DONEPEZIL HYDROCHLORIDE TABLETS USP

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Disponível em:

DR REDDY'S LABORATORIES LTD

Código ATC:

N06DA02

DCI (Denominação Comum Internacional):

DONEPEZIL

Dosagem:

5MG

Forma farmacêutica:

TABLET

Composição:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Via de administração:

ORAL

Unidades em pacote:

7/14/30/90/500/1000/9000

Tipo de prescrição:

Prescription

Área terapêutica:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0131548001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2013-12-27

Características técnicas

1
PRODUCT MONOGRAPH
Pr
DONEPEZIL HYDROCHLORIDE TABLETS USP
5 mg and 10 mg
donepezil hydrochloride (as donepezil hydrochloride monohydrate)
CHOLINESTERASE INHIBITOR
Manufactured by:
DR. REDDY’S LABORATORIES LTD.,
Bachupally – 500 090
India
Imported and Distributed by:
Date of Revision:
DR. REDDY’S LABORATORIES CANADA INC.,
October 31, 2022
Mississauga, ON L4W 4Y1
Canada
Submission
Control Number: 264379
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
3
ADVERSE REACTIONS
........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................15
DOSAGE AND ADMINISTRATION
....................................................................................17
OVERDOSAGE.....................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
...............................................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................21
PART II: SCIENTIFIC INFORMATION
...........................................................................22
PHARMACEUTICAL INFORMATION
................................................................................22
CLINICAL
TRIALS..........