TEVA-LOPERAMIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-11-2020
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Active ingredient:
LOPERAMIDE HYDROCHLORIDE
Available from:
TEVA CANADA LIMITED
ATC code:
A07DA03
INN (International Name):
LOPERAMIDE
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
LOPERAMIDE HYDROCHLORIDE 2MG
Administration route:
ORAL
Units in package:
12/100/500
Prescription type:
OTC
Therapeutic area:
ANTIDIARRHEA AGENTS
Product summary:
Active ingredient group (AIG) number: 0111332001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-09-17
Summary of Product characteristics
1
PRODUCT MONOGRAPH
TEVA-LOPERAMIDE
Loperamide Hydrochloride Tablets, 2 mg
USP
Oral antidiarrheal agent
TEVA CANADA LIMITED
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date of Revision:
November 23, 2020
Control No. 240985
2
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
...................................................................................................
6
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 TRIALS
.........................................................................................................
16
DETAILED PHARMACOLOGY
.....................
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