Pregabalin Mylan

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2023
Public Assessment Report Public Assessment Report (PAR)
19-07-2017

Active ingredient:

pregabalin

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptici sredstva,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Нейропатическая painPregabalin Mylan u indiciran za liječenje periferne i Centralne neuropatske boli u odraslih. EpilepsyPregabalin Mylan u naznačeno kao dodatni terapija u odraslih s парциальными судорогами Sa ili bez sekundarne generalizacije. Postati generalizirani anksioznosti DisorderPregabalin Mylan u indiciran za liječenje generalizirani anksiozni poremećaj (GAP) kod odraslih.

Product summary:

Revision: 16

Authorization status:

odobren

Authorization date:

2015-06-24

Patient Information leaflet

                                61
B. UPUTA O LIJEKU
62
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
PREGABALIN MYLAN 25 MG TVRDE KAPSULE
PREGABALIN MYLAN 50 MG TVRDE KAPSULE
PREGABALIN MYLAN 75 MG TVRDE KAPSULE
PREGABALIN MYLAN 100 MG TVRDE KAPSULE
PREGABALIN MYLAN 150 MG TVRDE KAPSULE
PREGABALIN MYLAN 200 MG TVRDE KAPSULE
PREGABALIN MYLAN 225 MG TVRDE KAPSULE
PREGABALIN MYLAN 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 Mylan i za što se koristi
2.
Što morate znati prije nego počnete uzimati Pregabalin Mylan
3.
Kako uzimati Pregabalin Mylan
4.
Moguće nuspojave
5.
Kako čuvati Pregabalin Mylan
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PREGABALIN MYLAN I ZA ŠTO SE KORISTI
Pregabalin Mylan sadrži djelatnu tvar pregabalin koja spada u skupinu
lijekova koji se upotrebljavaju
za liječenje epilepsije, neuropatske boli i generaliziranog
anksioznog poremećaja (GAP) u odraslih
osoba.
PERIFERNA I CENTRALNA NEUROPATSKA BOL:
Pregabalin Mylan se koristi za liječenje dugotrajne boli
uzrokovane oštećenjem živaca. Perifernu neuropatsku bol mogu
uzrokovati različite bolesti, primjerice
šećerna bolest ili herpes zoster. Osjet bola može se opisati kao
vrućina, žarenje, pulsirajuća bol,
sijevajuća bol, probadanje, oštra bol, grčevi, stalna tupa bol,
trnci, utrnulost, bockanje. Periferna i
centralna neuropatska bol mogu biti povezane i s promjenama
raspoloženja, poremećajem spavanja te
umorom (iscrpljenošću), a mogu utjecati na tjelesno i s
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Pregabalin Mylan 25 mg tvrde kapsule
Pregabalin Mylan 50 mg tvrde kapsule
Pregabalin Mylan 75 mg tvrde kapsule
Pregabalin Mylan 100 mg tvrde kapsule
Pregabalin Mylan 150 mg tvrde kapsule
Pregabalin Mylan 200 mg tvrde kapsule
Pregabalin Mylan 225 mg tvrde kapsule
Pregabalin Mylan 300 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Pregabalin Mylan 25 mg tvrde kapsule
Jedna tvrda kapsula sadrži 25 mg pregabalina.
Pregabalin Mylan 50 mg tvrde kapsule
Jedna tvrda kapsula sadrži 50 mg pregabalina.
Pregabalin Mylan 75 mg tvrde kapsule
Jedna tvrda kapsula sadrži 75 mg pregabalina.
Pregabalin Mylan 100 mg tvrde kapsule
Jedna tvrda kapsula sadrži 100 mg pregabalina.
Pregabalin Mylan 150 mg tvrde kapsule
Jedna tvrda kapsula sadrži 150 mg pregabalina.
Pregabalin Mylan 200 mg tvrde kapsule
Jedna tvrda kapsula sadrži 200 mg pregabalina.
Pregabalin Mylan 225 mg tvrde kapsule
Jedna tvrda kapsula sadrži 225 mg pregabalina.
Pregabalin Mylan 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.
3
Pregabalin Mylan 25 mg tvrde kapsule
Tvrda želatinska kapsula, veličine br. 4, sa svjetlonarančastom
neprozirnom kapicom i bijelim
neprozirnim tijelom, napunjena bijelim do bjelkastim praškom. Na
kapsuli je poprečno otisnuto
MYLAN
iznad
PB25 crnom tintom na kapici i tijelu.
Pregabalin Mylan 50 mg tvrde kapsule
Tvrda želatinska kapsula, veličine br. 3, s tamnonarančastom
neprozirnom kapicom i bijelim
neprozirnim tijelom, napunjena bijelim do bjelkastim praškom. Na
kapsuli je poprečno otisnuto
MYLAN iznad PB50 crnom tintom na kapici i tijelu.
Pregabalin Mylan 75 mg tvrde kapsule
Tvrda želatinska kapsula, veličine br. 4, sa svjetlonarančastom
neprozirnom kapicom i
svjetlonarančastim neprozirnim tijelom, napunjena bijelim do
bjelkastim praškom. Na kapsuli je
poprečno otisnuto MYLAN iznad PB75 crnom tintom na kapici i tijelu.
Pregabalin Mylan 100 mg 
                                
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Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

Marketed by Mylan Pharmaceuticals Limited

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INN (International Name) pregabalin

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