegħdin jieħdu sitagliptin:
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
Komuni: infezzjoni tal- passaġġi respiratorji ta ’ fuq, imnifsejn misduda jew imnieħer inixxi u uġigħ fil - ġerżuma, osteoartrite, uġigħ fid- driegħ jew fir- riġel.
During post-marketing experience with Efficib or sitagliptin, one of the medicines in Efficib, the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Waqt sorveljanza ta ’ wara t- tqegħid fis- suq b’ Efficib jew sitagliptin, waħda mill- mediċini f’ Efficib, ġew irrapportati wkoll l- effetti sekondarji li ġejjin (frekwenza mhux magħrufa): reazzjonijiet allerġiċi, inklużi raxx, urtikarja, u nefħa tal- wiċċ, xofftejn, ilsien, u ġerżuma li jistgħu jikkaġunaw diffikultà biex tieħu n- nifs jew biex tibla ’.
If you have an allergic reaction, stop taking Efficib and call your doctor right away.
Jekk ikollok reazzjoni allerġika, waqqaf Efficib u sejjaħ lit- tabib tiegħek minnufih.
Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
It- tabib tiegħek jista ’ jagħtik mediċina permezz ta ’ riċetta biex tikkura r- reazzjoni allerġika u mediċina differenti għad- dijabete.