Rivastigmine 3M Health Care Ltd

Country: European Union

Language: Spanish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
18-09-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
18-09-2014
Public Assessment Report Public Assessment Report (PAR)
18-09-2014

Active ingredient:

rivastigmina

Available from:

3M Health Care Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics, , Anticolinesterásicos

Therapeutic area:

Enfermedad de Alzheimer

Therapeutic indications:

Tratamiento sintomático de la demencia de Alzheimer de leve a moderadamente grave.

Product summary:

Revision: 1

Authorization status:

Retirado

Authorization date:

2014-04-03

Patient Information leaflet

                                41
B. PROSPECTO
Medicamento con autorización anulada
42
PROSPECTO: INFORMACIÓN PARA EL USUARIO
RIVASTIGMINA 3M HEALTH CARE LTD. 4,6 MG/24 H PARCHE TRANSDÉRMICO EFG
RIVASTIGMINA 3M HEALTH CARE LTD. 9,5 MG/24 H PARCHE TRANSDÉRMICO EFG
rivastigmina
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, farmacéutico o
enfermero.
-
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, farmacéutico
o enfermero, incluso si se
trata de efectos adversos que no aparecen en este prospecto. Ver
sección 4.
CONTENIDO DEL PROSPECTO
:
1.
Qué es Rivastigmina 3M Health Care Ltd. y para qué se utiliza
2.
Qué necesita saber antes de empezar a usar Rivastigmina 3M Health
Care Ltd.
3.
Cómo usar Rivastigmina 3M Health Care Ltd.
4.
Posibles efectos adversos
5
Conservación de Rivastigmina 3M Health Care Ltd.
6.
Contenido del envase e información adicional
1.
QUÉ ES RIVASTIGMINA 3M HEALTH CARE LTD. Y PARA QUÉ SE UTILIZA
El principio activo de Rivastigmina 3M Health Care Ltd. es
rivastigmina.
La rivastigmina pertenece al grupo de sustancias denominadas
inhibidores de la colinesterasa. En
pacientes con demencia de Alzheimer, determinadas células nerviosas
mueren en el cerebro,
provocando bajos niveles del neurotransmisor acetilcolina (una
substancia que permite que las células
nerviosas se comuniquen entre ellas). La rivastigmina actúa
bloqueando las enzimas que rompen la
acetilcolina: acetilcolinesterasa y butirilcolinesterasa. Bloqueando
estas enzimas, Rivastigmina 3M
Health Care Ltd. permite el aumento de acetilcolina en el cerebro,
ayudando a reducir los síntomas de
la enfermedad de Alzheimer.
Rivastigmina 3M Health Care Ltd. se utiliza para el tratamiento de
pacient
                                
                                Read the complete document

Summary of Product characteristics

                                ANEXO I
FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
Medicamento con autorización anulada
2
1.
NOMBRE DEL MEDICAMENTO
Rivastigmina 3M Health Care Ltd. 4,6 mg/24 h parche transdérmico EFG
2.
COMPOSICIÓN CUALITATIVA Y CUANTITATIVA
Cada parche transdérmico libera 4,6 mg de rivastigmina en 24 horas.
Cada parche transdérmico de
4,15 cm
2
contiene 7,17 mg de rivastigmina.
Para consultar la lista completa de excipientes, ver sección 6.1.
3.
FORMA FARMACÉUTICA
Parche transdérmico.
Parches rectangulares, de aproximadamente 2,5 cm por 1,8 cm, con las
esquinas redondeadas. Cada
parche se compone de una combinación de una lámina protectora
formada por dos hojas, transparente
y extraíble, una capa funcional con una matriz que contiene el
fármaco y el adhesivo y una capa
externa protectora. La capa externa es de transparente a translúcida
y está marcada con “R5” como
patrón repetido.
4.
DATOS CLÍNICOS
4.1
INDICACIONES TERAPÉUTICAS
Tratamiento sintomático de la demencia de Alzheimer leve a
moderadamente grave.
4.2
POSOLOGÍA Y FORMA DE ADMINISTRACIÓN
El tratamiento debe ser iniciado y estar supervisado por un médico
experimentado en el diagnóstico y
tratamiento de la demencia de Alzheimer. El diagnóstico debe basarse
en las directrices actuales.
Como con cualquier tratamiento en pacientes con demencia, sólo debe
iniciarse el tratamiento con
rivastigmina si se dispone de un cuidador que regularmente administre
y controle el tratamiento.
Posología
PARCHES TRANSDÉRMICOS
TASA DE LIBERACIÓN _IN VIVO_ DE
RIVASTIGMINA EN 24 H
Rivastigmina 3M Health Care Ltd.
4,6 mg/24 h
4,6 mg
Rivastigmina 3M Health Care Ltd.
9,5 mg/24 h
9,5 mg
Rivastigmina 3M Health Care Ltd.
13,3 mg/24 h
13,3 mg
Actualmente no se dispone de autorización de comercialización para
Rivastigmina 3M Health Care Ltd.
13,3 mg/24 h parches transdérmicos, aunque otros Laboratorios
Titulares pueden tener esta presentación.
Dosis inicial
Se inicia el tratamiento con 4,6 mg/24 h.
Dosis de mantenimiento
Tras un mínimo de cuatro 
                                
                                Read the complete document

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Patient Information leaflet Patient Information leaflet Bulgarian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 18-09-2014
Public Assessment Report Public Assessment Report Bulgarian 18-09-2014
Patient Information leaflet Patient Information leaflet Czech 18-09-2014
Summary of Product characteristics Summary of Product characteristics Czech 18-09-2014
Public Assessment Report Public Assessment Report Czech 18-09-2014
Patient Information leaflet Patient Information leaflet Danish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Danish 18-09-2014
Public Assessment Report Public Assessment Report Danish 18-09-2014
Patient Information leaflet Patient Information leaflet German 18-09-2014
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Public Assessment Report Public Assessment Report German 18-09-2014
Patient Information leaflet Patient Information leaflet Estonian 18-09-2014
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Public Assessment Report Public Assessment Report Estonian 18-09-2014
Patient Information leaflet Patient Information leaflet Greek 18-09-2014
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Public Assessment Report Public Assessment Report Greek 18-09-2014
Patient Information leaflet Patient Information leaflet English 18-09-2014
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Public Assessment Report Public Assessment Report English 18-09-2014
Patient Information leaflet Patient Information leaflet French 18-09-2014
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Public Assessment Report Public Assessment Report French 18-09-2014
Patient Information leaflet Patient Information leaflet Italian 18-09-2014
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Public Assessment Report Public Assessment Report Italian 18-09-2014
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Public Assessment Report Public Assessment Report Hungarian 18-09-2014
Patient Information leaflet Patient Information leaflet Maltese 18-09-2014
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Patient Information leaflet Patient Information leaflet Dutch 18-09-2014
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Patient Information leaflet Patient Information leaflet Polish 18-09-2014
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Public Assessment Report Public Assessment Report Portuguese 18-09-2014
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Summary of Product characteristics Summary of Product characteristics Romanian 18-09-2014
Public Assessment Report Public Assessment Report Romanian 18-09-2014
Patient Information leaflet Patient Information leaflet Slovak 18-09-2014
Summary of Product characteristics Summary of Product characteristics Slovak 18-09-2014
Public Assessment Report Public Assessment Report Slovak 18-09-2014
Patient Information leaflet Patient Information leaflet Slovenian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 18-09-2014
Public Assessment Report Public Assessment Report Slovenian 18-09-2014
Patient Information leaflet Patient Information leaflet Finnish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Finnish 18-09-2014
Public Assessment Report Public Assessment Report Finnish 18-09-2014
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Patient Information leaflet Patient Information leaflet Croatian 18-09-2014
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Public Assessment Report Public Assessment Report Croatian 18-09-2014

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