Pregabalin Mylan

Country: European Union

Language: Italian

Source: EMA (European Medicines Agency)

Buy It Now

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:

Antiepilettici,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Neuropatico painPregabalin Mylan è indicato per il trattamento della centrale e periferico dolore neuropatico in adulti. EpilepsyPregabalin Mylan è indicato come terapia aggiuntiva negli adulti con crisi parziali con o senza secondaria generalizzazione. D'Ansia generalizzata DisorderPregabalin Mylan è indicato per il trattamento del Disturbo d'Ansia Generalizzato (GAD) negli adulti.

Product summary:

Revision: 16

Authorization status:

autorizzato

Authorization date:

2015-06-24

Patient Information leaflet

                                66
B. FOGLIO ILLUSTRATIVO
67
FOGLIO ILLUSTRATIVO: INFORMAZIONI PER L'UTILIZZATORE
PREGABALIN MYLAN 25 MG CAPSULE RIGIDE
PREGABALIN MYLAN 50 MG CAPSULE RIGIDE
PREGABALIN MYLAN 75 MG CAPSULE RIGIDE
PREGABALIN MYLAN 100 MG CAPSULE RIGIDE
PREGABALIN MYLAN 150 MG CAPSULE RIGIDE
PREGABALIN MYLAN 200 MG CAPSULE RIGIDE
PREGABALIN MYLAN 225 MG CAPSULE RIGIDE
PREGABALIN MYLAN 300 MG CAPSULE RIGIDE
pregabalin
LEGGA ATTENTAMENTE QUESTO FOGLIO PRIMA DI PRENDERE QUESTO MEDICINALE
PERCHÉ CONTIENE
IMPORTANTI INFORMAZIONI PER LEI.
–
Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo.
–
Se ha qualsiasi dubbio, si rivolga al medico o al farmacista.
–
Questo medicinale è stato prescritto soltanto per lei. Non lo dia ad
altre persone, anche se i
sintomi della malattia sono uguali ai suoi, perché potrebbe essere
pericoloso.
–
Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non
elencati in questo foglio, si
rivolga al medico o al farmacista. Vedere paragrafo 4.
CONTENUTO DI QUESTO FOGLIO:
1.
Cos’è Pregabalin Mylan e a che cosa serve
2.
Cosa deve sapere prima di prendere Pregabalin Mylan
3.
Come prendere Pregabalin Mylan
4.
Possibili effetti indesiderati
5.
Come conservare Pregabalin Mylan
6.
Contenuto della confezione e altre informazioni
1.
COS’È PREGABALIN MYLAN E A CHE COSA SERVE
Pregabalin Mylan contiene la sostanza attiva pregabalin che appartiene
ad un gruppo di medicinali
utilizzati per trattare l'epilessia, il dolore neuropatico e il
Disturbo d'Ansia Generalizzata (Generalised
Anxiety Disorder, GAD) negli adulti.
DOLORE NEUROPATICO PERIFERICO E CENTRALE:
Pregabalin Mylan viene utilizzato per trattare il dolore
cronico causato da un danno del sistema nervoso. Diverse malattie
possono causare dolore neuropatico
periferico, come il diabete o l'herpes zoster. Le sensazioni di dolore
possono essere descritte come
calore, bruciore, pulsazioni, dolori pulsanti, dolori lancinanti,
dolori acuti, dolori crampiformi,
sofferenza, formicolio, intorpidimento, dolori pungenti. Il dolore
neur
                                
                                Read the complete document

Summary of Product characteristics

                                1
ALLEGATO I
RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO
2
1.
DENOMINAZIONE DEL MEDICINALE
Pregabalin Mylan 25 mg capsule rigide
Pregabalin Mylan 50 mg capsule rigide
Pregabalin Mylan 75 mg capsule rigide
Pregabalin Mylan 100 mg capsule rigide
Pregabalin Mylan 150 mg capsule rigide
Pregabalin Mylan 200 mg capsule rigide
Pregabalin Mylan 225 mg capsule rigide
Pregabalin Mylan 300 mg capsule rigide
2.
COMPOSIZIONE QUALITATIVA E QUANTITATIVA
Pregabalin Mylan 25 mg capsule rigide
Ogni capsula rigida contiene 25 mg di pregabalin.
Pregabalin Mylan 50 mg capsule rigide
Ogni capsula rigida contiene 50 mg di pregabalin
Pregabalin Mylan 75 mg capsule rigide
Ogni capsula rigida contiene 75 mg di pregabalin
Pregabalin Mylan 100 mg capsule rigide
Ogni capsula rigida contiene 100 mg di pregabalin.
Pregabalin Mylan 150 mg capsule rigide
Ogni capsula rigida contiene 150 mg di pregabalin
Pregabalin Mylan 200 mg capsule rigide
Ogni capsula rigida contiene 200 mg di pregabalin.
Pregabalin Mylan 225 mg capsule rigide
Ogni capsula rigida contiene 225 mg di pregabalin
Pregabalin Mylan 300 mg capsule rigide
Ogni capsula rigida contiene 300 mg di pregabalin
Per l’elenco completo degli eccipienti, vedere paragrafo 6.1.
3.
FORMA FARMACEUTICA
Capsula rigida.
3
Pregabalin Mylan 25 mg capsule rigide
Capsula di dimensioni No. 4, con guscio rigido di gelatina con
cappuccio opaco di colore pesca chiaro
e corpo opaco bianco, ripiena di polvere da bianca a biancastra. Sulla
capsula è stampato assialmente
in inchiostro nero, MYLAN
sopra a PB25 sul cappuccio e sul corpo.
Pregabalin Mylan 50 mg capsule rigide
Capsula di dimensioni No. 3, con guscio rigido di gelatina con
cappuccio opaco di colore pesca scuro
e corpo opaco bianco, ripiena di polvere da bianca a biancastra. Sulla
capsula è stampato assialmente
in inchiostro nero, MYLAN sopra a PB50 sul cappuccio e sul corpo.
Pregabalin Mylan 75 mg capsule rigide
Capsula di dimensioni No. 4, con guscio rigido di gelatina con
cappuccio opaco di colore pesca chiaro
e corpo opaco pesca chiaro, ripien
                                
                                Read the complete document

Similar products

Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

Marketed by Mylan Pharmaceuticals Limited

Mylan Pharmaceuticals Limited

INN (International Name) pregabalin

pregabalin

Documents in other languages

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
Patient Information leaflet Patient Information leaflet Spanish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2023
Public Assessment Report Public Assessment Report Spanish 19-07-2017
Patient Information leaflet Patient Information leaflet Czech 13-01-2023
Summary of Product characteristics Summary of Product characteristics Czech 13-01-2023
Public Assessment Report Public Assessment Report Czech 19-07-2017
Patient Information leaflet Patient Information leaflet Danish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Danish 13-01-2023
Public Assessment Report Public Assessment Report Danish 19-07-2017
Patient Information leaflet Patient Information leaflet German 13-01-2023
Summary of Product characteristics Summary of Product characteristics German 13-01-2023
Public Assessment Report Public Assessment Report German 19-07-2017
Patient Information leaflet Patient Information leaflet Estonian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Estonian 13-01-2023
Public Assessment Report Public Assessment Report Estonian 19-07-2017
Patient Information leaflet Patient Information leaflet Greek 13-01-2023
Summary of Product characteristics Summary of Product characteristics Greek 13-01-2023
Public Assessment Report Public Assessment Report Greek 19-07-2017
Patient Information leaflet Patient Information leaflet English 13-01-2023
Summary of Product characteristics Summary of Product characteristics English 13-01-2023
Public Assessment Report Public Assessment Report English 19-07-2017
Patient Information leaflet Patient Information leaflet French 13-01-2023
Summary of Product characteristics Summary of Product characteristics French 13-01-2023
Public Assessment Report Public Assessment Report French 19-07-2017
Patient Information leaflet Patient Information leaflet Latvian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Latvian 13-01-2023
Public Assessment Report Public Assessment Report Latvian 19-07-2017
Patient Information leaflet Patient Information leaflet Lithuanian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-01-2023
Public Assessment Report Public Assessment Report Lithuanian 19-07-2017
Patient Information leaflet Patient Information leaflet Hungarian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 13-01-2023
Public Assessment Report Public Assessment Report Hungarian 19-07-2017
Patient Information leaflet Patient Information leaflet Maltese 13-01-2023
Summary of Product characteristics Summary of Product characteristics Maltese 13-01-2023
Public Assessment Report Public Assessment Report Maltese 19-07-2017
Patient Information leaflet Patient Information leaflet Dutch 13-01-2023
Summary of Product characteristics Summary of Product characteristics Dutch 13-01-2023
Public Assessment Report Public Assessment Report Dutch 19-07-2017
Patient Information leaflet Patient Information leaflet Polish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Polish 13-01-2023
Public Assessment Report Public Assessment Report Polish 19-07-2017
Patient Information leaflet Patient Information leaflet Portuguese 13-01-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 13-01-2023
Public Assessment Report Public Assessment Report Portuguese 19-07-2017
Patient Information leaflet Patient Information leaflet Romanian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Romanian 13-01-2023
Public Assessment Report Public Assessment Report Romanian 19-07-2017
Patient Information leaflet Patient Information leaflet Slovak 13-01-2023
Summary of Product characteristics Summary of Product characteristics Slovak 13-01-2023
Public Assessment Report Public Assessment Report Slovak 19-07-2017
Patient Information leaflet Patient Information leaflet Slovenian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 13-01-2023
Public Assessment Report Public Assessment Report Slovenian 19-07-2017
Patient Information leaflet Patient Information leaflet Finnish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Finnish 13-01-2023
Public Assessment Report Public Assessment Report Finnish 19-07-2017
Patient Information leaflet Patient Information leaflet Swedish 13-01-2023
Summary of Product characteristics Summary of Product characteristics Swedish 13-01-2023
Public Assessment Report Public Assessment Report Swedish 19-07-2017
Patient Information leaflet Patient Information leaflet Norwegian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 13-01-2023
Patient Information leaflet Patient Information leaflet Icelandic 13-01-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 13-01-2023
Patient Information leaflet Patient Information leaflet Croatian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Croatian 13-01-2023
Public Assessment Report Public Assessment Report Croatian 19-07-2017

Search alerts related to this product

Alerts Pregabalin Mylan

Pregabalin Mylan

View documents history

Documents history Documents history

Pregabalin Mylan