Minims Fluorescein Sodium 1%, w/v Eye Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluorescein sodium

Available from:

Bausch Health Ireland Limited

ATC code:

S01JA; S01JA01

INN (International Name):

Fluorescein sodium

Dosage:

1 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Colouring agents; fluorescein

Authorization status:

Not marketed

Authorization date:

1983-04-01

Patient Information leaflet

Bausch & Lomb
MINIMS® FLUORESCEIN SODIUM 1% W/V
MINIMS® FLUORESCEIN SODIUM 2% W/V
EYE DROPS, SOLUTION
FLUORESCEIN SODIUM
Read all this leaflet carefully BEFORE you start using your medicine.
It contains a summary of the information available
on your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1.
What Minims
®
Fluorescein sodium eye drops are and what they are used for
2.
Before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Further information
1. WHAT MINIMS® FLUORESCEIN SODIUM EYE DROPS ARE AND WHAT THEY ARE
USED FOR
Minims
®
Fluorescein sodium contains a diagnostic agent. The active substance,
fluorescein sodium, is a temporary dye used
to:
.
help your doctor or eye specialist to examine your eye,
.
help your doctor or eye specialist to measure the pressure inside your
eye by a test called tonometry,
.
help in the fitting of hard contact lenses.
Scratches on the conjunctiva (the lining of the inside of the eyelids
and part of the eye) are stained yellow or orange by
fluorescein.
Damages to the cornea (the transparent membrane covering the surface
of the eye) are stained green.
Any foreign bodies which are stuck in your eye are surrounded by a
green ring.
This medicine is indicated for children, adults and the elderly.
2. BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
.
you are allergic to the active substance (fluorescein).
.
you wear soft contact lenses.
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
Tell your doctor or eye specialist, he/she may decide to use these
drops or to prescribe you an alternative.
CONTACT LENSES
Your doctor will ask you to remove your soft contact lenses prior to
the administration of the drops. There is no information on
the effect of this product on soft contact lenses. Therefore, do not
wear your soft contact lenses until the effects of the drops
have comp

Summary of Product characteristics

Health Products Regulatory Authority
02 May 2019
CRN008VKY
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Fluorescein Sodium 1%, w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1% w/v solution of Fluorescein Sodium
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Eye Drops, Solution (Eye Drops)
Clear, orange-red, aqueous single-use eye drop solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a diagnostic stain.
Fluorescein does not stain a normal cornea but conjunctival abrasions
are stained yellow or orange, corneal abrasions or ulcers
are stained a bright green and foreign bodies are surrounded by a
green ring.
Fluorescein can be used in diagnostic examinations including Goldmann
tonometry and in the fitting of hard contact lenses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, Children and the Elderly
Instil dropwise into the eye.
Sufficient solution should be applied to stain the damaged areas.
Excess may be washed away with sterile saline solution.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to Fluorescein.
Not to be used with soft contact lenses.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special care should be taken to avoid microbial contamination.
Each Minims unit should be discarded after a single use.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
Safety for use in pregnancy and lactation has not been established,
therefore use only when considered essential by the
physician.
Health Products Regulatory Authority
02 May 2019
CRN008VKY
Page 2 of 3
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause transient blurring of vision on instillation. Warn patients
not to drive or operate hazardous machinery until vision is
clear.
4.8 UNDESIRABLE EFFECTS
ADRs are very rare (<1/10,000), including isolated reports.
Symptoms of allergic-type reactions and anaphylaxis have been reported
following topical ophth