RAN-RISPERIDONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISPERIDONE

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

N05AX08

INN (International Name):

RISPERIDONE

Dosage:

0.25MG

Pharmaceutical form:

TABLET

Composition:

RISPERIDONE 0.25MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

Active ingredient group (AIG) number: 0124332006; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2012-06-13

Summary of Product characteristics

_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
RAN™-RISPERIDONE
risperidone tablets
0.25, 0.5, 1, 2, 3 and 4 mg
Antipsychotic Agent
This Product Monograph is the exclusive property of Ranbaxy
Pharmaceuticals Canada Inc.
It may not be copied in whole or in part without the written
permission of Ranbaxy Pharmaceuticals
Canada Inc.
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario L4W 0A5
Date of Revision:
March 5, 2009
Submission Control No: 128096
TM: Trade-Mark owned by Ranbaxy Laboratories Limited.
_Page 2 of 54 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL
USE...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND
PRECAUTIONS.......................................................................................
4
ADVERSE
REACTIONS.......................................................................................................
12
DRUG INTERACTIONS
.......................................................................................................
22
DOSAGE AND ADMINISTRATION
...................................................................................
25
OVERDOSAGE
.....................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 28
STORAGE AND
STABILITY...............................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 31
PART II: SCIENTIFIC INFORMATION
...................................................................