qanastek/EMEA-V3 huggingface dataset:
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
Il- potenzjament ta ’ effett ta ’ tnaqqis fil- glukosju fid- demm u għalhekk, kultant ipogliċemija, jistgħu jseħħu meta tittieħed xi waħda mill- mediċini li ġejjin, per eżempju:
phenylbutazone, azapropazon and oxyfenbutazone, insulin and oral antidiabetic products, metformin, salicylates and p-amino-salicylic acid, anabolic steroids and male sex hormones, chloramphenicol, coumarin anticoagulants, fenfluramine, fibrates, ACE inhibitors, fluoxetine, allopurinol, sympatholytics, cyclo-, tro-and iphosphamides,
phenylbutazone, azapropazon u oxyfenbutazone, insulina u prodotti anti- dijabetiċi, metformin, salicylates u aċidu p- amino- saliċiliku, sterojdi anaboliċi u ormoni tas- sess maskil, chloramphenicol,
sulphinpyrazone, certain long acting sulphonamides, tetracyclines, MAO-inhibitors, quinolone antibiotics, probenecid, miconazol, pentoxifylline (high dose parenteral), tritoqualine, fluconazole.
sulphinpyrazone, xi sulphonamides li jaħdmu fit- tul, tetracyclines, impedituri MAO, antibijotiċi quinolone, probenecid,
22 Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
Indeboliment ta ’ l- effett ta ’ tnaqqis ta ’ glukosju fid- demm u, għalhekk, livelli ogħla ta ’ glukosju fid - demm, jistgħu iseħħu meta tittieħed xi waħda mill- mediċini li ġejjin, per eżempju:
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable fashion.
It- teħid ta ’ alkoħol jista ’ jsaħħaħ jew idgħajjef l- azzjoni ipogliċemika ta ’ glimepiride b’ mod mhux mistenni.
For AVAGLIM no preclinical or clinical data on exposed pregnancies or lactation are available.
Għal AVAGLIM m’ hawnx disponibbli tagħrif prekliniku jew kliniku dwar it- tqala jew il- ħalib tas - sider.
The potential risk for humans is unknown.
Ir- riskju potenzjali għall - bniedem mhux magħruf.
Both rosiglitazone and glimepiride have been detected in the milk of experimental animals.
Kemm rosiglitazone u kemm glimepiride instabu fil- ħalib ta ’ annimali f’ esperimentazzjoni.
23 AVAGLIM Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
AVAGLIM Tagħrif minn studji double- blind jikkonferma li l- profil ta ’ sigurta` ta ’ rosiglitazone u glimepiride flimkien hu l- istess bħall- profil tar- reazzjoni avversa kombinata għaż- żewġ sustanzi attivi.
Table 1.
26 Tabella 1.
24 *The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is'common '.
* Il- kategorija ta ’ frekwenza għall- isfond ta ’ l- inċidenza ta ’ dan l- effett, kif meħud mit- tagħrif mill - grupp plaċebo fi provi kliniċi, hija ‘ komuni ’.
2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
2 Inċidenza miżjuda ta ’ waqfien tal- qalb ġiet osservata meta rosiglitazone ġie miżjud ma ’ sistemi ta ’ trattament b’ sulphonylurea (b’ terapija doppja jew trippla), u deher li kienet ogħla b’ 8 mg rosiglitazone meta mqabbla ma 4 mg rosiglitazone (doża sħiħa ta ’ kuljum).
Moreover in patients with congestive heart failure NYHA class I-II, a placebo- controlled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Barra dan, f’ pazjenti b’ waqfien tal- qalb konġestiva NYHA klassi I- II, prova ta ’ sena kontrollata bi plaċebo wriet deterjorament jew deterjorament possibbli ta ’ waqfien tal- qalb f’ 6. 4% ta ’ pazjenti trattati b’ rosiglitazone, meta mqabbla ma ’ 3. 5% fuq plaċebo.
3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 1.99% versus combined active and placebo comparators, 1.51% [Hazard ratio 1.31 (95% confidence interval 1.01 - 1.70)].
27 3 F’ analiżi retrospettiva ta ’ tagħrif minn 42 studji kliniċi fuq tul ta ’ żmien qasir, miġbura flimkien, l - inċidenza ġenerali ta ’ każi assoċjati tipikament ma ’ iskemija kardijaka kienet ogħla fil- każ ta ’ terapija li jkun fiha rosiglitazone, 1. 99% kontra komparaturi attivi kombinati u plaċebo, 1. 51% (Hazard ratio 1. 31 (95% confidence interval 1. 01 – 1. 70)).
This risk was increased when rosiglitazone was added to established insulin and in patients receiving nitrates for known ischaemic heart disease.
Dan ir- riskju żdied meta rosiglitazone ġie miżjud f’ pazjenti stabbiliti fuq insulina u f’ pazjenti li kienu qegħdin jieħdu nitrates minħabba mard iskemiku tal- qalb magħruf.
In a large observational study where patients were well-matched at baseline, the incidence of the composite endpoint myocardial infarction and coronary revascularization was 17.46 events per 1000 person years for rosiglitazone containing regimens and 17.57 events per 1000 person years for other anti-diabetic agents [Hazard ratio 0.93 (95% confidence interval 0.80 - 1.10)].
Fi studju estensiv ta ’ osservazzjoni li fih pazjenti kienu magħżulin tajjeb f’ linja bażika, l- inċidenza ta ’ infart mijokardijaku endpoint b’ mod kompost u rivaskularizzazzjoni koronarja kienet ta ’ 17. 46 każi kull 1000 ħajja ta ’ persuna fuq terapija li jkun fiha rosiglitazone u 17. 57 każi kull 1000 sena ħajja ta ’ persuna fil- każ ta ’ aġenti oħra anti- dijabetiċi (Hazard ratio 0. 93 (95% confidence interval 0. 80 – 1. 10)).
The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
L- inċidenza tal- każi avversi kolha relatati ma sistemi tal- fwied u biljari kienet < 1. 5% f’ kull grupp trattat u l- istess għall- plaċebo.
Post-marketing data In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
28 Tagħrif ta ’ wara t- tqegħid fis- suq Min barra r- reazzjonijiet mhux mixtieqa identifikati mit- tagħrif minn provi kliniċi, reazzjonijiet mhux mixtieqa ġew identifikati waqt l- użu ta ’ wara l- awtorizzazzjoni tar- rosiglitazone u dawn huma ppreżentati f’ tabella 2.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported. marketing experience.
Każi rari ta ’ enzimi tal- fwied għolja u funzjonament ħażin epatoċellulari kienu rappurtati.
26 Table 3.
29 Tabella 3.
Cross-allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Allerġeniċita` minn waħda għall- oħra b’ sulphonylureas, sulphonamides jew sustanzi relatati hi possibbli.
7 Mild hypersensitivity reactions may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock.
7 Reazzjonijiet ħfief ta ’ sensittivita` eċċessiva jistgħu jiżviluppaw f’ reazzjonijiet serji b’ dispneja, tnaqqis fil- pressjoni tad- demm u kultant xokk.
11 Hypersensitivity reactions of the skin may occuras itching, rash and urticaria.
10 L- epatite tista ’ twassal għal waqfien tal- funzjoni tal- fwied 11 Jista ’ jkun hemm reazzjonijiet ta ’ sensittivita` eċċessiva fil- ġilda bħal ħakk, raxx u urtikarja.
Transient visual disturbances may occur especially on initiation of treatment, due to changes in blood glucose levels.
30 Disturbi viżwali li jgħaddu jistgħu jseħħu speċjalment fil- bidu tat- trattament, minħabba bidliet fil - livelli ta ’ glukosju fid- demm.
27 4.9 Overdose
4. 9 Doża eċċessiva
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Fi studji kliniċi fuq voluntieri rosiglitazone ingħata f’ dożi individwali mill- ħalq sa 20 mg u baqa ’ tollerat tajjeb.
Overdose of sulphonylureas, including glimepiride, can result in severe life-threatening hypoglycaemia lasting 12 to 72 hours, which may recur after apparent recovery.
Doża eċċessiva ta ’ sulphonylureas, inkluż glimepiride, jistgħu iwasslu għal ipogliċemija li tista ’ tkun fatali u li ddum minn 12 sa 72 siegħa, li tista tirrepeti ruħha wara li tkun għaddiet.
Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas act primarily by stimulating release of insulin from functioning pancreatic β -cells.
Thiazolidinediones jaġixxu primarjament billi jnaqqsu r- reżistenza ta ’ l- insulina u sulphonylureas billi jistimulaw ir- rilaxx ta ’ l- insulina minn ċelluli β tal- pankreas li jiffunzjonaw.
A study comparing AVAGLIM to monotherapy rosiglitazone or glimepiride demonstrated incremental benefit in control of glycaemia of the fixed-dose combination over monotherapy.
Studju li jqabbel AVAGLIM ma ’ monoterapija b’ rosiglitazone jew glimepiride wera benefiċċju ikbar fil- kontroll ta ’ gliċemija tal- kombinazzjoni b’ doża fissa fuq monoterapija.
In clinical trials, the glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
Fi provi kliniċi, l- effetti li jnaqqsu l- glukosju osservati b’ rosiglitazone jibdew bil- mod waqt li kważi t - tnaqqis massimu fil- glukosju bi plażma fis- sawm (FPG) evidenti wara bejn wieħed u ieħor 8 ġimgħat ta ’ terapija.
Rosiglitazone was associated with increases in weight.
31 Rosiglitazone kien assoċjat ma ’ żjidiet fil- piż.
28 Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
Waqt li konsistenti fil- mekkaniżmu ta ’ azzjoni, rosiglitazone naqqas ir- reżistenza għall- insulina u tejjeb il- funzjoni biċ- ċellula ß fil- pankreas.
An outcome study has not been completed with rosiglitazone, therefore the long-term benefits associated with improved glycaemic control have not been demonstrated.
Studju dwar ir- riżultati finali dwar rosiglizatone għadu ma ġiex kompletat, għalhekk il- benefiċċji fit- tul assoċjati ma ’ kontroll gliċemiku aħjar għad ma dehrux.
Glimepiride Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group.
Glimepiride Glimepiride hi sustanza ipogliċemika attiva li tittieħed mill- ħalq u li tappartieni għall - grupp tas - sulphonylureas.
As with other sulphonylureas, this effect is based on an improvement in responsiveness of pancreatic beta cells to the physiological glucose stimulus.
Bħal fil- każ tas - sulphonylureas oħra, dan l- effett hu bażat fuq titjib fir- rispons taċ- ċelluli beta tal- pankreas għall - istimolu għal glukosju fisjoloġiku.
In addition, glimepiride seems to have pronounced extrapancreatic effects, also postulated for other sulphonylureas.
Barra dan, glimepiride jidher li għandha effetti ċari extra - pankreatiċi, li japplika wkoll għal sulphonylureas oħra.
Closure of the potassium channels leads to depolarisation of the beta cell and results by opening of the calcium channels – to an increased influx of calcium into the cell.
L- għeluq tal- kanali tal- potassju jwassal għal depolarizzazzjoni taċ - ċelluli beta u jirriżulta fil- ftuħ tal- kanali tal- kalċju – f’ influss miżjud ta ’ kalċju għal ġoċ- ċellula.
29 5.2 Pharmacokinetic properties
32 5. 2 Tagħrif farmakokinetiku
Single oral doses of glimepiride in 14 healthy adult subjects had no clinically significant effect on the steady-state pharmacokinetics of rosiglitazone.
Dożi individwali mill- ħalq ta ’ glimepiride f’ 14- il suġġett adulti u f’ saħħithom ma kellhom ebda effett sinifikanti kliniku fuq il- farmakokinetiċi steady- state ta ’ rosiglitazone.
The following statements reflect the pharmacokinetic properties of the individual components of AVAGLIM.
Il- fatti mniżżlin hawn taħt jirriflettu l- effetti farmakokinetiċi tal- komponenti individwali ta ’ AVAGLIM.
Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasted state.
It- teħid ta ’ rosiglitazone ma ’ l- ikel ma rriżulta f’ ebda bidla fl- esponiment ġenerali (AUC), għalkemm ġuw osservati tnaqqis żgħir fis - Cmax (bejn wieħed u ieħor 20- 28%) u dewmien fit - tmax (bejn wieħed u ieħor 1. 75 s) meta mqabbla ma ’ teħid ta ’ dożi fi stat ta ’ sawm.
The absorption of rosiglitazone is not affected by increases in gastric pH.
L- assorbiment ta ’ rosiglitazone ma jintlaqatx minn żjidiet fil- pH gastriku.
Distribution The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Distribuzzjoni Il- volum ta ’ distribuzzjoni ta ’ rosiglitazone hu bejn wieħed u ieħor 14 1 f’ voluntieri f’ saħħithom.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
L- irbit tal- proteini tal- plażma ta ’ rosiglitazone hu għoli (bejn wieħed u ieħor 99. 8%) u mhuwiex influwenzat minn konċentrazzjoni jew minn eta`.
The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high (> 99.99%).
L- irbit tal- proteini tal- metabolit prinċipali (sulfat para- hydroxy) hu għoli ħafna (99. 99%).
The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Ir- rotot ewlenin ta ’ metaboliżmu huma N- demetilazzjoni u idrosilazzjoni, segwiti b’ konjugazzjoni ma ’ sulfat u aċidu glukuroniku.
In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with a minor contribution by CYP2C9.
33 Studji in vitro juru li rosiglitazone hu prinċipalment metabolizzat b’ CYP2C8, b’ kontribuzzjoni żgħira ta ’ CYP2C9.
Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances
Billi m’ hemmx inibizzjoni in vitro sinifikanti ta ’ CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A jew 4A ma ’ rosiglitazone, hemm probabbilta` żgħira ta ’ interazzjonijiet sinifikanti bażati fuq metaboliżmu ma ’ sustanzi metabolizzati b’ dawn l- enzimi P450.
There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Ma hemm ebda evidenza ta ’ xi akkumulazzjoni mhux mistennija ta ’ rosiglitazone wara dożi ta ’ darba jew darbtejn kuljum.
Studies with single oral doses in normal subjects and with multiple oral doses in patients with type 2 diabetes mellitus have shown significant absorption of glimepiride within 1 h after administration and Cmax at approximately 2.5 h.
Studji b’ dożi individwali orali f’ suġġetti normali u b’ dożi orali multipli fuq pazjenti bid- dijabete mellitus tat - tip 2 urew assorbiment sinifikanti ta ’ glimepiride siegħa wara li jittieħdu u Cmax bejn wieħed u ieħor wara 2. 5 sigħat.
Metabolism Glimepiride is completely metabolised by oxidative biotransformation after either an intravenous or oral dose.
Metaboliżmu Glimepiride jiġi metabolizzat kompletament b’ bijotrasformazzjoni ossidattiva wara doża ġol- vini jew mill- ħalq.
M1, but not M2, possesses about 1/ 3 of the pharmacological activity as compared to its parent in an animal model.
M1, iżda mhux M2, tippossiedi kważi 1/ 3 ta ’ l- attivita` farmakoloġika meta mqabbla mal- ġenitur tagħha f’ annimal mudell.
Elimination The elimination half-life of glimepiride is approximately 5 to 8 h.
Eliminazzjoni L- eliminazzjoni tal- ħalf- life ta ’ glimepiride hi bejn wieħed u ieħor minn 5 sa 8 sigħat.
Hepatic impairment:
34 Ħsara fil- fwied:
31 Renal insufficiency:
Insuffiċjenza tal- kliewi:
A multiple-dose titration study with glimepiride conducted in 16 patients with type 2 diabetes mellitus with renal impairment using doses ranging from 1 to 8 mg daily for three months showed that all patients with a creatinine clearance less than 22 ml/ min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily (see section 4.2 and 4.4).
Studju ta ’ titrazzjoni b’ ħafna dożi ta ’ glimepiride li twettqu fuq 16- il pazjent bid- dijabete mellitus tat - tip 2 b’ indeboliment tal- kliewi bl- użu ta ’ dożi li jvarjaw minn 1 sa 8 mg kuljum għal tliet xhur urew li l- pazjenti kollha bi tneħħija ta ’ kreatinina li tkun inqas minn 22 ml/ min kellhom kontroll adegwat tal - livelli tal- glukosju tagħhom b’ sistema ta ’ dożi ta ’ 1 mg biss kuljum (ara sezzjoni 4. 2 u 4. 4).
An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
Żjieda fil- volum ta ’ plażma flimkien ma ’ tnaqqis fil- parametri taċ- ċelloli ħomor u żieda fil- piż tal - qalb.
Increases in liver weight, plasma ALT (dog only) and fat tissue were also observed.
Żidiet fil- piż tal- fwied, plażma ALT (klieb biss) u tessut xaħmi kienu wkoll osservati.
In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
Fi studji dwar tossiċità fuq is- sistema riproduttiva, l- ogħti ta ’ rosiglitazone lil firien bejn in- nofs u l - aħħar tal- ġestazzjoni kien assoċjat mal- mewt tal- fetu u żvilupp ritardjat tal- fetu.
In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
F’ mudell ta ’ annimal ittestjat għal polipożi familjali adenomatuża (FAP), il- kura b’ rosiglitazone b’ doża ta ’ 200 darba iktar mid- doża farmakoloġikament attiva żiedet il- multipliċità ta ’ tumuri fil - kolon.
In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
Barra minn hekk, rosiglitazone ma kienx ġenotossiku f’ serje ta ’ studji dwar ġenotossiċità kemm f’ in vivo kif ukoll f’ in vitro u ma hemm l- ebda evidenza ta ’ tumuri fil- kolon li toħroġ minn studji fuq rosiglitazone li saru tul il- ħajja kollha ta ’ żewġ speċi ta ’ annimali li jgerrmu.
High doses given to mother rats cause hypoglycaemia in suckling young rats (see section 4.6).
Dożi għolja mogħtija lil firien nisa jikkawżaw ipogliċemija fi ġrieden żgħar li jkunu jerdgħu (ara sezzjoni 4. 6)
6.1 List of excipients
35 6. 1 Lista ta ’ sustanzi mhux attivi
8/ 4 Tablet core:
8/ 4 Il- qalba tal- pillola:
32 Film coat:
Ir- rita tal- kisja:
Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Iron oxide red (E172).
Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Ossidu iswed tal- ħadid (E172) Ossidu aħmar tal- ħadid (E172).
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jitlobx kondizzjonijiet speċjali għall- ħażna tiegħu
Avenida de Extremadura, 3 09400 Aranda de Duero Burgos Spain
Avenida de Extremadura, 3 09400 Aranda de Duero Burgos Spanja
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET DWAR L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR L- UŻU BLA PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ għandu jiżgura li s - sistema ta ’ farmakoviġilanza qiegħda f’ postah u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq.
The MAH commits to perform the studies and the additional Pharmacovigliance activities detailed in the Pharmacovigilance Plan.
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ jintrabat li jwettaq l - istudji u l- attivitajiet ta ’ Farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza.
35 ANNEX III
39 ANNESS III
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
AVAGLIM 4 mg/ 4 mg film-coated tablets. rosiglitazone/ glimepiride
AVAGLIM pilloli ta ’ 4 mg/ 4 mg miksijin b’ rita rosiglitazone/ glimepiride
Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4 mg rosiglitazone u 4 mg glimepiride
Contains lactose, see leaflet for further information
Fih il- lattosju, ara l- fuljett għal aktar tagħrif
film-coated tablets
Pilloli miksijin b’ rita
14 tablets 28 tablets 56 tablets 84 tablets 112 tablets
14- il pillola 28 pillola 56 pillola 84 pillola 112- il pillola
Oral use Use only as directed by your doctor Read the package leaflet before use
Jintuża mill- ħalq Użah biss kif jgħidlek it- tabib Aqra l- fuljett li hemm mal- pakkett qabel tużah
SmithKline Beecham plc 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
SmithKline Beecham plc 980 Great West Road Brentford, Middlesex TW8 9GS Ir- Renju Unit
14 tablets 28 tablets 56 tablets 112 tablets 84 tablets
14- il pillola 28 pillola 56 pillola 112- il pillola 84 pillola
AVAGLIM 4 mg/ 4 mg
AVAGLIM 4mg/ 4mg
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
AVAGLIM 4 mg/ 4 mg film-coated tablets. rosiglitazone/ glimepiride
AVAGLIM pilloli ta ’ 4 mg/ 4 mg miksijin b’ rita Rosiglitazone/ glimepiride
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETTI TA ’ BARRA
AVAGLIM 8 mg/ 4 mg film-coated tablets. rosiglitazone/ glimepiride
AVAGLIM pilloli ta ’ 8 mg/ 4 mg miksijin b’ rita rosiglitazone- glimepiride
Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone and 4 mg glimepiride.
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 8 mg rosiglitazone u 4 mg glimepiride.
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U ROTOT TA ’ MNEJN JINGĦATA
Oral use Use only as directed by your doctor Read the package leaflet before use
Għal użu mill- ħalq Uża biss kif jgħidlek it- tabib Aqra l- fuljett fil- pakkett qabel tużah
AVAGLIM 8 mg/ 4 mg
AVAGLIM 8mg/ 4mg
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
AVAGLIM 8 mg/ 4 mg film-coated tablets. rosiglitazone/ glimepiride
AVAGLIM pilloli ta ’ 8 mg/ 4 mg miksijin b’ rita rosiglitazone/ glimepiride
44 PACKAGE LEAFLET:
48 FULJETT TA ’ TAGĦRIF:
AVAGLIM 4 mg/ 4 mg film-coated tablets AVAGLIM 8 mg/ 4 mg film-coated tablets rosiglitazone/ glimepiride
AVAGLIM pilloli ta ’ 8 mg/ 4 mg miksijin b’ rita. rosiglitazone/ glimepiride
- If any of the side effects gets serious, or if you notice any side effects not listed in this
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
leaflet, tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Avaglim is and what it is used for 2.
X’ inhu Avaglim u għalxiex jintuża 2.
Before you take Avaglim 3.
Qabel ma tieħu Avaglim 3.
How to take Avaglim 4.
Kif għandek tieħu Avaglim 4.
Possible side effects 5 How to store Avaglim 6.
Kif taħżen Avaglim 6.
WHAT AVAGLIM IS AND WHAT IT IS USED FOR
X’ INHU AVAGLIM U GĦALXIEX JINTUŻA
Avaglim tablets are a combination of two different medicines called rosiglitazone and glimepiride.
Il- pilloli ta ’ Avaglim huma kumbinazzjoni ta ’ żewġ mediċini differenti li jissejjħu rosiglitazone u glimepiride.
These two medicines are used to treat type 2 diabetes.
Dawn iż- żewġ mediċini jintużaw biex jikkuraw dijabete tat- tip 2.
People with type 2 diabetes either don’ t make enough insulin (a hormone that controls blood sugar levels), or don’ t respond normally to the insulin their body makes.
Nies li jbatu minn dijabete tat- tip- 2 jew ma jagħmlux biżżejjed insulina (ormon li jikkontrolla il- livelli ta ’ zokkor fid- demm), jew ma jirrispondux normalment għall- insulina li jagħmel ġisimhom.
Rosiglitazone and glimepiride work together so your body makes better use of the insulin it produces, and this helps reduce your blood sugar to a normal level.
Rosiglitazone u glimepiride jaħdmu flimkien biex ġismek jagħmel użu aħjar mill- insulina li jipproduċi, u dan jgħin biex inaqqas iz- zokkor fid- demm tiegħek għall- livell normali..
BEFORE YOU TAKE AVAGLIM
QABEL MA TIEĦU AVAGLIM
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avaglim.
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal rosiglitazone, glimepiride, jew xi
Don’ t take Avaglim: • if you are allergic (hypersensitive) to rosiglitazone, glimepiride, or any of the other ingredients of Avaglim (listed in Section 6), or to other medicines called sulphonylureas (like glibenclamide) or sulphonamides • if you have had a heart attack or severe angina, that’ s being treated in hospital • if you have heart failure, or have had heart failure in the past • if you have liver disease • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting) • if you have severe kidney disease • if you have type 1 diabetes – this needs different treatment.
wieħed mill- ingredjenti l- oħra ta ’ Avaglim (imniżżlin f’ Sezzjoni 6), jew għal mediċini oħra li jissejħu sulphonylureas (bħal glibenclamide) jew sulphonamides
Check with your doctor if you think any of these apply to you.
Iċċekja mat- tabib tiegħek jekk xi wieħed minn dawn japplikaw għalik.
Don’ t take Avaglim.
Tieħux Avaglim.
Take special care with Avaglim
Oqgħod attent ħafna b’ AVAGLIM:
Avaglim is not recommended for people aged under 18, as the safety and effectiveness are not known.
49 Avaglim m’ huwiex rakkomandat għal nies taħt it- 18- il sena, għax is- sigurta ’ u l- effettivita ’ m’ humiex magħrufa.
45 If you have been diagnosed with angina (chest pain), or peripheral arterial disease (reduced blood flow to the legs):
Jekk inti ġejt idjanjostikat b’ anġina (uġigħ fis- sider), jew mard arterjali periferali (tnaqqis fiċ - ċirkulazzjoni tad- demm fis- saqajn).
Check with your doctor, as Avaglim may not be suitable for you.
Iċċekkja mat- tabib tiegħek, għax Avaglim jista ’ ma jkunx jgħodd għalik.
Haemolytic anaemia:
Anemija emolitika:
If you have an inherited condition where your red blood cells don’ t produce enough of the enzyme G6PD, Avaglim may cause your red blood cells to be destroyed too quickly (haemolytic anaemia).
Jekk inti writ kundizzjoni fejn iċ- ċelloli ħomor tad- demm tiegħek ma jipproduċux biżżejjed l- enżima G6PD, Avaglim jista ’ jikkawża ċ- ċelloli ħomor tad- demm tiegħek li jiġu distrutti malajr wisq (anemija emolitika).
Tell your doctor if you have this condition, as Avaglim may not be suitable for you.
Għid lit- tabib tiegħek, jekk għandek din il- kundizzjoni għax Avaglim jista ’ ma jkunx jgħodd għalik.
Conditions to look out for Avaglim and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Kundizzjonijiet li għandek toqgħod attent għalihom Avaglim u mediċini oħra għad- dijabete jistgħu iġagħlu xi kondizzjonijiet eżistenti imorru għall- agħar, jew jikkawżaw effetti mhux mixtieqa serji.
You must look out for certain symptoms while you are taking Avaglim, to reduce the risk of any problems.
Għandek toqgħod attent għal ċerti sintomi waqt li tkun qed tieħu Avaglim, biex tnaqqas ir- riskju ta ’ xi problemi.
See ‘ Conditions you need to look out for’ in Section 4.
Ara ‘ Kundizzjonijiet li hemm bżonn toqgħod attent għalihom ’ f’ Sezzjoni 4.
Ovulation may restart Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avaglim.
Tista ’ terġa ’ tibda l- ovulazzjoni Nisa li huma infertili minħabba xi kundizzjoni li taffettwa l- ovarji tagħhom (bħal Sindromu Poliċestiku ta ’ l- Ovarji), jistgħu jerġgħu jibdew jovulaw meta jibdew jieħdu Avaglim.
If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘ Pregnancy and breast-feeding’ later in Section 2).
Jekk dan japplika għalik, uża kontraċezzjoni adattata biex tevita l- possibilita ’ ta ’ tqala mhux pjanata (ara ‘ Tqala u treddigħ ’ aktar ‘ il quddiem f’ Sezzjoni 2)
You will have regular blood tests Avaglim can cause reductions in some types of blood cells.
Inti jkollok testijiet tad- demm regolari Avaglim jista jikkawża tnaqqis f’ xi tipi ta ’ ċelloli tad- demm.
Your doctor should regularly test your blood while you are taking Avaglim.
It- tabib tiegħek għandu jiċċekkjalek id - demm regolarment waqt li tkun qed tieħu Avaglim.
Your kidney function will be checked If you have kidney disease, or are over 65, your kidney function should be checked while you are taking Avaglim.
Il- funzjoni tal- kliewi tiegħek tiġi iċċekjata Jekk għandek mard tal- kliewi, jew għandek aktar minn 65 sena, il- funzjoni tal- kliewi tiegħek għandha tkun iċċekkjata waqt li tkun qed tieħu Avaglim.
Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, if you’ ve taken any recently, or if you start taking new ones.
Meta tieħu mediċini oħra Għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu xi mediċini oħra, jekk ħadt xi mediċini riċentement, jew jekk tibda tieħu xi ġodda.
This includes herbal medicines and other medicines you bought without a prescription.
Dan jinkludi mediċini erbali u mediċini oħra li tkun xtrajt mingħajr riċetta.
Many medicines (or alcohol) can affect the way Avaglim controls the amount of sugar in your blood.
Ħafna mediċini (jew alkoħol) jistgħu jaffettwaw il- mod li Avaglim jikkontrolla l- ammont ta ’ zokkor fid- demm tiegħek.
Your blood sugar levels may become too high or too low (see ‘ Low blood sugar’ in Section 4).
Il- livelli ta ’ zokkor fid- demm tiegħek jistgħu jiġu għoljin iżżejjed jew baxxi żżejjed (ara ‘ Zokkor baxx fid- demm ’ f’ Sezzjoni 4).
Tell a doctor or pharmacist if you think that Avaglim is not working as it should, particularly if you are taking any other medicines.
Ftit mill- mediċini li l- aktar jistgħu jagħmlu hekk huma: • gemfibrozil (li jintuża biex ibaxxu l- kolesterol) • rifampicin (li jintuża biex jikkura t- tuberkulożi u nfezzjonijiet oħra) • fluconazole (li jintuża biex jikkura infezzjonijiet tal- fungus) Għid tabib jew ispiżjar jekk taħseb li Avaglim mhux qed jaħdem kif għandu jaħdem, speċjalment jekk tkun qed tieħu xi mediċini oħra.
You may need to have the dose adjusted or change the other medicines you are taking.
Jista ’ jkun hemm bżonn taġġusta d- doża jew tibdel il- mediċini l- oħra li tkun qed tieħu.
Some medicines used to treat high blood pressure (such as beta-blockers, clonidine, guanethidine or reserpine) may make you less aware of the warning signs of low blood sugar (sweating; fast irregular heartbeats).
Xi mediċini li jintużaw biex jikkuraw il- pressjoni għolja (bħal beta- blockers, clonidine, guanethidine jew reserpine) jistgħu jagħmluk anqas attent għal sinjali ta ’ twissija li z- zokkor fid- demm baxx (għaraq; taħbit mgħaġġel u rregolari tal- qalb).
Checking your blood sugar levels regularly is especially important if you are taking any of these medicines, even if you are feeling well
Li tiċċekkja il- livelli taz- zokkor fid- demm tiegħek regolarment huwa importanti specjalment jekk tkun qed tieħu xi wieħed minn dawn il- mediċini, anke jekk tkun qed tħossok tajjeb.
Avaglim can also strengthen or weaken the effects of medicines to prevent blood clots (anticoagulants such as warfarin).
50 Avaglim jista ’ wkoll isaħħaħ jew idgħajjef l- effetti ta ’ mediċini biex jipprevjenu għoqiedi tad- demm (antikoagulanti bħal warfarin).
Tell your doctor or pharmacist if you are taking anticoagulants.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu xi antikoagulanti.
46 Pregnancy and breast-feeding • Avaglim is not recommended during pregnancy.
Tqala u treddigħ • Avaglim m' huwiex rakkomandat waqt it- tqala.
If you are pregnant or could be pregnant, tell your doctor.
Jekk inti tqila jew tista ’ tkun tqila, għid lit - tabib tiegħek. • Treddgħax waqt li tkun qed tieħu Avandia.
The ingredients may pass into breast milk and so may harm your baby.
L- ingredjenti jistgħu jgħaddu fil- ħalib tas- sider u għalhekk jistgħu jagħmlu l- ħsara lit- tarbija tiegħek.
Driving and using machines Avaglim can make you dizzy or cause your blood sugar to become lower than normal (see ‘ Low blood sugar’ in Section 4).
Sewqan u tħaddim ta ’ magni Avaglim jista ’ jġiegħlek tħossok stordut jew iġiegħel iz- zokkor fid- demm tiegħek jitbaxxa aktar minn normal (ara Zokkor baxx fid- demm ’ f’ Sezzjoni 4).
Don’ t drive or operate machinery unless you’ re feeling well.
Issuqx jew tħaddem magni sakemm ma tkunx qed tħossok tajjeb.
Avaglim contains lactose Avaglim tablets contain a small amount of lactose.
Avaglim fih il- lattożju Il- pilloli ta ’ Avaglim fihom ammonti zgħar ta ’ lattożju.
Patients who are intolerant to lactose or have a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Pazjenti li għandhom intolleranza għal- lattożju jew bi problemi ereditarji rari ta ’ intolleranza għall- galattożju, in- nuqqas ta ’ Lapp lactase jew malassorbiment tal- lattożju- galattożju, m’ għandhomx jieħdu din il- mediċina.
HOW TO TAKE AVAGLIM
KIF GĦANDEK TIEĦU AVAGLIM
Always take Avaglim tablets exactly as your doctor has told you.
Dejjem għandek tieħu il- pilloli ta ’ Avaglim eżatt skond ma jkun qallek it- tabib tiegħek.
Check with your doctor or pharmacist if you are not sure.
Iċċekkja mat- tabib jew l- ispiżjar tiegħek jekk m’ intix żgur.
How much to take The usual starting dose is one combined tablet (4 mg rosiglitazone and 4 mg glimepiride), taken once a day.
Kemm tieħu Id- doża tal- bidu tas- soltu hija pillola waħda kombinata (4mg rosiglitazone u 4mg glimepiride), li tittieħed darba kuljum.
After about 8 weeks your doctor may need to increase your dose.
Wara xi 8 ġimgħat it- tabib tiegħek jista ’ jkollu bżonn iżidlek id- doża.
The maximum dose is one combined tablet of 8 mg rosiglitazone and 4 mg glimepiride, taken once a day.
Id- doża massima hija ta 'pillola kombinata ta ’ 8mg rosiglitazone u 4mg glimeperide, li tittieħed darba kuljum.
How to take Swallow the tablets with some water.
Kif tittieħed Ibla ’ l- pilloli bi ftit ilma.
It is best to take Avaglim with food, or just before food, usually with your first main meal of the day.
Ikun aħjar jekk tieħu Avaglim ma ’ l- ikel jew ftit qabel l- ikel, generalment ma ’ l- ewwel ikla kbira tal- ġurnata.
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Ħu l- pilloli tiegħek madwar l- istess ħin kuljum u segwi kull parir dijetitiku li jkun tak it- tabib tiegħek.
If you take more Avaglim than you should If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Jekk tieħu aktar Avaglim milli jmissek Jekk aċċidentalment tieħu ħafna pilloli, ikkuntatja lit- tabib jew lill- ispiżjar tiegħek għal parir.
You may be at risk of having low blood sugar and need hospital treatment.
Tista ’ tkun f’ riskju li jkollok iz- zokkor fid- demm baxx u li jkollok bżonn kura fl- isptar.
If you forget to take Avaglim Don’ t take extra tablets to make up for a missed dose.
Jekk tinsa tieħu Avaglim Tieħux pilloli żejda biex tpatti għal doża li tkun tlift.
Just take your next dose at the usual time.
Ħu biss id- doża tiegħek li jmiss fil- ħin tas- soltu.
Don’ t stop taking Avaglim Take Avaglim for as long as your doctor recommends.
Tieqafx tieħu Avaglim Ħu Avaglim sakemm jirrikmandalek it- tabib tiegħek.
If you stop taking Avaglim, your blood sugar will not be controlled, and you may become unwell.
Jekk tieqaf tieħu Avaglim, iz- zokkor fid- demm tiegħek ma jkunx ikkontrollat, u tista ’ tkun ma tiflaħx.
Talk to your doctor if you want to stop.
Kellem lit- tabib tiegħek jekk trid tieqaf.
Like all medicines, Avaglim can cause side effects, but not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Bħall- mediċini kollha, Avaglim jista ’ jikkawża effetti sekondarji, għalkemm mhux kulħadd ikollu.
Conditions you need to look out for
51 Kondizzjonijiet li għandek bżonn toqgħod għassa għalihom
These are very rare in people taking Avaglim.
Dawn huma rari ħafna f’ nies li jieħdu Avaglim.
Contact a doctor immediately if you get any of these symptoms.
Jinkludu sinjali bħal: • raxx imtella u bil- ħakk (hives) • nefħa, xi kultant tal- wiċċ jew tal- ħalq (anġjoedema), li tikkawża diffikulta ’ fin- nifs • kollass Ikkuntatja tabib immedjatament jekk ikollok xi wieħed minn dawn is- sintomi.
Stop taking Avaglim.
Ieqaf ieħu Avaglim.
Fluid retention and heart failure:
Ritenzjoni ta ’ fluwidu u falliment tal- qalb:
Avaglim can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Avaglim jista ’ jgiegħlek iżżomm l- ilma (ritenzjoni ta ’ fluwidu) li twassal għal nefħa u żieda fil- piż.
Extra body fluid can make some existing heart problems worse or lead to heart failure.
Fluwidu żejjed fil- ġisem jista ’ jagħmel xi problemi diġa ’ eżistenti tal- qalb agħar jew iwassal għal falliment tal- qalb.
This is more likely if you are also taking other medicines for your diabetes like insulin, if you have kidney problems, or if you are over 65.
Dan huwa aktar possibli jekk inti diġa ’ tkun qed tieħu mediċini oħra għad- dijabete tiegħek (bħal insulina), jekk għanded problemi bil- kliewi, jew jekk inti għandek aktar minn 65 sena.
Check your weight regularly; if it goes up rapidly, tell your doctor.
Iċċekkja l- piż tiegħek regolarment; jekk iżid b’ mod rapidu, għid lit- tabib tiegħek.
Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Sintomi ta ’ falliment tal- qalb jinkludu: • qtigħ ta ’ nifs, tqum bil- qtigħ ta ’ nifs bil- lejl • tgħejja malajr wara attivita ’ fisika ħafifa bħal mixi • żieda rapida fil- piż tiegħek • egħkiesi jew riġlejn minfuħa Għid lit- tabib tiegħek mill- aktar fis possibli jekk ikollok xi wieħed minn dawn is- sintomi – jew għall- ewwel darba jew jekk imorru għall- agħar.
Certain conditions can make you more likely to suffer from low blood sugar while you are taking Avaglim.
Zokkor baxx fid- demm (ipogliċemija): Ċertu kundizzjonijiet jistgħu jagħmluha aktar faċli li inti ssofri minn zokkor baxx fid- demm waqt li tkun qed tieħu Avaglim.
The severity can increase, leading to confusion and loss of consciousness.
Dawn jinkludu: • li tieħu mediċini oħra biex tikkura d- dijabete • mard tal- kliewi • piż baxx tal- ġisem jew dieta mhux tajba • sitwazzjonijiet ta ’ stress (bħal trawma, operazzjoni jew infezzjonijiet) Sintomi bikrin ta ’ zokkor baxx fid- demm jinkludu: • rogħda, għaraq, iħossok ħażin • nervożità, palpitazzjonijiet • ġuħ Is- severita ’ tista ’ żżid, u twassal għal konfużżjoni u telf ta 'sensi.
Tell your doctor as soon as possible if you get any of these symptoms.
Għid lit- tabib tiegħek mill- aktar fis possibli jekk ikollok xi wieħed minn dawn is- sintomi.
The dose of your medicines may need to be reduced.
Id - doża tal- mediċini tiegħek jista ’ jkollha bżonn titnaqqas.
Liver problems:
Problemi fil- fwied:
Before you start taking Avaglim you will have a blood sample taken to check your liver function.
Qabel ma tibda ’ tieħu Avaglim jittieħidlek kampjun tad- demm biex tiċċekkja il - funzjoni tal- fwied tiegħek.
This check may be repeated at intervals.
Dan l- iċċekkjar jista ’ jkun ripetut f’ intervalli.
Tell your doctor as soon as possible if you get these symptoms.
Dawn jistgħu ikunu sinjali ta ’ problemi fil- fwied: • dardir u rimettar • uġigħ fl- istonku (addomenu) • nuqqas ta ’ aptit • awrina kulur skur Għid lit- tabib tiegħek mill- aktar fis jekk ikollok xi wieħed minn dawn is- sintomi.
Eye problems:
Problemi fl- għajnejn:
Swelling of the retina at the back of the eye which can cause blurred vision (macular oedema) can be a problem for people with diabetes.
Nefħa fir- retina fuq in- naħa ta ’ wara ta ’ l- għajn li tista ’ tikkawża vista mċajpra (edema makulari) tista ’ tkun problema għal nies bid- dijabete.
New or worse cases of macular oedema have occurred on rare occasions in people taking Avaglim and similar medicines.
Ġraw każi ta ’ edema makulari ġodda jew li marru għall- agħar f’ okkażjonijiet rari f’ nies li jkunu fuq Avaglim u mediċini simili.
Discuss with your doctor any concerns about your eyesight.
Iddiskuti mat- tabib tiegħek kull inkwiet dwar il- vista tiegħek.
Broken bones:
Ksur fl- għadam:
Bone fractures can occur in people with diabetes.
Jista ’ jkun hemm ksur fl- għadam f’ nies bid- dijabete.
The chances of this happening may be higher in women taking rosiglitazone for more than one year.
Il- possibilitajiet li jiġri dan jista ’ jkun aktar għoli f’ nisa li ilhom jieħdu rosiglitazone għal aktar minn sena.
The most common are breaks in feet, hands and arms.
Effetti sekondarji komuni ħafna
48 Very common side effects These may affect more than 1 in 10 people: • lower blood sugar than normal (hypoglycaemia) • swelling (oedema) due to water retention.
52 Dawn jistgħu jaffettwaw aktar minn persuna 1 kull 10 • zokkor fid- demm aktar baxx minn normal (ipogliċemija) • nefħa (edema) minħabba ritenzjoni ta ’ fluwidu.
Common side effects These may affect up to 1 in 10 people: • chest pain (angina) • heart failure • broken bones • increased weight, increased appetite • dizziness • constipation • reduction in blood count (anaemia) low numbers of white blood cells (leucopaenia) and blood cells needed for blood clotting (thrombocytopaenia) • small increases in blood cholesterol, increased amount of fats in the blood
Effetti sekondarji komuni Dawn jistgħu jaffetwaw sa persuna waħda minn kull 10 • uġigħ fis- sider (anġina) • falliment tal- qalb • ksur ta ’ għadam • żjieda fil- piż, żjieda fl- aptit • sturdament • stitikezza • tnaqqis fin- numru ta ’ ċelluli fid- demm (anemija) numru baxx ta ’ ċelloli bojod fid- demm (lewkopenja) u ċelloli tad- demm neċessarji biex jagħqad id- demm (tromboċitopenja). • żidiet żgħar tal- kolesterol fid- demm, żieda fl- ammont ta ’ xaħmijiet fid- demm.
Rare side effects These may affect up to 1 in 1,000 people: • fluid in the lungs (pulmonary oedema) causing breathlessness • swelling of the retina at the back of the eye (macular oedema) • reduction in the number of red blood cells, or a type of white blood cell (granulocytopaenia) which can be severe (agranulocytosis), reduction in the number of all types of blood cells (pancytopaenia) • liver doesn’ t function as well as it should (increase in liver enzymes).
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa wieħed 1 minn kull 1, 000 persuna • fluwidu fil- pulmun (edema pulmonari) li tikkawża qtugħ ta ’ nifs • nefħa fir- retina fuq wara ta ’ l- għajn (edema makulari) • tnaqqis fin- numru ta ’ ċelloli ħomor fid- demm, jew tip ta ’ ċellola bajda fid- demm (granuloċitopenja) li tista ’ tkun severa (agranuloċitosi), tnaqqis fin- numru tat- tipi kollha taċ - ċelloli tad- demm (panċitopenja) • il- fwied ma jiffunzjonax tajjeb kemm imissu (żieda fl- enżimi tal- fwied)
Very rare side effects These may affect up to 1 in 10,000 people: • allergic reactions, inflammation of blood vessels (allergic vasculitis) • increased sensitivity to the sun causing skin rash • inflammation of the liver (hepatitis), yellowing of the skin (jaundice) • rapid and excessive weight gain caused by fluid retention • stomach pain, bloating, feeling sick (nausea), vomiting or diarrhoea • decrease in the amount of sodium in your blood.
Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa 1 minn kull 10, 000 persuna • reazzjonijiet allerġiċi, infjammazzjoni ta ’ l- arterji tad- demm (vaskulite allerġika) • żieda fis- sensittivita ’ għax- xemx li tikkawża raxx fil- ġilda • infjammazzjoni tal- fwied (epatite), sfura fil- ġilda (suffejra) • żieda rapida u eċċessiva fil- piż ikkawżata minn ritenzjoni ta ’ fluwidu • uġigħ fl- istonku, nefħa bil- gass, tħossok imdardar (nawsja), rimettar jew dijarrea • nuqqas fl- ammont ta ’ sodju fid- demm tiegħek
If you get side effects Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Jekk ikollok effetti mhux mixtieqa Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed minn dawn l- effetti mhux mixtieqa hawn fuq isir sever jew itik il- problemi, jew jekk tinnota xi effetti mhux mixtieqa mhux imsemmija f’ dan il- fuljett.
HOW TO STORE AVAGLIM
KIF TAĦŻEN AVAGLIM
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfaL.
Do not use Avaglim after the expiry date shown on the pack.
Tużax Avaglim wara d- data ta ’ skadenza li tidher fuq il- pakkett.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn kondizzjonijiet speċjali għall- ħażna.
If you have any unwanted tablets, don’ t put them in waste water or household rubbish.
Jekk għandek xi pilloli li m’ għandekx bżonn, tagħmilhomx fl- ilma tad- drenaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of tablets you don’ t need.
Staqsi lill- ispiżjar tiegħek kif għandek tarmi pilloli li m' għandekx bżonn.
This will help to protect the environment.
Dan jgħin biex tipproteġi l- ambjent.
49 6.
53 6.
What Avaglim contains The active substances are rosiglitazone and glimepiride.
X’ fih Avaglim Is- sustanzi attivi huma rosiglitazone u glimepiride.
Avaglim tablets come in different strengths.
Il- pilloli ta ’ Avaglim jiġu f’ dożi differenti.
Each tablet contains either:
Kull pillola fiha jew:
4 mg or 8 mg rosiglitazone and 4 mg glimepiride.
4 mg jew 8 mg rosiglitazone u 4 mg glimepiride.
The other ingredients are: sodium starch glycollate (Type A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400, iron oxide black and/ or red (E172).
Is- sustanzi l- oħra huma: sodium starch glycollate (Tip A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400, iron oxide black u/ jew red (E172).
What Avaglim looks like and contents of the pack Avaglim 4 mg/ 4 mg tablets are pink, rounded triangular-shaped, and marked "gsk" on one side and "4/ 4" on the other.
Id- dehra ta ’ Avaglim u l- kontenuti tal- pakkett Il- pilloli Avaglim 4mg/ 4mg huma roża, ittundjati, forma ta ’ trijanglu, u mmarkati "gsk" fuq naħa waħda u "4/ 4" fuq l- oħra.
Avaglim 8 mg/ 4 mg tablets are red, rounded triangular-shaped, and marked "gsk" on one side and "8/ 4" on the other.
Il- pilloli Avaglim 8mg/ 4mg huma ħomor, ittundjati, forma ta ’ trijanglu u immarkati "gsk" fuq naħa waħda u "8/ 4" fuq l- oħra.
The tablets are supplied in blister packs containing 14, 28, 56, 84 or 112 film-coated tablets.
Il- pilloli issibhom f’ pakki blister li fihom 14, 28, 56, 84 u 112 pillola miksijin b’ rita.
Not all pack sizes may be available in your country.
Mhux id- daqsijiet tal- pakketti kollha jistgħu ikunu disponibbli fil- pajjiż tiegħek.
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq: SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex TW8 9GS, Ir- Renju Unit
Glaxo Wellcome S. A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Glaxo Wellcome S. A., Avenida de Extremadura 3, E- 09400 Aranda de Duero, Burgos, Spanja
50 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
54 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda Tel: + 351 21 412 95 00 FI. PT@gsk. com
Tel.: + 48 (0) 22 576 9000 Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda Tel: + 351 21 412 95 00 FI. PT@ gsk. com
This leaflet was last approved in
Dan il- fuljett ġie approvat l- aħħar fi
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- mediċini (EMEA) http: // www. emea. europa. eu /