Overview

This medicine is used to help ease discomfort of inflamed areas of skin and to protect them while they heal. Lidocaine is a local anaesthetic that will numb the area it is applied to, helping to reduce discomfort.

The medicine is mixed with Lutrol^® F127 (a thickening agent), which is a liquid when cold (from the fridge) but thickens at body temperature. This means that it forms a barrier when applied to the wound or affected area, helping it to stay in place. Because of this, it might provide longer-lasting pain relief than other lidocaine products.

Each 5ml of gel contains the following: 100mg lidocaine, Lutrol F127 and water.

The specific name of this preparation is 'lidocaine 2% w/v in Lutrol F127 24% w/v gel'.

You should not use this product if you have a known allergy to lidocaine or Lutrol.

Medicine – using an unlicensed medicine

Lidocaine is a widely used local anaesthetic for numbing painful skin. Licensed products are available, but none of them contain lidocaine in Lutrol gel. This medicine is specially made for each patient, in a specialist hospital manufacturing unit, and is unlicensed. This means that it does not have a product licence, but your doctor thinks that it might help you.

Read our information about unlicensed medicines. You can also call our pharmacy medicines helpline, phone 020 7188 8748, Monday to Friday, 9am to 5pm, or email [email protected]

How to use this medicine

• Use this product only as prescribed by your doctor.
• Put the gel in the fridge 30 minutes before you want to use it. This makes the gel runny, which makes it easier to apply. Use it immediately after removing it from the fridge, as it thickens quickly.
• Wash your hands and put on a pair of clean medical gloves. These may be provided by your doctor, or you will need to buy some online or from a pharmacy.
• Pour the gel over the affected area, and use a gloved finger to spread it to form a thin layer. 1 small bottle (vial) will cover an area of about 10cm x 10cm.
• The numbing effect of the gel usually lasts 6 to 8 hours. How often you use the gel will depend on how much pain you have, and how well the gel works for you.

Do not use more than 5 bottles of gel in any 24 hour period.

• Throw away any remaining gel, used bottles and medical gloves after use, either in a clinical waste bag or a sharps bin (which should be provided by your doctor or nurse). These should be returned to your local pharmacy, medical centre or hospital for disposal.
• Wash your hands after use.
• Allow the area to dry until it does not feel sticky (which might take up to 10 minutes) before replacing any dressings or clothing. The gel, which is water based, will be absorbed into the wound over the next few hours.
• Treatment with the gel can continue as long as needed. Your doctor will let you know how long you should use it for.

If you forget to use the medicine

If you forget to apply the gel, use it when you remember, or at the next dressing change, or when convenient. Do not use any extra doses.

If you use too much

If you use too much of the gel, contact your doctor or hospital immediately for advice. When seeking emergency treatment show them this information, and take a sample of the gel with you, so that they can identify the medicine.

Side effects

Mild side effects

Everyone absorbs the lidocaine differently, and side effects are rare (less than 1 in 100 patients). Side effects are more likely to occur if there has been a high absorption of lidocaine into the body. Signs include:

• skin irritation
• redness
• itching
• dryness or rash at the site of application

If these persist, or get worse, with each application of the gel, report this to the doctor who prescribed it for you, for advice about continuing use of the gel.

Serious side effects

Allergic reactions to this product are rare (less than 1 in 1,000 patients). Signs of an allergic reaction to lidocaine include:

• swelling of the mouth and face
• a rash or itching (this might be over your whole body, not just where the gel was applied).

If this happens you should stop using the gel, and get urgent medical advice.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, nurse or prescribing doctor. This includes any possible side effects not listed in this information.

You can also report side effects directly via the Yellow Card Scheme,
web: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

Taking other medicines while using the gel

Some medicines should not be used while you are using this gel. Please let the person prescribing this medicine for you know about any other medicines that you are taking. This includes prescribed medicines, anything you buy from a pharmacy or shop, and any herbal, homeopathic or alternative medicines.

How to store the gel

It should be stored at room temperature (below 25C), out of the sight and reach of children. Remember that it needs to be placed in a fridge 30 minutes before it is applied.

Do not store permanently in the fridge.

Disposing of unused gel

Each bottle is for 1 use only, and any unused gel should be thrown away. If the product is being applied by a nurse, they will do this for you. If you are applying it yourself, your GP can provide a supply of medicine waste boxes with lids (usually yellow) with instructions on how to use and dispose of them.

Do not throw away any medicines in waste water or household waste.

Do not use any opened products after the expiry date on the bottle. Any expired medicine should be disposed of as above.

Driving and operating machinery

The area of your body where the gel has been applied may be numb for 6 to 8 hours after application. If this is likely to affect your ability to drive or use machinery, you should wait for the effect to wear off before you try to do so. Ask your doctor when it would be safe to resume these activities.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using any of the gel.

Repeat prescriptions

This product has to be specially made, and this can take up to 4 weeks. Please make sure that you contact your prescriber in plenty of time to arrange for more gel. If it is prescribed by a hospital doctor, please take the prescription to the hospital pharmacy. If it is prescribed by a doctor outside the hospital, take the prescription to a local pharmacy.

Please show them this information so they know how to order it. The pharmacy manufacturing unit at Guy’s Hospital can be contacted by the prescriber or pharmacist, on phone: 020 7188 4922, or email: [email protected]