Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Nulbia 5% cream
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Prilocaine, Lidocaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Nulbia contains two active substances called lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics.
Nulbia 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: o
Having an injection.
o
Medical procedures such as removal of warts.
A doctor or nurse should apply Nulbia 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 take it
e Nulbia
Do not use Nulbia: 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 Nulbia: if you or your child have a rare inherited illness that affects the blood called "glucose6-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.
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 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.
Other medicines and Nulbia
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.
Pregnancy, breastfeeding and fertility 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.
Driving and using machines Nulbia has no or negligible influence on the ability to drive and use machines when used at the recommended doses.
Nulbia contains castor oil polyoxyl hydrogenated. Castor oil polyoxyl hydrogenated may cause skin reactions.
3.
How to take it
Nulbia
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.
Using Nulbia 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. 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 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 you should 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.
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 Nulbia.
A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which Nulbia 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 Nulbia, 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) 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) during treatment of the skin. 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 Nulbia accidentally comes into contact with them during treatment of the skin. Frequency not known (cannot be estimated from available data)
- Chemical burns to the eyes if Nulbia accidentally comes into contact with them during treatment. Additional side effects in children Methaemoglobinaemia, a blood disorder, which is more frequently observed, often in connection with overdose in newborn infants and infants aged 0 to 12 months.
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 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.
5.
How to store it
Nulbia
Store below 30°C. Do not refrigerate or freeze. After first opening use within 6 months. Keep this medicine out of the sight and reach of children. 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 to protect the environment.
6.
Contents of the pack and other information
What Nulbia 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 Castor oil polyoxyl hydrogenated, carbomer 974P, sodium hydroxide and water purified.
What Nulbia looks like and contents of the pack 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 and Manufacturer
Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited Laxmi House 2B Draycott Avenue Kenton, Middlesex HA3 0BU United Kingdom
Manufacturer Rafarm SA, Thesi Pousi-Xatzi, Agiou Louka, Paiania, Attiki-19002, P.O. Box 37, Greece.
This leaflet was last revised in October 2025.
Frequently asked questions about Nulbia 5% cream
How do I take Nulbia 5% cream?
Nulbia 5% cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Nulbia 5% cream?
The active substance in Nulbia 5% cream is prilocaine, lidocaine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nulbia 5% cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Nulbia 5% cream without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: prilocaine, lidocaine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Nulbia is indicated for:
• Topical anaesthesia of the skin in connection with:
o needle insertion, e.g. intravenous catheters or blood sampling;
o superficial surgical procedures;
in adults and in the paediatric population
• Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥ 12 years
• Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only
4.2. Posology and method of administration
Administration of Nulbia on genital mucosa, genital skin or leg ulcers should only be performed by a healthcare professional.
Posology
Adults and adolescents
The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2.
For further guidance on the appropriate use of the product in such procedures, please refer to Method of administration.
Table 1. Adults and adolescents 12 years of age and above
Indication/Procedure
Dosage and Application Time
Skin
Minor procedures, e.g. needle insertion and surgical treatment of localized lesions.
2 g (approximately half a 5 g tube) or approximately 1.5 g / 10 cm2 for 1 to 5 hours1)
Dermal procedures on newly shaven skin of large body areas, e.g. laser hair removal (self-application by patient)
Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours1).
Dermal surgical procedures on larger areas in a hospital setting, e.g. split-skin grafting.
Approximately 1.5-2 g / 10 cm2 for 2 to 5 hours1).
Skin of male genital organs
Prior to injection of local anaesthetics
Skin of female genital organs
Prior to injection of local anaesthetics2)
1 g / 10 cm2 for 15 minutes
1-2 g / 10 cm2 for 60 minutes
Genital mucosa
Surgical treatment of localized lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics
Approximately 5-10 g of cream for 5-10 minutes1)3)4).
Prior to cervical curettage
10 g of cream should be administered in the lateral vaginal fornices for 10 minutes.
Leg ulcer(s)
Adults only
Mechanical cleansing/debridement
Approximately 1-2 g/10 cm2 up to a total of 10 g to the leg ulcer(s)3)5).
Application time: 30-60 minutes
1) After a longer application time anaesthesia decreases.
2) On female genital skin, Nulbia alone applied for 60 or 90 minutes does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.
3) Plasma concentrations have not been determined in patients treated with doses of >10 g, (See also Section 5.2).
4) In adolescents weighing less than 20 kg the maximum dose of Nulbia on genital mucosa should be proportionally reduced.
5) Nulbia has been used for the treatment of leg ulcers up to 15 times over a period of 1-2 months without loss of efficacy or increased number or severity of adverse events.
Paediatric population
Table 2 . Paediatric patients 0-11 years of age
Age group
Procedure
Dosage and Application time
Minor procedures, e.g. needle insertion and surgical treatment of localized lesions.
Approximately 1g/10 cm2 for one hour (see details below)
Newborn infants and infants 0-2 months1)2)3)
Up to 1 g and 10 cm2 for one hour4)
Infants 3-11 months1)2)
Up to 2 g and 20 cm2 for one hour5)
Toddlers and children 1-5 years
Up to 10 g and 100 cm2 for 1-5 hours6)
Children 6-11 years
Up to 20 g and 200 cm2 for 1-5 hours6)
Paediatric patients with atopic dermatitis
prior to removal of mollusca
Application time: 30 minutes
1) In term newborn infants and infants below 3 months, only one single dose should be applied in any 24 hour period. For children aged 3 months and above, a maximum of 2 doses, separated by at least 12 hours can be given within any 24 hour period, see section 4.4 and 4.8.
2) Nulbia should not be used in infants up to 12 months of age receiving treatment with methaemoglobin-inducing agents, because of safety concerns, see sections 4.4 and 4.8
3) Nulbia should not be used at less than 37 weeks gestational age, because of safety concerns, see section 4.4.
4) Application for > 1 hour has not been documented.
5) No clinically significant increase in methaemoglobin levels has been observed after an application time of up to 4 hours on 16 cm2.
6) After longer application times anaesthesia decreases.
Safety and efficacy for the use of Nulbia on genital skin and genital mucosa have not been established in children younger than 12 years.
Available paediatric data do not demonstrate adequate efficacy for circumcision.
Elderly
No dose reduction is necessary in elderly patients (see sections 5.1 and 5.2).
Hepatic impairment
A reduction of a single dose is not necessary in patients with impaired hepatic function (see section 5.2)
Renal impairment
A dose reduction is not necessary among patients with restricted renal function.
Method of administration
Cutaneous use
The protective membrane of the tube is perforated by applying the cap.
One gram of Nulbia pressed out of a tube of 30 g is approximately 3.5 cm. If high levels of accuracy in dosing are required to prevent overdose (i.e., at doses approaching the maximum in newborn infants or if two applications may be required in a 24 hour period), a syringe can be used where 1 mL = 1 g.
A thick layer of Nulbia should be applied to the skin, including genital skin, under an occlusive dressing. For application to larger areas, such as split-skin grafting, an elastic bandage should be applied on top of the occlusive dressing to give an even distribution of cream and protect the area. In the presence of atopic dermatitis, the application time should be reduced.
For procedures related to genital mucosa, no occlusive dressing is required. The procedure should be commenced immediately after removal of the cream.
For procedures related to leg ulcers, a thick layer of Nulbia should be applied under an occlusive dressing.
Cleansing should start without delay after removal of the cream.
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.
4.3. Contraindications
Hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Patients with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia are more susceptible to active-substance-induced signs of methaemoglobinaemia. In glucose-6-phosphate dehydrogenase deficient patients the antidote methylene blue is ineffective at methaemoglobin reduction, and is capable of oxidising haemoglobin itself, and therefore methylene blue therapy cannot be given.
Due to insufficient data on absorption Nulbia should not be applied to open wounds (excluding leg ulcers).
Due to the potentially enhanced absorption on the newly shaven skin, it is important to adhere to the recommended dosage area and time of application (see Section 4.2).
Care should be taken when applying Nulbia to patients with atopic dermatitis. A shorter application time, 15-30 minutes, may be sufficient (see Section 5.1). Application times of longer than 30 minutes in patients with atopic dermatitis may result in an increased incidence of local vascular reactions, particularly application site redness and in some cases petechia and purpura (see Section 4.8). Prior to removal of mollusca in children with atopic dermatitis, it is recommended to apply cream for 30 minutes.
When applied in the vicinity of the eyes, Nulbia should be used with particular care since it may cause eye irritation and chemical burns to the eyes (see section 4.8). Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, the eye should immediately be rinsed with water or sodium chloride solution and protected until sensation returns.
When Nulbia is used in children at any site of the body, children should be carefully watched to prevent them from accidental self-administration of Nulbia in their eyes.
Nulbia should not be applied to an impaired tympanic membrane. Tests on laboratory animals have shown that Nulbia has an ototoxic effect when instilled into the middle ear. Animals with an intact tympanic membrane, however, show no abnormality when exposed to Nulbia in the external auditory canal.
Patients treated with anti-arrhythmic of class III (e.g., amiodarone) should be carefully monitored and ECG monitoring considered as cardiac effects may be additive.
Lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0.5 – 2%. For this reason, although one clinical study suggests that the immunization response, as assessed by local wheal formation, is not affected when Nulbia is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.
Nulbia contains castor oil polyoxyl hydrogenated which may cause skin reactions.
Paediatric population
Studies have been unable to demonstrate the efficacy of Nulbia for heel lancing in newborn infants.
In newborn infants/infants younger than 3 months a transient, clinically insignificant increase in methaemoglobin level is commonly observed up to 12 hours after an application of Nulbia within the recommended dosing.
If the recommended dose is exceeded the patient should be monitored for system adverse reactions secondary to methaemoglobinaemia (see sections 4.2, 4.8 and 4.9).
Nulbia should not be used
- in newborn infants/infants up to 12 months of age receiving concomitant treatment with methaemoglobin-inducing agents.
- in pre-term newborn infants with a gestational age less than 37 weeks as they are at risk of developing increased methaemoglobin levels.
Safety and efficacy for the use of Nulbia on genital skin and genital mucosa have not been established in children younger than 12 years.
Available paediatric data do not demonstrate adequate efficacy for circumcision.
4.5. Interaction with other medicinal products and other forms of interaction
Prilocaine in high doses may cause an increase in methaemoglobin levels particularly in conjunction with methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin, phenobarbital). This list is not exhaustive.
With large doses of Nulbia, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anaesthetics or medicinal products structurally related to local anaesthetics, since the toxic effects are additive.
Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic drugs class III (e.g., amiodarone) have not been performed, but caution is advised (see also section 4.4).
Medicinal products that reduce the clearance of lidocaine (e.g., cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period.
Paediatric population
Specific interaction studies in children have not been performed. Interactions are likely to be similar to the adult population.
4.6. Fertility, pregnancy and lactation
Pregnancy
Although topical application is associated with only a low level of systemic absorption, the use of Nulbia in pregnant women should be undertaken with care because insufficient data are available concerning the use of Nulbia in pregnant women. However, animal studies do not indicate any direct or indirect negative effects on pregnancy, embryo-foetal development, parturition or postnatal development. Reproduction toxicity has been shown with subcutaneous/intramuscular administration of high doses of lidocaine or prilocaine much exceeding the exposure from topical application (see section 5.3).
Lidocaine and prilocaine cross the placental barrier and may be absorbed by the foetal tissues. It is reasonable to assume that lidocaine and prilocaine have been used in a large number of pregnant women and women of childbearing age. No specific disturbances to the reproductive process have so far been reported, e.g. an increased incidence of malformations or other directly or indirectly harmful effects on the foetus.
Breastfeeding
Lidocaine and, in all probability, prilocaine are excreted in breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.
Nulbia can be used during breastfeeding if clinically needed.
Fertility
Animal studies have shown no impairment of the fertility of male or female rats (see section 5.3).
4.7. Effects on ability to drive and use machines
Nulbia has no or negligible influence on the ability to drive and use machines when used at the recommended doses.
4.8. Undesirable effects
Summary of the safety profile
The most frequently observed adverse drug reactions (ADRs) are related to administration site conditions (transient local reactions at application site), reported as common.
Tabulated list of adverse reactions
The incidences of the Adverse Drug Reactions (ADRs) associated with Nulbia therapy is tabulated below.
The table is based on adverse events reported during clinical trials, and/or post-marketing use. Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level.
Within each System Organ Class, adverse reactions are listed under frequency categories of: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3. Adverse reactions
System Organ Class
Common
Uncommon
Rare
Not known
Blood and lymphatic system disorders
Methaemoglobinaemia1
Immune system disorders
Hypersensitivity1, 2, 3
Injury, poisoning and procedural complications
Chemical burns to eyes (see section 4.4)
Eye disorders
Corneal irritation1
Skin and subcutaneous tissue disorders
Purpura1, Petechiae1 (especially after longer application times in children with atopic dermatitis or mollusca contagiosa)
General disorders and administration site conditions
Burning sensation2, 3
Application site pruritus2, 3
Application site erythema1, 2, 3
Application site oedema1, 2, 3
Application site warmth2, 3
Application site pallor1, 2, 3
Burning sensation1
Application site irritation3
Application site pruritus1
Application site paraesthesia2 such as tingling
Application site warmth1
1Skin
2Genital mucosa
3Leg ulcer
Paediatric population
Frequency, type and severity of adverse reactions are similar in the paediatric and adult age groups, except for methaemoglobinaemia, which is more frequently observed, often in connection with overdose (see Section 4.9), in newborn infants and infants aged 0 to 12 months.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Rare cases of clinically significant methaemoglobinaemia have been reported. Prilocaine in high doses may cause an increase in methaemoglobin levels particularly in susceptible individuals (section 4.4), with too frequent dosing in newborn infants and infants below 12 months of age (section 4.2) and in conjunction with methaemoglobin-inducing medicinal products (e.g. sulfonamides, nitrofurantoin, phenytoin and phenobarbital). Consideration should be given to the fact that pulse oximeter values may overestimate the actual oxygen saturation in case of increased methaemoglobin fraction; therefore, in cases of suspected methaemoglobinaemia, it may be more helpful to monitor oxygen saturation by co-oximetry.
Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue (see also section 4.4).
Should other symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes of administration. Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression. Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products; circulatory signs are treated in line with recommendations for resuscitation.
Since the rate of absorption from intact skin is slow, a patient showing signs of toxicity should be kept under observation for several hours following emergency treatment.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ROMLA 25 mg/25 mg/g over the counterCOMBINATII (LIDOCAINUM+PRILOCAINUM) · skin / topical
- FORTACIN 150 mg/ml+50 mg/ml prescriptionCOMBINATII (LIDOCAINUM+PRILOCAINUM) · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Emla PlasterLidocainum + Prilocainum · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Nulbia 5% cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.