CYCLOGYL DROPS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYCLOPENTOLATE HYDROCHLORIDE

Available from:

ALCON CANADA INC

ATC code:

S01FA04

INN (International Name):

CYCLOPENTOLATE

Dosage:

1%

Pharmaceutical form:

DROPS

Composition:

CYCLOPENTOLATE HYDROCHLORIDE 1%

Administration route:

OPHTHALMIC

Units in package:

15ML

Prescription type:

Prescription

Therapeutic area:

MYDRIATICS

Product summary:

Active ingredient group (AIG) number: 0108675001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-05-22

Summary of Product characteristics

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_CYCLOGYL_
_®_
_ Prescribing Information _
_Page 1 of 11_
PRESCRIBING INFORMATION
Pr
CYCLOGYL
*
Cyclopentolate Hydrochloride Ophthalmic Solution, USP
1% w/v
Sterile
Anticholinergic
Alcon Canada Inc.
2665 Meadowpine Blvd.
Mississauga, ON, Canada L5N 8C7
www.alcon.ca
Date of Preparation:
April 21, 2016
Date of Revision:
September 11, 2020
Submission Control No: 242648
*
a trademark of Novartis
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_CYCLOGYL_
_®_
_ Prescribing Information _
_Page 2 of 11_
TABLE OF CONTENTS
HEALTH PROFESSIONAL INFORMATION
.........................................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
..............................................................7
STORAGE AND STABILITY
............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................8
CONSUMER INFORMATION
...................................................................................................9
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_CYCLOGYL_
_®_
_ Prescribing Information _
_Page 3 of 11_
Pr
CYCLOGYL
*
Cyclopentolate Hydrochloride Ophthalmic Solut