Pregabalin Mylan

Country: European Union

Language: Spanish

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:

pregabalina

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Los antiepilépticos,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Neuropático painPregabalin Mylan está indicado para el tratamiento de la central y periférico dolor neuropático en adultos. EpilepsyPregabalin Mylan está indicado como terapia adyuvante en pacientes adultos con crisis parciales con o sin generalización secundaria. De Ansiedad generalizada DisorderPregabalin Mylan está indicado para el tratamiento del Trastorno de Ansiedad Generalizada (TAG) en adultos.

Product summary:

Revision: 16

Authorization status:

Autorizado

Authorization date:

2015-06-24

Patient Information leaflet

                                66
B. PROSPECTO
67
PROSPECTO: INFORMACIÓN PARA EL USUARIO
PREGABALINA MYLAN 25 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 50 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 75 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 100 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 150 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 200 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 225 MG CÁPSULAS DURAS EFG
PREGABALINA MYLAN 300 MG CÁPSULAS DURA EFG
pregabalina
LEA TODO EL PROSPECTO DETENIDAMENTE ANTES DE EMPEZAR A TOMAR ESTE
MEDICAMENTO, PORQUE
CONTIENE INFORMACIÓN IMPORTANTE PARA USTED.
–
Conserve este prospecto, ya que puede tener que volver a leerlo.
–
Si tiene alguna duda, consulte a su médico o farmacéutico.
–
Este medicamento se le ha recetado solamente a usted y no debe
dárselo a otras personas,
aunque tengan los mismos síntomas que usted, ya que puede
perjudicarles.
–
Si experimenta efectos adversos, consulte a su médico o
farmacéutico, incluso si se trata de
efectos adversos que no aparecen en este prospecto. Ver sección 4.
CONTENIDO DEL PROSPECTO
1.
Qué es Pregabalina Mylan y para qué se utiliza
2.
Qué necesita saber antes de empezar a tomar Pregabalina Mylan
3.
Cómo tomar Pregabalina Mylan
4.
Posibles efectos adversos
5.
Conservación de Pregabalina Mylan
6.
Contenido del envase e información adicional
1.
QUÉ ES PREGABALINA MYLAN Y PARA QUÉ SE UTILIZA
Pregabalina Mylan contiene el principio activo pregabalina, que
pertenece a un grupo de
medicamentos que se utilizan para el tratamiento de la epilepsia, del
dolor neuropático y del trastorno
de ansiedad generalizada (TAG) en adultos.
DOLOR NEUROPÁTICO PERIFÉRICO Y CENTRAL:
Pregabalina Mylan se utiliza para el tratamiento del dolor
crónico causado por daños en los nervios. Hay diversas enfermedades
que pueden causar dolor
neuropático periférico, como la diabetes o el herpes. La sensación
de dolor se podría describir como
calor, quemazón, dolor pulsátil, dolor fulgurante, dolor punzante,
dolor agudo, espasmos, dolor
continuo, hormigueo, entumecimiento y sensac
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANEXO I
FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
2
1.
NOMBRE DEL MEDICAMENTO
Pregabalina Mylan 25 mg cápsulas duras EFG
Pregabalina Mylan 50 mg cápsulas duras EFG
Pregabalina Mylan 75 mg cápsulas duras EFG
Pregabalina Mylan 100 mg cápsulas duras EFG
Pregabalina Mylan 150 mg cápsulas duras EFG
Pregabalina Mylan 200 mg cápsulas duras EFG
Pregabalina Mylan 225 mg cápsulas duras EFG
Pregabalina Mylan 300 mg cápsulas duras EFG
2.
COMPOSICIÓN CUALITATIVA Y CUANTITATIVA
Pregabalina Mylan 25 mg cápsulas duras
Cada cápsula dura contiene 25 mg de pregabalina.
Pregabalina Mylan 50 mg cápsulas duras
Cada cápsula dura contiene 50 mg de pregabalina.
Pregabalina Mylan 75 mg cápsulas duras
Cada cápsula dura contiene 75 mg de pregabalina.
Pregabalina Mylan 100 mg cápsulas duras
Cada cápsula dura contiene 100 mg de pregabalina.
Pregabalina Mylan 150 mg cápsulas duras
Cada cápsula dura contiene 150 mg de pregabalina.
Pregabalina Mylan 200 mg cápsulas duras
Cada cápsula dura contiene 200 mg de pregabalina.
Pregabalina Mylan 225 mg cápsulas duras
Cada cápsula dura contiene 225 mg de pregabalina.
Pregabalina Mylan 300 mg cápsulas duras
Cada cápsula dura contiene 300 mg de pregabalina.
Para consultar la lista completa de excipientes, ver sección 6.1.
3.
FORMA FARMACÉUTICA
Cápsula dura.
Pregabalina Mylan 25 mg cápsulas duras
Cápsula de gelatina dura rellena de polvo blanco o blanquecino con un
cuerpo opaco de color blanco y
una tapa opaca de color melocotón claro del n.º 4. La cápsula está
impresa axialmente con MYLAN
sobre PB25 en tinta negra en la tapa y en el cuerpo
3
Pregabalina Mylan 50 mg cápsulas duras
Cápsula de gelatina dura rellena de polvo blanco o blanquecino con un
cuerpo opaco de color blanco y
una tapa opaca de color melocotón oscuro del n.º 3. La cápsula
está impresa axialmente con MYLAN
sobre PB50
en tinta negra en la tapa y en el cuerpo.
Pregabalina Mylan 75 mg cápsulas duras
Cápsula de gelatina dura rellena de polvo blanco o blanquecino con un
cuerpo opa
                                
                                Read the complete document

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Active ingredient pregabalina

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ATC code N03AX16

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INN (International Name) pregabalin

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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 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 Italian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Italian 13-01-2023
Public Assessment Report Public Assessment Report Italian 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
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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

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