ZANTAC TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Tersedia dari:

SANOFI CONSUMER HEALTH INC

Kode ATC:

A02BA02

INN (Nama Internasional):

RANITIDINE

Dosis:

75MG

Bentuk farmasi:

TABLET

Komposisi:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG

Rute administrasi :

ORAL

Unit dalam paket:

2/4/10/30/60/124

Jenis Resep:

OTC

Area terapi:

HISTAMINE H2-ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0115150003; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2022-02-18

Karakteristik produk

_ _
_ZANTAC_
_®_
_ and ZANTAC_
_®_
_ Maximum Strength Non-Prescription Tablets _
_Page 1 of 35_
PRODUCT MONOGRAPH
ZANTAC
®
Ranitidine Tablets USP 75 mg (as ranitidine hydrochloride)
ZANTAC
® MAXIMUM STRENGTH NON-PRESCRIPTION
Ranitidine Tablets USP 150 mg (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
Sanofi Consumer Health Inc.
2905 Place Louis-R. Renaud
Laval, QC, Canada H7V 0A3
Date of Revision:
December 5, 2019
Submission Control No: 231962
_ _
_ZANTAC_
_®_
_ and ZANTAC_
_®_
_ Maximum Strength Non-Prescription Tablets _
_Page 2 of 35 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
.........