SANDOZ-DICLOFENAC SUPPOSITORY
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-01-2020
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Active ingredient:
DICLOFENAC SODIUM
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
M01AB05
INN (International Name):
DICLOFENAC
Dosage:
100MG
Pharmaceutical form:
SUPPOSITORY
Composition:
DICLOFENAC SODIUM 100MG
Administration route:
RECTAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0114417001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-01-25
Summary of Product characteristics
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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PRODUCT MONOGRAPH
PR
SANDOZ-DICLOFENAC
PR
SANDOZ-DICLOFENAC SR
(diclofenac sodium)
50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 and 100 mg Suppositories
Acetic Acid Derivatives and Related Substances
Sandoz Canada Inc.
Date of revision:
110 Rue de Lauzon,
January 6, 2020
Boucherville, Quebec
J4B 1E6
Control no. 233855
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
15
DRUG INTERACTIONS
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................
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