VOLTAREN SR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC SODIUM

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

M01AB05

INN (International Name):

DICLOFENAC

Dosage:

100MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

DICLOFENAC SODIUM 100MG

Administration route:

ORAL

Units in package:

100/250

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0114417001; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-05-07

Summary of Product characteristics

_VOLTAREN_
_ _
_and VOLTAREN SR diclofenac sodium _
_ Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VOLTAREN
®
PR
VOLTAREN
® SR
(Diclofenac sodium suppositories)
(Diclofenac sodium slow-release tablets)
Slow-Release Tablets, 100 mg, for oral use
Suppositories, 50 mg, for rectal use
Mfr. Std.
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Novartis Pharmaceuticals Canada Inc.
Date of Initial Authorization:
385 Bouchard Blvd.,
July 5, 1989
Dorval, Quebec H9S 1A9
www.novartis.ca
Date of Revision:
JUN 08, 2022
Control no. 260554
VOLTAREN and VOLTAREN SR are registered trademark.
_ _
_VOLTAREN_
_ _
_and VOLTAREN SR diclofenac sodium _
_ Page 2 of 50_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX-
Risk in Pregnancy
10/2021
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests,
_Pregnancy_
10/2021
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions _
10/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2021
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
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................................