Minims Tropicamide 0.5% 5mg/mL eye drops tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tropicamide, Quantity: 5 mg/mL

Available from:

Bausch & Lomb Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; purified water

Administration route:

Ophthalmic

Units in package:

20 X 0.5mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

To produce mydriasis and cycloplegia.

Product summary:

Visual Identification: A clear, colourless solution, reasonably 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
® TROPICAMIDE
_Tropicamide Eye Drops_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Tropicamide, 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
Tropicamide 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
TROPICAMIDE IS USED
FOR
Minims Tropicamide belongs to a
class of medicines called
antimuscarinic agents. It is used to
enlarge the pupil of the eye and to
temporarily paralyse the lens so that
your doctor can examine your eye. 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 TROPICAMIDE
_WHEN YOU MUST NOT USE IT_
DO NOT USE MINIMS TROPICAMIDE IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
tropicamide
•
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 TROPICAMIDE IF
YOU HAVE NARROW ANGLE GLAUCOMA
(HIGH PRESSURE IN THE EYE).
Tropicamide can increase the
pressure in the eye.
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 damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF YOU HAVE HAD AN
ALLERGY TO ANY OTHER MEDICI

Summary of Product characteristics

Minims Tropicamide PI-A20200602 v4
Page 1 of 6 AUSTRALIAN PRODUCT INFORMATION – MINIMS TROPICAMIDE
(TROPICAMIDE) EYE DROPS
1
NAME OF THE MEDICINE
Tropicamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Tropicamide Eye Drops contain tropicamide 0.5% and 1% w/v. No
preservatives are
contained in the formulation.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A single-use eye drops, solution.
Minims Tropicamide are clear, colourless sterile ophthalmic solution.
No preservatives are
contained in the formulation.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Minims Tropicamide Eye Drops is one of the antimuscarinics used to
produce mydriasis and
cycloplegia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults (including the elderly):
To produce mydriasis, 1 or 2 drops of a 0.5% solution are instilled 15
to 20 minutes before
examination of the eye.
To produce cycloplegia 1 or 2 drops of a 1% solution are required,
repeated after 5 minutes. A
further drop may be necessary to prolong the effect after 20 to 30
minutes.
Systemic absorption can be minimised by pressure on the tear duct
immediately after application.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to tropicamide or any other component listed in the
formulation.
Narrow angle glaucoma.
Minims Tropicamide PI-A20200602 v4
Page 2 of 6
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
For topical ophthalmic use only. Not for injection.
Tropicamide should not be used in patients with a narrow angle
glaucoma since it may raise intra-
ocular pressure and precipitate an acute attack.
As with other antimuscarinic agents, tropicamide should be used with
caution in conditions
characterised by tachycardia such as thyrotoxicosis, heart failure and
in cardiac surgery where it
may further accelerate the heart rate. Care is required in patients
with acute myocardial infarction
as ischaemia and infarction may be made worse.
Tropicamide may significantly increase intraocular pressure.
Use with caution in an inflamed