ZANTAC TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Disponibil de la:

SANOFI CONSUMER HEALTH INC

Codul ATC:

A02BA02

INN (nume internaţional):

RANITIDINE

Dozare:

75MG

Forma farmaceutică:

TABLET

Compoziție:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG

Calea de administrare:

ORAL

Unități în pachet:

2/4/10/30/60/124

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

HISTAMINE H2-ANTAGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2022-02-18

Caracteristicilor produsului

_ _
_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
.........