Numeca cream 5% – patient leaflet, side effects, dosage

1. What Numeca Cream is and what it is used for

Numeca Cream contains two active substances called lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics.

Numeca Cream works by numbing the surface of the skin for a short time. It is put on the skin before certain medical procedures. This helps to stop pain on the skin, however you may still have the feelings of pressure and touch.

Adults, Adolescents and Children

It can be used to numb the skin before:

• Having a needle put in (for example, if you are having an injection or a blood

  test).

• Minor skin operations.

Adults and Adolescents

It can also be used:

• To numb the genitals before:

A doctor or nurse should apply Numeca Cream on the genitals.

Adults

It can also be used to numb the skin before:

• Cleansing or removal of damaged skin of leg ulcers.

For other purposes than application to intact skin, the product should be used only upon recommendation of a doctor, nurse or pharmacist.

2. What you need to know before you use Numeca Cream

Do not use Numeca Cream:

• if you are allergic to lidocaine or prilocaine, other similar local anaesthetics or

  any of the other ingredients of this medicine (listed in section 6). Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Numeca Cream:

• if you or your child have a rare inherited illness that affects the blood called

  'glucose-6-phosphate dehydrogenase deficiency'.

• if you or your child have a problem with blood pigment levels called

  “methaemoglobinaemia”.

• Do not use Numeca Cream on areas with skin rash, cuts, grazes or other open

  wounds, with the exception of a leg ulcer. If any of these problems are present, check with your doctor, pharmacist or nurse before using the cream.

• if you or your child have an itchy skin condition called 'atopic dermatitis', a

  shorter application time may be sufficient. Application times of longer than 30 minutes may result in an increased incidence of local skin reaction (see also section 4 “Possible side effects”).

• if you take particular products for heart rhythm disorders (class III

  antiarrhythmics, such as amiodarone). In that case the doctor will monitor your heart function.

Due to the potentially enhanced absorption on the newly shaven skin, it is important to follow the recommended dosage, skin area and application time. Avoid getting Numeca Cream in the eyes, as it may cause irritation. If you accidentally get Numeca Cream in your eye, you should immediately rinse it well with lukewarm water or salt (sodium chloride) solution. Be careful to avoid getting anything in your eye until feeling returns.

Numeca Cream should not be applied to an impaired eardrum.

When you use Numeca Cream before being vaccinated with live vaccines (e.g. tuberculosis vaccine), you should return to your doctor or nurse after the time period requested to follow-up the vaccination result.

Children and adolescents

In infants/newborn infants younger than 3 months a transient, clinically not relevant increase in blood pigment levels “methaemoglobinaemia” is commonly observed up to 12 hours after Numeca Cream is put on.

The effectiveness of Numeca Cream when drawing blood from the heel of newborn infants or to provide adequate analgesia for circumcision could not be confirmed in clinical studies.

Numeca Cream should not be applied to the genital skin (e.g. penis) and genital mucosa (e.g. in the vagina) of children (below 12 years of age) owing to insufficient data on absorption of active substances.

Numeca Cream should not be used in children younger than 12 months of age who are being treated at the same time with other medicines that affect blood pigment levels “methaemoglobinaemia”. (e.g. sulphonamides, see also Section 2 Other medicines and Numeca Cream).

Numeca Cream should not be used in preterm newborn infants.

Other medicines and Numeca Cream

Tell your doctor, pharmacist or nurse if you are using/ taking, have recently used/ taken or might use/ take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Numeca Cream can affect the way some medicines work and some medicines can have an effect on.

In particular, tell your doctor, pharmacist or nurse if you or your child have recently used or been given any of the following medicines:

• Medicines used to treat infections, called 'sulphonamides' and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines to treat an uneven heartbeat, such as amiodarone.

• Cimetidine or beta-blockers, which may cause an increase in the blood levels of

  lidocaine. This interaction is of no clinical relevance in short-term treatment with Numeca Cream in recommended doses.

Pregnancy, breastfeeding and fertility

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 this medicine. Occasional use of Numeca Cream during pregnancy is unlikely to have any adverse effects on the foetus.

The active substances in Numeca Cream (lidocaine and prilocaine) are passed into breast milk. However, the amount is so small that there is generally no risk to the child.

Animal studies have shown no impairment of male or female fertility. Driving and using machines

Numeca Cream has no or negligible influence on the ability to drive and use machines when used at the recommended doses.

Numeca Cream contains macrogolglycerol hydroxystearate Macrogolglycerol hydroxystearate may cause skin reactions.

3. How to use Numeca Cream

Always use Numeca Cream exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

This product is available in different pack sizes. You will have been provided with a suitable pack size for your intended use.

Using Numeca Cream

Where to put the cream, how much to use and how long to leave it on will depend on what it is used for. Half a 5 g tube corresponds to about 2 g Numeca Cream. One gram of Numeca Cream pressed out of a tube of 30g is approximately 3.5 cm.

• Numeca Cream should be used on the genitals only by a doctor or nurse.

• When Numeca Cream is used on leg ulcers, a doctor or nurse should supervise its

  use.

Do not use Numeca Cream on the following areas:

• Cuts, grazes or wounds, excluding leg ulcers.
• Where there is a skin rash or eczema.
• In or near the eyes.
• Inside the nose, ear or mouth.
• In the back passage (anus).
• On the genitals of children.

Persons frequently applying or removing cream should ensure that contact is avoided in order to prevent the development of hypersensitivity. The protective membrane of the tube is perforated by applying the cap. Use on the skin before small procedures (such as having a needle put in or minor skin operations):

• The cream is put on to the skin in a thick layer. Follow the instructions on the

  leaflet or those from your health care professional. In certain cases your healthcare professional has to apply the cream.

• The cream is then covered by a dressing [plastic wrap]. This is taken off just

  before the procedure starts. If you are applying the cream yourself, make sure that you have been given dressings by your doctor, pharmacist or nurse.

• The usual dose for adults and adolescents over 12 years is 2 g (grams).

• For adults and adolescents over 12 years put the cream on at least 60 minutes

  before the procedure (unless the cream is being used on the genitals). However, do not put it on more than 5 hours before.

Children

Use on the skin before small procedures (such as having a needle put in or minor skin operations) Application time: approx. 1 hour.

Newborn infants and infants 0-2 months: Up to 1 g of cream on a skin area not

2 larger than 10 cm (10 square centimetres) in size. Application time: 1 hour, not more. Only one single dose should be given in any 24 hour period. Infants aged 3-11 months: Up to 2 g of cream on a total skin area not larger than 20

²cm (20 square centimetres) in size. Application time: approx 1 hour. Children aged 1-5 years: Up to 10 g of cream on a total skin area not larger than 100

²cm (100 square centimetres) in size. Application time: approx 1 hour, maximum 5 hours.

2 Children aged 6-11 years: Up to 20 g of cream on a total skin area not larger than 200 cm (200 square centimetres) in size. Application time: approx 1 hour, maximum 5 hours. A maximum of 2 doses at least 12 hours apart may be given to children over 3 months of age in any 24 hour period.

Numeca Cream can be used on children with a skin condition called “atopic dermatitis” but the application time is then 30 minutes, no longer. When you apply the cream, it is very important to exactly follow the instructions below

1. 1.

   Squeeze the cream into a mound where it is needed on your skin (for example

   where the needle is going to be put in). Half a 5 g tube corresponds to about 2 g Numeca Cream. One- gram of Numeca Cream pressed out of a tube of 30g is approximately 3.5 cm. Do not rub the cream in.

2. 2.

   Peel the paper layer from the 'centre cut- out' of the non-adhesive side of the

   dressing (leaving a frame of paper).

   If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor or pharmacist if any of the following side effects bother you or do not seem to go away. Tell your doctor about anything else that makes you feel unwell while you are using Numeca Cream.

If you experience any of the following effects while you are using Numeca Cream, stop using it and check with your doctor or pharmacist as soon as possible: Allergic reactions, which in rare cases may develop into anaphylactic shock (skin rash, swelling, fever, respiratory difficulties and fainting) during treatment of skin, genital mucosa or leg ulcers.

Methaemoglobinaemia (blood disorder), which in rare cases may develop during treatment of the skin, and may cause signs and symptoms of hypoxaemia (abnormally low level of oxygen in the blood). Methaemoglobinaemia is more frequently observed, often in connection with overdose, in newborn infants and infants aged 0 to 12 months.

A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which Numeca Cream is used. These are normal reactions to the cream and the anaesthetics and will disappear in a short while without any measures being needed.

If you experience any troublesome or unusual effects while you are using Numeca Cream, stop using it and check with your doctor or pharmacist as soon as possible. Common (may affect up to 1 in 10 people)

• Transient local skin reactions (paleness, redness, swelling) in the treated area during treatment of skin, genital mucosa or leg ulcers.
• An initially mild sensation of burning, itching or warmth at the treated area during treatment of genital mucosa or leg ulcers.

Uncommon (may affect up to 1 in 100 people)

• An initially mild sensation of burning, itching or warmth at the treated area during treatment of the skin.
• Numbness (tingling) in the treated area during treatment of genital mucosa.
• Irritation of the treated skin during treatment of leg ulcers.

Rare (may affect up to 1 in 1,000 people)

• Small dot-shaped bleeding on the treated area (particularly on children with eczema after longer application times) during treatment of the skin.
• Irritation of the eyes if Numeca Cream accidentally comes into contact with them during treatment of the skin.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: 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.

5. How to store Numeca Cream

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C and do not freeze.
• Do not use this medicine after the expiry date which is stated on the package and tube after 'EXP:'. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Numeca Cream 5% contains

• The active substances are lidocaine and prilocaine. Each gram of cream contains

  25 mg of lidocaine and 25 mg of prilocaine.

• The other ingredients are macrogolglycerol hydroxystearate, carbomer 934 P, sodium hydroxide and purified water.

What Numeca Cream 5% looks like and contents of the pack

Numeca Cream 5% is a white homogenous cream. Your cream will come in “Pre-medication pack” containing 5 x 5 g tubes Numeca and 12 occlusive dressings or Pack containing 1 x 5 g tube of Numeca and 2 occlusive dressings or Pack containing 1 x 5 g tube of Numeca and 3 occlusive dressings or 1 x 30 g tube

1 x 5 g tube

5 x 5 g tubes

1 x 10 g tube

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Limited

Micro House,

Bury Street,

Ruislip, HA4 7TL,

United Kingdom.

This leaflet was last revised in 02/2026

220.00 mm

Package leaflet: Information for the user

Numeca Cream 5%

lidocaine/prilocaine

Apply approximately 1.5–2 g/10 cm2 Numeca Cream 5%, at least 2 hours and not more than 5 hours before split skin graft procedure.

1. 1.

   Shave the skin of the selected donor site area. Clean the area of skin with

   alcohol.

2. 2.

   Select the exact area of the donor site by using the graduated ruled edge of

   this leaflet, e.g. 10 cm x 10 cm or 10 cm x 20 cm – and mark this area using an indelible thick marker pen to delineate the margins of the site.

   User Leaflet for Healthcare Professionals

   Numeca Cream 5%

   (for 30g pack)

   Application instructions for surgical use only (split skin grafting).

   2

   1. 3.

      Squeeze out between ½–1 (30 g) tube of Numeca Cream 5% per 100 cm on

      the area of the donor site to be anaesthetised.

   2. 4.

      Spread the Numeca Cream 5% to form an even, thick layer. It is important to

      cover completely the entire donor area including over the marked margins of the site.

   3. 5.

      Take a strip of transparent occlusive plastic film wrapping cut to the

      appropriate size (slightly larger than the area of the donor site). Carefully apply the wrapping to cover completely the layer of Numeca Cream 5%.

      1. 6.

         Smooth down and tape the edges of the occlusive film wrapping to the skin

         using a surgical synthetic adhesive tape.

      2. 7.

         Wrap the entire site using an elastic crepe bandage to protect the site and

         avoid leakage of Numeca Cream 5% and occlusive wrapping in place for at least 2 hours. As a reminder, the time can be written on the wrapping or bandage.

      3. 8.

         After 1 hour and hourly thereafter – remove only the crepe bandage (not the

         adhesive tape or film wrapping) and massage the Numeca Cream 5% through the film wrapping to ensure a thick, even layer of Numeca is maintained over the entire donor site. Replace the bandage.

         1. 9. After a minimum of 2 hours – just prior to surgery – remove the bandage and occlusive wrapping. Wipe off the Numeca Cream 5%. Analgesic efficacy may decline if application time is >5 hours. The anaesthetised donor site may appear either pale or red. These reactions are normal and are associated with the skin anaesthesia. Disinfect and prepare the anaesthetised donor site prior to cutting the split skin graft.