Pregabalin Mylan Pharma

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
26-04-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
26-04-2022
Public Assessment Report Public Assessment Report (PAR)
26-04-2022

Active ingredient:

pregabalin

Available from:

Mylan S.A.S.

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptici sredstva,

Therapeutic area:

Anxiety Disorders; Neuralgia; Epilepsy

Therapeutic indications:

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

Product summary:

Revision: 7

Authorization status:

povučen

Authorization date:

2015-06-25

Patient Information leaflet

                                63
B. UPUTA O LIJEKU
Lijek koji više nije odobren
64
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
PREGABALIN MYLAN PHARMA 25 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 50 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 75 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 100 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 150 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 200 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 225 MG TVRDE KAPSULE
PREGABALIN MYLAN PHARMA 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 Pharma i za što se koristi
2.
Što morate znati prije nego počnete uzimati Pregabalin Mylan Pharma
3.
Kako uzimati Pregabalin Mylan Pharma
4.
Moguće nuspojave
5.
Kako čuvati Pregabalin Mylan Pharma
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PREGABALIN MYLAN PHARMA I ZA ŠTO SE KORISTI
Pregabalin Mylan Pharma sadrži djelatnu tvar pregabalin koja pripada
skupini lijekova koji se koriste
za liječenja epilepsije i generaliziranog anksioznog poremećaja
(GAP) u odraslih osoba.
EPILEPSIJA:
Pregabalin Mylan Pharma se koristi za liječenje nekih oblika
epilepsije (parcijalnih
napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
Liječnik će Vam propisati lijek
Pregabalin Mylan Pharma za liječenje epilepsije kada lijekovi koje
ste do sada uzimali bolest ne drže
pod kontrolom. Lijek Pregabalin Mylan Pharma morate uzimati kao
dodatak postojećim lijekovima.
Pregabalin Mylan Pharma nije namijenjen za samostalnu primjenu, nego
se u
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
Pregabalin Mylan Pharma 25 mg tvrde kapsule
Pregabalin Mylan Pharma 50 mg tvrde kapsule
Pregabalin Mylan Pharma 75 mg tvrde kapsule
Pregabalin Mylan Pharma 100 mg tvrde kapsule
Pregabalin Mylan Pharma 150 mg tvrde kapsule
Pregabalin Mylan Pharma 200 mg tvrde kapsule
Pregabalin Mylan Pharma 225 mg tvrde kapsule
Pregabalin Mylan Pharma 300 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Pregabalin Mylan Pharma 25 mg tvrde kapsule
Jedna tvrda kapsula sadrži 25 mg pregabalina.
Pregabalin Mylan Pharma 50 mg tvrde kapsule
Jedna tvrda kapsula sadrži 50 mg pregabalina.
Pregabalin Mylan Pharma 75 mg tvrde kapsule
Jedna tvrda kapsula sadrži 75 mg pregabalina.
Pregabalin Mylan Pharma 100 mg tvrde kapsule
Jedna tvrda kapsula sadrži 100 mg pregabalina.
Pregabalin Mylan Pharma 150 mg tvrde kapsule
Jedna tvrda kapsula sadrži 150 mg pregabalina.
Pregabalin Mylan Pharma 200 mg tvrde kapsule
Jedna tvrda kapsula sadrži 200 mg pregabalina.
Pregabalin Mylan Pharma 225 mg tvrde kapsule
Jedna tvrda kapsula sadrži 225 mg pregabalina.
Pregabalin Mylan Pharma 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 Mylan Pharma 25 mg tvrde kapsule
Lijek koji više nije odobren
3
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 Pharma 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 Pharma 75 mg tvrde kapsule
Tvrda želatinska kapsula, veličine br. 4 sa svjetlonarančastom
neprozirnom kapicom i
                                
                                Read the complete document

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Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

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INN (International Name) pregabalin

pregabalin

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Patient Information leaflet Patient Information leaflet Bulgarian 26-04-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 26-04-2022
Public Assessment Report Public Assessment Report Bulgarian 26-04-2022
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Public Assessment Report Public Assessment Report Spanish 26-04-2022
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