Cyclogyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cyclopentolate hydrochloride 1%

Available from:

Alcon Laboratories (New Zealand) Limited

INN (International Name):

Cyclopentolate hydrochloride 1%

Dosage:

1 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Cyclopentolate hydrochloride 1% Excipient: Benzalkonium chloride Boric acid Disodium edetate dihydrate Hydrochloric acid Potassium chloride Purified water Sodium carbonate

Units in package:

Bottle, dropper, 1x15ml, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Union Quimico Farmaceutica SA (Uquifa SA)

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, 1x15ml - 15 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1969-12-31

Patient Information leaflet

Internal document code
1
Cyc080920cNZ
CYCLOGYL
TM
EYE DROPS 1.0%
_CYCLOPENTOLATE HYDROCHLORIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE YOU START
TO USE CYLCOGYL
TM EYE DROPS.
This leaflet answers some common questions
about Cyclogyl Eye Drops. It does not contain
all the available information. It does not take
the place of talking to your doctor or
pharmacist.
The information in this leaflet was last updated
on the date listed on the final page. More
recent information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR
PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP
TO DATE INFORMATION ON THE MEDICINE.
You can also download the most up to date
leaflet from www.medsafe.govt.nz.
The updates may contain important
information about the medicine and its use of
which you should be aware.
All medicines have risks and benefits. Your
doctor has weighed the risks of you using
Cyclogyl against the benefits they expect it
will have for you.
The information in this leaflet applies to
Cyclogyl Eye Drops only. This information
does not apply to similar products, even if they
contain the same ingredients.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT CYCLOGYL IS USED FOR
Cyclogyl Eye Drops are used to enlarge
(dilate) the pupil and to prevent the eye from
focussing. Your doctor may use Cyclogyl Eye
Drops prior to a surgical procedure or prior to
examining the inside of your eye.
Cyclogyl Eye Drops may also be used to relax
the muscles of your eye. This may be
necessary when some parts of the eye are
inflamed (iridocyclitis).
_HOW CYCLOGYL WORKS _
Cyclogyl Eye Drops contain the active
ingredient cyclopentolate hydrochloride which
belongs to a class of medicines known as
cycloplegics / mydriatics.
The effect of Cyclogyl Eye Drops is usually
no longer than 24 hour.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR

Summary of Product characteristics

Internal document code
1
Cyc20062023iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CYCLOGYL
TM
(cyclopentolate hydrochloride) Eye Drops 1.0%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Cyclogyl
TM
contains cyclopentolate hydrochloride 10 mg in 1 mL.
The pH of the drops is approximately 4.5.
Excipient with known effect
Benzalkonium chloride 0.1 mg in 1.0 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For mydriasis and cycloplegia in diagnostic procedures. For some pre-
and post-operative
states when mydriasis is required and when a shorter acting mydriatic
and cycloplegic is
needed in the therapy of iridocyclitis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Adults
One drop, followed by a second drop in 5 minutes.
Complete recovery usually occurs in 24 hours.
Children
One drop is instilled in each eye, followed 5 minutes later by a
second application if
necessary.
Pretreatment with Cyclogyl
TM
Eye Drops on the day prior to examination usually is not
necessary.
In order to minimise systemic absorption, apply pressure to the tear
duct for two minutes
immediately after administration.
4.3.
CONTRAINDICATIONS
Should not be used when narrow-angle glaucoma or anatomically narrow
angles are
present,
or
when
there
is
hypersensitivity
to
cyclopentolate
hydrochloride
or
any
component of this preparation (see Section 6.1. List of excipients).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR OPHTHALMIC USE ONLY - NOT FOR INJECTION.
General
This preparation may cause psychotic reactions, behavioural
disturbances and other CNS
disturbances in patients with increased susceptibility to
anticholinergic drugs. This is
especially true in younger age groups, but may occur at any age.
Premature and small
infants are especially prone to CNS and cardiopulmonary side effects
from systemic
absorption of cyclopentolate and, therefore, Cyclogyl
TM
Eye Drops should not be used in
Internal document code
2
Cyc20062023iNZ
t