Sitagliptin / Metformin hydrochloride Accord

Country: European Union

Language: Latvian

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:

Cukura diabēts

Therapeutic area:

Cukura diabēts, 2. tips

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. , triple kombinēto terapiju), kā palīglīdzekli, lai diētu un vingrošanu pacientiem nepietiekami kontrolē par to maksimālā pieļaujama devu metformīns un sulfonilurīnvielas pamata. 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:

Autorizēts

Authorization date:

2022-07-22

Patient Information leaflet

                                35
B.
LIETOŠANAS INSTRUKCIJA
36
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA PACIENTAM
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD 50 MG/850 MG APVALKOTĀS
TABLETES
SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD 50 MG/1000 MG APVALKOTĀS
TABLETES
sitagliptinum/metformini hydrochloridum
PIRMS ZĀĻU LIETOŠANAS UZMANĪGI IZLASIET VISU INSTRUKCIJU, JO TĀ
SATUR JUMS SVARĪGU INFORMĀCIJU.
-
Saglabājiet šo instrukciju! Iespējams, ka vēlāk to vajadzēs
pārlasīt.
-
Ja Jums rodas jebkādi jautājumi, vaicājiet ārstam, farmaceitam vai
medmāsai.
-
Šīs zāles ir parakstītas tikai Jums. Nedodiet tās citiem. Tās
var nodarīt ļaunumu pat tad, ja šiem
cilvēkiem ir līdzīgas slimības pazīmes.
-
Ja Jums ir jebkādas blakusparādības, konsultējieties ar ārstu,
farmaceitu vai medmāsu. Tas
attiecas arī uz iespējamajām blakusparādībām, kas nav minētas
šajā instrukcijā. Skatīt 4. punktu.
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT:
1.
Kas ir Sitagliptin/Metformin hydrochloride Accord un kādam nolūkam
to lieto
2.
Kas Jums jāzina pirms Sitagliptin/Metformin hydrochloride Accord
lietošanas
3.
Kā lietot Sitagliptin/Metformin hydrochloride Accord
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Sitagliptin/Metformin hydrochloride Accord
6.
Iepakojuma saturs un cita informācija
1.
KAS IR SITAGLIPTIN/METFORMIN HYDROCHLORIDE ACCORD UN KĀDAM NOLŪKAM
TO LIETO
Šīs zāles satur divas dažādas aktīvās vielas, ko sauc par
sitagliptīnu un metformīnu.
•
sitagliptīns pieder zāļu grupai, ko sauc par DPP-4 inhibitoriem
(dipeptidilpeptidāzes-4
inhibitoriem),
•
metformīns pieder zāļu grupai, ko sauc par biguanīdiem.
Tās darbojas kopā, lai kontrolētu cukura līmeni pieaugušajiem
pacientiem ar diabēta veidu, ko sauc
par "2. tipa cukura diabētu". Šīs zāles palīdz paaugstināt pēc
ēdienreizes izdalītā insulīna līmeni un
samazināt organismā saražotā cukura daudzumu.
Vienlaicīgi ar uzturu un fiziskajiem vingrinājumiem šīs zāles
palīdz samazināt cukura līmeni Jūsu
asinīs. Šīs zāles v
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg apvalkotās
tabletes
Sitagliptin/Metformin hydrochloride Accord 50 mg/1000 mg apvalkotās
tabletes
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg apvalkotās
tabletes
Katra tablete satur sitagliptīna hidrohlorīda monohidrātu, kas
atbilst 50 mg sitagliptīna (sitagliptinum),
un 850 mg metformīna hidrohlorīda (metformini hydrochloridum).
Sitagliptin/Metformin hydrochloride Accord 50 mg/1000 mg apvalkotās
tabletes
Katra tablete satur sitagliptīna hidrohlorīda monohidrātu, kas
atbilst 50 mg sitagliptīna (sitagliptinum),
un 1000 mg metformīna hidrohlorīda (metformini hydrochloridum).
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3.
ZĀĻU FORMA
Apvalkotā tablete (tablete)
Sitagliptin/Metformin hydrochloride Accord 50 mg/850 mg apvalkotās
tabletes
Sārtas krāsas, kapsulas formas apvalkotās tabletes ar iespiestu
uzrakstu 'SM2’ vienā pusē un gludu
otru pusi. Izmērs: 20x10 mm.
Sitagliptin/Metformin hydrochloride Accord 50 mg/1000 mg apvalkotās
tabletes
Sarkanas krāsas, kapsulas formas apvalkotās tabletes ar iespiestu
uzrakstu 'SM3’ vienā pusē un gludu
otru pusi. Izmērs: Garums: 21x10 mm
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
TERAPEITISKĀS INDIKĀCIJAS
Pieaugušajiem pacientiem ar 2. tipa cukura diabētu.
Papildus diētai un fiziskajām aktivitātēm tas ir paredzēts
glikēmijas kontroles uzlabošanai pacientiem,
kuriem augstākā panesamā metformīna monoterapijas deva
nenodrošina pietiekamu glikēmijas
kontroli, vai pacientiem, kuri jau lieto sitagliptīnu kopā ar
metformīnu.
Papildus diētai un fiziskajām aktivitātēm tas ir paredzēts
kombinācijā ar sulfonilurīnvielas
atvasinājumu (t.i. trīskārša kombinētā terapija) pacientiem,
kuriem augstākā panesamā metformīna
monoterapijas deva kopā ar sulfonilurīnvielas atvasinājumu
nenodrošina pietiekamu glikēmijas
kontroli.
Papildus diētai un fiziskajām aktivit
                                
                                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
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