Pregabalin Mylan

Country: European Union

Language: Slovak

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:

pregabalín

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptiká,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Neuropatickej painPregabalin Mylan je indikovaný na liečbu periférneho a centrálneho neuropatickej bolesti u dospelých. EpilepsyPregabalin Mylan je označené ako adjunctive terapia u dospelých pacientov s parciálne záchvaty s alebo bez sekundárnej zovšeobecnenie. Všeobecný Úzkosť DisorderPregabalin Mylan je indikovaný na liečbu Všeobecných Úzkostnej Poruchy (GAD) v dospelí.

Product summary:

Revision: 16

Authorization status:

oprávnený

Authorization date:

2015-06-24

Patient Information leaflet

                                59
B. PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
60
PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
PREGABALIN MYLAN 25 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 50 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 75 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 100 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 150 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 200 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 225 MG TVRDÉ KAPSULY
PREGABALIN MYLAN 300 MG TVRDÉ KAPSULY
pregabalín
POZORNE SI PREČÍTAJTE CELÚ PÍSOMNÚ INFORMÁCIU PREDTÝM, AKO
ZAČNETE UŽÍVAŤ TENTO LIEK, PRETOŽE
OBSAHUJE PRE VÁS DÔLEŽITÉ INFORMÁCIE.
-
Túto písomnú informáciu si uschovajte. Možno bude potrebné, aby
ste si ju znova prečítali.
-
Ak máte akékoľvek ďalšie otázky, obráťte sa na svojho lekára
alebo lekárnika.
-
Tento liek bol predpísaný iba vám. Nedávajte ho nikomu inému.
Môže mu uškodiť, dokonca aj
vtedy, ak má rovnaké prejavy ochorenia ako vy.
-
Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa
na svojho lekára alebo lekárnika.
To sa týka aj akýchkoľvek vedľajších účinkov, ktoré nie sú
uvedené v tejto písomnej informácii.
Pozri časť 4.
V TEJTO PÍSOMNEJ INFORMÁCII SA DOZVIETE:
1.
Čo je Pregabalin Mylan a na čo sa používa
2.
Čo potrebujete vedieť predtým, ako užijete Pregabalin Mylan
3.
Ako užívať Pregabalin Mylan
4.
Možné vedľajšie účinky
5.
Ako uchovávať Pregabalin Mylan
6.
Obsah balenia a ďalšie informácie
1.
ČO JE PREGABALIN MYLAN A NA ČO SA POUŽÍVA
Pregabalin Mylan obsahuje liečivo pregabalín, ktoré patrí do
skupiny liekov používaných na liečbu
epilepsie, neuropatickej bolesti a generalizovanej úzkostnej poruchy
(GAD = Generalised Anxiety
Disorder) u dospelých pacientov.
PERIFÉRNA A CENTRÁLNA NEUROPATICKÁ BOLESŤ:
Pregabalin Mylan sa používa na liečbu dlhotrvajúcej
bolesti vyvolanej poškodením nervov. Rôzne ochorenia, ako sú
cukrovka alebo pásový opar, môžu
byť príčinou periférnej neuropatickej bolesti. Pocity bolesti
môžu byť popísané ako teplo, pálenie,
pulzovanie, 
                                
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Summary of Product characteristics

                                1
PRÍLOHA I
SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
2
1.
NÁZOV LIEKU
Pregabalin Mylan 25 mg tvrdé kapsuly
Pregabalin Mylan 50 mg tvrdé kapsuly
Pregabalin Mylan 75 mg tvrdé kapsuly
Pregabalin Mylan 100 mg tvrdé kapsuly
Pregabalin Mylan 150 mg tvrdé kapsuly
Pregabalin Mylan 200 mg tvrdé kapsuly
Pregabalin Mylan 225 mg tvrdé kapsuly
Pregabalin Mylan 300 mg tvrdé kapsuly
2.
KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE
Pregabalin Mylan 25 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 25 mg pregabalínu.
Pregabalin Mylan 50 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 50 mg pregabalínu.
Pregabalin Mylan 75 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 75 mg pregabalínu.
Pregabalin Mylan 100 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 100 mg pregabalínu.
Pregabalin Mylan 150 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 150 mg pregabalínu.
Pregabalin Mylan 200 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 200 mg pregabalínu.
Pregabalin Mylan 225 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 225 mg pregabalínu.
Pregabalin Mylan 300 mg tvrdé kapsuly
Jedna tvrdá kapsula obsahuje 300 mg pregabalínu.
Úplný zoznam pomocných látok, pozri časť 6.1.
3.
LIEKOVÁ FORMA
Tvrdá kapsula
3
Pregabalin Mylan 25 mg tvrdé kapsuly
Nepriesvitné želatínové kapsuly veľkosti 4 s tvrdým obalom, s
bielym telom a viečkom
svetlobroskyňovej farby, obsahujúce biely až takmer biely prášok.
Na viečku a tele kapsuly je pozdĺž
jej osi čiernym atramentom vytlačený nápis MYLAN a pod ním
označenie PB25.
Pregabalin Mylan 50 mg tvrdé kapsuly
Nepriesvitné želatínové kapsuly veľkosti 3 s tvrdým obalom, s
bielym telom a viečkom
tmavobroskyňovej farby, obsahujúce biely až takmer biely prášok.
Na viečku a tele kapsuly je pozdĺž
jej osi čiernym atramentom vytlačený nápis MYLAN a pod ním
označenie PB50.
Pregabalin Mylan 75 mg tvrdé kapsuly
Nepriesvitné želatínové kapsuly veľkosti 4 s tvrdým obalom, s
telom a viečkom svetlobroskyňovej
farby, obsahujúce biely až takmer b
                                
                                Read the complete document

Similar products

Active ingredient pregabalín

pregabalín

ATC code N03AX16

N03AX16

Marketed by Mylan Pharmaceuticals Limited

Mylan Pharmaceuticals Limited

INN (International Name) pregabalin

pregabalin

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Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2023
Public Assessment Report Public Assessment Report Bulgarian 19-07-2017
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Public Assessment Report Public Assessment Report Czech 19-07-2017
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Public Assessment Report Public Assessment Report German 19-07-2017
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