Sitagliptin / Metformin hydrochloride Accord

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
01-09-2022
Download Summary of Product characteristics (SPC)
01-09-2022
Download 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:

Lijekovi koji se koriste u dijabetesu

Therapeutic area:

Dijabetes Mellitus, tip 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. trostruki kombinovanu terapiju) kao dodatak prehrani i vježbe kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой doze метформина i sulfonilurejom. 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:

odobren

Authorization date:

2022-07-22

Patient Information leaflet

                                35
B. UPUTA O LIJEKU
36
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
SITAGLIPTIN/METFORMINKLORID ACCORD 50 MG/850 MG
FILMOM OBLOŽENE TABLETE
SITAGLIPTIN/METFORMINKLORID ACCORD 50 MG/1000 MG
FILMOM OBLOŽENE TABLETE
sitagliptin/metforminklorid
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili
medicinskoj sestri.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte dio
4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Sitagliptin/metforminklorid Accord i za što se koristi
2.
Što morate znati prije nego počnete uzimati
Sitagliptin/metforminklorid Accord
3.
Kako uzimati Sitagliptin/metforminklorid Accord
4.
Moguće nuspojave
5.
Kako čuvati Sitagliptin/metforminklorid Accord
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE SITAGLIPTIN/METFORMINKLORID ACCORD I ZA ŠTO SE KORISTI
Ovaj lijek sadrži dva različita lijeka koji se zovu sitagliptin i
metformin.
•
sitagliptin pripada skupini lijekova koji se zovu DPP-4 inhibitori
(inhibitori dipeptidil
peptidaze-4)
•
metformin pripada skupini lijekova koji se zovu bigvanidi.
Ova dva lijeka djeluju zajedno i reguliraju razine šećera u krvi u
odraslih bolesnika s oblikom šećerne
bolesti koja se zove „šećerna bolest tip 2“. Ovaj lijek pomaže
povisiti razine inzulina koji se proizvodi
nakon obroka i snižava količinu šećera kojeg proizvodi Vaše
tijelo.
Uz dijetu i tjelovježbu, ovaj lijek Vam pomaže sniziti šećer u
krvi. Ovaj lijek se može uzimati sam ili s
nekim drugim lijekovima za šećernu bolest (inzulin, sulfonilureje
ili glitazoni).
Što je šećerna bolest tip 2?
Šećerna bolest tip 2 
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Sitagliptin/metforminklorid Accord 50 mg/850 mg filmom obložene
tablete
Sitagliptin/metforminklorid Accord 50 mg/1000 mg filmom obložene
tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Sitagliptin/metforminklorid Accord 50 mg/850 mg filmom obložene
tablete
Jedna tableta sadrži sitagliptinklorid hidrat u količini koja
odgovara 50 mg sitagliptina i 850 mg
metforminklorida.
Sitagliptin/metforminklorid Accord 50 mg/1000 mg filmom obložene
tablete
Jedna tableta sadrži sitagliptinklorid hidrat u količini koja
odgovara 50 mg sitagliptina i 1000 mg
metforminklorida.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Filmom obložena tableta (tableta).
Sitagliptin/metforminklorid Accord 50 mg/850 mg filmom obložene
tablete
Ružičasta filmom obložena tableta u obliku kapsule, s utisnutom
oznakom „SM2“ na jednoj strani i
bez oznake na drugoj strani. Dimenzije: 20x10 mm.
Sitagliptin/metforminklorid Accord 50 mg/1000 mg filmom obložene
tablete
Crvena filmom obložena tableta u obliku kapsule, s utisnutom oznakom
„SM3“ na jednoj strani i bez
oznake na drugoj strani. Dimenzije: duljina: 21x10 mm
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
U odraslih bolesnika s dijabetes melitusom tipa 2:
Indiciran je kao dopuna dijeti i tjelovježbi za poboljšanje
regulacije glikemije u bolesnika u kojih ista
nije odgovarajuće regulirana primjenom najviše podnošljive doze
samo metformina ili u onih koji se
već liječe kombinacijom sitagliptina i metformina.
Indiciran je u kombinaciji sa sulfonilurejom (tj. kao dio trojne
kombinirane terapije) kao dopuna dijeti
i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani
primjenom najviše podnošljive doze
metformina i sulfonilureje.
Indiciran je kao dio trojne kombinirane terapije s agonistom receptora
za aktivator proliferacije
peroksisoma-gama (engl. _peroxisome proliferator-activated receptor
gamma_, PPARγ) (tj.
tiazolidindionom) kao dopuna dijeti i tjelovježbi u bolesnika koji
                                
                                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

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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
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Public Assessment Report Public Assessment Report Spanish 03-08-2022
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Sitagliptin / Metformin hydrochloride Accord