PATANOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

S01GX09

INN (International Name):

OLOPATADINE

Dosage:

0.1%

Pharmaceutical form:

SOLUTION

Composition:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.1%

Administration route:

OPHTHALMIC

Units in package:

5ML/10ML/15ML

Prescription type:

Prescription

Therapeutic area:

ANTIHISTAMINE DRUGS

Product summary:

Active ingredient group (AIG) number: 0132394001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-02-02

Summary of Product characteristics

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_PATANOL_
_®_
_ Product Monograph _
_Page 1 of 19 _
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PRODUCT MONOGRAPH
PR
PATANOL
®
Olopatadine Hydrochloride Ophthalmic Solution
0.1% w/v olopatadine (as olopatadine hydrochloride)
Anti-allergy Agent
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
Canada H9S 1A9
www.novartis.ca
Date of Revision:
March 2, 2018
Control Number: 211652
PATANOL and DROP-TAINER are registered trademarks.
*All trademarks and registered trademarks are the property of their
respective owners.
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_PATANOL_
_®_
_ Product Monograph _
_Page 2 of 19 _
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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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................6
STORAGE AND STABILITY
............................................................................................8
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................8
PART II: SCIENTIFIC INFORMATION
.................................................................................9
PHARMACEUTICAL INFORMATION
...