SUMMARY CMI

ALCAINE™

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 using ALCAINE?

ALCAINE contains the active ingredient proxymetacaine hydrochloride. ALCAINE is used to temporarily numb or block the feeling of pain in your eye(s).

For more information, see Section 1. Why am I using ALCAINE? in the full CMI.

2. What should I know before I use ALCAINE?

Do not use if you have ever had an allergic reaction to ALCAINE 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 use ALCAINE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ALCAINE 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 do I use ALCAINE?

• The usual dose of ALCAINE is one to two drops in your eye(s). This may be repeated every 5-10 minutes, for up to 3 doses.
• ALCAINE is only to be used by your doctor during a medical procedure.

More instructions can be found in Section 4. How do I use ALCAINE? in the full CMI.

5. What should I know while using ALCAINE?

For more information, see Section 5. What should I know while using ALCAINE? in the full CMI.

6. Are there any side effects?

All medicines can have side effects although not everybody gets them. The most common side effects of ALCAINE include irritation, stinging and burning feeling in the eye, redness or watery eyes, increased blinking. Less common side effects can include dilated pupils causing blurred vision, drying and splitting of the skin on fingertips, a severe, immediate allergic reaction on the surface of the eye.

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

ALCAINE™

Active ingredient(s): proxymetacaine hydrochloride

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I using ALCAINE?
2. What should I know before I use ALCAINE?
3. What if I am taking other medicines?
4. How do I use ALCAINE?
5. What should I know while using ALCAINE?
6. Are there any side effects?
7. Product details

1. Why am I using ALCAINE?

ALCAINE contains the active ingredient proxymetacaine hydrochloride. ALCAINE (proxymetacaine hydrochloride) belongs to a group of medicines called local anaesthetics.

ALCAINE Eye Drops are only to be used by your doctor during eye procedures.

ALCAINE is used by your doctor to temporarily numb or block the feeling (anaesthetise) of pain in your eye(s) during short-term medical procedures. These procedures can include measuring the pressure in your eye, cataract surgery, removing stitches or a foreign body from your eye e.g. a bit of dirt.

The numbing effect of ALCAINE will wear off quickly, usually about 15 minutes after the last drop is put in your eye(s).

Ask your doctor if you have any questions or concerns about why this medicine has been used on your eye(s).

Your doctor may have prescribed it for another reason.

2. What should I know before I use ALCAINE?

Warnings

Do not use ALCAINE if:

• you are allergic to proxymetacaine hydrochloride, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• Do not use ALCAINE if you have an allergy to any other local anaesthetics.
• 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 ALCAINE after the expiry date printed on the pack or if the seal around the pack is broken or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
• ALCAINE has been developed for use in the eye only. It is not to be swallowed or injected.
• If you are not sure whether you should be given ALCAINE talk to your doctor.

Check with your doctor if you:

• have any other medical conditions, especially:
  - Epilepsy
  - Heart problems
  - Lung or breathing problems
  - Myasthenia gravis (a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs)
• have ever experienced a reaction to any other local anaesthetics
• 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?

Pregnancy and breastfeeding

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

ALCAINE is not recommended for use in pregnancy. Your doctor will discuss the possible risks and benefits of using ALCAINE during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Your doctor will discuss the possible risks and benefits involved.

Long term use

• may lessen the anaesthetic effect so that more of the medicine is needed to produce the numbing effect
• it may also damage the surface of the eye, cause an eye infection or permanent loss of sight.

Protect your eyes

It is very important that you protect your eyes from irritating chemicals, avoid touching or rubbing your eye(s) until the numbness has worn off.

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 may interfere with ALCAINE and affect how it works.

Telling your doctor is particularly important if you are currently using any medicines called "cholinesterase inhibitors".

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

Your doctor will advise you and decide whether or not to give you ALCAINE.

4. How do I use ALCAINE?

How much to use

• Your doctor will put the correct number of drops of ALCAINE into your eye(s) before starting the procedure on your eye(s).
• Your doctor will not write a prescription for ALCAINE for your own use. ALCAINE has been specifically developed to help a doctor numb the feeling in your eye(s) while attending to your eye(s).
• The usual dose of ALCAINE is one to two drops in your eye(s).
• The number of times you will be given ALCAINE during the procedure will depend on the type and length of procedure to be performed. For example, your doctor will put one to two drops into your eye(s) just before measuring the pressure in your eye. However, if you are to have minor surgery such as removal of stitches your doctor will put one to two drops in your eye(s) every 5 to 10 minutes for up to three doses.

When to use ALCAINE

ALCAINE is only to be used by your doctor during an eye procedure.

If you are given too much ALCAINE

The doctor giving you ALCAINE will be experienced in the use of local anaesthetics, so it is unlikely that you will be given too much.

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

If you think that you or someone else has swallowed too much ALCAINE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre in Australia (by calling 13 11 26), 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 while using ALCAINE?

Things you should do

• You must protect your anaesthetised eye(s) from dust particles, which could cause infection.
• If you are wearing soft contact lenses, you will be asked to remove them prior to instillation of the drops by your doctor. You may put your soft contact lenses back into your eyes after the numbing effect has worn off and at least 15 minutes after you have been given ALCAINE

Things you should not do

Do not touch or rub your eye(s) while they are 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 ALCAINE affects you and your vision.

As with any eye medicines, temporary blurred vision or another visual disorder may affect your ability to drive or use machinery in some people. If blurred vision occurs, wait until your vision is clear before you drive or use machines or tools.

Looking after your medicine

ALCAINE will be stored by your doctor or pharmacist under the recommended conditions.

• Store in a fridge between 2°C and 8°C
• Do not freeze
• Protect from light

When to discard your medicine (as relevant)

ALCAINE should be used in a single patient only.

Do not use if seal is broken.

Do not use if the liquid is discoloured.

Discard the container 4 weeks after opening.

Getting rid of any unwanted medicine

Do not use any medicine after the expiry date.

Unwanted medicines can be taken to any pharmacy for safe disposal.

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 if you have any further questions about side effects.

Less serious side effects

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 affects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor, nurse, 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 ALCAINE contains

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

What ALCAINE looks like

ALCAINE eye drops is a sterile, clear liquid that comes in a 15 mL dropper bottle. (AUST R 24299).

Who distributes ALCAINE

ALCAINE is distributed in Australia by:

Alcon Laboratories (Australia) Pty Ltd
ABN 88 000 740 83054
15 Talavera Road
Macquarie Park NSW 2113
Telephone: 1800 224 153

This leaflet was prepared in June 2023. Internal document code alc120923c.

You should ensure that you speak to your doctor to obtain the most up to date information on the medicine.

You can also obtain a copy of the most up to date leaflet from your pharmacist. The updates may contain important information about the medicine and its use of which you should be aware.

Published by MIMS October 2023

1 Name of Medicine

Proxymetacaine hydrochloride.

2 Qualitative and Quantitative Composition

Alcaine Eye Drops contain 5 mg/mL (0.5%) proxymetacaine hydrochloride.
Proxymetacaine hydrochloride is a white or almost white, crystalline powder, odourless or almost odourless. It is soluble in water and in chloroform; very soluble in absolute ethanol, practically insoluble in ether.

Excipient with known effect.

3 Pharmaceutical Form

Eye drops, sterile solution, preserved.

4 Clinical Particulars

4.1 Therapeutic Indications

Alcaine Eye Drops are indicated for procedures in which a rapid and short acting topical ophthalmic anaesthetic is indicated, such as in cataract surgery and suture removal from the cornea, and in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, and other short corneal and conjunctival procedures.

4.2 Dose and Method of Administration

For ocular use only.
Single patient use only.
After cap is removed, if tamper evident snap collar is loose, remove before using product. Discard container 4 weeks after opening.
If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.
For tonometry and other procedures of short duration, instil one or two drops just prior to evaluation.
For minor surgical procedures such as foreign body or suture removal, instil one to two drops every five to ten minutes for one to three doses.
For prolonged anaesthesia as in cataract extraction, instil one to two drops in the eye(s) every five to ten minutes for three to five doses.

Note.

4.3 Contraindications

Alcaine is contraindicated in patients with known hypersensitivity to proxymetacaine hydrochloride or any of the excipients (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

Not for injection into the eye.
Prolonged use of a topical ocular anaesthetic may produce a diminished duration of the effect, thus more and more of the medication is required to produce the desired anaesthetic effect. Prolonged use or abuse may result in corneal epithelial toxicity and may manifest as epithelial defects, subsequent corneal damage, corneal infection, corneal perforation and/or corneal opacification with accompanying permanent loss of vision. The long-term toxicity of proxymetacaine hydrochloride is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anaesthetics, it should be borne in mind that systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur.
Local anaesthetics should be used cautiously and sparingly in patients with known allergies, epilepsy, cardiac disease, hyperthyroidism or in patients with respiratory problems. Patients who suffer from myasthenia gravis are particularly sensitive to the effects of anaesthetics. Patients with a low amount of acetylcholinesterase in the plasma, and patients being treated with cholinesterase inhibitors exhibit an increased risk for systemic side effects during topical application of ester type anaesthetics.
Protection of the eyes from irritating chemicals, foreign bodies and rubbing during the period of anaesthesia is very important. Tonometers soaked in sterilising or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use.
Advise patients that, due to the effect of the anaesthetic, their eyes will be insensitive and that care should be taken to avoid accidental eye injuries.
Alcaine Eye Drops may cause allergic contact dermatitis. Avoid contact with the skin.
Alcaine Eye Drops are intended for administration by a healthcare professional for ophthalmic procedures. Topical ophthalmic anaesthetics are not intended for use by patients for self administration.

Contact lenses.

Use in patients with hepatic impairment.

Use in patients with renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The metabolism of local anaesthetics derived from esters may be inhibited by anticholinesterases thus increasing the risk of systemic toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after administration, the patient must wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Pupillary dilatation or cycloplegic effect have rarely been observed with proxymetacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anaesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proxymetacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking. However, some local irritation and stinging may occur several hours after instillation.
Rarely, a severe, immediate type, apparently hyperallergic corneal reaction may occur which include acute, intense and diffuse epithelial keratitis; a grey, ground glass appearance; sloughing of large areas of necrotic epithelium; corneal filaments and, sometimes, iritis and descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. Softening and erosion of the corneal epithelium and conjunctival congestion and haemorrhage have been reported.

Postmarketing experience.

Reporting suspected adverse effects.

4.9 Overdose

In the event of overdose or accidental ingestion, systemic effects may manifest as central nervous system (CNS) stimulation and may include nervousness, tremors or convulsions, followed by depression in CNS which may result in loss of consciousness and respiratory depression. A topical overdose of Alcaine Eye Drops can be flushed from the eyes with warm water. Appropriate symptomatic treatment is indicated if any systemic effects are observed.
For information on management of overdose in Australia contact the Poisons Information Centre on 13 11 26; in New Zealand, call 0800 POISON or 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

After topical administration, proxymetacaine hydrochloride is absorbed into the system and generally decomposes quickly in the plasma; however, high doses can cause undesirable systemic effects.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzalkonium chloride, glycerol, hydrochloric acid and/or sodium hydroxide (to adjust pH), 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

24 months.
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° to 8°C. Refrigerate do not freeze. Protect from light.

6.5 Nature and Contents of Container

Alcaine Eye Drops are supplied in multi-dose, opaque LDPE Drop-Tainer dispenser bottles; 15 mL.

6.6 Special Precautions for Disposal

In Australia, any unused eye drops should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes