CLARITIN RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-04-2020
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Active ingredient:
LORATADINE
Available from:
BAYER INC
ATC code:
R06AX13
INN (International Name):
LORATADINE
Dosage:
5MG
Pharmaceutical form:
TABLET (ORALLY DISINTEGRATING)
Composition:
LORATADINE 5MG
Administration route:
ORAL
Units in package:
5/10
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0120416003; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-12-18
Summary of Product characteristics
_CLARITIN ALLERGY, CLARITIN RAPID DISSOLVE, CLARITIN KIDS RAPID
DISSOLVE & CLARITIN KIDS_
_Page 1 of 40_
PRODUCT MONOGRAPH
CLARITIN
®
ALLERGY
Loratadine Tablets USP 10 mg
CLARITIN
®
RAPID DISSOLVE™
Loratadine Orally Disintegrating Tablets USP 10 mg
Loratadine Orally Disintegrating Tablets USP 5 mg
CLARITIN
®
KIDS RAPID DISSOLVE™
Loratadine Orally Disintegrating Tablets USP 5 mg
CLARITIN KIDS
®
Loratadine Oral Solution USP 1 mg/mL
Histamine H
1
receptor antagonist
Bayer Inc.
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Revision:
April 30
th
, 2020
Submission Control No: 228699
® TM see www.bayer.ca/tm-mc
_CLARITIN ALLERGY, CLARITIN RAPID DISSOLVE, CLARITIN KIDS RAPID
DISSOLVE & CLARITIN KIDS_
_Page 2 of 40_
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...........................................................................................................5
DRUG INTERACTIONS
...........................................................................................................9
DOSAGE AND
ADMINISTRATION.......................................................................................9
OVERDOSAGE
.......................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
...................................................................11
STORAGE AND
STABILITY.................................................................................................15
SPECIAL HANDL
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