APO-DICLO SR TABLET (EXTENDED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DICLOFENAC SODIUM

Disponible depuis:

APOTEX INC

Code ATC:

M01AB05

DCI (Dénomination commune internationale):

DICLOFENAC

Dosage:

75MG

forme pharmaceutique:

TABLET (EXTENDED-RELEASE)

Composition:

DICLOFENAC SODIUM 75MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0114417005; AHFS:

Statut de autorisation:

DORMANT

Date de l'autorisation:

2019-10-03

Résumé des caractéristiques du produit

_APO-DICLO and APO-DICLO SR diclofenac sodium Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DICLO
Diclofenac Sodium Delayed-Release Tablets
Delayed-Release Tablets, 25 mg and 50 mg, for oral use
USP
PR
APO-DICLO SR
Diclofenac Sodium Slow-Release Tablets
Slow Release Tablets, 75 mg and 100 mg, for oral use
Apotex Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
SEP 22, 2022
Submission Control Number: 260911
_APO-DICLO and APO-DICLO SR diclofenac sodium Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX- Risk in Pregnancy
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests,
_Pregnancy_
09/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2022
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
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
..............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND
ADMINISTRATION......