Country: Canada
Language: English
Source: Health Canada
LOPERAMIDE HYDROCHLORIDE
TEVA CANADA LIMITED
A07DA03
LOPERAMIDE
2MG
TABLET
LOPERAMIDE HYDROCHLORIDE 2MG
ORAL
6/12/24/48/100/500
OTC
ANTIDIARRHEA AGENTS
Active ingredient group (AIG) number: 0111332001; AHFS:
CANCELLED POST MARKET
2019-06-21
1 PRODUCT MONOGRAPH DIARRHEA RELIEF (Loperamide Hydrochloride) 2 mg Tablets Oral antidiarrheal agent TEVA CANADA LIMITED 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 www.tevacanada.com Date of Revision: February 28, 2017 Control No. 202633 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 ........................ Read the complete document