Tandemact

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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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, glimepiride

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

A10BD06

INN (International Name):

pioglitazone, glimepiride

Therapeutic group:

Zdravila, ki se uporabljajo pri diabetesu

Therapeutic area:

Diabetes Mellitus, tip 2

Therapeutic indications:

Tandemact je indicirano za zdravljenje bolnikov s sladkorno boleznijo tipa 2, ki kažejo nestrpnosti v metforminom ali za katere je kontraindiciran metformin in ki se že zdravijo s kombinacijo pioglitazone in glimepiride.

Product summary:

Revision: 22

Authorization status:

Pooblaščeni

Authorization date:

2007-01-08

Patient Information leaflet

                                24
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Nemčija
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/06/366/018 28 tablet
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Tandemact 30 mg/2 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC
SN
NN
25
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Tandemact 30 mg/4 mg tablete
pioglitazon/glimepirid
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega
klorida) in 4 mg glimepirida.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktozo monohidrat. Za nadaljnje informacije glejte navodilo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
28 tablet
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
26
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Nemčija
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/06/366/006 28 tablet
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Tandemact 30 mg/4 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC
SN
NN
27
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU
ALI DVOJNEM TRAKU
PRETISNI OMOT
1.
IME ZDRAVILA
Tandemact 30 mg/2 mg tablete
pioglitazon/glimepirid
2.
IME IMETNIKA 
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Tandemact 30 mg/2 mg tablete
Tandemact 30 mg/4 mg tablete
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Tandemact 30 mg/2 mg tablete
Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega
klorida) in 2 mg glimepirida.
_Pomožna snov z znanim učinkom _
Ena tableta vsebuje približno 125 mg laktoze monohidrata (glejte
poglavje 4.4).
Tandemact 30 mg/4 mg tablete
Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega
klorida) in 4 mg glimepirida.
_Pomožna snov z znanim učinkom _
Ena tableta vsebuje približno 177 mg laktoze monohidrata (glejte
poglavje 4.4).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Tableta
Tandemact 30 mg/2 mg tablete
Tablete so bele do sivobele barve, okrogle, izbočene z oznako ‘4833
G’ na eni in ‘30/2’ na drugi
strani.
Tandemact 30 mg/4 mg tablete
Tablete so bele do sivobele barve, okrogle, izbočene z oznako ‘4833
G’ na eni in ‘30/4’ na drugi
strani.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Tandemact je indicirano kot drugi izbor
zdravljenja sladkorne bolezni tipa 2 pri odraslih
bolnikih, ki kažejo intoleranco za metformin, ali pri bolnikih, pri
katerih je metformin kontraindiciran
in se že zdravijo s kombinacijo pioglitazona in glimepirida.
Po začetku zdravljenja s pioglitazonom je treba bolnike pregledati po
3 do 6 mesecih, da se oceni
ustreznost odziva na zdravljenje (npr. zmanjšanje HbA
1c
). Pri bolnikih, ki ne pokažejo ustreznega
odziva, je treba pioglitazon ukiniti. Glede na možna tveganja pri
dolgotrajni terapiji, mora zdravnik
potrditi pri rednih rutinskih pregledih, da je korist pioglitazona
ohranjena (glejte poglavje 4.4).
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočeni odmerek zdravila Tandemact je ena tableta vzeta enkrat
dnevno.
Če bolniki poročajo o hipoglikemiji, je treba odmerek zdravila
Tandemact znižati ali razmisliti o
kombinacijski terapiji.
3
Bolnike, ki prejemajo pioglitazon v kombinaciji z drugimi
su
                                
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Similar products

Active ingredient pioglitazone, glimepiride

pioglitazone, glimepiride

ATC code A10BD06

A10BD06

Marketed by CHEPLAPHARM Arzneimittel GmbH

CHEPLAPHARM Arzneimittel GmbH

INN (International Name) pioglitazone, glimepiride

pioglitazone, glimepiride

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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
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Public Assessment Report Public Assessment Report French 14-06-2016
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Summary of Product characteristics Summary of Product characteristics Finnish 13-09-2023
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Summary of Product characteristics Summary of Product characteristics Croatian 13-09-2023
Public Assessment Report Public Assessment Report Croatian 14-06-2016

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Tandemact