MINIMS CYCLOPENTOLATE HYDROCHLORIDE 0.5% 5mg/ml eye drops tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyclopentolate hydrochloride, Quantity: 5 mg/mL

Available from:

Bausch & Lomb Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: purified water; hydrochloric acid

Administration route:

Ophthalmic

Units in package:

20 X 0.5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

To produce mydriasis and cycloplegia

Product summary:

Visual Identification: A clear, colourless solution, reasonable free from visible particulate matter; Container Type: Tube; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-30

Patient Information leaflet

MINIMS
®
CYCLOPENTOLATE
EYE DROPS
_Cyclopentolate Hydrochloride Eye Drops_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Cyclopentolate Eye Drops, including
how to use the eye drops.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Minims
Cyclopentolate Eye Drops against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MINIMS
CYCLOPENTOLATE EYE
DROPS IS USED FOR
Minims Cyclopentolate Eye Drops
belongs to a class of medicines called
antimuscarinic agents. It is used to
dilate (enlarge) the pupil of the eye
and to temporarily paralyse the lens
so that your doctor can examine your
eye(s). It is usually used at the
beginning of an eye examination.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
MINIMS
CYCLOPENTOLATE EYE
DROPS
_WHEN YOU MUST NOT USE IT_
DO NOT USE MINIMS CYCLOPENTOLATE
EYE DROPS IF YOU HAVE AN ALLERGY
TO:
•
Any medicine containing
cyclopentolate
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty
breathing
•
Swelling of the face, lips,
tongue or other parts of the
body
•
Rash, itching or hives on the
skin
DO NOT USE MINIMS CYCLOPENTOLATE
EYE DROPS IF YOU HAVE OR SUSPECT
YOU HAVE ANGLE CLOSURE GLAUCOMA
(HIGH PRESSURE IN THE EYE).
Cyclopentolate can increase the
pressure in the eye.
DO NOT USE THIS MEDICINE IN
NEONATES OR INFANTS LESS THAN 3
MONTHS OLD.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is

Summary of Product characteristics

Minims Cyclopentolate PI-A20210428v6
Page 1 of 10_ _
AUSTRALIAN PRODUCT INFORMATION – MINIMS®
CYCLOPENTOLATE HYDROCHLORIDE (CYCLOPENTOLATE
HYDROCHLORIDE) EYE DROPS
1 NAME OF THE MEDICINE
Cyclopentolate hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Cyclopentolate Eye Drops are sterile preservative-free
solutions containing
cyclopentolate hydrochloride 0.5% (5 mg/mL) or 1% w/v (10 mg/mL) as
the active
ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Minims Cyclopentolate Eye Drops are clear colourless solutions,
reasonably free from
visible particulate matter.
4 CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Minims Cyclopentolate Eye Drops are indicated to produce mydriasis and
cycloplegia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults (including the elderly)
Minims Cyclopentolate Eye Drops should be instilled drop wise into the
eye according to
the recommended dosage below.
One drop as required. Maximum effect is induced 30 – 60 minutes
after instillation. For
refraction and examination of the back of the eye: 1 drop of solution,
which may be
repeated after five minutes, is usually sufficient.
For anterior and posterior uveitis (if associated with signs of
anterior uveitis) and for the
breakdown of posterior synechiae: 1 drop is instilled every 6 – 8
hours.
Resistance to cycloplegia can occur in young children, in patients
with dark skin and/or
patients with dark irides. Therefore, if the 0.5% solution does not
induce cycloplegia, the
dosage regimen (children) and/or the strength of cyclopentolate used
should be increased
accordingly.
Minims Cyclopentolate PI-A20210428v6
Page 2 of 10_ _
Children
<3 months:
not recommended
3 months – 12 years:
1 drop of a 0.5% solution to each eye
12 years – adult:
1 drop of 0.5% or 1% solution to each eye repeated after 10
minutes if necessary
Children should be observed for 45 minutes after installation.
Parents are advised to avoid contact of the solution with the
child’s