Consumer medicine information

Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

BRAND INFORMATION

Brand name

Minims Lidocaine (Lignocaine) and Fluorescein

Active ingredient

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

Schedule

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 the face, lips, tongue or other parts of the body
rash, itching or hives on the skin

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.

This medicine has been developed for use in the eye only. It should not be swallowed or injected.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have had an allergy to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or breast-feeding. Your doctor will discuss the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops may interfere with each other. These medicines may be affected by Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor will advise you and decide whether or not to give you Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops.

How Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops is given

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

How much to use

Your doctor will put the correct number of drops of Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops into your eye(s) before starting the procedure on your eye(s). Your doctor will not give you a prescription for your own use. This medicine has been specifically developed for use by your doctor to numb the feeling in your eye(s) while he/she is attending to your eye(s).

The usual dose is one or more drops into your eye(s) as required before starting the procedure on your eye(s). The number of times your doctor will put drops in your eye(s) will depend on the type and length of the procedure to be performed.

Your eye drops are not intended for long-term use. Frequent use of a local anaesthetic in the eye over long periods of time may affect your eyesight.

If you are wearing contact lenses, you will be asked to remove them before putting in the eye drops. You may put your contact lenses back into your eye after the numbness has worn off or when your doctor tells you to.

Do not touch or rub your eye while your eye is numb. You may scratch the surface of the eye and damage it. Your doctor will put a patch over your eye after finishing the procedure to protect your eye and stop you from touching it.

If you use too much (overdose)

The doctor giving you Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops will be experienced in its use, so it is unlikely that you will be given an overdose.

If too many drops have accidentally been put into your eye(s), immediately rinse your eye(s) with warm water.

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of Lidocaine & Fluorescein. If you think that you or anyone else may have swallowed any or all of the contents of the container of Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

After being given Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops

Things you must do

Protect your eyes from dust. You should protect your anesthetised eye from dust particles, which could cause infections.

Things you must not do

Things to be careful of

Be careful driving or operating machinery until you know how Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause transient blurred vision at the time of application and sufficient time should be allowed to regain clear vision before driving or operating hazardous machinery.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops.

This medicine helps most people to numb the eye, but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

irritation or feeling of having something in the eye

The above list includes the more common side effects of your medicine. They are usually mild and short lived.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Some of the side effects considered very rare include swelling around the eye, difficulty breathing, symptoms of shock, itchy skin rash with raised blotches.

After using Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops

Storage

Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops will be stored by your doctor in a refrigerator (2-8°C). The eye drops should not be frozen or exposed to strong light.

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Product description

What it looks like

Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops come in single dose units containing 0.5mL of a clear, fluorescent red-orange solution. Each carton contains 20 single dose units.

Ingredients

Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops contains Lidocaine Hydrochloride 4%w/v and Fluorescein 0.25%w/v as the active ingredients.

They also contain:

Povidone
Hydrochloric acid
Water - Purified

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia, Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Chatswood, NSW 2067
Phone: 1800 251 150

Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops AUST R 32272

In New Zealand, Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Toll free number: 0508375394

Date of preparation
This leaflet was prepared in May 2020

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Minims Lidocaine (Lignocaine) and Fluorescein

Active ingredient

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

Schedule

1 Name of 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 Therapeutic Indications

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

4.2 Dose 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 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 Contraindications

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 Special Warnings and Precautions for Use

Identified precautions.

Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops are for topical ophthalmic application only. The solution should not be injected.
The anaesthetised eye should be protected from foreign contamination, particularly in elderly patients in whom the duration of anaesthesia may exceed 30 minutes.
Patients should be warned not to touch or rub the eye while anaesthesia persists. The anaesthetised eye should be protected from dust and bacterial contamination.
Use with caution in an inflamed eye as hyperaemia increases the rate of systemic absorption through the conjunctiva.
Prolonged use of topical anaesthetics in the eye can lead to severe chemical keratitis.
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 blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa.)

Use in the elderly.

A second drop may be needed to obtain the anaesthetic effect.

Paediatric use.

Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops should be used with caution in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been performed in either animals or humans to evaluate the potential fertility impairing effects of lidocaine and fluorescein, either alone or in combination.
(Category A)
No animal or well controlled human studies have been conducted with lidocaine and fluorescein in combination to evaluate the potential effects on embryofoetal development. Lidocaine readily crosses the placenta. However, no foetal harm was observed in animal studies with either of the single agents, and this combination has been used for a number of years without apparent ill consequences.
Lidocaine and fluorescein are excreted in breast milk. However, this combination has been used for a number of years without apparent ill consequences.

4.7 Effects on Ability to Drive and Use Machines

Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops may cause stinging and transient blurring of vision. Patients should be advised not to drive or operate hazardous machinery until vision is clear.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
Adverse reactions associated with topical fluorescein and anaesthetic-fluorescein combination are usually limited to transient irritation of the cornea or conjunctiva.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Overdose is not expected to cause any adverse effects, however, overuse of local anaesthetics can cause keratitis, with loss of corneal epithelium and stromal opacity.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Lidocaine is an established topical anaesthetic of the amide type which blocks the sensory nerve endings of the cornea.
Fluorescein sodium is used as a diagnostic dye in ophthalmic procedures. It stains damaged cornea and ocular fluids and is applied to the eye for the detection of corneal lesions and foreign bodies, as an aid to the fitting of hard contact lenses, and in various other diagnostic ophthalmic procedures. Fluorescein does not stain a normal cornea. With slit lamp examination using a blue filler, corneal abrasions or ulcers are stained a bright green and foreign bodies may be surrounded by a green ring.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Studies have not been performed in either animals or humans to evaluate the potential genotoxic effects of lidocaine and fluorescein, either alone or in combination. A metabolite of lidocaine, 2,6-xylidine, showed weak mutagenic and clastogenic activity in vitro, although it did not display genotoxicity in vivo.

Carcinogenicity.

Studies have not been performed in either animals or humans to evaluate the potential carcinogenic effects of lidocaine and fluorescein, either alone or in combination. In a 2 year oral carcinogenic study in rats, the compound caused adenomas and carcinomas of the nasal cavity and subcutaneous fibromas and fibrosarcomas at a daily dose of 150 mg/kg. The carcinogenic potential of Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops, used infrequently and at low doses, is likely to be low.

6 Pharmaceutical Particulars

6.1 List of Excipients

Povidone, hydrochloric acid and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.). Do not expose to strong light.

6.5 Nature and Contents of Container

Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops are supplied as a clear fluorescent red-orange coloured sterile eye drops in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units. Each unit contains approximately 0.5 mL solution.

6.6 Special Precautions for Disposal

Each Minims Lidocaine (Lignocaine) and Fluorescein Eye Drops unit should be discarded after a single use.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Lidocaine hydrochloride monohydrate.

Chemical name: 2-(diethylamino)-N- (2,6-dimethylphenyl) acetamide hydrochloride monohydrate.
Synonyms: Lignocaine hydrochloride.
Molecular formula: C₁₄H₂₂N₂O.HCl.H₂O.
Molecular weight: 288.8.

CAS number.

6108-05-0.

Chemical structure.

Fluorescein sodium.

Chemical name: disodium 2-(6-oxido-3-oxo-3H-xanthen-9-yl) benzoate.
Molecular formula: C₂₀H₁₀Na₂O₅.
Molecular weight: 376.3.

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Minims Lidocaine (Lignocaine) & Fluorescein Eye Drops

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

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