LMX4 Cream Ref.[27730] Active ingredients: Lidocaine

For cutaneous use only.

Venous cannulation or venipuncture

Adults, including elderly, and children over one month of age:

Apply 1g to 2.5g of cream onto the skin to cover a 2.5cm x 2.5cm (6.25cm²) area where venous cannulation or venipuncture will occur. No more than 1g of cream should be applied to infants below the age of 1 year. 1g of cream equates to approximately 5cm of cream squeezed from the 5g tube, or 3.5cm from the 30g tube.

The cream should remain undisturbed and the area can be covered with an occlusive dressing to prevent disturbance or interference by the patient or other external factors. Adequate anaesthesia should be obtained after 30 minutes, but the LMX4 Cream may be applied for up to 5 hours under a dressing. Prior to starting the procedure, the LMX4 Cream should be removed using a clean gauze swab and the site for venous cannulation or venipuncture prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed. Maximum application time for 1 month up to 3 month infant should not exceed 60 minutes. Maximum application time for 3 month up to 12 month infant should not exceed 4 hours. Maximum application for 12 month infant – adult should not exceed 5 hours.

LMX4 is not recommended for use in infants under one month of age.

Painful topical treatments on larger surface areas of intact skin

Adults, including the elderly.

Apply the cream at a dosage of approximately 1.5g to 2g LMX4 /10cm² skin to be treated, or multiples thereof, up to a maximum area of 900cm². Apply until response is achieved, which is generally for between 30 to 60 minutes in clinical studies.

Typical estimated larger quantities would be 30g-40g/200cm² (approximately 10cm x 20cm, or covering a face), 45g-60g/300cm² (approximately 10cm x 30cm or covering an arm), or 135g-180g/900cm² (approximately 30cm x 30cm, or covering a torso or back).

Indirect evidence has shown that successive applications of lidocaine-based topical treatments can lead to systemic accumulation of lidocaine. LMX4 must therefore not be reapplied for 12 hours following its removal, giving a maximum of 2 doses in any 24 hour period.

The LMX4 cream should be applied evenly at the specified dosage with a uniform thickness across the area where the topical treatment will occur. Measures may be taken to ensure the cream remains undisturbed until adequate analgesia has been achieved.

Prior to starting the procedure, the LMX4 Cream should be removed using a clean gauze swab and the site for topical treatment prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed.

Use of LMX4 is not recommended for this indication in patients below 18 years of age.

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.

Unopened: three years.

Opened: 3 months.

This medicinal product does not require any special storage conditions.

Do not freeze.

For storage conditions after first opening of the medicinal product, see section 6.3.

The pack sizes are 5g and 30g. Both packs comprise either:

• an aluminium tube with an epoxyphenolic internal lacquer, fitted with a polypropylene cap or
• an aluminium tube with a polyamide-imide internal lacquer fitted with a polyethylene cap.

The following packaging options are approved but not all of these packaging options may be marketed:

1. A carton containing one 5g tube.
2. A carton containing five 5g tubes.
3. A carton containing one 5g tube with two Tegaderm occlusive dressings.
4. A carton containing five 5g tubes with ten Tegaderm occlusive dressings.
5. A carton containing one 30g tube.

No special requirements for disposal.