PMS-PIOGLITAZONE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-05-2018
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Active ingredient:
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
Available from:
PHARMASCIENCE INC
ATC code:
A10BG03
INN (International Name):
PIOGLITAZONE
Dosage:
30MG
Pharmaceutical form:
TABLET
Composition:
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
THIAZOLIDINEDIONES
Product summary:
Active ingredient group (AIG) number: 0141541002; AHFS:
Authorization status:
APPROVED
Authorization date:
2007-12-05
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-PIOGLITAZONE
Pioglitazone Hydrochloride Tablets
15 mg, 30 mg, 45 mg
USP
Anti-Diabetic Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
May 14, 2018
www.pharmascience.com
Submission Control No: 215147
_pms-PIOGLITAZONE Product Monograph _
_Page 2 of 46_
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
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL TRIALS
..........................................................
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