CLARITIN LIQUID CAPSULES
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-05-2019
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Active ingredient:
LORATADINE
Available from:
BAYER INC
ATC code:
R06AX13
INN (International Name):
LORATADINE
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
LORATADINE 10MG
Administration route:
ORAL
Units in package:
24/36/84
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0120416001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-12-05
Summary of Product characteristics
PRODUCT MONOGRAPH
CLARITIN
® LIQUID CAPSULES LORATADINE CAPSULES, 10 MG
HISTAMINE H
1
RECEPTOR ANTAGONIST
Bayer Inc.
DATE OF PREPARATION:
2920 Matheson Blvd. E
May 10
th
, 2019
Mississauga, ON
L4W 5R6
Control #: 225631
® TM see www.bayer.ca/tm-mc
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_CLARITIN LIQUID CAPSULES _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
………………………………….…...
3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL
USE.................................................................................
3
CONTRAINDICATIONS
......................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................
3
ADVERSE REACTIONS
......................................................................................................
4
DRUG INTERACTIONS
.......................................................................................................
6
DOSAGE AND ADMINISTRATION
...................................................................................
7
OVERDOSAGE
.....................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 7
STORAGE AND STABILITY
..............................................................................................
8
SPECIAL HANDLING INSTRUCTIONS
............................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 9
PART II: SCIENTIFIC INFORMATION
…………………………………………………….
. 10
PHARMACEUTICAL INFORMATION
............................................................................
10
CLINICAL
TRIALS...........................................................
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