ACT DICLO-MISO TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-12-2015
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Active ingredient:
DICLOFENAC SODIUM; MISOPROSTOL
Available from:
ACTAVIS PHARMA COMPANY
ATC code:
M01AB55
INN (International Name):
DICLOFENAC, COMBINATIONS
Dosage:
75MG; 200MCG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG
Administration route:
ORAL
Units in package:
100/250/500
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0222885004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-08-08
Summary of Product characteristics
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_Page 1 of 54_
PRODUCT MONOGRAPH
PR
ACT_ _DICLO-MISO
Diclofenac sodium and Misoprostol Enteric-coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
and
75 mg diclofenac/200 mcg misoprostol
NSAID with a
Mucosal Protective Agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date of Revision:
December 09, 2015
Submission Control No: 190014
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_Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
........................................................................
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