Tandemact

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
13-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-09-2023
Public Assessment Report Public Assessment Report (PAR)
14-06-2016

Active ingredient:

pioglitazone, glimepirida

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

A10BD06

INN (International Name):

pioglitazone, glimepiride

Therapeutic group:

Lijekovi koji se koriste u dijabetesu

Therapeutic area:

Dijabetes Mellitus, tip 2

Therapeutic indications:

Glubravu je indiciran za liječenje bolesnika s tip 2 dijabetes mellitus koji pokazuju nepodnošenja metformina ili kojih metformin je kontraindiciran i koji se već liječe kombinacijom pioglitazon i glimepiridom.

Product summary:

Revision: 22

Authorization status:

odobren

Authorization date:

2007-01-08

Patient Information leaflet

                                29
B. UPUTA O LIJEKU
30
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
TANDEMACT 30 MG/2 MG TABLETE
TANDEMACT 30 MG/4 MG TABLETE
pioglitazon/glimepirid
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 svom liječniku ili
ljekarniku.
-
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 ili ljekarnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
:
1.
Što je Tandemact i za što se koristi
2.
Što morate znati prije nego počnete uzimati Tandemact
3.
Kako uzimati Tandemact
4.
Moguće nuspojave
5.
Kako čuvati Tandemact
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE TANDEMACT I ZA ŠTO SE KORISTI
Tandemact sadrži pioglitazon i glimepirid, koji su antidijabetički
lijekovi i primjenjuju se za kontrolu
razine šećera u krvi.
Tandemact se primjenjuje u odraslih kad metformin nije prikladan za
liječenje šećerne bolesti tipa 2
(neovisne o inzulinu). Ovaj tip 2 šećerne bolesti obično nastaje u
odrasloj dobi kad tijelo ili ne
proizvodi dovoljno inzulina (hormona koji kontrolira razinu šećera u
krvi) ili ne može učinkovito
iskoristiti inzulin koji proizvodi.
Tandemact pomaže u kontroli razine šećera u krvi kad imate
šećernu bolest tipa 2 tako što povećava
količinu dostupnog inzulina i pomaže Vašem tijelu da ga bolje
iskoristi. Liječnik će provjeriti
djelovanje lijeka Tandemact 3 do 6 mjeseci nakon što ga počnete
uzimati.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI LIJEK TANDEMACT
NEMOJTE UZIMATI TANDEMACT
-
ako ste alergični na pioglitazon, glimepirid, druge sulfonilureje ili
sulfonamide ili neki drugi
sastojak ovog lijeka (naveden u dijelu 6)
-
ako imate ili ste prije imali zatajenje srca
-
ako i
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Tandemact 30 mg/2 mg tablete
Tandemact 30 mg/4 mg tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Tandemact 30 mg/2 mg tablete
Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida)
i 2 mg glimepirida.
_Pomoćna tvar s poznatim učinkom _
Jedna tableta sadrži približno 125 mg laktoze hidrata (vidjeti dio
4.4).
Tandemact 30 mg/4 mg tablete
Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida)
i 4 mg glimepirida.
_Pomoćna tvar s poznatim učinkom _
Jedna tableta sadrži približno 177 mg laktoze hidrata (vidjeti dio
4.4).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tableta.
Tandemact 30 mg/2 mg tablete
Bijela do gotovo bijela, okrugla, konveksna s utisnutim ‘4833 G’
na jednoj strani i ‘30/2’ na drugoj.
Tandemact 30 mg/4 mg tablete
Bijela do gotovo bijela, okrugla, konveksna s utisnutim ‘4833 G’
na jednoj strani i ‘30/4’ na drugoj.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Tandemact je indiciran kao druga linija liječenja u odraslih
bolesnika sa šećernom bolešću tipa 2 koji
ne podnose metformin ili u kojih je metformin kontraindiciran i koji
se već liječe kombinacijom
pioglitazona i glimepirida.
Bolesnike se mora pregledati 3 do 6 mjeseci nakon početka terapije
pioglitazonom kako bi se
procijenila prikladnost odgovora na liječenje (npr. sniženje HbA
1c
). U bolesnika koji nemaju prikladni
odgovor primjenu pioglitazona je nužno prekinuti. S obzirom na
moguće rizike dugotrajnije terapije,
liječnici koji propisuju lijek moraju naknadnim rutinskim procjenama
potvrđivati da je korist od
liječenja pioglitazonom održana (vidjeti dio 4.4).
3
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena doza lijeka Tandemact je jedna tableta jedanput na dan.
Ako bolesnici prijave hipoglikemiju, doza lijeka Tandemact se mora
sniziti ili se mora razmotriti
terapija slobodnom kombinacijom lijekova.
Ako bolesnici uzimaju pioglitazon u kombinaciji s derivatom
sulfonilureje koj
                                
                                Read the complete document

Similar products

Active ingredient pioglitazone, glimepirida

pioglitazone, glimepirida

ATC code A10BD06

A10BD06

Marketed by CHEPLAPHARM Arzneimittel GmbH

CHEPLAPHARM Arzneimittel GmbH

INN (International Name) pioglitazone, glimepiride

pioglitazone, glimepiride

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-09-2023
Public Assessment Report Public Assessment Report Bulgarian 14-06-2016
Patient Information leaflet Patient Information leaflet Spanish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Spanish 13-09-2023
Public Assessment Report Public Assessment Report Spanish 14-06-2016
Patient Information leaflet Patient Information leaflet Czech 13-09-2023
Summary of Product characteristics Summary of Product characteristics Czech 13-09-2023
Public Assessment Report Public Assessment Report Czech 14-06-2016
Patient Information leaflet Patient Information leaflet Danish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Danish 13-09-2023
Public Assessment Report Public Assessment Report Danish 14-06-2016
Patient Information leaflet Patient Information leaflet German 13-09-2023
Summary of Product characteristics Summary of Product characteristics German 13-09-2023
Public Assessment Report Public Assessment Report German 14-06-2016
Patient Information leaflet Patient Information leaflet Estonian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Estonian 13-09-2023
Public Assessment Report Public Assessment Report Estonian 14-06-2016
Patient Information leaflet Patient Information leaflet Greek 13-09-2023
Summary of Product characteristics Summary of Product characteristics Greek 13-09-2023
Public Assessment Report Public Assessment Report Greek 14-06-2016
Patient Information leaflet Patient Information leaflet English 13-09-2023
Summary of Product characteristics Summary of Product characteristics English 13-09-2023
Public Assessment Report Public Assessment Report English 14-06-2016
Patient Information leaflet Patient Information leaflet French 13-09-2023
Summary of Product characteristics Summary of Product characteristics French 13-09-2023
Public Assessment Report Public Assessment Report French 14-06-2016
Patient Information leaflet Patient Information leaflet Italian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Italian 13-09-2023
Public Assessment Report Public Assessment Report Italian 14-06-2016
Patient Information leaflet Patient Information leaflet Latvian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Latvian 13-09-2023
Public Assessment Report Public Assessment Report Latvian 14-06-2016
Patient Information leaflet Patient Information leaflet Lithuanian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-09-2023
Public Assessment Report Public Assessment Report Lithuanian 14-06-2016
Patient Information leaflet Patient Information leaflet Hungarian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 13-09-2023
Public Assessment Report Public Assessment Report Hungarian 14-06-2016
Patient Information leaflet Patient Information leaflet Maltese 13-09-2023
Summary of Product characteristics Summary of Product characteristics Maltese 13-09-2023
Public Assessment Report Public Assessment Report Maltese 14-06-2016
Patient Information leaflet Patient Information leaflet Dutch 13-09-2023
Summary of Product characteristics Summary of Product characteristics Dutch 13-09-2023
Public Assessment Report Public Assessment Report Dutch 14-06-2016
Patient Information leaflet Patient Information leaflet Polish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Polish 13-09-2023
Public Assessment Report Public Assessment Report Polish 14-06-2016
Patient Information leaflet Patient Information leaflet Portuguese 13-09-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 13-09-2023
Public Assessment Report Public Assessment Report Portuguese 14-06-2016
Patient Information leaflet Patient Information leaflet Romanian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Romanian 13-09-2023
Public Assessment Report Public Assessment Report Romanian 14-06-2016
Patient Information leaflet Patient Information leaflet Slovak 13-09-2023
Summary of Product characteristics Summary of Product characteristics Slovak 13-09-2023
Public Assessment Report Public Assessment Report Slovak 14-06-2016
Patient Information leaflet Patient Information leaflet Slovenian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 13-09-2023
Public Assessment Report Public Assessment Report Slovenian 14-06-2016
Patient Information leaflet Patient Information leaflet Finnish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Finnish 13-09-2023
Public Assessment Report Public Assessment Report Finnish 14-06-2016
Patient Information leaflet Patient Information leaflet Swedish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Swedish 13-09-2023
Public Assessment Report Public Assessment Report Swedish 14-06-2016
Patient Information leaflet Patient Information leaflet Norwegian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 13-09-2023
Patient Information leaflet Patient Information leaflet Icelandic 13-09-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 13-09-2023

Search alerts related to this product

Alerts Tandemact pioglitazone, glimepirida glimepiride

Tandemact pioglitazone, glimepirida glimepiride

View documents history

Documents history Documents history

Tandemact