Sitagliptin / Metformin hydrochloride Accord

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-09-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
01-09-2022
Public Assessment Report Public Assessment Report (PAR)
03-08-2022

Active ingredient:

metformin hydrochloride, sitagliptin hydrochloride monohydrate

Available from:

Accord Healthcare S.L.U.

ATC code:

A10BD07

INN (International Name):

sitagliptin, metformin hydrochloride

Therapeutic group:

Narkotika anvendt i diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

For adult patients with type 2 diabetes mellitus:It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. It is indicated in combination with a sulphonylurea (i. - , trepersoners-kombinationsbehandling) som supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på deres maksimal tolereret dosis af metformin og et sulphonylurea. It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. It is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Product summary:

Revision: 1

Authorization status:

autoriseret

Authorization date:

2022-07-22

Patient Information leaflet

                                34
B. INDLÆGSSEDDEL
35
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD 50 MG/850 MG
FILMOVERTRUKNE TABLETTER
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD 50 MG/1.000 MG
FILMOVERTRUKNE TABLETTER
sitagliptin/metformin-hydrochlorid
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT TAGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er
mere, du vil vide.
-
Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor
være med at give medicinen
til andre. Det kan være skadeligt for andre, selvom de har de samme
symptomer, som du har.
-
Kontakt lægen, apotekspersonalet eller sygeplejersken, hvis du får
bivirkninger, herunder
bivirkninger, som ikke er nævnt i denne indlægsseddel. Se punkt 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk
OVERSIGT OVER INDLÆGSSEDLEN
1.
VIRKNING OG ANVENDELSE
2.
Det skal du vide, før du begynder at tage Sitagliptin/Metformin
hydrochloride Accord
3.
Sådan skal du tage Sitagliptin/Metformin hydrochloride Accord
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Dette lægemiddel indeholder to forskellige lægemidler, sitagliptin
og metformin.
•
Sitagliptin tilhører en klasse af lægemidler, der kaldes
DPP-4-hæmmere (dipeptidylpeptidase-4-
hæmmere).
•
Metformin tilhører en klasse af lægemidler, der kaldes biguanider.
Sammen kontrollerer de blodsukkeret hos voksne patienter med type
2-diabetes mellitus. Dette
lægemiddel hjælper med at øge mængden af insulin, der frigives
efter et måltid, og nedsætter
mængden af sukker, der dannes af kroppen.
Sammen med diæt og motion kan dette lægemiddel hjælpe med at sænke
dit blodsukker. Lægemidlet
kan bruges alene eller sammen med visse andre lægemidler til
behandling af diabetes (insulin,
sulfonylurinstof eller glitazoner).
Hvad er type 2-diabetes?
Type 2-diabetes er en tilstand
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmovertrukne
tabletter
Sitagliptin/Metformin hydrochloride Accord 50 mg/1.000 mg
filmovertrukne tabletter
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmovertrukne
tabletter
Hver tablet indeholder sitagliptinhydrochloridmonohydrat svarende til
50 mg sitagliptin og 850 mg
metforminhydrochlorid.
Sitagliptin/Metformin hydrochloride Accord 50 mg/1.000 mg
filmovertrukne tabletter
Hver tablet indeholder sitagliptinhydrochloridmonohydrat svarende til
50 mg sitagliptin og 1.000 mg
metforminhydrochlorid.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Filmovertrukken tablet
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmovertrukne
tabletter
Lyserød, kapselformet, filmovertrukken tablet præget med ’SM2’
på den ene side og glat på den anden
side. Dimension: 20×10 mm.
Sitagliptin/Metformin hydrochloride Accord 50 mg/1.000 mg
filmovertrukne tabletter
Rød, kapselformet, filmovertrukken tablet præget med ’SM3’ på
den ene side og glat på den anden
side. Dimension: Længde: 21×10 mm.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Til voksne patienter med type 2-diabetes mellitus:
Det er indiceret som supplement til diæt og motion til forbedring af
den glykæmiske kontrol hos
patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt
tolererede dosis metformin alene
eller hos de patienter, som allerede er i behandling med en
kombination af sitagliptin og metformin.
Det er indiceret i kombination med et sulfonylurinstof (dvs. tripel
kombinationsbehandling) som
supplement til diæt og motion hos patienter, der ikke er
tilstrækkeligt kontrolleret på den maksimalt
tolererede dosis metformin og sulfonylurinstof.
Det er indiceret som tripel kombinationsbehandling sammen med en
peroxisom proliferator-aktiveret
receptor-gamma (PPARγ)-agonist (dvs. et glitazon) som supplement til
diæt og motion hos patienter,
                                
                                Read the complete document

Similar products

Active ingredient metformin hydrochloride, sitagliptin hydrochloride monohydrate

metformin hydrochloride, sitagliptin hydrochloride monohydrate

ATC code A10BD07

A10BD07

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) sitagliptin, metformin hydrochloride

sitagliptin, metformin hydrochloride

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-09-2022
Public Assessment Report Public Assessment Report Bulgarian 03-08-2022
Patient Information leaflet Patient Information leaflet Spanish 01-09-2022
Summary of Product characteristics Summary of Product characteristics Spanish 01-09-2022
Public Assessment Report Public Assessment Report Spanish 03-08-2022
Patient Information leaflet Patient Information leaflet Czech 01-09-2022
Summary of Product characteristics Summary of Product characteristics Czech 01-09-2022
Public Assessment Report Public Assessment Report Czech 03-08-2022
Patient Information leaflet Patient Information leaflet German 01-09-2022
Summary of Product characteristics Summary of Product characteristics German 01-09-2022
Public Assessment Report Public Assessment Report German 03-08-2022
Patient Information leaflet Patient Information leaflet Estonian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Estonian 01-09-2022
Public Assessment Report Public Assessment Report Estonian 03-08-2022
Patient Information leaflet Patient Information leaflet Greek 01-09-2022
Summary of Product characteristics Summary of Product characteristics Greek 01-09-2022
Public Assessment Report Public Assessment Report Greek 03-08-2022
Patient Information leaflet Patient Information leaflet English 01-09-2022
Summary of Product characteristics Summary of Product characteristics English 01-09-2022
Public Assessment Report Public Assessment Report English 03-08-2022
Patient Information leaflet Patient Information leaflet French 01-09-2022
Summary of Product characteristics Summary of Product characteristics French 01-09-2022
Public Assessment Report Public Assessment Report French 03-08-2022
Patient Information leaflet Patient Information leaflet Italian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Italian 01-09-2022
Public Assessment Report Public Assessment Report Italian 03-08-2022
Patient Information leaflet Patient Information leaflet Latvian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Latvian 01-09-2022
Public Assessment Report Public Assessment Report Latvian 03-08-2022
Patient Information leaflet Patient Information leaflet Lithuanian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-09-2022
Public Assessment Report Public Assessment Report Lithuanian 03-08-2022
Patient Information leaflet Patient Information leaflet Hungarian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 01-09-2022
Public Assessment Report Public Assessment Report Hungarian 03-08-2022
Patient Information leaflet Patient Information leaflet Maltese 01-09-2022
Summary of Product characteristics Summary of Product characteristics Maltese 01-09-2022
Public Assessment Report Public Assessment Report Maltese 03-08-2022
Patient Information leaflet Patient Information leaflet Dutch 01-09-2022
Summary of Product characteristics Summary of Product characteristics Dutch 01-09-2022
Public Assessment Report Public Assessment Report Dutch 03-08-2022
Patient Information leaflet Patient Information leaflet Polish 01-09-2022
Summary of Product characteristics Summary of Product characteristics Polish 01-09-2022
Public Assessment Report Public Assessment Report Polish 03-08-2022
Patient Information leaflet Patient Information leaflet Portuguese 01-09-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 01-09-2022
Public Assessment Report Public Assessment Report Portuguese 03-08-2022
Patient Information leaflet Patient Information leaflet Romanian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Romanian 01-09-2022
Public Assessment Report Public Assessment Report Romanian 03-08-2022
Patient Information leaflet Patient Information leaflet Slovak 01-09-2022
Summary of Product characteristics Summary of Product characteristics Slovak 01-09-2022
Public Assessment Report Public Assessment Report Slovak 03-08-2022
Patient Information leaflet Patient Information leaflet Slovenian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 01-09-2022
Public Assessment Report Public Assessment Report Slovenian 03-08-2022
Patient Information leaflet Patient Information leaflet Finnish 01-09-2022
Summary of Product characteristics Summary of Product characteristics Finnish 01-09-2022
Public Assessment Report Public Assessment Report Finnish 03-08-2022
Patient Information leaflet Patient Information leaflet Swedish 01-09-2022
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Public Assessment Report Public Assessment Report Swedish 03-08-2022
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Summary of Product characteristics Summary of Product characteristics Norwegian 01-09-2022
Patient Information leaflet Patient Information leaflet Icelandic 01-09-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 01-09-2022
Patient Information leaflet Patient Information leaflet Croatian 01-09-2022
Summary of Product characteristics Summary of Product characteristics Croatian 01-09-2022
Public Assessment Report Public Assessment Report Croatian 03-08-2022

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Sitagliptin / Metformin hydrochloride Accord