Pioglitazone Accord

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022
Public Assessment Report Public Assessment Report (PAR)
17-05-2017

Active ingredient:

pioglitazonhydrochlorid

Available from:

Accord Healthcare S.L.U.

ATC code:

A10BG03

INN (International Name):

pioglitazone

Therapeutic group:

Narkotika anvendt i diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

Pioglitazon er angivet i behandlingen af type-2-diabetes mellitus:som monotherapyin voksne patienter (specielt overvægtige patienter), der ikke er tilstrækkeligt kontrolleret med diæt og motion, for hvem metformin er uegnet på grund af kontraindikationer eller intolerance. Efter initiering af behandling med pioglitazon, patienter bør revurderes efter 3 til 6 måneder for at vurdere tilstrækkeligheden af respons på behandlingen (e. reduktion i HbA1c). Hos patienter, der undlader at vise et passende svar, pioglitazon bør seponeres. I lyset af potentielle risici med langvarig terapi, ordinerende læger bør bekræftes ved en efterfølgende rutinemæssige vurderinger, der har gavn af pioglitazon er fastholdt.

Product summary:

Revision: 7

Authorization status:

autoriseret

Authorization date:

2012-03-21

Patient Information leaflet

                                32
B. INDLÆGSSEDDEL
33
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
PIOGLITAZONE ACCORD 15 MG TABLETTER
PIOGLITAZONE ACCORD 30 MG TABLETTER
PIOGLITAZONE ACCORD 45 MG TABLETTER
Pioglitazon
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DE BEGYNDER AT TAGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. De kan få brug for at læse den igen.
-
Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
-
Lægen har ordineret Pioglitazone Accord til Dem personligt. Lad
derfor være med at give
medicinen til andre. Det kan være skadeligt for andre, selvom de har
de samme symptomer,
som De har.
-
Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver
værre, eller De får
bivirkninger, som ikke er nævnt her. Se punkt 4.
OVERSIGT OVER INDLÆGSSEDLEN:
1.
Virkning og anvendelse
2.
Det skal De vide, før De begynder at tage Pioglitazone Accord
3.
Sådan skal De tage Pioglitazone Accord
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Pioglitazone Accord indeholder pioglitazon. Det er en antidiabetisk
medicin, der anvendes til
behandling af type 2-diabetes mellitus (ikke-insulinkrævende
diabetes) hos voksne, når metformin
ikke er egnet eller ikke har haft tilstrækkelig virkning. Dette er
den diabetesform, der normalt udvikler
sig i voksenalderen.
Pioglitazone Accord hjælper med at kontrollere sukkerniveauet i Deres
blod, hvis De har type 2-
diabetes, ved at hjælpe Deres krop til bedre at udnytte den insulin,
kroppen producerer. Når De har
taget Pioglitazone Accord i 3-6 måneder, vil Deres læge undersøge,
om medicinen virker.
Pioglitazone Accord kan anvendes alene til patienter, som ikke er i
stand til at tage metformin, og hos
hvem diæt og motion ikke har været i stand til at kontrollere
blodsukkeret, eller det kan anvendes som
supplement til andre lægemidler (såsom metformin, sulfonylurinstof
eller insulin), hvis disse ikke har
været i stand til at kontrollere blodsukkeret tilstrækkeligt.
2.
DET SKAL DE VI
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
2
1.
LÆGEMIDLETS NAVN
Pioglitazone Accord 15 mg tabletter
Pioglitazone Accord 30 mg tabletter
Pioglitazone Accord 45 mg tabletter
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Pioglitazone Accord 15 mg tabletter
Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
Hjælpestof(fer), som behandleren skal være opmærksom på:
Hver tablet indeholder 37,24 mg lactosemonohydrat (se pkt. 4.4).
Pioglitazone Accord 30 mg tabletter
Hver tablet indeholder 30 mg pioglitazon (som hydrochlorid).
Hjælpestof(fer), som behandleren skal være opmærksom på:
Hver tablet indeholder 74,46 mg lactosemonohydrat (se pkt. 4.4).
Pioglitazone Accord 45 mg tabletter
Hver tablet indeholder 45 mg pioglitazon (som hydrochlorid).
Hjælpestof(fer), som behandleren skal være opmærksom på:
Hver tablet indeholder 111,70 mg lactosemonohydrat (se pkt. 4.4).
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Tablet.
Pioglitazone Accord 15 mg tabletter
Tabletterne er hvide til offwhite, runde, bikonvekse, uden overtræk,
præget med ‘P’ på den ene side og
‘15’ på den anden side.
Pioglitazone Accord 30 mg tabletter
Tabletterne er hvide til offwhite, flade, runde tabletter uden
overtræk, præget med ‘PIO’ på den ene
side og ‘30’ på den anden side.
Pioglitazone Accord 45 mg tabletter
Tabletterne er hvide til offwhite, flade, runde tabletter uden
overtræk, præget med ‘PIO’ på den ene
side og ‘45’ på den anden side.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Pioglitazon er indiceret som andet- eller tredjevalgsbehandling af
type 2-diabetes mellitus som
beskrevet nedenfor:
som
MONOTERAPI
:
-
hos voksne patienter (specielt overvægtige patienter), der er
utilstrækkeligt reguleret via diæt og
motion, og for hvem metformin ikke er velegnet på grund af
kontraindikationer eller intolerans
3
som
ORAL KOMBINATIONSBEHANDLING
, sammen med
-
metformin hos voksne patienter (specielt overvægtige patienter) med
utilstrækkelig glykæmisk
kontrol på metformin-monoterapi p
                                
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Active ingredient pioglitazonhydrochlorid

pioglitazonhydrochlorid

ATC code A10BG03

A10BG03

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) pioglitazone

pioglitazone

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