Avandamet

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-06-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
08-06-2016
Public Assessment Report Public Assessment Report (PAR)
08-06-2016

Active ingredient:

rosiglitazone, metformin hydrochloride

Available from:

SmithKline Beecham Plc

ATC code:

A10BD03

INN (International Name):

rosiglitazone, metformin

Therapeutic group:

Drogi użati fid-dijabete

Therapeutic area:

Diabetes Mellitus, Tip 2

Therapeutic indications:

AVANDAMET huwa indikat fit-trattament tad-dijabete tat-tip 2 mellitus il-pazjenti, l-aktar dawk b'piż żejjed:li ma laħqux kontroll gliċemiku suffiċjenti fl-għola doża ttollerata ta ' metformin mill-ħalq waħdu. f'terapija orali trippla ma 'mediċina tat-tip sulphonylurea, f'pazjenti b'kontroll gliċemiku insuffiċjenti minkejja terapija doppja mill-ħalq bl-ogħla doża ttollerata ta' metformin u sulphonylurea (ara sezzjoni 4.

Product summary:

Revision: 16

Authorization status:

Irtirat

Authorization date:

2003-10-20

Patient Information leaflet

                                106
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
107
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNHA
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
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA.
-
ŻOMM DAN IL-FULJETT. JISTA’ JKOLLOK BŻONN TERĠA’ TAQRAH.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek. M’għandekx tagħaddiha lil
persuni oħra. Tista’ tagħmlilhom
il-ħsara, anki jekk ikollhom l-istess sintomi bħal tiegħek.
-
JEKK XI WIEĦED MILL-EFFETTI SEKONDARJI JIGGRAVA JEW JEKK TINNOTA XI
EFFETTI SEKONDARJI LI
M’HUMIEX IMSEMMIJIN F’DAN IL-FULJETT, GHID LIT-TABIB JEW
LILL-ISPIŻJAR TIEGĦEK
F’DAN IL-FULJETT:
1.
X’inhu Avandamet u għalxiex jintuża
2.
Qabel ma tieħu Avandamet
3.
Kif għandek tieħu Avandamet
4.
Effetti sekondarji li jista’ jkollu
5.
Kif taħżen Avandamet
6.
Aktar tagħrif
1.
X’INHU AVANDAMET U GĦALXIEX JINTUŻA
IL-PILLOLI TA' AVANDAMET HUMA KUMBINAZZJONI TA' ŻEWĠ MEDIĊINI
DIFFERENTI li jisimhom
_rosiglitazone _u _metformin. _Dawn iż-żewġ mediċini jintużaw
biex jikkuraw DIJABETE MELLITUS TAT-TIP 2.
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 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 jista’ jintuża waħdu jew ma’
sulphonylurea, mediċina oħra għad-dija
bete.
2.
QABEL MA TIEĦU AV
ANDAMET
Biex tgħin fl-imaniġġjar tad-dijabete tiegħek, huwa mportanti li
ssegwi kull parir ta’ dieta jew stil ta'
ħajja mingħand it-tabib tiegħek kif ukol
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI T
AL-PRODOT
T
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI
AVANDAMET 1 mg/500 mg pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola fiha 1 mg rosiglitazone (bħala rosiglitazone maleate) u
500 mg metformin hydrochloride
(jikkorrespondu għal bażi ta’ 390 mg metformin liberu ).
Sustanzi mhux attivi
Kull pillola fiha lattosju (bejn wieħed u ieħor 6 mg)
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita.
Pilloli sofor miksija b’rita, bil-marka “gsk” fuq naħa waħda u
“1/500” fuq in-naħa l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
AVANDAMET huwa ndikat għall-kura ta’ pazjenti bid-dijabete tip 2,
l-aktar dawk b’piż żejjed:
-
li ma jkunux jistgħu jikkontrollaw tajjeb il-livell tal-glukożju
fid-demm bl-ogħla doża li jifilħu
ta’ metformin waħdu.
-
f’terapija orali trippla ta’ dijabete b’sulphonylurea f’dawk
il-pazjenti li ma jistgħux jiksbu
kontroll gliċemiku biżżejjed minkejja terapija orali doppja b'
metformin u sulphonylurea fl-
akbar doża li jittolleraw (ara sezzjoni 4.4).
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Id-doża ta’ AVANDAMET li tinbeda ġeneralment tkun 4 mg kuljum
rosiglitazone u 2000 mg kuljum
metformin hydrochloride.
Wara tmien ġimgħat, id-doża ta’ rosiglitazone tista’ tiżdied
għal 8 mg kuljum jekk ikun meħtieġ
kontroll gliċemiku akbar. L-ogħla doża ta’ AVANDAMET rakkomandata
hija
8 mg rosiglitazone u
2000m
g metformin hydrochloride.
Id-doża totali ta’ kuljum ta’ AVANDAMET għandha tingħata
f’żewġ dożi maqsumin.
Qabel ma’ l-pazjent jinqaleb fuq AVANDAMET, wieħed jista jnaqqas
d-doża b’rosiglitazone (billi
jżidu ma’ l-aħjar doża ta’ metformin).
Meta jkun jixraq klinikament, wieħed jista jaqleb minn metformin
waħdu għal AVANDAMET mill-
ewwel.
AVANDAMET, meħud waħdu jew eżatt wara l-ikel jista jnaqqas
is-sintomi gastro
                                
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Active ingredient rosiglitazone, metformin hydrochloride

rosiglitazone, metformin hydrochloride

ATC code A10BD03

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INN (International Name) rosiglitazone, metformin

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