MYLAN-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-02-2018
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Active ingredient:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
A02BC05
INN (International Name):
ESOMEPRAZOLE
Dosage:
20MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0145162001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-06-16
Summary of Product characteristics
Page 1 of 58
PRODUCT MONOGRAPH
PR
MYLAN-ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
20 mg and 40 mg esomeprazole (as esomeprazole magnesium trihydrate)
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario Canada
M8Z 2S6
Control Number: 212758
Date of Revision: February 9, 2018
Page 2 of 58
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
....................................................................................................
9
DRUG
INTERACTIONS
..................................................................................................
17
DOSAGE
AND
ADMINISTRATION
................................................................................
20
OVERDOSAGE
..................................................................................................................
23
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................... 24
STORAGE
AND
STABILITY
..........................................................................................
28
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ................................................ 28
PART II: SCIENTIFIC INFORMATION .......................................................................
30
PHARMACEUTICAL
INFORMATION
.........................................................................
30
DETAILED
PHARMACOLOGY
.......................................................................................
38
TOXICOLOGY
.............................................
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