APO-DONEPEZIL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE)

Verfügbar ab:

APOTEX INC

ATC-Code:

N06DA02

INN (Internationale Bezeichnung):

DONEPEZIL

Dosierung:

5MG

Darreichungsform:

TABLET

Zusammensetzung:

DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100/500

Verschreibungstyp:

Prescription

Therapiebereich:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2013-12-24

Fachinformation

_APO-DONEPEZIL Tablets Product Monograph_
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
APO-DONEPEZIL
Donepezil Hydrochloride Tablets
Tablets, 5 mg and 10 mg
(as donepezil hydrochloride monohydrate)
USP
Cholinesterase Inhibitor
APOTEX INC.
Date of Revision:
150 Signet Drive
January 17, 2023
Weston, Ontario
M9L 1T9
Submission Control No.: 266376
_APO-DONEPEZIL Tablets Product Monograph_
_Page 2 of 46_
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
..............................................................................
16
OVERDOSAGE
..............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 18
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 20
PART II: SCIENTIFIC INFORMATION
........................................................................
21
PHARMACEUTICAL INFORMATION
..........................................................................
21
CLINICAL TRIALS
................................................................................................