ATROPT 1% atropine sulfate monohydrate 10mg/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atropine sulfate monohydrate, Quantity: 9.9737 mg/mL

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: boric acid; disodium edetate; benzalkonium chloride; hypromellose; water for injections

Administration route:

Ophthalmic

Units in package:

15mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 06 AUGUST 1999: ATROPT Eye Drops are indicated where it is necessary to dilate the pupil and paralyse accomodation.

Product summary:

Visual Identification: A clear or almost clear, slightly viscous, colourless liquid which foams on shaking. Odourless.; Container Type: Bottle; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert

Authorization status:

Registered

Authorization date:

1991-10-14

Patient Information leaflet

ATROPT 1%
_(At-rop-t)_
_Atropine sulphate monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ATROPT 1% EYE DROPS.
It does not contain all of the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks
and benefits. Your doctor
has weighed the risks of
you using
ATROPT 1%
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need
to read it again.
WHAT IS ATROPT 1%
The name of your medicine
is
ATROPT 1%
Eye Drops.
The active ingredient is
called atropine sulphate
monohydrate.
Atropt 1% widens the pupil
of the eye and blocks the
ability to change the focus
of the eye.
ATROPT 1% EYE DROPS
are
for use in the eyes only.
They should not be taken by
mouth.
WHAT IS IT USED FOR
ATROPT 1% EYE DROPS
are
used in eye examinations as
well as other circumstances
when the pupil is to be
widened and/or the
accommodation frozen.
Your doctor, however, may
have prescribed
ATROPT 1%
EYE DROPS
for another
purpose.
Ask your doctor if you have
any questions about why
ATROPT 1% EYE DROPS
have
been prescribed for you.
If you have any concerns,
you should discuss this with
your doctor or in his/her
absence with your
pharmacist.
ATROPT 1% EYE DROPS
are
available only on a doctor’s
prescription.
BEFORE YOU USE IT
_When you must not use it_
Do not use
ATROPT 1% EYE
DROPS
if you are allergic to:
•
Atropine or any of the
ingredients listed at the
end of this leaflet.
Do not use
ATROPT 1%
EYE DROPS
if you have
angle closure glaucoma or
a family history of
glaucoma.
ATROPT 1%
like all
medicines, should not be
used during pregnancy
unless your doctor
specifically tells you to
.
DO NOT USE ATROPT 1%
EYE DROPS AFTER THE
EXPIRY DATE PRINTED ON
THE PACK.
If you use it after the expiry
date has passed, it may have
no effect at all, or worse,
there may be an entirely
unexpected effect.
DO NOT PURCHA

Summary of Product characteristics

ATROPT
1%
EYE DROPS- Product Information
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
ATROPT 1% EYE DROPS (ATROPINE SULFATE MONOHYDRATE 1%) STERILE
OPTHALMIC SOLUTION
1
NAME OF THE MEDICINE
Atropine sulfate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATROPT 1% EYE DROPS
contains atropine sulfate monohydrate (1%) in a sterile ophthalmic
solution.
ATROPT 1% EYE DROPS contains Benzalkonium chloride.
For the full list of excipients, see 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ATROPT 1% eye drops are a clear or almost clear, odourless, slightly
viscous, colourless liquid
which foams on shaking.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATROPT 1% Eye Drops are indicated where it is necessary to dilate the
pupil and paralyse
accommodation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Instil one drop into the eye as required for treatment. To minimise
the risk of systemic
absorption,
gentle
pressure
should
be
applied
to
the
tear
duct
for
one
minute
after
application.
4.3
CONTRAINDICATIONS
ATROPT 1% eye drops are contraindicated in the presence of angle
closure glaucoma or where
angle closure glaucoma is suspected. If used in glaucoma susceptible
patients, an estimation
of the depth of the angle of the anterior chamber should be performed
prior to the initiation
of therapy.
Hypersensitivity to any of the ingredients of ATROPT 1% Eye Drops.
ATROPT
1%
EYE DROPS- Product Information
Page 2 of 7
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients treated prior to ophthalmic examination should be escorted to
and from the surgery.
Risk benefit should be considered when the following medical problems
exist:
Keratoconus (atropine may produce fixed dilated pupil), synechiae
between the iris and lens.
USE IN THE ELDERLY
Geriatric patients are more susceptible to the effects of atropine,
thus increasing the potential
for systemic side effects.
PAEDIATRIC USE
ATROPT 1% must not be used in children less than 2 years old as it
contains boron which may
impair fertility in the future.
Atropine sulfate monohydrate shoul