DIVALPROEX TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-06-2014
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Active ingredient:
VALPROIC ACID (DIVALPROEX SODIUM)
Available from:
SANIS HEALTH INC
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
125MG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
VALPROIC ACID (DIVALPROEX SODIUM) 125MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0112996004; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-02-11
Summary of Product characteristics
Page 1 of 49
PRODUCT MONOGRAPH
Pr
DIVALPROEX
DIVALPROEX SODIUM ENTERIC-COATED TABLETS
125 MG, 250 MG AND 500 MG VALPROIC ACID (AS DIVALPROEX SODIUM)
HOUSE STANDARD
ANTIEPILEPTIC
SANIS HEALTH INC.
DATE OF REVISION:
333 CHAMPLAIN ST. SUITE 102
DIEPPE, NEW BRUNSWICK
JUNE 16, 2014
E1A 1P2
CONTROL NUMBER: 174536
Page 2 of 49
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
....................................................................................................................
16
DRUG INTERACTIONS
.....................................................................................................................
23
DOSAGE AND
ADMINISTRATION
..............................................................................................
29
OVERDOSAGE
...................................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
32
STORAGE AND STABILITY
.............................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 35
PART II: SCIENTIFIC INFORMATION
...........................................................................................
36
PHARMACEUTICAL INFORMATION
....................
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