ACID REDUCER TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-02-2019
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Active ingredient:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Available from:
LABORATOIRE RIVA INC.
ATC code:
A02BA02
INN (International Name):
RANITIDINE
Dosage:
75MG
Pharmaceutical form:
TABLET
Composition:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG
Administration route:
ORAL
Units in package:
6/10/12/20/24/30/36/40/42/50/54/60
Prescription type:
OTC
Therapeutic area:
HISTAMINE H2-ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0115150003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-05-17
Summary of Product characteristics
_ACID REDUCER - Product Monograph _
_Page 1 of 31 _
PRODUCT MONOGRAPH
ACID REDUCER
Ranitidine Tablets, USP
(As Ranitidine Hydrochloride)
75 mg
HISTAMINE H
2
-RECEPTOR ANTAGONIST
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
Submission Control No.: 223956
Date of revision:
February 11, 2019
_ACID REDUCER - Product Monograph _
_Page 2 of 31 _
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
...................................................................................................
5
DRUG INTERACTIONS
....................................................................................................
7
DOSAGE AND ADMINISTRATION
..............................................................................
10
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
................................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
...........................................................................................
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