SANDOZ METOPROLOL SR TABLET (EXTENDED-RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

METOPROLOL TARTRATE

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

C07AB02

INN (Internationale Bezeichnung):

METOPROLOL

Dosierung:

100MG

Darreichungsform:

TABLET (EXTENDED-RELEASE)

Zusammensetzung:

METOPROLOL TARTRATE 100MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

BETA-ADRENERGIC BLOCKING AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0111923003; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2021-01-04

Fachinformation

_Sandoz Metoprolol (Type L) and Sandoz Metoprolol SR _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ METOPROLOL (TYPE L)
PR
SANDOZ METOPROLOL SR
Metoprolol tartrate
50 and 100 mg tablets
100 mg and 200 mg slow-release tablets
β-Adrenergic Receptor Blocking Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Revision:
November 20, 2020
Submission Control No: 240568
_Sandoz Metoprolol (Type L) and Sandoz Metoprolol SR _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
26
TOXI