Consumer medicine information

Minims Lidocaine & Fluorescein

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

BRAND INFORMATION

Brand name

Minims Lidocaine and Fluorescein

Active ingredient

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Lidocaine & Fluorescein.

SUMMARY CMI

Minims® Lidocaine & Fluorescein

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I being given Minims Lidocaine & Fluorescein?

Minims Lidocaine & Fluorescein contains the active ingredients lidocaine hydrochloride monohydrate and fluorescein sodium. Minims Lidocaine & Fluorescein is 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.

For more information, see Section 1. Why am I being given Minims Lidocaine & Fluorescein? in the full CMI.

2. What should I know before I am given Minims Lidocaine & Fluorescein?

Do not use if you have ever had an allergic reaction to lidocaine, fluorescein, any other local anaesthetic, or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given Minims Lidocaine & Fluorescein? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Minims Lidocaine & Fluorescein and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given Minims Lidocaine & Fluorescein?

  • Your doctor will put the correct number of drops of Minims Lidocaine & Fluorescein into your eye(s) before starting the procedure on 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).

More information can be found in Section 4. How will I be given Minims Lidocaine & Fluorescein? in the full CMI.

5. What should I know after being given Minims Lidocaine & Fluorescein?

Things you should do
  • Protect your eyes from dust.
Things you should not do
  • Do not touch or rub your eye while your eye is numb.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Minims Lidocaine & Fluorescein affects you. It may cause blurred vision for a short time when it is given. Allow enough time to regain clear vision before driving or using machines.
Looking after your medicine
  • Minims Lidocaine & Fluorescein will be stored by your doctor or nurse in a refrigerator (2-8°C). The eye drops should not be frozen or exposed to strong light.

For more information, see Section 5. What should I know after being given Minims Lidocaine & Fluorescein? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.

The side effects of Minims Lidocaine & Fluorescein usually include irritation or the feeling of having something in the eye. These side effects generally last for a short time only. Serious side effects that require urgent medical attention include an allergic reaction.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Minims® Lidocaine & Fluorescein

Active ingredients: Lidocaine Hydrochloride Monohydrate & Fluorescein Sodium

Consumer Medicine Information (CMI)

This leaflet provides important information about Minims Lidocaine & Fluorescein. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about Minims Lidocaine & Fluorescein.

Where to find information in this leaflet:

1. Why am I being given Minims Lidocaine & Fluorescein?
2. What should I know before I am given Minims Lidocaine & Fluorescein?
3. What if I am taking other medicines?
4. How will I be given Minims Lidocaine & Fluorescein?
5. What should I know after being given Minims Lidocaine & Fluorescein?
6. Are there any side effects?
7. Product details

1. Why am I being given Minims Lidocaine & Fluorescein?

Minims Lidocaine & Fluorescein contains the active ingredients lidocaine hydrochloride monohydrate and fluorescein sodium. Lidocaine 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 & Fluorescein is 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.

2. What should I know before I am given Minims Lidocaine & Fluorescein?

Warnings

Do not be given Minims Lidocaine & Fluorescein if:

  • you are allergic to lidocaine, fluorescein, any other local anaesthetic, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • have an inflamed eye
  • have allergies to any other medicines, foods, preservatives or dyes
  • have any other medical conditions
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

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

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Some medicines and Minims Lidocaine & Fluorescein may interfere with each other. These medicines may be affected by Minims Lidocaine & Fluorescein or may affect how well it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Minims Lidocaine & Fluorescein.

4. How will I be given Minims Lidocaine & Fluorescein?

How much is given

  • Your doctor will put the correct number of drops of Minims Lidocaine & Fluorescein into your eye(s) before starting the procedure on your eye(s). Your doctor will not give you a prescription for your own use.
  • 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.

If too much Minims Lidocaine & Fluorescein is given

The doctor giving you Minims Lidocaine & Fluorescein 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 and fluorescein.

If you think that you or anyone else may have swallowed Minims Lidocaine & Fluorescein, you should immediately:

  • phone the Poisons Information Centre
    (in Australia phone 13 11 26; in New Zealand phone 0800 764 766), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know after being given Minims Lidocaine & Fluorescein?

Things you should do

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

Things you should not do

  • 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Minims Lidocaine & Fluorescein affects you.

This medicine generally does not cause any problems with your ability to drive a car or use machines. However, it may cause blurred vision for a short time when it is given. Allow enough time to regain clear vision before driving or using machines.

Looking after your medicine

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

When to discard your medicine

Your doctor or nurse will discard each single dose unit and any remaining solution in it immediately after use.

Getting rid of any unwanted medicine

Your doctor or nurse will dispose of any unused medicine.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Eyes:
  • irritation or feeling of having something in the eye
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Symptoms of an allergic reaction, such as:
  • 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
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects online (in Australia, go to www.tga.gov.au/reporting-problems; in New Zealand, go to nzphvc.otago.ac.nz/reporting. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Minims Lidocaine & Fluorescein contains

Active ingredients
(main ingredient)
  • Lidocaine hydrochloride monohydrate (4% w/v)
  • Fluorescein sodium (0.25% w/v)
Other ingredients
(inactive ingredients)
  • Povidone
  • Hydrochloric acid
  • Purified water

Do not be given this medicine if you are allergic to any of these ingredients.

The eye drops do not contain any preservatives.

What Minims Lidocaine & Fluorescein looks like

Minims Lidocaine & Fluorescein come in single dose units (tubes) containing 0.5mL of a clear, fluorescent red-orange solution. Each tube is wrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units (AUST R 32272).

Who distributes Minims Lidocaine & Fluorescein

In Australia, Minims Lidocaine & Fluorescein is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067
Phone: 1800 251 150

In New Zealand, Minims Lidocaine & Fluorescein is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand
Toll free number: 0508375394

This leaflet was prepared in May 2024.

Published by MIMS July 2024

BRAND INFORMATION

Brand name

Minims Lidocaine and Fluorescein

Active ingredient

Lidocaine (lignocaine) hydrochloride; Fluorescein sodium

Schedule

S4

 

1 Name of Medicine

Lidocaine hydrochloride monohydrate and fluorescein sodium.

2 Qualitative and Quantitative Composition

Minims Lidocaine and Fluorescein eye drops contain lidocaine 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 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 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 and Fluorescein eye drops unit should be discarded after a single use.

4.3 Contraindications

Minims Lidocaine 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 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 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 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 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 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 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.

CAS number.

518-47-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes