LMX4 Lidocaine 4% w/w Cream

Always use this medicine exactly as described in this leaflet or as instructed for your treatment.

• Keep this leaflet. You may need to read it again.
• Ask your doctor, nurse, or other trained person involved in your treatment if you need more information or advice.
• If you get any side effects, talk to a doctor, nurse or other trained person involved in your treatment. This includes any possible side effects not listed in this leaflet. See section 4.

1. What LMX4 is and what it is used for
2. What you need to know before you use LMX4
3. How to use LMX4
4. Possible side effects
5. How to store LMX4
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to lidocaine or any of the other ingredients listed in this medicine (listed in section 6).
• If you are allergic to any similar local anaesthetics.

Talk to your doctor, nurse or other trained person involved in your treatment before use if:

• You are acutely ill, debilitated or elderly (you will be more sensitive to lidocaine).
• You have a history of being sensitive to the ingredients of any medicines, particularly other local anaesthetics.
• You have a severe liver (hepatic) disease.

Tell your doctor, nurse or other trained person involved in your treatment if you have recently used any other medicines, with or without a prescription, but specifically:

• LMX4, lidocaine or any other local anaesthetic.
• Any medicine used to prevent or treat an irregular heart beat, such as tocainide, mexiletime or amiodarone.
• The beta−blocker propranolol, for the treatment of hypertension.
• Cimetidine, for the treatment of heartburn or stomach ulcers.
• If you are about to receive a vaccination with live vaccine (e.g. tuberculosis vaccine). Live vaccines should not be administered in areas where LMX4 has been applied as the effect of the vaccine may be affected.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask for advice before taking this medicine.

• This medicine contains 75mg propylene glycol in each 1g. Propylene glycol may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist. Do not use on infants below one month.
• This medicine contains 15mg benzyl alcohol in each 1g. Benzyl alcohol may cause allergic reactions or mild irritation.
• This medicine contains polysorbate 80. Polysorbates can cause allergic reactions.

• For external use only. Do not exceed the recommended dose.
• Do not apply to raw or blistered skin, in the ear, inside the nose, in the mouth, to the anus (back passage), where there is a skin rash or eczema, or where there are cuts, grazes or wounds.
• Avoid getting LMX4 cream in your eyes, as it may cause irritation. If you accidentally get any in your eye, immediately rinse it well with lukewarm water or sodium chloride (salt) solution and protect it until sensation returns.
• LMX4 blocks all sensations in the treated area. Avoid scratching, rubbing and exposure to extreme hot and cold until the anaesthetic effect has worn off.

1g of cream is approximately equal to a 5cm length of cream squeezed from the 5g tube or 3.5cm squeezed from the 30g tube.

Adults, including the elderly, and children over 1 year of age:

1g to 2.5g of cream, to cover an area of skin 2.5cm x 2.5cm (1”x1”) where the needle will be inserted. Do not leave on the skin for longer than 5 hours.

Infants over 3 months but below 1 year of age:

No more than 1g of cream should be applied. Do not leave on the skin for longer than 4 hours.

Infants over 1 month but below 3 months of age: No more than 1g of cream should be applied. Do not leave on the skin for longer than 1 hour.

Do not use on infants below one month old.

1. Apply LMX4 at least 30 minutes before the procedure starts.

2. Using the quantity stated above, apply the cream in a uniform layer to the skin.

3. If told to do so, cover the cream with a dressing, to prevent it being accidentally rubbed off the skin.

4. Shortly before the procedure is due to begin, remove the dressing and remove the cream thoroughly with a gauze swab.

1g of cream is approximately equal to a 5cm length of cream squeezed from the 5g tube or 3.5cm squeezed from the 30g tube.

Adults and the elderly aged 18 years and over:

Use 1.5g to 2g on each 10cm² area of skin, to cover a maximum total area of 900cm² (approximately equal to a back or thigh).

Do not exceed the recommended dose.

1. Apply LMX4 approximately 30 to 60 minutes before the procedure starts.

2. Using the quantities stated above, apply the cream in a uniform layer to the skin.

3. Ensure the cream is not accidentally rubbed off the skin.

4. Shortly before the procedure is due to begin, remove the cream thoroughly with a gauze swab.

The cream should not be reapplied for at least 12 hours after it has been removed.

Do not use on patients below 18 years of age for large surface areas.

Overdose is unlikely, but talk to a doctor, nurse or other trained person involved in your treatment straight away, even if you do not feel any symptoms. An overdose may include using more than the recommended amount, applying the cream to large areas or using the cream for longer than recommended.

The following overdose symptoms may be experienced: blurred vision, dizziness or drowsiness, difficulty breathing, trembling, chest pain or an irregular heartbeat.

If you get any side effects, talk to a doctor, nurse or other trained person involved in your treatment. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA’s Yellow Card Scheme, available at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is lidocaine. 1g of cream contains 40mg of lidocaine.

The other ingredients are benzyl alcohol, carbomers, cholesterol, phospholipon 80H (hydrogenated soy lecithin), polysorbate 80, propylene glycol, trolamine, vitamin E acetate and purified water.

LMX4 is a white to off-white cream presented in a 5g or 30g tube. It may be packed into a carton that also contains dressings that can be used to cover and protect the cream after it has been applied to the skin.

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