ACT PANTOPRAZOLE TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-02-2018
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Active ingredient:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
A02BC02
INN (International Name):
PANTOPRAZOLE
Dosage:
40MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0133229001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-09
Summary of Product characteristics
_ACT Pantoprazole _
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PRODUCT MONOGRAPH
Pr
ACT PANTOPRAZOLE
Pantoprazole Delayed-Release tablets
40 mg Pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Actavis Pharma Company
Date of Revision:
6733 Mississauga Road, Suite 400 February 8, 2018
Mississauga, Ontario
L5N 6J5
Submission Control No: 212943
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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
.......................................................................................................................................
10
DOSAGE
AND
ADMINISTRATION....................................................................................................................
12
OVERDOSAGE
.....................................................................................................................................................
13
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
13
STORAGE
AND
STABILITY
...............................................................................................................................
15
DOS
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