GD-DICLOFENAC/MISOPROSTOL 75 TABLET (DELAYED-RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DICLOFENAC SODIUM; MISOPROSTOL

Beschikbaar vanaf:

GENMED A DIVISION OF PFIZER CANADA ULC

ATC-code:

M01AB55

INN (Algemene Internationale Benaming):

DICLOFENAC, COMBINATIONS

Dosering:

75MG; 200MCG

farmaceutische vorm:

TABLET (DELAYED-RELEASE)

Samenstelling:

DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG

Toedieningsweg:

ORAL

Eenheden in pakket:

250

Prescription-type:

Prescription

Therapeutisch gebied:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0222885004; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2010-01-26

Productkenmerken

_ _
PRODUCT MONOGRAPH
PR
GD
®
-DICLOFENAC/MISOPROSTOL 50
diclofenac sodium and misoprostol enteric-coated tablets
50 mg diclofenac/200 mcg misoprostol
PR
GD
®
-DICLOFENAC/MISOPROSTOL 75
diclofenac sodium and misoprostol enteric-coated tablets
75 mg diclofenac/200 mcg misoprostol
NSAID with a
Mucosal Protective Agent
GenMed, a division of Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
www.pfizer.ca
DATE OF PREPARATION:
January 21, 2010
DATE OF REVISION:
September 2, 2022
Submission Control No: 261769
®
GD is a trademark of Pfizer Canada ULC
GenMed, a division of Pfizer Canada ULC, Licensee

Pfizer Canada ULC 2022
_GD-diclofenac/misoprostol (diclofenac sodium plus misoprostol) -
Product Monograph _
_Page 2 of 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................18
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................28
STORAGE AND STABILITY
..........................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................