Sitagliptin / Metformin hydrochloride Accord

Country: European Union

Language: Swedish

Source: EMA (European Medicines Agency)

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:

Läkemedel som används vid diabetes

Therapeutic area:

Diabetes Mellitus, typ 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. - , trippel kombinationsterapi) som ett komplement till kost och motion hos patienter bristfälligt kontrollerad på deras maximal tolererad dos av metformin och en 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:

auktoriserad

Authorization date:

2022-07-22

Patient Information leaflet

                                1
BILAGA I
PRODUKTRESUMÉ
2
1.
LÄKEMEDLETS NAMN
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmdragerade
tabletter
Sitagliptin/Metformin hydrochloride Accord 50 mg/1 000 mg
filmdragerade tabletter
2.
KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmdragerade
tabletter
En tablett innehåller sitagliptinhydrokloridmonohydrat motsvarande 50
mg sitagliptin och 850 mg
metforminhydroklorid.
Sitagliptin/Metformin hydrochloride Accord 50 mg/1 000 mg
filmdragerade tabletter
En tablett innehåller sitagliptinhydrokloridmonohydrat motsvarande 50
mg sitagliptin och 1 000 mg
metforminhydroklorid.
För fullständig förteckning över hjälpämnen, se avsnitt 6.1.
3.
LÄKEMEDELSFORM
Filmdragerad tablett (tablett).
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmdragerade
tabletter
Rosa, kapselformad, filmdragerad tablett präglad med ”SM2” på
den ena sidan och slät på den andra
sidan. Mått: 20 x 10 mm
Sitagliptin/Metformin hydrochloride Accord 50 mg/1 000 mg
filmdragerade tabletter
Röd, kapselformad, filmdragerad tablett präglad med ”SM3” på
den ena sidan och slät på den andra
sidan. Mått: 21 x 10 mm
4.
KLINISKA UPPGIFTER
4.1
TERAPEUTISKA INDIKATIONER
För vuxna patienter med diabetes mellitus typ 2:
Det är avsett som ett tillägg till kost och motion för att
förbättra den glykemiska kontrollen hos
patienter med otillräcklig glykemisk kontroll trots maximal
tolererbar dos av metformin i monoterapi
eller patienter som redan behandlas med en kombination av sitagliptin
och metformin i separata
tabletter.
Det är avsett i kombination med en sulfonureid (d.v.s. trippel
kombinationsterapi) som ett tillägg till
kost och motion hos patienter med otillräcklig glykemisk kontroll
trots maximal tolererbar dos av
metformin och en sulfonureid.
Det är avsett som en trippel kombinationsterapi med en PPARγ
(peroxisome proliferator-activated
receptor gamma)-agonist (d.v.s. en tiazolidindion) som ett tillägg
till kost och motion hos patient
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAGA I
PRODUKTRESUMÉ
2
1.
LÄKEMEDLETS NAMN
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmdragerade
tabletter
Sitagliptin/Metformin hydrochloride Accord 50 mg/1 000 mg
filmdragerade tabletter
2.
KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmdragerade
tabletter
En tablett innehåller sitagliptinhydrokloridmonohydrat motsvarande 50
mg sitagliptin och 850 mg
metforminhydroklorid.
Sitagliptin/Metformin hydrochloride Accord 50 mg/1 000 mg
filmdragerade tabletter
En tablett innehåller sitagliptinhydrokloridmonohydrat motsvarande 50
mg sitagliptin och 1 000 mg
metforminhydroklorid.
För fullständig förteckning över hjälpämnen, se avsnitt 6.1.
3.
LÄKEMEDELSFORM
Filmdragerad tablett (tablett).
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg filmdragerade
tabletter
Rosa, kapselformad, filmdragerad tablett präglad med ”SM2” på
den ena sidan och slät på den andra
sidan. Mått: 20 x 10 mm
Sitagliptin/Metformin hydrochloride Accord 50 mg/1 000 mg
filmdragerade tabletter
Röd, kapselformad, filmdragerad tablett präglad med ”SM3” på
den ena sidan och slät på den andra
sidan. Mått: 21 x 10 mm
4.
KLINISKA UPPGIFTER
4.1
TERAPEUTISKA INDIKATIONER
För vuxna patienter med diabetes mellitus typ 2:
Det är avsett som ett tillägg till kost och motion för att
förbättra den glykemiska kontrollen hos
patienter med otillräcklig glykemisk kontroll trots maximal
tolererbar dos av metformin i monoterapi
eller patienter som redan behandlas med en kombination av sitagliptin
och metformin i separata
tabletter.
Det är avsett i kombination med en sulfonureid (d.v.s. trippel
kombinationsterapi) som ett tillägg till
kost och motion hos patienter med otillräcklig glykemisk kontroll
trots maximal tolererbar dos av
metformin och en sulfonureid.
Det är avsett som en trippel kombinationsterapi med en PPARγ
(peroxisome proliferator-activated
receptor gamma)-agonist (d.v.s. en tiazolidindion) som ett tillägg
till kost och motion hos patient
                                
                                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 Danish 01-09-2022
Summary of Product characteristics Summary of Product characteristics Danish 01-09-2022
Public Assessment Report Public Assessment Report Danish 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 Norwegian 01-09-2022
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

Search alerts related to this product

Alerts Sitagliptin Metformin hydrochloride Accord hydrochloride, monohydrate sitagliptin,

Sitagliptin Metformin hydrochloride Accord hydrochloride, monohydrate sitagliptin,

View documents history

Documents history Documents history

Sitagliptin / Metformin hydrochloride Accord