TEVA-CLARITHROMYCIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-08-2018
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Active ingredient:
CLARITHROMYCIN
Available from:
TEVA CANADA LIMITED
ATC code:
J01FA09
INN (International Name):
CLARITHROMYCIN
Dosage:
250MG
Pharmaceutical form:
TABLET
Composition:
CLARITHROMYCIN 250MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
OTHER MACROLIDES
Product summary:
Active ingredient group (AIG) number: 0123752001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-05-28
Summary of Product characteristics
Page 1
PRODUCT MONOGRAPH
Including Patient Medication Information
PR
TEVA-CLARITHROMYCIN
clarithromycin tablets, film-coated
250 mg and 500 mg
Teva Standard
_ _
_ _
Antibiotic
NOTE: WHEN USED IN COMBINATION WITH ACID ANTISECRETORY DRUGS
AND OTHER ANTIMICROBIALS FOR THE ERADICATION OF _HELICOBACTER _
_PYLORI_, THE PRODUCT MONOGRAPH FOR THOSE AGENTS SHOULD BE
CONSULTED
.
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control Number: 217581
Date of Revision:
August 23, 2018
Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.........................................................................................
6
ADVERSE
REACTIONS
.........................................................................................................
13
DRUG
INTERACTIONS
.........................................................................................................
22
DOSAGE
AND
ADMINISTRATION
.....................................................................................
33
OVERDOSAGE
.......................................................................................................................
35
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
36
STORAGE
AND
STABILITY
.................................................................................................
39
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 39
PART II: SCIENTIFIC INFORMATION
...............................................................................
41
PHARMACEUTICAL
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