PMS-DICLOFENAC-MISOPROSTOL TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-06-2022
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Active ingredient:
DICLOFENAC SODIUM; MISOPROSTOL
Available from:
PHARMASCIENCE INC
ATC code:
M01AB55
INN (International Name):
DICLOFENAC, COMBINATIONS
Dosage:
75MG; 200MCG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0222885004; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-10-01
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC-MISOPROSTOL
Diclofenac Sodium and Misoprostol
Enteric-Coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
75 mg diclofenac/200 mcg misoprostol
NSAID WITH A MUCOSAL PROTECTIVE AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 1, 2022
Submission
Control No: 263143
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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
............................................................................
5
ADVERSE REACTIONS
...........................................................................................
17
DRUG
INTERACTIONS............................................................................................
22
DOSAGE AND
ADMINISTRATION.........................................................................
26
OVERDOSAGE
.........................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND
STABILITY....................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 31
PART II: SCIENTIFIC
INFORMATION...........................................................................
32
PHARMACEUTICAL
INFORMATION.....................................................................
32
CLINICAL TRIALS
...................................................................................................
34
DE
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