Minims Lidocaine Hydrochloride 4% w/v & Fluorescein Sodium 0.25% w/v Eye Drops, solution

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Fluorescein sodium; Lidocaine hydrochloride

Disponibil de la:

Bausch + Lomb Ireland Limited

Codul ATC:

S01JA; S01JA51

INN (nume internaţional):

Fluorescein sodium; Lidocaine hydrochloride

Forma farmaceutică:

Eye drops, solution

Zonă Terapeutică:

Colouring agents; fluorescein, combinations

Statutul autorizaţiei:

Marketed

Data de autorizare:

1983-03-24

Prospect

Bausch & Lomb
MINIMS® LIDOCAINE HYDROCHLORIDE 4% W/V
AND FLUORESCEIN SODIUM 0.25% W/V
EYE DROPS, SOLUTION
LIDOCAINE HYDROCHLORIDE AND 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® Lidocaine Hydrochloride and 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® LIDOCAINE HYDROCHLORIDE AND FLUORESCEIN SODIUM EYE
DROPS ARE AND WHAT
THEY ARE USED FOR
Minims® Lidocaine Hydrochloride and Fluorescein Sodium contains a
local anaesthetic (lidocaine)
and a diagnostic agent (fluorescein).
Lidocaine Hydrochloride is a local anaesthetic which temporarily numbs
the surface of the eye.
Fluorescein sodium is a temporary dye which helps the doctor or eye
specialist to examine your eye.
Your eye drops are used to:
numb and stain the surface of the eye, for a short time only, to help
the 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.
Scratches on the conjunctiva (the lining of the inside of the eyelids
and part of the eye) are stained
yellow or orange by fluorescein.
Damage to the cornea (the transparent membrane covering the surface of
the eye) is 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 one of the active substances (lidocaine or
fluorescein) or any of the other
ingredients (refer to the end of this leaflet).
you are allergic to other similar types of local anaesthetic.
TAKE S

Caracteristicilor produsului

Health Products Regulatory Authority
03 June 2022
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Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Lidocaine Hydrochloride 4% w/v & Fluorescein Sodium 0.25% w/v
Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride 4 % w/v and Fluorescein Sodium 0.25 % w/v
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops)
Single use, sterile, clear, slightly yellow, slightly viscous eye
drops, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a diagnostic stain and local anaesthetic combined. Minims Lidocaine
& Fluorescein can be used in the measurement of
intraocular pressure by Goldmann tonometry.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly):_
One to two drops, as required.
_Children:_
As directed by the physician.
4.3 CONTRAINDICATIONS
Do not use in patients with a known hypersensitivity to either of the
active ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution on an inflamed eye, as hyperaemia greatly increases
the rate of systemic absorption through the conjunctiva.
The cornea may be damaged by prolonged application of anaesthetic eye
drops.
The anaesthetised eye should be protected from dust and contamination.
Systemic absorption may be minimised by compressing the lacrimal sac
at the medial canthus for one minute during and after
the instillation of the drops. This blocks the passage of the drops
via the naso lacrimal duct to the wide absorptive area of the
nasal and pharyngeal mucosa. It is especially advisable in children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
None known.
Health Products Regulatory Authority
03 June 2022
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Page 2 of 3
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
ADRs are very rare (<1/10,000), including isolated reports.
Symptoms of allergic-type reactions and anaphylaxis