Sitagliptin / Metformin hydrochloride Sun

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

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:

Drogi użati fid-dijabete

Therapeutic area:

Diabetes Mellitus, Tip 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. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u 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:

Awtorizzat

Authorization date:

2023-03-31

Patient Information leaflet

                                35
B. FULJETT TA’ TAGĦRIF
36
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN 50 MG/850
MG PILLOLI MIKSIJIN B’RITA
SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN 50 MG/1 000
MG PILLOLI MIKSIJIN B’RITA
sitagliptin/metformin hydrochloride
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, lill-ispiżjar jew
lill-infermier tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anke jekk għandhom l-istess sinjali ta’
mard bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Sitagliptin/Metformin hydrochloride SUN u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Sitagliptin/Metformin
hydrochloride SUN
3.
Kif għandek tieħu Sitagliptin/Metformin hydrochloride SUN
4.
Effetti sekondarji possibbli
5.
Kif taħżen Sitagliptin/Metformin hydrochloride SUN
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU SITAGLIPTIN/METFORMIN HYDROCHLORIDE SUN U GĦALXIEX JINTUŻA
Sitagliptin/Metformin hydrochloride SUN fih żewġ mediċini
differenti msejħin sitagliptin u
metformin.
•
sitagliptin jappartieni għall-klassi ta’ mediċini msejħin
impedituri DPP-4 (impedituri dipeptidyl
peptidase-4 )
•
metformin jappartieni għall-klassi ta’ mediċini msejħin
biguanides.
Huma jaħdmu flimkien biex jikkontrollaw livelli ta’ zokkor fid-demm
f’pazjenti adulti b’tip ta’
dijabete msejħa ‘dijabete mellitus tip 2’. Din il-mediċina
tgħin biex iżżid il-livelli ta’ insulina li l-
ġisem tiegħek jipproduċi wara ikla u tbaxxi l-ammont ta’ zokkor
li huwa jagħmel.
Flimkien ma’ dieta u eżerċizzju, din il-medi
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg pilloli miksijin
b’rita
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg pilloli
miksijin b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg
pilloli miksijin b’rita
Kull pillola fiha sitagliptin fumarate ekwivalenti għal 50 mg ta’
sitagliptin u 850 mg ta’ metformin
hydrochloride.
_Eċċipjent b'effett magħruf _
Kull pillola miksija b'rita fiha 6.9 mg ta' żejt ir-riġnu
hydrogenated.
_ _
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg
pilloli miksijin b’rita
Kull pillola fiha sitagliptin fumarate ekwivalenti għal 50 mg ta’
sitagliptin u 1 000 mg ta’ metformin
hydrochloride.
_Eċċipjent b'effett magħruf _
Kull pillola miksija b'rita fiha 8,0 mg ta' żejt ir-riġnu
hydrogenated.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita (pillola).
Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg
pilloli miksijin b’rita
Pilloli miksija b
’
rita roża, forma ta
’
kapsula, qisien bejn wieħed u ieħor 20 mm x 10 mm x 6 mm,
imnaqqxa b
’“
SC1
”
fuq naħa waħda.
Sitagliptin/Metformin hydrochloride SUN 50 mg/1 000 mg
pilloli miksijin b’rita
Pilloli miksijin b
’
rita kannella għal kannella ħamrani, forma ta
’
kapsula, qisien bejn wieħed u ieħor 22
mm x 11 mm x 7 mm, imnaqqxa b
’“
SC7
”
fuq naħa waħda.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Għal pazjenti adulti b’dijabete mellitus tip 2:
Sitagliptin/Metformin hydrochloride SUN huwa indikat bħala żieda
mad-dieta u ma’ l-eżerċizzju biex
itejjeb il-kontroll gliċemiku għal pazjenti mhux ikkontrollati
adegwatament, fuq id-doża massima
ttollerata ta’ metformin waħdu jew għal dawk li diġà qegħdin
jiġu kkurati b’kumbinazzjoni ta’
sitagliptin u
_ _
metformin.
3
Sitagliptin/Metformin hydrochloride SUN huwa indikat f’kumbinazzjoni
ma’ sulphony
                                
                                Read the complete document

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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

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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
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Public Assessment Report Public Assessment Report Spanish 17-07-2023
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