Pregabalin Sandoz GmbH

Country: European Union

Language: Italian

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:

Antiepilettici,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Sandoz GmbH è indicato come terapia aggiuntiva negli adulti con crisi parziali con o senza secondaria generalizzazione. D'Ansia generalizzata DisorderPregabalin Sandoz GmbH è indicato per il trattamento del Disturbo d'Ansia Generalizzato (GAD) negli adulti.

Product summary:

Revision: 16

Authorization status:

Ritirato

Authorization date:

2015-06-19

Patient Information leaflet

                                71
B. FOGLIO ILLUSTRATIVO
Medicinale non più autorizzato
72
FOGLIO ILLUSTRATIVO: INFORMAZIONI PER L’UTILIZZATORE
PREGABALIN SANDOZ GMBH 25 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 50 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 75 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 100 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 150 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 200 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 225 MG CAPSULE RIGIDE
PREGABALIN SANDOZ GMBH 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 Sandoz GmbH e a cosa serve
2.
Cosa deve sapere prima di prendere Pregabalin Sandoz GmbH
3.
Come prendere Pregabalin Sandoz GmbH
4.
Possibili effetti indesiderati
5.
Come conservare Pregabalin Sandoz GmbH
6.
Contenuto della confezione e altre informazioni
1.
COS'È PREGABALIN SANDOZ GMBH E A COSA SERVE
Pregabalin Sandoz GmbH appartiene ad una gruppo di medicinali
utilizzati per trattare l’epilessia e il
Disturbo d’Ansia Generalizzata (GAD) negli adulti.
EPILESSIA:
Pregabalin Sandoz GmbH viene utilizzato per trattare alcune forme di
epilessia negli adulti
(attacchi epilettici parziali con o senza generalizzazione
secondaria). Il medico le prescriverà
Pregabalin Sandoz GmbH per aiutarla nel trattamento dell’epilessia
quando il trattamento già in corso
non controlla la situazione. Dovrà assumere Pregabalin Sandoz GmbH in
aggiunta al trattamento cui è
già sottoposto. Pregabalin Sandoz GmbH non viene utilizza
                                
                                Read the complete document

Summary of Product characteristics

                                1
ALLEGATO I
RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO
Medicinale non più autorizzato
2
1.
DENOMINAZIONE DEL MEDICINALE
Pregabalin Sandoz GmbH 25 mg capsule rigide
Pregabalin Sandoz GmbH 50 mg capsule rigide
Pregabalin Sandoz GmbH 75 mg capsule rigide
Pregabalin Sandoz GmbH 100 mg capsule rigide
Pregabalin Sandoz GmbH 150 mg capsule rigide
Pregabalin Sandoz GmbH 200 mg capsule rigide
Pregabalin Sandoz GmbH 225 mg capsule rigide
Pregabalin Sandoz GmbH 300 mg capsule rigide
2.
COMPOSIZIONE QUALITATIVA E QUANTITATIVA
Pregabalin Sandoz GmbH 25 mg capsule rigide
Ogni capsula rigida contiene 25 mg di pregabalin.
Pregabalin Sandoz GmbH 50 mg capsule rigide
Ogni capsula rigida contiene 50 mg di pregabalin.
Pregabalin Sandoz GmbH 75 mg capsule rigide
Ogni capsula rigida contiene 75 mg di pregabalin.
Pregabalin Sandoz GmbH 100 mg capsule rigide
Ogni capsula rigida contiene 100 mg di pregabalin.
Pregabalin Sandoz GmbH 150 mg capsule rigide
Ogni capsula rigida contiene 150 mg di pregabalin.
Pregabalin Sandoz GmbH 200 mg capsule rigide
Ogni capsula rigida contiene 200 mg di pregabalin.
Pregabalin Sandoz GmbH 225 mg capsule rigide
Ogni capsula rigida contiene 225 mg di pregabalin.
Pregabalin Sandoz GmbH 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.
Pregabalin Sandoz GmbH 25 mg capsule rigide
Cappuccio e corpo opachi di colore giallo-bruno chiaro, capsula misura
4 (14,3 mm x 5,3 mm),
contenente una polvere da bianca a biancastra.
Pregabalin Sandoz GmbH 50 mg capsule rigide
Cappuccio e corpo opachi di colore giallo chiaro, capsula misura 3
(15,9 mm x 5,8 mm), contenente
una polvere da bianca a biancastra.
Pregabalin Sandoz GmbH 75 mg capsule rigide
Cappuccio opaco di colore rosso e corpo opaco di colore bianco,
capsula misura 4 (14,3 mm x
5,3 mm), contenente una polvere da bianca a biancastra.
Medicinale non più autorizzato
3
Pregabalin Sandoz GmbH 100 mg capsule rigide
Cappuccio e corpo opachi di
                                
                                Read the complete document

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Patient Information leaflet Patient Information leaflet Bulgarian 12-10-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 12-10-2023
Public Assessment Report Public Assessment Report Bulgarian 12-10-2023
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