APO-LOPERAMIDE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
11-07-2019
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Werkstoffen:
LOPERAMIDE HYDROCHLORIDE
Beschikbaar vanaf:
APOTEX INC
ATC-code:
A07DA03
INN (Algemene Internationale Benaming):
LOPERAMIDE
Dosering:
2MG
farmaceutische vorm:
TABLET
Samenstelling:
LOPERAMIDE HYDROCHLORIDE 2MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500/UD 12/24/100/620
Prescription-type:
OTC
Therapeutisch gebied:
ANTIDIARRHEA AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0111332001; AHFS:
Autorisatie-status:
MARKETED
Autorisatie datum:
1996-12-31
Productkenmerken
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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