qanastek/EMEA-V3 huggingface dataset:
45 thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
46 maleate, membru tal- klassi thiazolidinedione, u metformin hydrochloride, membru tal- klassi biguanide.
There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone in combination with metformin.
M’ hemmx studji konklużi li jkejlu r- riżultati kardjovaskulari fuq medda twila f’ pazjenti li jieħdu rosiglitazone flimkien ma ’ metformin.
46 Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
47 Metformin Metformin huwa biguanide b’ effetti anti- ipergliċemiċi, li jbaxxu kemm il- livell bażi u l- livell ta ’ wara l- ikel tal- glukożju fil- plażma.
Rosiglitazone Absorption Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
48 Rosiglitazone Assorbiment Biodisponibilità assoluta ta ’ rosiglitazone wara doża orali kemm ta ’ 4 mg kif ukoll ta ’ 8 mg hija ta ’ madwar 99%.
Elderly:
49 Anzjani:
48 Renal insufficiency:
Insuffiċjenza tal- kliewi:
Rosiglitazone Undesirable effects observed in animal studies with possible relevance to clinical use were as follows:
50 Rosiglitazone Effetti mhux mixtieqa osservati fi studji fuq annimali b’ relevanza possibbli għal użu kliniku huma kif ġej:
49 Metformin Non-clinical 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 Tagħrif mhux kliniku għal metformin ma jiżvela l- ebda periklu speċjali għall- bniedem ibbażat fuq studji konvenzjonali dwar farmakoloġija ta ’ sigurta ’, tossiċità f’ dożi ripetuti, ġenotossiċità, potenzjal kanċeroġenu u tossiċità ta ’ riproduzzjoni.
6.5 Nature and contents of container
51 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Packs of 14, 28, 56, 112 (2x56), 168 (3x56) and 180 tablets.
Pakki ta ’ 14, 28, 56, 112 (2x56), 168 (3x56) u 180 pillola.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: www. emea. europa. eu
AVANDAMET 4 mg/ 1000 mg film-coated tablets
AVANDAMET 4 mg/ 1000 mg pilloli miksija b’ rita.
Each tablet contains 4 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Kull pillola fiha 4 mg rosiglitazone (bħala rosiglitazone maleate) u 1000 mg metformin hydrochloride (jikkorrespondu għal bażi ta ’ 780 mg metformin liberu).
Each tablet contains lactose (approximately 23 mg)
Sustanzi mhux attivi, Kull pillola fiha lattosju (bejn wieħed u ieħor 23 mg)
Pink film-coated tablets marked "gsk" on one side and "4/ 1000" on the other.
Pilloli roża miksija b’ rita, bil- marka “ gsk ” fuq naħa waħda u “ 4/ 1000 ” fuq in- naħa l- oħra.
52 Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4)
53 Terapija orali trippla (rosiglitazone, metformin u sulphonylurea) (ara sezzjoni 4. 4)
- acute conditions with the potential to alter renal function such as:
54 4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
55 L- insulina għandha tiżdied biss f’ kura stabbilita b’ rosiglitazone f’ każijiet speċjali u taħt osservazzjoni mill- viċin.
54 Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
Sindromu Koronarju Akut (ACS) Pazjenti li esperjenzaw ACS ma ġewx studjati fi studji kliniċi kkontrollati b’ rosiglitazone.
Surgery As AVANDAMET contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
56 operazzjoni bil- loppju ġenerali, u ġeneralment m’ għandux jerġa ’ jinbeda qabel igħaddu 48 siegħa.
55 noted after the first year of treatment and remained during the course of the study.
Din l- inċidenza akbar ġiet innotata wara l- ewwel sena tat- trattament u matul il- kumplament ta ’ l- istudju.
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of AVANDAMET (see section 4.4).
Hemm riskju ikbar ta ’ aċidu lattiku f’ każ ta ’ intossikazzjoni alkoħolika akuta (partikolarment f’ każ ta ’ sawm, dieta mhux sustanzjuża jew insuffiċjenza fil- fwied) minħabba s- sustanza attiva metformin f’ AVANDAMET (ara sezzjoni 4. 4).
Cationic medicinal products that are eliminated by renal tubular secretion (e. g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
57 Prodotti mediċinali katajoniċi li jiġu eliminati permezz ta’ sekrezzjoni tubulari renali (e. ż. cimetidine) jistagħu ma jaqblux ma metformin billi jikkompetu għall- istess sistema ta ’ trasport tubulari renali.
Therefore, AVANDAMET should not be used during pregnancy.
58 Għalhekk, AVANDAMET m’ għandux jintuża waqt it- tqala.
57 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVANDAMET or if it occurred at a higher frequency than that listed for a component part.
Reazzjoni mhux mixtieqa għad- doża fissa kombinata hija ppreżentata biss jekk din ma ’ tfaċċatx f’ wieħed mill- komponenti ta ’ AVANDAMET jew jekk ġrat b’ frekwenza ogħla minn dik indikata f - komponent minnhom
58 Table 1.
59 Tabella 1.
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
60 ma ’ l- insulina (rosiglitazone miżjud ma ’ terapija b’ insulina stabbilita) kienet ta ’ 2. 4%, meta mqabbla ma ’ insulina waħedha, 1. 1%.
In a placebo-controlled one-year trial in patients with congestive heart failure NYHA class I-II, worsening or possible worsening of heart failure occurred in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Fi prova ta ’ sena kkontrollata bi plaċebo, f’ pazjenti b’ waqfien tal- qalb konġestiva NYHA klassi I- II, kien hemm deterjorament jew deterjorament possibbli ta ’ insuffiċjenza tal- qalb f’ 6. 4% tal- pazjenti trattati b’ rosiglitazone, meta mqabbla ma ’ 3. 5% bi plaċebo.
59 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)].
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)].
Table 2.
61 Tabella 2.
angioedema skin reaction (e. g. urticaria, pruritis, rash) 5
anġjodema reazzjonijiet fil- ġilda (eż. urtikarja, ħakk, raxx)
62 There are no studies completed assessing long-term cardiovascular outcome in patients receiving rosiglitazone in combination with metformin.
M’ hemmx studji konklużi li jkejlu r- riżultati kardjovaskulari fuq medda twila f’ pazjenti li jieħdu rosiglitazone flimkien ma ’ metformin.
63 Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Metformin Metformin huwa biguanide b’ effetti anti- ipergliċemiċi, li jbaxxu kemm il- livell bażi u l- livell ta ’ wara l- ikel tal- glukożju fil- plażma.
Metformin may act via three mechanisms:
64 Metformin jista ’ jaġixxi permezz ta ’ tlett mekkaniżmi:
Rosiglitazone Absorption Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Rosiglitazone Assorbiment Biodisponibilità assoluta ta ’ rosiglitazone wara doża orali kemm ta ’ 4 mg kif ukoll ta ’ 8 mg hija ta ’ madwar 99%.
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
65 L- ogħti ta ’ rosiglitazone ma ’ l- ikel ma rriżulta fl- ebda bidla fl- esponiment globali (AUC), għalkemm tnaqqis żgħir fis- Cmax (madwar 20- 28%) u ttardjar fit- tmax (madwar 1. 75 h) ġew osservati meta imqabbla ma ’ l- ogħti ta ’ doża fi stat ta ’ sawm.
In cirrhotic patients with moderate (Child-Pugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
66 Indeboliment tal- fwied: f’ pazjenti morda b’ ċirrożi b’ indeboliment moderat (Child- Pugh B) tal- fwied, unbound Cmax u AUC kienu darbtejn u 3 darbiet ogħla minn f’ suġġetti normali.
65 Renal insufficiency:
Insuffiċjenza tal- kliewi:
In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/ menstrual cycles and fertility (see section 4.4).
67 plażma ta ’ dawn l- ormoni biex b’ hekk wassal għal effetti fuq iċ- ċikli oestrus/ menstruwali u fertilità (ara sezzjoni 4. 4).
66 Metformin Non-clinical 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 Tagħrif mhux kliniku għal metformin ma jiżvela l- ebda periklu speċjali għall- bniedem ibbażat fuq studji konvenzjonali dwar farmakoloġija ta ’ sigurta ’, tossiċità f’ dożi ripetuti, ġenotossiċità, potenzjal kanċeroġenu u tossiċità ta ’ riproduzzjoni.
Sodium starch glycollate Hypromellose (E464) Microcrystalline cellulose (E460) Lactose monohydrate Povidone (E1201) Magnesium stearate.
Sodium starch glycollate Hypromellose (E464) Microcrystalline cellulose (E460) Lactose monohydrate Povidone (E1201) Magnesium stearate..
Hypromellose (E464) Titanium dioxide (E171) Macrogol Iron oxide red (E172).
Hypromellose (E464) Titanium dioxide (E171) Macrogol Iron oxide red (E172)..
69 A.
69 ANNESS II
• 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
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 (August 2007) 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 ’ Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkommetti li jwettaq l- istudji u l- attivitajiet addizjonali ta ’ farmakoviġilanza ddettaljati fil- Pjan ta 'Farmakoviġilanza kif miftiehem f’ verżjoni 2 (Awissu 2007) tal- Pjan għall- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Module 1. 8. 2 ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament ta ’ l- RMP miftiehem mis- CHMP.
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, RMP aġġornat għandu jkun sottomess • Meta tkun irċevuta informazzjoni ġdida li tista ’ tagħmel impatt fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskju. • F’ 60 ġurnata sa meta jrid tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA.
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit yearly PSURs until otherwise decided by the CHMP.
Wara t- tiġdid ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, id- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq jissottometti PSUR kull sena sakemm jiġi deċiż mod ieħor mis- CHMP.
71 A.
71 ANNESS III
72 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
KARTUNA TA ’ BARRA (B’ KAXXA BLU) (MA JINKLUDIX PAKKETTI MULTIPLI)
AVANDAMET 1 mg/ 500 mg film-coated tablets rosiglitazone/ metformin HCl
AVANDAMET 1 mg/ 500 mg pilloli miksija b’ rita rosiglitazone/ metformin HC1
Each tablet contains 1 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Kull pillola fiha 1 mg ta ’ rosiglitazone (bħala maleate) u 500 mg metformin hydrochloride
Contains lactose, see the package leaflet for further information.
Fih il- lattosju, ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
28 tablets 56 tablets 112 tablets 360 tablets
28 pillola 56 pillola 112 pillola 360 pillola
Read the package leaflet before use.
Jittieħed mill- ħalq Uża biss kif preskritt mit- tabib tiegħek Aqra l- fuljett ta ’ tagħrif qabel l- użu
73 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 03/ 258/ 001 28 tablets EU/ 1/ 03/ 258/ 002 56 tablets EU/ 1/ 03/ 258/ 003 112 tablets EU/ 1/ 03/ 258/ 019 360 tablets
EU/ 1/ 03/ 258/ 001 28 pillola EU/ 1/ 03/ 258/ 002 56 pillola EU/ 1/ 03/ 258/ 003 112 pillola EU/ 1/ 03/ 258/ 019 360 pillola
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
75 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
TIKKETTA TA ’ BARRA (B’ KAXXA BLU) PAKKETTI MULTIPLI BISS (3x112 PILLOLI)
Contains lactose, see the package leaflet for further information.
Fih il- lattosju, ara l- fuljett ta 'tagħrif għal aktar informazzjoni
Multipack comprising 3 packs, each containing 112 film-coated tablets.
Pakkett multiplu li fih 3 pakketti li kull wieħed minnhom fih 112 pinnola miksija b’ rita
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (112 TABLETS)
KARTUNA INTERMEDJA (BLA KAXXA BLU) PAKKETTI MULTIPLI BISS (112 PILLOLI)
Component of a multipack comprising 3 packs, each containing 112 film-coated tablets.
112 pillola Parti minn pakkett multiplu li fih 3 pakketti, li kull wieħed minnhom fih 112 pillola miksija b’ rita
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENUR TA ’ L- AWTORIZZAZZJONI GĦALL - KUMMERĊ
BLISTERS
FOLJI (BLISTER)
AVANDAMET 1 mg/ 500 mg tablets rosiglitazone/ metformin HCl
AVANDAMET 1 mg/ 500 mg pilloli rosiglitazone/ metformin HC1
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENUR TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
AVANDAMET 2 mg/ 500 mg film-coated tablets rosiglitazone/ metformin HCl
AVANDAMET 2 mg/ 500 mg pilloli miksija b’ rita rosiglitazone/ metformin HC1
Each tablet contains 2 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Kull pillola fiha 2 mg ta ’ rosiglitazone (bħala maleate) u 500 mg metformin hydrochloride
80 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 03/ 258/ 004 28 tablets EU/ 1/ 03/ 258/ 005 56 tablets EU/ 1/ 03/ 258/ 006 112 tablets EU/ 1/ 03/ 258/ 020 360 tablets
EU/ 1/ 03/ 258/ 004 28 pillola EU/ 1/ 03/ 258/ 005 56 pillola EU/ 1/ 03/ 258/ 006 112 pillola EU/ 1/ 03/ 258/ 020 360 pillola
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
- PAKKETTI MULTIPLI BISS (3x112) PILLOLI
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
- PAKKETTI MULTIPLI BISS (3x112 PILLOLI)
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
AVANDAMET 2 mg/ 500 mg tablets rosiglitazone/ metformin HCl
AVANDAMET 2 mg/ 500 mg pilloli rosiglitazone/ metformin HC1
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
86 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
AVANDAMET 2 mg/ 1000 mg film-coated tablets rosiglitazone/ metformin HCl
AVANDAMET 2 mg/ 1000 mg pilloli miksija b’ rita rosiglitazone/ metformin HC1
Each tablet contains 2 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Kull pillola fiha 2 mg ta ’ rosiglitazone (bħala maleate) u 1000 mg metformin hydrochloride
14 tablets 28 tablets 56 tablets 180 tablets
14 pillola 28 pillola 56 pillola 180 pillola
87 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 03/ 258/ 007 14 tablets EU/ 1/ 03/ 258/ 008 28 tablets EU/ 1/ 03/ 258/ 009 56 tablets EU/ 1/ 03/ 258/ 021 180 tablets
EU/ 1/ 03/ 258/ 007 14 pillola EU/ 1/ 03/ 258/ 008 28 pillola EU/ 1/ 03/ 258/ 009 156 pillola EU/ 1/ 03/ 258/ 021 180 pillola
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)
- PAKKETTI MULTIPLI BISS (2x56 PILLOLI IMGEŻWRIN FI PLASTIK TRASPARENTI)
Multipack comprising 3 packs, each containing 56 film-coated tablets.
Pakkett multiplu li fih 2 pakketti li kull wieħed minnhom fih 56 pinnola miksija b’ rita Pakkett multiplu li fih 3 pakketti li kull wieħed minnhom fih 56 pinnola miksija b’ rita
89 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 03/ 258/ 017, 56 tablets, component of a 168 tablet multipack.
EU/ 1/ 03/ 258/ 013 56 pillola parti minn pakkett multiplu b’ 112 pilloli EU/ 1/ 03/ 258/ 017 56 pillola parti minn pakkett multiplu b’ 168 pilloli
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
91 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (56 TABLETS)
- PAKKETTI MULTIPLI BISS (56 PILLOLI)
Component of a multipack comprising 2 packs, each containing 56 film-coated tablets.
56 pillola Parti minn pakkett multiplu li fih 2 pakketti, li kull wieħed minnhom fih 56 pillola miksija b’ rita
Component of a multipack comprising 3 packs, each containing 56 film-coated tablets.
56 pillola Parti minn pakkett multiplu li fih 3 pakketti, li kull wieħed minnhom fih 56 pillola miksija b’ rita
EU/ 1/ 03/ 258/ 017, 56 tablets, component of a 168 tablet multipack.
EU/ 1/ 03/ 258/ 013, 56 pilloli, parti minn pakkett multiplu b’ 112 pillola EU/ 1/ 03/ 258/ 017, 56 pilloli, parti minn pakkett multiplu b’ 168 pillola
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
93 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJI (BLISTER)
AVANDAMET 2 mg/ 1000 mg tablets rosiglitazone/ metformin HCl
AVANDAMET 2 mg/ 1000 mg pilloli rosiglitazone/ metformin HC1
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
94 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
AVANDAMET 4 mg/ 1000 mg film-coated tablets rosiglitazone/ metformin HCl
AVANDAMET 4 mg/ 1000 mg pilloli miksija b’ rita rosiglitazone/ metformin HC1
Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Kull pillola fiha 4 mg ta ’ rosiglitazone (bħala maleate) u 1000 mg metformin hydrochloride
94 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 03/ 258/ 010 14 tablets EU/ 1/ 03/ 258/ 011 28 tablets EU/ 1/ 03/ 258/ 012 56 tablets EU/ 1/ 03/ 258/ 022 180 tablets
EU/ 1/ 03/ 258/ 010 14 pillola EU/ 1/ 03/ 258/ 011 28 pillola EU/ 1/ 03/ 258/ 012 56 pillola EU/ 1/ 03/ 258/ 022 180 pillola
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
96 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
96 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
EU/ 1/ 03/ 258/ 018, 56 tablets, component of a 168 tablet multipack.
EU/ 1/ 03/ 258/ 014, 56 pillola, parti minn pakkett multiplu b’ 112 pillola EU/ 1/ 03/ 258/ 018, 56 pillola, parti minn pakkett multiplu b’ 168 pillola
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Kull pillola fiha 4 mg ta ’ rosiglitazone (bħala maleate) u1000 mg metformin hydrochloride
99 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
100 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTERS
FOLJI (BISTERS)
AVANDAMET 4 mg/ 1000 mg tablets rosiglitazone/ metformin HCl
AVANDAMET 4 mg/ 1000 mg pilloli rosiglitazone/ metformin HC1
100 B.
OĦRAJN
101 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
AVANDAMET 1 mg/ 500 mg film-coated tablets AVANDAMET 2 mg/ 500 mg film-coated tablets AVANDAMET 2 mg/ 1000 mg film-coated tablets AVANDAMET 4 mg/ 1000 mg film-coated tablets rosiglitazone/ metformin HCl
AVANDAMET, 1mg/ 500mg pilloli miksijin b’ rita AVANDAMET, 2mg/ 500mg pilloli miksijin b’ rita AVANDAMET, 2mg/ 1000mg pilloli miksijin b’ rita AVANDAMET, 4mg/ 1000mg pilloli miksijin b’ rita rosiglitazone/ metformin HCl
leaflet, tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, ghid lit- tabib jew lill- ispiżjar tiegħek
What Avandamet is and what it is used for 2.
X’ inhu Avandamet u għalxiex jintuża 2.
Before you take Avandamet 3.
Qabel ma tieħu Avandamet 3.
How to take Avandamet 4.
Kif għandek tieħu Avandamet 4.
Possible side effects 5 How to store Avandamet 6.
Kif taħżen Avandamet 6.
WHAT AVANDAMET IS AND WHAT IT IS USED FOR
X’ INHU AVANDAMET U GĦALXIEX JINTUŻA
Avandamet tablets are a combination of two different medicines called rosiglitazone and metformin.
Il- pilloli ta 'Avandamet huma kumbinazzjoni ta' żewġ mediċini differenti li jisimhom rosiglitazone u metformin.
These two medicines are used to treat type 2 diabetes.
Dawn iż- żewġ mediċini jintużaw biex jikkuraw dijabete mellitus 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 mellitus 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 metformin 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 metformin jaħdmu flimkien biex ġismek juża aħjar l- insulina li jipproduċi, u dan jgħin biex inaqqsu z- zokkor fid- demm tiegħek għal livell normali.
Avandamet can be used alone or with a sulphonylurea, another medicine for diabetes.
Avandamet jista ’ jintuża waħdu jew ma ’ sulphonylurea, mediċina oħra għad- dijabete.
BEFORE YOU TAKE AVANDAMET
QABEL MA TIEĦU AVANDAMET
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandamet.
Biex tgħin fl- imaniġġjar tad- dijabete tiegħek, huwa mportanti li ssegwi kull parir ta ’ dieta jew stil ta 'ħajja mingħand it- tabib tiegħek kif ukoll tieħu Avandamet.
Don’ t take Avandamet: • if you are allergic (hypersensitive) to rosiglitazone or metformin or any of the other ingredients of Avandamet (listed in Section 6) • 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 severe breathing difficulties • if you have liver disease • if you are a heavy drinker of alcohol – if you regularly drink a lot, or if you have occasional sessions of heavy drinking (binge drinking) • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting) • if you have kidney disease
wieħed mill- ingredjenti l- oħra ta ’ Avandamet (imniżżlin f’ Sezzjoni 6)
102
dardir jew rimettar)
•
- jekk għandek mard fil- kliewi
if you are very dehydrated or have a severe infection (see ‘While you take Avandamet your doctor needs to know’ later in Section 2)
- jekk inti disidratat ħafna jew għandek infezzjoni severa (ara ‘ Waqt li qed tieħu Avandamet
if you are going to have an X-ray using an injected dye (see ‘While you take Avandamet your doctor needs to know’ later in Section 2)
(ara ‘ Waqt li qed tieħu Avandamet it -
•
tabib tiegħek għandu bżonn ikun jaf ’ aktar ‘ il quddiem f’ Sezzjoni 2)
if you are breast-feeding (see ‘Pregnancy and breast-feeding’ later in Section 2).
- jekk qed tredda (ara ‘ Tqala u treddigħ ’ aktar ‘ il quddiem f’ Sezzjoni 2)
Don’t take Avandamet.
Tieħux Avandamet.
Take special care with Avandamet
Oqgħod attent ħafna b’ Avandamet
Avandamet is not recommended for people aged under 18, as the safety and effectiveness are not known.
Avandamet m’ huwiex rakkomandat għal nies taħt it- 18- il sena, għax m’ humiex magħrufa is - sigurta ’ u l- effikaċja.
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 Avandamet may not be suitable for you.
Iċċekkja mat- tabib tiegħek, għax Avandamet jista ’ jkun ma jgħoddx għalik.
Conditions to look out for Avandamet and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Kundizzjonijiet li għandek toqgħod attent għalihom Avandamet 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 Avandamet, to reduce the risk of any problems.
Għandek toqgħod attent għal ċerti sintomi waqt li tkun qed tieħu Avandamet, 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 Avandamet.
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 Avandamet.
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 ‘ Waqt li qed tieħu Avandamet it- tabib tiegħek għandu bżonn ikun jaf ’ aktar ‘ il quddiem f’ Sezzjoni 2)
Your kidney function will be checked Your kidneys should be checked at least once a year – more often if you are over 65, or if your kidney function is close to abnormal.
Tiġi ċċekkjata l- funzjoni tal- kliewi tiegħek Il- kliewi tiegħek għandhom jiġu ċċekkjati darba fis- sena – aktar spiss jekk għandek aktar minn 65 sena, jew jekk il- funzjoni tal- kliewi tiegħek hija viċin li tkun abnormali.
While you take Avandamet your doctor needs to know: if you become dehydrated – for example, after severe vomiting, diarrhoea or fever.
Waqt li tkun qed tieħu Avandamet it- tabib tiegħek għandu bżonn ikun jaf: • jekk tiġi disidratat – per eżempju, wara rimettar, dijarrea jew deni qawwi.
These can lead to severe loss of water (dehydration).
Dawn jistgħu iwasslu għal telf qawwi ta ’ ilma (deidratazzjoni).
Speak to your doctor, as you may need to stop taking Avandamet for a short while. • if you are going to have an operation under general anaesthetic.
Kellem lit- tabib tiegħek, għax hemm mnejn ikollok bżonn tieqaf tieħu Avandamet għal xi żmien qasir.
Your doctor will advise you to stop taking Avandamet for at least 48 hours before and after the operation. • if you are going to have an X-ray using an injected dye.
It- tabib tiegħek itik parir biex tieqaf tieħu Avandamet mill- anqas għal 48 siegħa qabel u wara l- operazzjoni.
Your doctor will advise you to stop taking Avandamet before the X-ray and for 48 hours after it.
It- tabib tiegħek itik parir biex tieqaf tieħu Avandamet qabel l- X- ray u għal 48 siegħa wara li tieħdu.
The doctor will check your kidney function before restarting treatment.
It- tabib jiċċekkja il- funzjoni tal- kliewi tiegħek qabel terġa tibda l- kura.
103 Taking other medicines Tell your doctor or ph armacist 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.
Certain medicines are especially likely to affect the amount of sugar in your blood: • steroids (used to treat inflammation) such as prednisolone or dexamethasone • beta-2-agonists (used to treat asthma), such as salbutamol or salmeterol • diuretics (used to get rid of water), such as furosemide or indapamide • ACE inhibitors (used to treat high blood pressure), such as enalapril or captopril • gemfibrozil (used to lower cholesterol) • rifampicin (used to treat tuberculosis and other infections) • cimetidine (used to reduce stomach acid).
Ċerti mediċini għandhom speċjalment aktar possibilita ’ li jaffettwaw l- ammont ta ’ zokkor fid- demm tiegħek: • sterojdi (li jintużaw biex jikkuraw fjammazzjonijiet) bħal prednisolone jew dexamethasone • agonisti beta- 2 (li jintużaw biex jikkuraw l- ażma), bħal salbutamol u salmeterol • dijuretiċi (li jintużaw biex ineħħu l- ilma), bħal furosemide jew indapamide • inibituri ACE (li jintużaw biex jikkuraw pressjoni għolja), bħal enalapril u captopril • gemfibrozil (li jintuża biex ibaxxu l- kolesterol) • rifampicin (li jintuża jikkura t- tuberkulożi u nfezzjonijiet oħra)
Tell a doctor or pharmacist if you are taking any of these.
Għid lit- tabib jew lill- ispiżjar jekk tkun qed tieħu xi wieħed minn dawn.
Your blood sugar will be checked, and your dose of Avandamet may need to be changed.
Ikun iċċekkjat il - livell ta ’ zokkor fid- demm tiegħek u d- doża tiegħek ta ’ Avandamet jista ’ jkun hemm bżonn li tinbidel.
Pregnancy and breast-feeding • Avandamet is not recommended during pregnancy.
Tqala u Treddigħ • Avandamet m' huwiex rakkomandat waqt it- tqala.
If you are pregnant or could be pregnant, tell your doctor before you take Avandamet.
Jekk inti tqila jew tista ’ tkun tqila, għid lit- tabib tiegħek qabel ma tieħu Avandamet.
• Don’t breast-feed while you are taking Avandamet.
• Treddgħax waqt li tkun qed tieħu Avandamet.
Driving and using machines This medicine should not affect your ability to drive or use machines.
Din il- mediċina m’ ghandiex ikollha effett fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Avandamet contains lactose Avandamet tablets contain a small amount of lactose.
Avandamet fiha l- lattożju Il- pilloli ta ’ Avandamet 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 rari ta ’ intolleranza għall- galattożju, in- nuqqas ta ’ Lapp lactase jew malassorbiment tal- lattożju- galattożju, m’ għandhomx jieħdu din il- mediċina.
HOW TO TAKE AVANDAMET
KIF GĦANDEK TIEĦU AVANDAMET
Always take Avandamet tablets exactly as your doctor has told you.
Dejjem għandek tieħu il- pilloli ta ’ Avandamet eżatt skond ma jkun qallek it- tabib tiegħek.
How much to take The usual starting dose is one combined tablet (2 mg rosiglitazone and 1000 mg metformin), taken twice a day, morning and evening.
Kemm tieħu Id- doża tal- bidu tas- soltu hija ta ’ pillola kombinata (2mg ta ’ rosiglitazone u 1000mg ta ’ metformin), darbtejn kuljum, filgħodu u filgħaxija.
(You can also take this dose as two 1 mg/500 mg tablets, twice a day.)
(Tista ’ wkoll tieħu din id- doża bħala żewġ pilloli ta ’ 1mg/ 500mg, darbtejn kuljum.)
The maximum dose is 4 mg rosiglitazone and 1000 mg metformin, taken twice a day.
Id- doża massima hija ta '4mg ta' rosiglitazone u 1000mg ta 'metformin, mehuda darbtejn kuljum.
(You can also take this dose as two 2 mg/500 mg tablets, twice a day.)
(Tista 'wkoll tieħu din id- doża bħala żewġ 2mg/ 500mg, darbtejn kuljum.)
It is best to take Avandamet with food, or just after food.
Huwa aħjar jekk tieħu Avandamet ma ’ l- ikel, jew eżatt wara l- ikel.
This helps to reduce any problems with your stomach (including indigestion, nausea, vomiting and diarrhoea).
Dan jgħin biex inaqqas xi problemi bl- istonku tiegħek (li jinkludu indiġistjoni, dardir, rimettar u dijarrea).
104 If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Jekk tieħu aktar Avandamet milli jmissek Jekk aċċidentalment tieħu ħafna pilloli, ikkuntatja lit- tabib jew lill- ispiżjar tiegħek għal parir.
If you forget to take Avandamet Don’t take extra tablets to make up for a missed dose.
Jekk tinsa tieħu Avandamet Tieħux pilloli żejda biex tpatti għal doża li tkun tlift.
Don’t stop taking Avandamet Take Avandamet for as long as your doctor recommends.
Tieqafx tieħu Avandamet Ħu Avandamet sakemm jirrikmandalek it- tabib tiegħek.
If you stop taking Avandamet, your blood sugar will not be controlled, and you may become unwell.
Jekk tieqaf tieħu Avandamet, iz- zokkor fid - demm tiegħek ma jkunx ikkontrollat, u tista ’ tkun ma tiflaħx.
Like all medicines, Avandamet can cause side effects, but not everybody gets them.
Bħal kull mediċina oħra, Avandamet jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Conditions you need to look out for
Kondizzjonijiet li għandek bżonn toqgħod għassa għalihom
These are very rare in people taking Avandamet.
Dawn huma rari ħafna f’ nies li jieħdu Avandamet.
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 ikollox xi wieħed minn dawn is- sintomi.
Stop taking Avandamet.
Ieqaf ieħu Avandamet
An increase in the amount of lactic acid in the blood (lactic acidosis) is a very rare side effect of metformin.
Żieda fil- livell ta ’ aċidu lattiku fid- demm (aċidożi lattika) hija effett sekondarju rari ħafna ta ’ metformin.
This most often affects people who have severe kidney disease.
Din taffettwa l- aktar spiss nies li għandhom mard tal- kliewi sever.
Contact a doctor immediately if you get these symptoms.
Sintomi ta ’ aċidożi lattika jinkludu: • nifs mgħaġġel • tħoss il- kesħa • uġigħ fl- istonku, dardir u rimettar. • Ikkuntattja tabib immedjatament jekk ikollok dawn is- sintomi.
Stop taking Avandamet.
Ieqaf ieħu Avandamet.
Avandamet can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Avandamet jista ’ jgiegħlek iżżomm l- ilma (ritenzjoni ta ’ fluwidu) li twassal għal nefħa u żieda fil- piż.
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.
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.
Low blood sugar (hypoglycaemia):
Zokkor baxx fid- demm (ipogliċemija):
If you are taking Avandamet with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level.
Jekk qed tieħu Avandamet ma 'mediċini oħra għad- dijabete, huwa aktar possibli li z- zokkor fid- demm tiegħek jinżel taħt il- livell normali.
Tell your doctor as soon as possible if you get any of these symptoms.
Sintomi bikrin ta 'zokkor baxx fid- demm huma: • rogħda, għaraq, iħossok ħażin • nervożità, palpitazzjonijiet • ġuħ Is- severita ’ tista ’ żżid, u twassal għal konfużżjoni u telf ta' sensi. → 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.
Before you start taking Avandamet you will have a blood sample taken to check your liver function.
Qabel ma tibda ’ tieħu Avandamet jittieħidlek kampjun tad- demm biex tiċċekkja il- funzjoni tal- fwied tiegħek.
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.
New or worse cases of macular oedema have occurred on rare occasions in people taking Avandamet and similar medicines.
Ġraw każi ta ’ edema makulari ġodda jew li marru għall- agħar f’ okkażjonijiet rari f’ nies li jkunu fuq Avandamet u mediċini simili.
Discuss with your doctor any concerns about your eyesight.
106 → Iddiskuti mat- tabib tiegħek kull inkwiet dwar il- vista tiegħek.
The most common are breaks in feet, hands and arms.
L- aktar ksur komuni huma fis- saqajn, fl- idejn u fid- dirgħajn.
Very common side effects These may affect more than 1 in 10 people: • stomach pain, feeling sick (nausea), vomiting, diarrhoea or loss of appetite.
Effetti sekondarji komuni ħafna Dawn jistgħu jafettwaw aktar minn persuna waħda kull 10: • uġigħ fl- istonku, tħossok imqalla (dardir), rimettar, dijarrea u nuqqas ta ’ aptit.
Common side effects These may affect up to 1 in 10 people: • chest pain (angina) • broken bones • reduction in blood count (anaemia) • small increases in blood cholesterol, increased amount of fats in the blood • increased weight, increased appetite • dizziness • constipation • lower blood sugar than normal (hypoglycaemia) • swelling (oedema) due to water retention • metallic taste in the mouth.
Effetti sekondarji komuni Dawn jistgħu jaffetwaw sa persuna waħda minn kull 10 • uġigħ fis- sider (angina) • ksur ta ’ għadam • tnaqqis fin- numru ta ’ ċelluli fid- demm (anemija) • żidiet żgħar tal- kolesterol fid- demm, żieda fl- ammont ta ’ xaħmijiet fid- demm. • żjieda fil- piż, żjieda fl- aptit • sturdamenti • stitikezza • zokkor aktar baxx fid- demm minn normal (ipoglikemja) • nefħa (edema) minħabba ritenzjoni ta ’ ilma • togħma ta ’ metal fil- ħalq
Rare side effects These may affect up to 1 in 1,000 people: • fluid in the lungs (pulmonary oedema) causing breathlessness • heart failure • swelling of the retina at the back of the eye (macular oedema) • liver doesn’t function as well as it should (increase in liver enzymes).
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa wieħed 1 minn kull 1000 persuna • fluwidu fil- pulmun (edema pulmonari) li tikkawża qtugħ ta ’ nifs • falliment tal- qalb • nefħa fir- retina fuq wara ta ’ l- għajn (edema makulari) • 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 the liver (hepatitis) • decrease in amount of vitamin B12 in the blood • rapid and excessive weight gain caused by fluid retention • increase of lactic acid in the blood.
Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa pazjent 1 minn kull 10, 000 persuna • reazzjonijiet allerġiċi • infjammazzjoni tal- fwied (epatite) • tnaqqis fl- ammont ta ’ vitamina B12 fid- demm • żieda rapida u eċċessiva fil- piż ikkawżata minn ritenzjoni ta ’ fluwidu • żieda fl- aċidu laktiku fid- demm
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 xi 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 AVANDAMET
KIF TAĦŻEN AVANDAMET
Do not use Avandamet after the expiry date shown on the pack.
Tużax Avandamet wara d- data ta ’ skadenza li tidher fuq il- pakkett.
106 This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn ħażna speċjali.
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.
What Avandamet contains The active substances are rosiglitazone and metformin.
X’ fih AVANDAMET Is- sustanzi attivi huma rosiglitazone u metformin.
Avandamet tablets come in different strengths.
Il- pilloli ta ’ Avandamet jiġu f’ dożi differenti.
1 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 500 mg metformin; 2 mg rosiglitazone and 1000 mg metformin or 4 mg rosiglitazone and 1000 mg metformin.
1mg rosiglitazone u 500mg metformin; 2mg rosiglitazone u 500mg metformin; 2mg rosiglitazone u 1000mg metformin jew 4mg rosiglitazone u 1000mg metformin.
The other ingredients are: sodium starch glycollate, hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, povidone (E1201), magnesium stearate, titanium dioxide (E171), macrogol, iron oxide yellow or red (E172).
Is- sustanzi l- oħra huma: sodium starch glycollate, microcrystalline cellulose, lactose monohydrate, povidone (E1210), magnesium stearate. hypromellose (E464), titanium dioxide (171), macrogol, iron oxide yellow jew red (E172).
What Avandamet looks like and contents of the pack Avandamet 1 mg/500 mg tablets are yellow and marked "gsk" on one side and "1/500" on the other.
Id- dehra ta ’ AVANDAMET u l- kontenuti tal- pakkett Il- pilloli ta ’ Avandamet 1mg/ 500mg huma sofor u mmarkati b ’ "gsk" fuq naħa waħda u "1/ 500 ” fuq l- oħra.
Avandamet 2 mg/500 mg tablets are pink, marked "gsk" on one side and "2/500" on the other.
Il- pilloli ta ’ Avandamet 2mg/ 500mg huma roża, mmarkati b ’ "gsk" fuq naħa u "2/ 500" fuq l- oħra.
These strengths are supplied in blister packs containing 28, 56, 112, 3x112 or 360 film-coated tablets.
Dawn id- dożi issibhom f’ pakki blister li fihom 28, 56, 112, 3x112 jew 360 pillola miksijin b’ rita.
Avandamet 2 mg/1000 mg tablets are yellow, marked "gsk" on one side and "2/1000" on the other.
Il- pilloli ta ’ Avandamet 2mg/ 1000mg huma sofor, immarkati "gsk" fuq naħa waħda u "2/ 1000" fuq l - oħra.
Avandamet 4 mg/1000 mg tablets are pink, marked "gsk" on one side and "4/1000" on the other.
Il- pilloli ta ’ Avandamet 4mg/ 1000mg huma roża, immarkati "gsk" fuq naħa waħda u "4/ 1000" fuq l - oħra.
These strengths are supplied in blister packs containing 14, 28, 56, 2x56, 3x56 or 180 film-coated tablets.
Dawn id- dożi issibhom f’ pakki blister li fihom 28, 56, 112, 3x112 jew 360 pillola miksijin b’ rita.
Marketing Authorisation Holder:
Id- Dententur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Renju Unit.
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Glaxo Wellcome S. A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanja.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- AwtorizzazzjonI għat- tqegħid fis- Suq.
Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk
108 Danmark GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00 info@ glaxosmithkline. dk
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 kien approvat l- aħħar f ’ [Xahar] 2008.
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
110 GROUNDS FOR ONE ADDITIONAL RENEWAL
110 ANNESS IV
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of AVANDAMET remains positive.
Abbażi tad- dejta li saret disponibbli sa mill- għoti ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq inizjali, is- CHMP jikkunsidra li l- bilanċ bejn il- benefiċċju u r- riskju ta ’ AVANDAMET jibqa ’ wieħed pożittiv.
AVANDAMET has a place in the treatment of patients with type 2 diabetes after careful individual benefit-risk assessment and provided that the precautions and warnings included in the product information are adhered to.
AVANDAMET huwa stabbilit fit- trattament tal- kura ta ’ pazjenti b’ dijabete ta ’ tip 2 wara valutazzjoni individwali attenta tal- benefiċċju- riskju u diment li l- prekawzjonijiet u t- twissijiet kollha fit- tagħrif dwar il- prodott jiġu segwiti.
However, its safety profile is to be closely monitored for the following reasons:
Madankollu, il- profil tas- sigurtà tiegħu għandu jiġi mmonitorjat mill- qrib għar- raġunijiet li ġejjin:
The cardiac safety of rosiglitazone is a major concern.
Is- sigurtà kardijaka ta ’ rosiglitazone hija ta ’ tħassib ewlieni.
Currently, no definite conclusion can be drawn on the risk of cardiac ischemia (both Congestive Heart Failure and Myocardial ischaemia).
Fil- preżent, ma tista ’ ssir l- ebda konklużjoni definita dwar ir- riskju ta ’ iskemija kardijaka (kemm Indeboliment Konġestiv tal- Qalb kif ukoll iskemija Mijokardijaka).
More data are needed, among which the results of the RECORD-study, to draw a conclusion on the cardiac safety and the related clinical implications.
Hemm bżonn ta ’ aktar dejta, fost l- oħrajn ir- riżultati ta ’ l- istudju RECORD, sabiex issir konklużjoni dwar is- sigurtà kardijaka u l- implikazzjonijiet kliniċi relatati.
Furthermore the risk of bone fractures remains another source of concern.
Barra minn hekk, ir- riskju ta ’ ksur ta ’ l- għadam jibqa ’ sors ieħor ta ’ tħassib.
Because of the uncertainties concerning the cardiovascular safety and the risk of bone fractures of rosiglitazone, the benefit-risk balance of AVANDAMET should be re-evaluated on a regular basis in PSURs or when new relevant information becomes available.
Il- MAH għandu jissottometti PSURs wieħed fis- sena.