PENNSAID SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC SODIUM

Available from:

PALADIN LABS INC.

ATC code:

M02AA15

INN (International Name):

DICLOFENAC

Dosage:

1.5%

Pharmaceutical form:

SOLUTION

Composition:

DICLOFENAC SODIUM 1.5%

Administration route:

TOPICAL

Units in package:

60ML

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0114417007; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-03-03

Summary of Product characteristics

_PENNSAID_
_®_
_ (diclofenac sodium) _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PENNSAID®
Diclofenac sodium solution
Solution, 1.5% w/w, Topical
ATC Code: M02AA15
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Paladin Labs Inc.
100 Alexis-Nihon Blvd., Suite 600
St-Laurent, Quebec
H4M 2P2
Date of Initial Authorization:
October 20, 2003
Date of Revision:
February 16, 2022
Version: 6.0
Submission Control Number: 255809
PENNSAID® is a registered trademark of NUVO PHARMACEUTICALS INC.
_ _
_PENNSAID_
_®_
_ (diclofenac sodium)_
_ _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions
02/2022
7 Warnings and Precautions
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (<18 years of age)
..............................................................................
4
1.2
Geriatrics (≥65 years of
age)...............................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
.......................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment......................................