APO-LOPERAMIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-07-2019
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Active ingredient:
LOPERAMIDE HYDROCHLORIDE
Available from:
APOTEX INC
ATC code:
A07DA03
INN (International Name):
LOPERAMIDE
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
LOPERAMIDE HYDROCHLORIDE 2MG
Administration route:
ORAL
Units in package:
100/500/UD 12/24/100/620
Prescription type:
OTC
Therapeutic area:
ANTIDIARRHEA AGENTS
Product summary:
Active ingredient group (AIG) number: 0111332001; AHFS:
Authorization status:
MARKETED
Authorization date:
1996-12-31
Summary of Product characteristics
Page 1 of 31
PRODUCT MONOGRAPH
APO-LOPERAMIDE
LOPERAMIDE HYDROCHLORIDE TABLETS USP
2 MG
ORAL ANTIDIARRHEAL AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JULY 11, 2019
TORONTO, ONTARIO
M9L 1T9
Control # 229317
Page 2 of 31
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
7
DRUG INTERACTIONS
..............................................................................................................
9
DOSAGE AND ADMINISTRATION
........................................................................................
10
OVERDOSAGE
..........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
12
STORAGE AND STABILITY
....................................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 13
PART II: SCIENTIFIC INFORMATION
......................................................................................
15
PHARMACEUTICAL INFORMATION
....................................................................................
15
CLINICAL TRI
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