MINIMS lidocaine (lignocaine) 4% and fluorescein 0.25% eye drops tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lidocaine hydrochloride monohydrate, Quantity: 40 mg/mL; fluorescein sodium, Quantity: 2.5 mg/mL

Available from:

Bausch & Lomb Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: purified water; hydrochloric acid; povidone

Administration route:

Ophthalmic

Units in package:

20 X 0.5mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

As a diagnostic stain and topical anaesthetic combined, Minims Lignocaine and Fluorescein is intended primarily to facilitate Goldmann applanation tonometry.

Product summary:

Visual Identification: A clear yellow solution substantially free from foreign 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
® LIDOCAINE
(LIGNOCAINE) &
FLUORESCEIN EYE DROPS
_Lidocaine (Lignocaine) Hydrochloride & Fluorescein Sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims Lidocaine
(Lignocaine) & Fluorescein 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 Lidocaine
(Lignocaine) & Fluorescein Eye
Drops against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT MINIMS
LIDOCAINE
(LIGNOCAINE) &
FLUORESCEIN EYE
DROPS IS USED FOR
Minims Lidocaine (Lignocaine) &
Fluorescein Eye Drops contains
lidocaine (lignocaine) hydrochloride
and fluorescein sodium. Lidocaine
(also known as lignocaine) belongs
to a group of medicines called local
anaesthetics, which temporarily
numbs the surface of the eye.
Fluorescein temporarily colours your
eye orange or green and helps your
doctor to examine them.
Minims Lidocaine (Lignocaine) &
Fluorescein Eye Drops are used to
numb and stain the surface of your
eye(s), for a short time only, to allow
your doctor to examine your eye.
Most often, the eye drops are used to
allow the pressure inside your eyes to
be measured.
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 ARE GIVEN
MINIMS LIDOCAINE
(LIGNOCAINE) &
FLUORESCEIN EYE
DROPS
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE MINIMS LIDOCAINE
(LIGNOCAINE) & FLUORESCEIN EYE
DROPS IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
Lidocaine or Fluorescein
•
any other local anaesthetic
•
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

Summary of Product characteristics

Minims Lidocaine and Fluorescein PI-A20200505 v4
1
AUSTRALIAN PRODUCT INFORMATION – MINIMS
® LIDOCAINE
(LIGNOCAINE) AND FLUORESCEIN [LIDOCAINE (LIGNOCAINE)
HYDROCHLORIDE MONOHYDRATE AND FLUORESCEIN SODIUM] EYE
DROPS
1
NAME OF THE MEDICINE
Lidocaine (Lignocaine) Hydrochloride Monohydrate and Fluorescein
Sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops contain
lidocaine (lignocaine)
hydrochloride monohydrate 4% w/v and fluorescein sodium 0.25% 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 Lidocaine (Lignocaine) and Fluorescein Eye Drops are clear,
fluorescent red-orange
sterile eye drops. No preservatives are contained in the formulation.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
As a diagnostic stain and topical anaesthetic combined, Minims
Lidocaine (Lignocaine) and
Fluorescein is intended primarily to facilitate Goldmann applanation
tonometry.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY)
One or more drops as required.
CHILDREN
One or more drops as required or as directed by the physician.
Systemic absorption of lidocaine and fluorescein may be reduced by
compressing the lacrimal
sac at the medial canthus for a minute during and following the
instillation of the drops. (This
Minims Lidocaine and Fluorescein PI-A20200505 v4
2
blocks the passage of the drops via the naso-lacrimal duct to the wide
absorptive area of the
nasal and pharyngeal mucosa.)
Each Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops unit
should be discarded after a
single use.
4.3
C
ONTRAINDICATIONS
Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops are
contraindicated in patients with
hypersensitivity to any of the components of the preparation or other
amide-type local
anaesthetics.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Minims Lidocaine (Lignocaine) and Fluorescein Eye