Pioglitazone Krka

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
26-09-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
26-09-2014
Public Assessment Report Public Assessment Report (PAR)
26-09-2014

Active ingredient:

pioglitazone hydrochloride

Available from:

Krka, d.d., Novo mesto

ATC code:

A10BG03

INN (International Name):

pioglitazone

Therapeutic group:

Drogi użati fid-dijabete

Therapeutic area:

Diabetes Mellitus, Tip 2

Therapeutic indications:

Pioglitazone huwa indikat bħala t-tieni jew it-tielet linja tal-it-trattament tad-dijabete tat-tip 2 mellitus kif deskritt hawn taħt: bħala monotherapija - fil-pazjenti adulti (speċjalment pażjenti b'piż żejjed) li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal - mediċina tat-tip sulphonylurea, biss f'pazjenti adulti li juru intolleranza għal metformina jew li għalihom il-metformin huwa kontra-indikat, b'kontroll gliċemiku insuffiċjenti minkejja l-ogħla doża ttollerata ta ' monoterapija b'sulphonylurea; Pioglitazone huwa indikat ukoll għall-użu flimkien ma ' insulina fil-dijabete tat-tip 2 mellitus f'pazjenti adulti b'kontroll gliċemiku insuffiċjenti bl-insulina u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza. Wara l-bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu riveduti wara 3 sa 6 xhur biex tevalwa l-adegwatezza tal-rispons għall-kura (e. it-tnaqqis fl-HbA1c). F'pazjenti li jonqsu li juru rispons adegwat, pioglitazone għandu jitwaqqaf. Fid-dawl tar-riskji potenzjali fit-tul mal-terapija, it-tobba għandhom jikkonfermaw fil-sussegwenti ta 'rutina reviżjonijiet li l-benefiċċju ta' pioglitazone jinżamm.

Product summary:

Revision: 2

Authorization status:

Irtirat

Authorization date:

2012-03-21

Patient Information leaflet

                                58
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
59
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
PIOGLITAZONE KRKA 15 MG PILLOLI
Pioglitazone
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
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 biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Pioglitazone Krka u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Pioglitazone Krka
3.
Kif għandek tieħu Pioglitazone Krka
4.
Effetti sekondarji possibbli
5.
Kif taħżen Pioglitazone Krka
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU PIOGLITAZONE KRKA U GĦALXIEX JINTUŻA
Pioglitazone Krka fih pioglitazone. Huwa mediċina antidijabetika
użata biex tikkura dijabete mellitus
tat-tip 2 (mhux dipendenti mill-insulina) meta metformin ma jkunx
xieraq jew ikun naqas li jaħdem
b’mod adegwat. Din hija d-dijabete li ġeneralment tiżviluppa fi
stat adult.
Pioglitazone Krka jgħin jikkontrolla l-livell ta’ żokkor fid-demm
tiegħek meta jkollok dijabete tat-tip 2
billi jgħin lill-ġismek jagħmel użu aħjar mill-insulina li qed
jipproduċi. It-tabib tiegħek ser jiċċekkja
jekk Pioglitazone Krka qed jaħdem 3 sa 6 xhur wara li tibda tieħdu.
Pioglitazone Krka jista’ jintuża waħdu f’pazjenti li ma
jistgħux jieħdu metformin, u fejn trattament
ma’ dieta u eżercizzju naqas milli jikkontrolla z-zokkor fid-demm
jew jista’ jittieħed flimkien
ma’terapiji oħra (bħal sulphonylurea jew insulina) li naqsu milli
jipprovdu kontroll biżżejjed taz-
zokkor fid-dem
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Pioglitazone Krka 15 mg pilloli
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola fiha 15 mg ta’ pioglitazone (bħala hydrochloride).
Eċċipjent b’effett magħruf:
Kull pillola fiha 88.83 mg ta’ lactose (ara sezzjoni 4.4).
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola.
Pilloli tondi u bojod għal kważi bojod bi truf imċandrin u
intaljati bi “15” fuq naħa waħda (dijametru
7.0 mm).
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Pioglitazone huwa indikat bħala kura sekondarja jew terzjarja ta’
dijabete mellitus tat-tip 2 kif deskritt
hawn taħt:
bħala MONOTERAPIJA
-
f’pazjenti adulti (speċjalment pażjenti b’piż żejjed) li
mhumiex ikkontrollati sew minn dieta u
eżerċizzju li għalihom metformin mhux adattat minħabbla
kontraindikazzjonijiet jew
intolleranza
bħala TERAPIJA DOPPJA MILL-ĦALQ f’taħlita ma’
-
mediċina tat-tip sulphonylurea, f’pazjenti adulti li wrew
intolleranza għal metformin jew li
għalihom metformin huwa kontraindikat, b’kontroll gliċemiku
insuffiċjenti minkejja
monoterpija b’mediċina tat-tip sulphonylurea fl-ogħla doża
ttollerata
-
Pioglitazone huwa indikat ukoll għall-użu flimkien ma’ insulina
f’pazjenti adulti b’dijabete
mellitus tat-tip 2 b’kontroll gliċemiku insuffiċjenti bl-insulina
u li għalihom metformin mhux
adattat minħabba kontraindikazzjonijiet jew intolleranza (ara
sezzjoni 4.4).
Wara bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu
eżaminati mill-ġdid wara 3 sa 6 xhur
sabiex tiġi evalwata s-suffiċjenza tar-rispons għat-trattament
(eż. tnaqqis fl-HbA1c). F'pazjenti li juru
nuqqas ta’ rispons suffiċjenti, pioglitazone għandu jitwaqqaf.
Fid-dawl ta' riskji potenzjali marbuta ma'
terapija fit-tul, it-tobba għandhom jikkonfermaw f’evalwazzjonijiet
ta’ rutina sussegwenti li l-
benefiċċju ta' pioglitazone hu mmantenut (
                                
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Similar products

Active ingredient pioglitazone hydrochloride

pioglitazone hydrochloride

ATC code A10BG03

A10BG03

Marketed by Krka, d.d., Novo mesto

Krka, d.d., Novo mesto

INN (International Name) pioglitazone

pioglitazone

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