SUMMARY CMI

LMX4^®

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.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

1. Why am I using LMX4^®?

LMX4^® contains the active ingredient lidocaine (lignocaine). LMX4^® is used for topical anaesthesia of intact skin prior to superficial skin procedures, including insertion of IV catheters and blood sampling.

For more information, see Section 1. Why am I using LMX4^®? in the full CMI.

2. What should I know before I use LMX4^®?

Do not use if you have ever had an allergic reaction to LMX4^® or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist 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 LMX4^®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with LMX4^® 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 LMX4^®?

• Adults, the elderly and children 1 year of age and older: Apply up to 1g to 2.5g of cream onto the skin where venous cannulation or venipuncture will occur.
• Full term neonates and infants up to 1 year of age: Apply up to 1g of cream onto the skin where venous cannulation or venipuncture will occur. Not more than 1g of cream should be applied to infants below the age of 1 year.

More instructions can be found in Section 4. How do I use LMX4^®? in the full CMI.

5. What should I know while using LMX4^®?

For more information, see Section 5. What should I know while using LMX4^®? in the full CMI.

6. Are there any side effects?

Local reaction such as itching, swelling, paleness, redness or a burning sensation are common side effects of LMX4^®. They are usually mild and short-lived. A rash at a spot where LMX4^® is not being used or difficulty breathing, are very serious side effects which may require urgent medical attention or hospitalisation.

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.

WARNING: FOR EXTERNAL USE ONLY. DO NOT APPLY NEAR EYES. NOT TO BE USED ON BROKEN SKIN. Do not apply to large areas of the body except on the advice of a healthcare practitioner. If skin irritation occurs, stop immediately and seek medical attention. Also contains benzyl alcohol as a preservative.

FULL CMI

LMX4^®

Active ingredient(s): lidocaine (lignocaine)

Consumer Medicine Information (CMI)

This leaflet provides important information about using LMX4^®. 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 LMX4^®.

Where to find information in this leaflet:

1. Why am I using LMX4^®?
2. What should I know before I use LMX4^®?
3. What if I am taking other medicines?
4. How do I use LMX4^®?
5. What should I know while using LMX4^®?
6. Are there any side effects?
7. Product details

1. Why am I using LMX4^®?

LMX4^® contains the active lidocaine (lignocaine). LMX4^® belongs to a group of medicines called local anaesthetics. It works by numbing the area where the cream has been applied.

LMX4^® is used for topical anaesthesia of intact skin prior to superficial skin procedures, including insertion of IV catheters and blood sampling.

Ask your doctor if you have any questions about this medicine.

Your doctor may have given it for another reason.

LMX4^® is not addictive.

This medicine is not expected to affect your ability to drive a car or operate machinery.

2. What should I know before I use LMX4^®?

Warnings

Do not use LMX4^® if you or your child have an allergy to:

• LMX4^®, or any of the ingredients listed at the end of this leaflet.
• Any medicine containing lignocaine.
• Any other similar medicines (other local anesthetics, for example those used at the dentist).
• Adhesives or sticking plasters
  Always check the ingredients to make sure you can use this medicine.

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 on premature babies.

Safety and effectiveness in infants who are not full term, have not been established.

Do not use LMX4^® after the expiry date printed on the pack or if the packing is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should use LMX4^®, talk to your doctor.

Before you start to use it

Tell your doctor if you or your child have allergies to any other medicine, foods, preservatives, or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• You are acutely ill or elderly (you will be more sensitive to lignocaine)
• You have severe liver (hepatic) disease

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

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

The ingredients in LMX4^® have been used for many years and no ill effects have been shown if they are used while you are pregnant.

Only very small amounts of LMX4^® get into the blood, so even though your baby can take LMX4^® from breast milk if you are breast feeding, it is unlikely to cause any problems.

If you have not told your doctor about any of the above, tell him/her before you start using LMX4^®.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you or your child is 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 LMX4^®may interfere with each other. These include:

• Medicines used to treat arrhythmia (irregular heartbeat) such as tocainide, mexiletine and amiodarone.
• Other local anaesthetics.

These medicines may be affected by LMX4^® or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

4. How do I use LMX4^®?

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the package leaflet, ask your doctor or pharmacist for help.

How much to use

• 1g is approximately equal to 5cm length of cream squeezed from the 5g tube and 3.5cm from the 30g tube.
• Adults, the elderly and children 1 year of age and older:
  Apply 1g – 2.5g of the cream to cover an area of skin 2.5 x 2.5 cm.
• Full term neonates and infants up to 1 year of age:
  No more than 1g of cream should be applied

When to use LMX4^®

• Apply LMX4^® at least 30 minutes before you are due for the procedure.
• Depending on the procedure, your doctor may advise for the cream to be left on for a longer time if you choose not to occlude the cream with a dressing. Refer to package leaflet for more information.

How to use LMX4^®

• Apply a small amount of cream and if required or not using an occlusive dressing gently massage it into the skin.
• Then apply the specified amount of cream (refer above ‘How much to use’) to the area undergoing the procedure.
• The cream can then be left uncovered or covered with a dressing for the time specified below.
• Adults, the elderly and children 12 years of age and older:
  Do not leave on the skin for longer than 5 hours
• Full term neonates, infants and children under 12 years of age:
  Do not leave on the skin for longer than an hour.

Refer to package leaflet for detailed directions for use.

If you forget to use LMX4^®

Apply LMX4^® as soon as you realise you have forgotten.

If it is less than 30 minutes before your procedure, talk to your doctor.

If you use too much LMX4^®

If you think that you have used too much LMX4^®, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (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.

Overdose with LMX4^® cream is unlikely. However, if you use too much you may feel nervous, dizzy, have blurred vision and shaky hands.

5. What should I know while using LMX4^®?

Things you must do

• Remember to apply LMX4^® on intact skin at least half an hour (30 minutes) before your procedure is due.
• Depending on your procedure this time may vary and your doctor will advise you of this.
• If you do not, you or your child's appointment may have to be delayed, or the procedure may hurt more than it would otherwise.
• Be sure to follow the instruction in the package leaflet on how to apply LMX4^® cream carefully.
• Make sure the dressing covering the cream is firmly fixed, especially on young children.
• If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

Remind any doctor, dentist or pharmacist you visit that you are using LMX4^®.

Things you must not do

• Do not apply LMX4^® to damaged or diseased skin. LMX4^® is for external use only.
• Do not use LMX4^® to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

• Be careful not to let LMX4^® get into your eyes.
  It may cause eye irritation. If LMX4^® does get into your eyes, immediately rinse them with large amounts of water and contact your doctor or pharmacist for advice.
• Be careful not to inadvertently injure the anaesthetised area where LMX4^® has been applied.
  Be careful not to scratch, rub or accidently expose the treated area to extreme cold or heat until complete sensation has returned.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how LMX4^® affects you.

Looking after your medicine

• Keep the cream in the carton until it is time to use it.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place where the temperature stays below 25°C. Do not freeze, do not refrigerate. Do not store LMX4^®:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

Ask your pharmacist what to do with any LMX4^® that is left over or you find it has expired.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you or your child do not feel well while using LMX4^®.

This medicine helps most people during superficial skin procedures, including insertion of IV catheters and blood sampling, but it may have unwanted side effects in a few people.

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.

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

Common side effects

Serious side effects

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

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What LMX4^® contains

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

What LMX4^® looks like

LMX4^® is a white to off-white, yellowish cream.

LMX4^® cream is registered with the following packs:

Aust R 126095

• Carton containing one 5g tube
• Carton containing 5x5g tubes
• Carton containing one 15g tube
• Carton containing one 30g tube

Aust R 208815

• Carton containing 5x5g tubes with 10 occlusive dressings

Some packs may not be currently marketed.

Who distributes LMX4^®

Dermocosmetica
Unit 8, 14-16 Lens Street
Coburg North, VIC 3058
Australia

This leaflet was prepared in November 2020.

Published by MIMS August 2024

1 Name of Medicine

LMX4 (lidocaine).

2 Qualitative and Quantitative Composition

The active ingredient of LMX4 is lidocaine 40 mg.
Chemical name: 2-diethylaminoaceto-2',6'-xylidide.
Molecular formula: C₁₄H₂₂N₂O.
Molecular weight: 234.3.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Topical cream. A white to off-white yellowish cream.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical anaesthesia of intact skin prior to superficial skin procedures, including insertion of IV catheters and blood sampling.

4.2 Dose and Method of Administration

For cutaneous use only.

Adults, the elderly and children 1 year of age and older.

Full term neonates and infants up to 1 year of age.

Adults, the elderly and children 12 years of age and older.

Full term neonates, infants and children under 12 years of age.

4.3 Contraindications

Hypersensitivity to the active substance, or any of the amide-type local anaesthetics, or any of the excipients.

4.4 Special Warnings and Precautions for Use

For external use only.
Avoid contact with eyes. Lidocaine coming in contact with the eye should be avoided because animal studies have demonstrated severe eye irritation. Also, the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of lidocaine in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Do not apply to irritated skin or if excessive irritation develops. If condition worsens, or if symptoms persist unaltered for more than seven days or clear up and occur again within only a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw or blistered areas.
LMX4 should not been applied to wounds, mucous membranes or in areas of atopic dermatitis.
Application of lidocaine to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine resulting in serious adverse effects.
Repeated doses of lidocaine may increase blood levels of lidocaine. Lidocaine should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine including acutely ill, debilitated, or elderly patients.
Lidocaine should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible. Studies in laboratory animals (guinea pigs) have shown that lidocaine has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine in the external auditory canal only showed no abnormality.
Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine; however, lidocaine should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to metabolize local anaesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine. Patients with severe cardiac or renal impairment are also at greater risk.
When lidocaine is used, the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.
Lidocaine has bactericidal and antiviral properties in concentrations above 0.5%. For this reason, the results of intracutaneous injections of live vaccines (such as BCG vaccination) should be monitored.

Paediatric use.

Use in the elderly.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Lidocaine should be used with caution in patients receiving class III and Ib antiarrhythmic drugs (such as amiodarone, tocainide and mexiletine) since the toxic effects are additive and generally synergistic.
The risk of additional systemic toxicity should be considered when large doses of LMX4 are applied to patients already using other local anaesthetics.
Drugs that reduce the clearance of lidocaine - for instance, cimetidine or beta-blockers - may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions should not be of clinical importance following short-term treatment of LMX4 at recommended doses.

4.6 Fertility, Pregnancy and Lactation

(Category A)
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. Lidocaine should be used during pregnancy only if clearly needed.
Lidocaine is not contraindicated in labour and delivery. Should LMX4 be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.
Lidocaine crosses the placental barrier.
Lidocaine is excreted in human milk. Therefore, caution should be exercised when LMX4 is administered to a nursing mother since the milk-plasma ratio of lidocaine is 0.4.

4.7 Effects on Ability to Drive and Use Machines

None known.

4.8 Adverse Effects (Undesirable Effects)

Common side effects (> 1/100) can include irritation, redness, itching, or rash.
In rare cases local anaesthetics have been associated with allergic reactions including anaphylactic shock.
To the best of our knowledge there have been no reports of methaemaglobinaemia directly associated with LMX4.
Corneal irritation after accidental eye exposure.
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.

4.9 Overdose

In an event of an overdose contact the Poisons Information Centre (telephone 13 11 26 in Australia and 0800 764 766 in New Zealand). Overdose with LMX4 cream is unlikely, but signs of systemic toxicity would be consistent with those of lidocaine.
An indication of systemic toxicity may include blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain, or irregular heartbeat.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Anaesthetics for topical use. Lidocaine is an amide-type local anaesthetic agent which stabilises neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anaesthetic action.

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Patient accountability.

5.2 Pharmacokinetic Properties

It has been reported that the amount of lidocaine systemically absorbed is directly related to both the duration of application and to the area over which it is applied. It is not known if it is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine. The end metabolite, 2,6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats (Parker et al 1996). Following IV administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of administered lidocaine serum concentrations, respectively. The half-life of lidocaine elimination from the plasma following IV administration is approximately 65 to 150 minutes (mean 110, ± 24 SD, n =13). This half-life may be increased in cardiac or hepatic dysfunction. More than 98% of an absorbed dose of can be recovered in the urine as metabolites or parent drug. The systemic clearance is 10 to 20 mL/min/kg (mean 13, ± 3 SD, n =13) (Benowitz and Meister, 1978).
When applied topically to intact skin, the absorption of lidocaine is very low. Increased absorption is therefore to be expected when applied to mucosa or previously damaged skin. LMX 4 should not be applied to mucosa or previously damaged skin.
The maximum plasma level of active ingredient was very low (0.3 microgram/mL or less) in a study investigating the application of LMX4 in 120 children aged 5-7 years, well below the therapeutic (1.2 microgram/mL) and toxic (> 5 microgram/mL) plasma level (Eichenfield, 2002).
Another study evaluated the potential absorption and clinical toxicity of either 30 g or 60 g of occluded LMX4 lidocaine cream (removed after 60 minutes) in healthy adult volunteers (Nestor, 2006). Blood levels of lidocaine and monoethylglycinexylidide (MEGX) were measured at 1, 2, 6 and 24 hours post application. Additionally, the volunteers were assessed for any clinical signs of lidocaine toxicity. All blood samples showed less than 0.5 microgram/mL of serum lidocaine and MEGX metabolite. Patients reported no systemic effects and did not show any clinical signs of lidocaine toxicity. This study demonstrates the safety of topically applied 4% lidocaine cream, when up to 60 g of product is applied under occlusion to an area of up to 600 cm² in healthy subjects.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, carbomer 940, cholesterol, lecithin - hydrogenated, polysorbate 80, propylene glycol, triethanolamine, dl-alpha tocopheryl acetate, water - purified.

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 below 25°C.

6.5 Nature and Contents of Container

LMX4 is a white to off-white yellowish cream packaged in aluminium tubes fitted with a polypropylene cap in pack sizes of 5 g, 15 g and 30 g. The tubes are packed in individual cartons in the sizes below. All tubes and cartons are branded with the LMX4 registered trademark.
The following packaging options are approved but not all of these packaging options may be marketed.

AUST R 126095.

AUST R 208815.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 2 (Pharmacy Medicine).

Summary Table of Changes