Nulbia 5% cream

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

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

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

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.

It can also be used:

• To numb the genitals before:
  • Having an injection.
  • Medical procedures such as removal of warts.

A doctor or nurse should apply Nulbia on the genitals.

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.

• 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).

Talk to your doctor, pharmacist or nurse before using Nulbia:

• 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 Nulbia 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 Nulbia in the eyes, as it may cause irritation and chemical burns to the eyes. If you accidentally get Nulbia 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.

Children should be carefully watched when using Nulbia on any part of their body to prevent them from accidentally getting Nulbia in the eye(s).

Nulbia should not be applied to an impaired eardrum.

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

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 Nulbia is put on.

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

Nulbia 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.

Nulbia 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 Nulbia).

Nulbia should not be used in preterm newborn infants.

Tell your doctor or pharmacist 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 Nulbia can affect the way some medicines work and some medicines can have an effect on Nulbia.

In particular, tell your doctor or pharmacist 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 Nulbia in recommended doses.

If you are pregnant or breast-feeding, 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 Nulbia during pregnancy is unlikely to have any adverse effects on the foetus.

The active substances in Nulbia (lidocaine and prilocaine) are excreted 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.

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

Castor oil polyoxyl hydrogenated may cause skin reactions.

• 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 Nulbia. One gram of Nulbia pressed out of a tube is approximately 3.5 cm.
• Nulbia should be used on the genitals only by a doctor or nurse.
• When Nulbia is used on leg ulcers, a doctor or nurse should supervise its use.

Do not use Nulbia 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.

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 larger than 10 cm² (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 cm² (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 cm² (100 square centimetres) in size. Application time: approx. 1 hour, maximum 5 hours.

Children aged 6-11 years: Up to 20 g of cream on a total skin area not larger than 200 cm² (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.

Nulbia 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. 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 Nulbia. One gram of cream pressed out of a tube is approximately 3.5 cm.

Do not rub the cream in.

2. Remove the covers of the dressing.

3. Then place the dressing carefully over the mound of the cream. Do not spread the cream under the dressing.

4. Remove the paper backing. Smooth down the edges of the dressing carefully. Then leave it in place for at least 60 minutes if the skin has not been damaged. The cream should not be left in place for more than 60 minutes in children under 3 months or for more than 30 minutes in children with an itchy skin condition called ‘atopic dermatitis’.

5. Your doctor or nurse will take the dressing off and remove the cream just before they do the medical procedure (for example just before the needle is put in).

Use on larger areas of newly shaven skin before outpatient procedures (such as hair removal techniques):

Follow the instructions from your health care professional.

The usual dose is 1 g of cream for each area of skin that is 10 cm² (10 square centimetres) in size, applied for 1 to 5 hours under a dressing. Nulbia should not be used on an area of newly shaven skin larger than 600 cm² (600 square centimetres, e.g. 30 cm by 20 cm) in size. The maximum dose is 60 g.

Use on the skin before hospital procedures (such as split-skin grafting) that require deeper skin anaesthesia:

• Nulbia can be used in this way on adults and adolescents over 12 years, but only under the supervision of a doctor or nurse.
• The usual dose is 1.5 g to 2 g of cream for each of area of skin that is 10 cm² (10 square centimetres) in size.
• The cream is put on under a dressing for 2 to 5 hours.

Use on the skin prior to removal of wart-like spots called “mollusca”

• Nulbia can be used on children and adolescents with a skin condition called “atopic dermatitis”.
• The usual dose depends on the child’s age and is used for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse or pharmacist will tell you how much cream to use.

Use on genital skin before injections of local anaesthetics

• Nulbia can be used in this way only by healthcare professionals on adults and adolescents over 12 years.
• The usual dose is 1 g of cream (1g to 2 g for female genital skin) for each area of skin that is 10 cm² (10 square centimetres) in size.
• The cream is put on under a dressing. This is done for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on the genitals before minor skin surgery (such as removal of warts)

Nulbia can be used in this way only by healthcare professionals on adults and adolescents over 12 years.

The usual dose is 5 g to 10 g of cream for 10 minutes. A dressing is not used. The medical procedure should then start straight away.

Use on leg ulcers before cleaning or removal of damaged skin

• Nulbia can be used in this way in adults, but only under the supervision of a doctor or nurse.
• The usual dose is 1g to 2 g of cream for each area of skin that is 10 cm2 up to a total of 10 g.
• The cream is put on under an airtight dressing such as plastic wrap. This is done for 30 to 60 minutes before the ulcer is to be cleansed. Remove the cream with cotton gauze and start cleansing without delay.
• Nulbia can be used before cleansing of leg ulcers for up to 15 times over a period of 1-2 months.
• The Nulbia tube is intended for single use when used on leg ulcers: The tube with any remaining contents should be discarded after each occasion that a patient has been treated.

If you use more Nulbia than what is described in this leaflet or more than your doctor, pharmacist or nurse have told you to, talk to one of them straight away, even if you do not feel any symptoms.

Symptoms of using too much Nulbia are listed below. These symptoms are unlikely to happen if Nulbia is used as recommended.

• Feeling light-headed or dizzy.
• Tingling of the skin around the mouth and numbness of the tongue.
• Abnormal taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of ‘acute methaemoglobinaemia’ (a problem with blood pigment levels). This is more likely when certain medicines have been taken at the same time. If this happens, the skin becomes bluish-grey due to a lack of oxygen.

In serious cases of overdose, symptoms may include fits, low blood pressure, slowed breathing, stopped breathing and altered heartbeat. These effects may be life threatening.

Methaemoglobinaemia, a blood disorder, which is more frequently observed, often in connection with overdose in newborn infants and infants aged 0 to 12 months.

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 the 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.

• 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 Castor oil polyoxyl hydrogenated, carbomer 974P, sodium hydroxide and water purified.

Nulbia is a white soft cream. It is presented in collapsible aluminium tubes of 5g and 30g, internally covered with an epoxyphenolic lacquer.

Pack sizes:

1 x 30g tube

1 x 5g tube

1 x 5g tube with 2 dressings

1 x 5g tube with 3 dressings

5 x 5g tubes

5 x 5g tubes with 12 dressings

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer