Pregabalin Sandoz GmbH

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-10-2023
Public Assessment Report Public Assessment Report (PAR)
12-10-2023

Active ingredient:

pregabalin

Available from:

Sandoz GmbH

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptici sredstva,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Сандоз Gmbh prikazan kao dodatna terapija kod osoba s парциальными судорогами Sa ili bez sekundarne generalizacije. Postati generalizirani anksioznosti DisorderPregabalin Сандоз Gmbh je indiciran za liječenje generalizirani anksiozni poremećaj (GAP) kod odraslih.

Product summary:

Revision: 16

Authorization status:

povučen

Authorization date:

2015-06-19

Patient Information leaflet

                                70
B. UPUTA O LIJEKU
Lijek koji više nije odobren
71
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
PREGABALIN SANDOZ GMBH 25 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 50 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 75 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 100 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 150 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 200 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 225 MG TVRDE KAPSULE
PREGABALIN SANDOZ GMBH 300 MG TVRDE KAPSULE
pregabalin
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 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 Pregabalin Sandoz GmbH
i za što se koristi
2.
Što morate znati prije nego počnete uzimati Pregabalin Sandoz GmbH
3.
Kako uzimati Pregabalin Sandoz GmbH
4.
Moguće nuspojave
5.
Kako čuvati Pregabalin Sandoz GmbH
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PREGABALIN SANDOZ
GMBH I ZA ŠTO SE KORISTI
Pregabalin Sandoz GmbH pripada skupini lijekova koji se koriste za
liječenje epilepsije i
generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
EPILEPSIJA:
Pregabalin Sandoz GmbH se koristi za liječenje nekih oblika
epilepsije (parcijalnih
napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
Liječnik će Vam propisati lijek
Pregabalin Sandoz GmbH za liječenje epilepsije kada lijekovi koje ste
do sada uzimali bolest ne drže
pod kontrolom. Lijek Pregabalin Sandoz GmbH morate uzimati kao dodatak
postojećim lijekovima.
Pregabalin Sandoz GmbH nije namijenjen za samostalnu primjenu, nego se
uvijek mora uzimati u
kombinaciji s drugim antiepileptič
                                
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Summary of Product characteristics

                                1
PRILOG I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
Pregabalin Sandoz GmbH 25 mg tvrde kapsule
Pregabalin Sandoz GmbH 50 mg tvrde kapsule
Pregabalin Sandoz GmbH 75 mg tvrde kapsule
Pregabalin Sandoz GmbH 100 mg tvrde kapsule
Pregabalin Sandoz GmbH 150 mg tvrde kapsule
Pregabalin Sandoz GmbH 200 mg tvrde kapsule
Pregabalin Sandoz GmbH 225 mg tvrde kapsule
Pregabalin Sandoz GmbH 300 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Pregabalin Sandoz GmbH 25 mg tvrde kapsule
Jedna tvrda kapsula sadrži 25 mg pregabalina.
Pregabalin Sandoz GmbH 50 mg tvrde kapsule
Jedna tvrda kapsula sadrži 50 mg pregabalina.
Pregabalin Sandoz GmbH 75 mg tvrde kapsule
Jedna tvrda kapsula sadrži 75 mg pregabalina.
Pregabalin Sandoz GmbH 100 mg tvrde kapsule
Jedna tvrda kapsula sadrži 100 mg pregabalina.
Pregabalin Sandoz
GmbH 150 mg tvrde kapsule
Jedna tvrda kapsula sadrži 150 mg pregabalina.
Pregabalin Sandoz GmbH 200 mg tvrde kapsule
Jedna tvrda kapsula sadrži 200 mg pregabalina.
Pregabalin Sandoz GmbH 225 mg tvrde kapsule
Jedna tvrda kapsula sadrži 225 mg pregabalina.
Pregabalin Sandoz GmbH 300 mg tvrde kapsule
Jedna tvrda kapsula sadrži 300 mg pregabalina.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula
Pregabalin Sandoz GmbH 25 mg tvrde kapsule
Blijeda žutosmeđa neprozirna kapica i tijelo, kapsula veličine 4
(14,3 mm x 5,3 mm), ispunjena
bijelim do gotovo bijelim praškom.
Pregabalin Sandoz GmbH 50 mg tvrde kapsule
Svijetložuta neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm
x 5,8 mm), ispunjena bijelim do
gotovo bijelim praškom
Pregabalin Sandoz GmbH 75 mg tvrde kapsule
Crvena neprozirna kapica i bijelo neprozirno tijelo, kapsula veličine
4 (14,3 mm x 5,3 mm), ispunjena
bijelim do gotovo bijelim praškom.
Lijek koji više nije odobren
3
Pregabalin Sandoz GmbH 100 mg tvrde kapsule
Crvena neprozirna kapica i tijelo, kapsula veličine 3 (15,9 mm x 5,8
mm), ispunjena bijelim do gotovo
bijelim praškom.
Pregabalin Sandoz GmbH 15
                                
                                Read the complete document

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Active ingredient pregabalin

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ATC code N03AX16

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INN (International Name) pregabalin

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Patient Information leaflet Patient Information leaflet Bulgarian 12-10-2023
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