ARTHROTEC 50 TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC SODIUM; MISOPROSTOL

Available from:

PFIZER CANADA ULC

ATC code:

M01AB55

INN (International Name):

DICLOFENAC, COMBINATIONS

Dosage:

50MG; 200MCG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG

Administration route:

ORAL

Units in package:

250

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0222885001; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-02-07

Summary of Product characteristics

_Product Monograph _
_ _
_ARTHROTEC (diclofenac sodium and misoprostol) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ARTHROTEC
® 50
diclofenac sodium and misoprostol enteric-coated tablets
50 mg diclofenac/200 mcg misoprostol, Oral
PR
ARTHROTEC
® 75
diclofenac sodium and misoprostol enteric-coated tablets
75 mg diclofenac/200 mcg misoprostol, Oral
NSAID with a Mucosal Protective Agent
Pfizer Canada ULC
17,300 Trans Canada Highway
Kirkland, QC H9J 2M5
Date of Initial Authorization:
JAN 15, 1993
Date of Revision:
FEB 13, 2024
Submission Control Number: 279263
Wyeth Holdings LLC
®
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC
_ _
_Product Monograph _
_ _
_ARTHROTEC (diclofenac sodium and misoprostol) _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2022
7 WARNINGS AND PRECAUTIONS, Skin
02/2022
7 WARNINGS AND PRECAUTIONS, Skin
02/2024
7 WARNING AND PRECAUTIONS, 7.1.1 pregnant women
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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