Sitagliptin / Metformin hydrochloride Sun

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
17-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
17-07-2023
Public Assessment Report Public Assessment Report (PAR)
17-07-2023

Active ingredient:

sitagliptin fumarate, metformin hydrochloride

Available from:

Sun Pharmaceutical Industries Europe B.V.

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:Sitagliptin/Metformin hydrochloride SUN 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. Sitagliptin/Metformin hydrochloride SUN 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. Sitagliptin/Metformin hydrochloride SUN 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. Sitagliptin/Metformin hydrochloride SUN 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.

Authorization status:

autoriseret

Authorization date:

2023-03-31

Patient Information leaflet

                                35
B. INDLÆGSSEDDEL
36
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN 50 MG/850 MG FILMOVERTRUKNE
TABLETTER
SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN 50 MG/1 000
MG FILMOVERTRUKNE TABLETTER
sitagliptin/metforminhydrochlorid
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
lægemidlet 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 SUN
3.
Sådan skal du tage Sitagliptin/Metformin hydrochloride SUN
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Sitagliptin/Metformin hydrochloride SUN indeholder to forskellige
lægemidler, sitagliptin og
metformin.
•
Sitagliptin tilhører en klasse af lægemidler, som 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 e
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg filmovertrukne
tabletter
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg filmovertrukne
tabletter
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg filmovertrukne
tabletter
Hver tablet indeholder sitagliptinfumarat svarende til 50 mg
sitagliptin og 850 mg
metforminhydrochlorid.
_Hjælpestoffer, som behandleren skal være opmærksom på_
Hver filmovertrukket tablet indeholder 6,9 mg hydrogeneret
ricinusolie.
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg filmovertrukne
tabletter
Hver tablet indeholder sitagliptinfumarat svarende til 50 mg
sitagliptin og 1 000 mg
metforminhydrochlorid.
_Hjælpestoffer, som behandleren skal være opmærksom på_
Hver filmovertrukket tablet indeholder 8,0 mg hydrogeneret
ricinusolie.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Filmovertrukket tablet (tablet).
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg filmovertrukne
tabletter
Lyserøde, kapselformede filmovertrukne tabletter, dimensioner ca. 20
mm × 10 mm × 6 mm, præget
med ”SC1” på den ene side.
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg filmovertrukne
tabletter
Brune til rødbrune, kapselformede filmovertrukne tabletter,
dimensioner ca. 22 mm × 11 mm × 7 mm,
præget med ”SC7” på den ene side.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Til voksne patienter med type 2-diabetes mellitus:
Sitagliptin/Metformin hydrochloride SUN 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.
Sitagliptin/Metformin hydrochloride SUN er indiceret som supplement
til diæt og motion i
kombination med et sulfonylurinstof (dvs. tripel
kombinationsbehandling) hos patienter, der ikke er

                                
                                Read the complete document

Similar products

Active ingredient sitagliptin fumarate, metformin hydrochloride

sitagliptin fumarate, metformin hydrochloride

ATC code A10BD07

A10BD07

Marketed by Sun Pharmaceutical Industries Europe B.V.

Sun Pharmaceutical Industries Europe B.V.

INN (International Name) sitagliptin, metformin hydrochloride

sitagliptin, metformin hydrochloride

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 17-07-2023
Public Assessment Report Public Assessment Report Bulgarian 17-07-2023
Patient Information leaflet Patient Information leaflet Spanish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Spanish 17-07-2023
Public Assessment Report Public Assessment Report Spanish 17-07-2023
Patient Information leaflet Patient Information leaflet Czech 17-07-2023
Summary of Product characteristics Summary of Product characteristics Czech 17-07-2023
Public Assessment Report Public Assessment Report Czech 17-07-2023
Patient Information leaflet Patient Information leaflet German 17-07-2023
Summary of Product characteristics Summary of Product characteristics German 17-07-2023
Public Assessment Report Public Assessment Report German 17-07-2023
Patient Information leaflet Patient Information leaflet Estonian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Estonian 17-07-2023
Public Assessment Report Public Assessment Report Estonian 17-07-2023
Patient Information leaflet Patient Information leaflet Greek 17-07-2023
Summary of Product characteristics Summary of Product characteristics Greek 17-07-2023
Public Assessment Report Public Assessment Report Greek 17-07-2023
Patient Information leaflet Patient Information leaflet English 17-07-2023
Summary of Product characteristics Summary of Product characteristics English 17-07-2023
Public Assessment Report Public Assessment Report English 17-07-2023
Patient Information leaflet Patient Information leaflet French 17-07-2023
Summary of Product characteristics Summary of Product characteristics French 17-07-2023
Public Assessment Report Public Assessment Report French 17-07-2023
Patient Information leaflet Patient Information leaflet Italian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Italian 17-07-2023
Public Assessment Report Public Assessment Report Italian 17-07-2023
Patient Information leaflet Patient Information leaflet Latvian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Latvian 17-07-2023
Public Assessment Report Public Assessment Report Latvian 17-07-2023
Patient Information leaflet Patient Information leaflet Lithuanian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 17-07-2023
Public Assessment Report Public Assessment Report Lithuanian 17-07-2023
Patient Information leaflet Patient Information leaflet Hungarian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 17-07-2023
Public Assessment Report Public Assessment Report Hungarian 17-07-2023
Patient Information leaflet Patient Information leaflet Maltese 17-07-2023
Summary of Product characteristics Summary of Product characteristics Maltese 17-07-2023
Public Assessment Report Public Assessment Report Maltese 17-07-2023
Patient Information leaflet Patient Information leaflet Dutch 17-07-2023
Summary of Product characteristics Summary of Product characteristics Dutch 17-07-2023
Public Assessment Report Public Assessment Report Dutch 17-07-2023
Patient Information leaflet Patient Information leaflet Polish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Polish 17-07-2023
Public Assessment Report Public Assessment Report Polish 17-07-2023
Patient Information leaflet Patient Information leaflet Portuguese 17-07-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 17-07-2023
Public Assessment Report Public Assessment Report Portuguese 17-07-2023
Patient Information leaflet Patient Information leaflet Romanian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Romanian 17-07-2023
Public Assessment Report Public Assessment Report Romanian 17-07-2023
Patient Information leaflet Patient Information leaflet Slovak 17-07-2023
Summary of Product characteristics Summary of Product characteristics Slovak 17-07-2023
Public Assessment Report Public Assessment Report Slovak 17-07-2023
Patient Information leaflet Patient Information leaflet Slovenian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 17-07-2023
Public Assessment Report Public Assessment Report Slovenian 17-07-2023
Patient Information leaflet Patient Information leaflet Finnish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Finnish 17-07-2023
Public Assessment Report Public Assessment Report Finnish 17-07-2023
Patient Information leaflet Patient Information leaflet Swedish 17-07-2023
Summary of Product characteristics Summary of Product characteristics Swedish 17-07-2023
Public Assessment Report Public Assessment Report Swedish 17-07-2023
Patient Information leaflet Patient Information leaflet Norwegian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 17-07-2023
Patient Information leaflet Patient Information leaflet Icelandic 17-07-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 17-07-2023
Patient Information leaflet Patient Information leaflet Croatian 17-07-2023
Summary of Product characteristics Summary of Product characteristics Croatian 17-07-2023
Public Assessment Report Public Assessment Report Croatian 17-07-2023

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