TARO-CARBAMAZEPINE CR TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-08-2018
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Active ingredient:
CARBAMAZEPINE
Available from:
TARO PHARMACEUTICALS INC
ATC code:
N03AF01
INN (International Name):
CARBAMAZEPINE
Dosage:
400MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
CARBAMAZEPINE 400MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0108674004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-02-04
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
TARO- CARBAMAZEPINE TABLETS 200 MG
(CARBAMAZEPINE TABLETS, TARO STANDARD)
Pr
TARO- CARBAMAZEPINE
CHEWABLE TABLETS 100 MG AND 200 MG
(CARBAMAZEPINE CHEWABLE TABLETS)
Pr
TARO- CARBAMAZEPINE CR
TABLETS 200 MG AND 400 MG
(CARBAMAZEPINE EXTENDED-RELEASE TABLETS, TARO STANDARD)
Pr
TARO- CARBAMAZEPINE SUSPENSION 100 MG/5 ML
(CARBAMAZEPINE ORAL SUSPENSION, USP) ANTICONVULSANT
FOR SYMPTOMATIC RELIEF OF TRIGEMINAL NEURALGIA
ANTIMANIC
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
August 31, 2018
Brampton, Ontario
L6T 1C1
Control No: 218942
2
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
........................................................................................................
19
DOSAGE AND ADMINISTRATION
....................................................................................
24
OVERDOSAGE
......................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 28
STORAGE AND STABILITY
................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 30
PART II: SCIENTIFIC INFORMATION
..........................................
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