TEVA-CLONIDINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-05-2014
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Active ingredient:
CLONIDINE HYDROCHLORIDE
Available from:
TEVA CANADA LIMITED
ATC code:
C02AC01
INN (International Name):
CLONIDINE
Dosage:
0.2MG
Pharmaceutical form:
TABLET
Composition:
CLONIDINE HYDROCHLORIDE 0.2MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
CENTRAL ALPHA-AGONISTS
Product summary:
Active ingredient group (AIG) number: 0108891002; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-12-13
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
TEVA-CLONIDINE
(Clonidine Hydrochloride)
0.1 mg and 0.2 mg Tablets
USP
Antihypertensive
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 171843
Date of Revision:
April 25, 2014
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
...........................................................................................................
7
DRUG
INTERACTIONS
............................................................................................................
9
DOSAGE
AND
ADMINISTRATION
......................................................................................
11
OVERDOSAGE
........................................................................................................................
12
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
13
STORAGE
AND
STABILITY
.................................................................................................
14
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL
INFORMATION
.................................................................................
16
DETAILED
PHARMACOLOGY
............................................................................................
17
TOXICOLOGY
...........................
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