ALLERTIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-09-2019
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Active ingredient:
LORATADINE
Available from:
APOTEX INC
ATC code:
R06AX13
INN (International Name):
LORATADINE
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
LORATADINE 10MG
Administration route:
ORAL
Units in package:
12/24
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0120416001; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-08-02
Summary of Product characteristics
Page 2 of 20
PRODUCT MONOGRAPH
ALLERTIN
LORATADINE CAPSULES, 10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
SEPTEMBER 25, 2019
TORONTO, ONTARIO
CANADA M9L 1T9
CONTROL #: 231181
Page 3 of 20
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
SUMMARY PRODUCT INFORMATION
.............................................................................................
4
INDICATIONS AND CLINICAL USE
...................................................................................................
4
CONTRAINDICATIONS
........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
5
DRUG INTERACTIONS
.........................................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................................
7
OVERDOSAGE
.......................................................................................................................................
7
ACTION AND CLINICAL
PHARMACOLOGY....................................................................................
8
STORAGE AND STABILITY
.................................................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
..............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................... 9
PART II: SCIENTIFIC INFORMATION
.....................................................................
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