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NULBIA 5% CREAM

Active substance(s): LIDOCAINE / PRILOCAINE

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Package leaflet: Information for the patient

Nulbia 5% cream
Lidocaine + Prilocaine

Read all of this leaflet carefully before you start using
this medicine because it contains important
information for you.
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has 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.
• You must talk to a doctor if you do not feel better or if
you feel worse.
What is in this leaflet
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
1. What Nulbia is and what it is used 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:
– Having an injection.
– Medical procedures such as removal of warts.
A doctor or nurse should supervise the use of Nulbia on
the genitals.
Adults
It can also be used to numb the skin before:
• Cleansing or removal of damaged skin of leg ulcers
2. What you need to know before you use 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 or pharmacist 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 or pharmacist 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 incident of local
skin reaction (see also section 4 “Possible side
effects”).
• if you take particular medicines 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 of 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. 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.
Nulbia should not be applied to an impaired eardrum.
When you use Nulbia 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 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 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, pharmacist or nurse if you are using, or
have recently used, or might use 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 nitrofuradantin.
• 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, breast-feeding 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 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 macrogolglycerol hydroxystearate.
This may cause skin reactions.
3. How to use Nulbia
Always use this medicine 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.
Using Nulbia
• Where to put the cream, how much to use and how
long to leave it on for will depend on what it is
needed for.
• Your doctor, pharmacist or nurse will put the cream
on or show you how to do it yourself.
• When Nulbia is used on the genitals, 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. Your
doctor, pharmacist or nurse will tell you where to put
it.
• 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.
• For children the amount of Nulbia used and how long
depends on their age. Your doctor, nurse or
pharmacist will tell you how much to use and when it
should be applied.
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). A line of cream of about
3.5 cm from the 30 g tube is
equal to 1 g of cream. Half a
5 g tube corresponds to about
2 g Nulbia.

2. Do not rub the cream in.
3. Peel the “centre cut-out”
from the dressing.

4. Remove the covers of the
dressing. Then place the
dressing carefully over the
mound of the cream. Do not
spread the cream under the
dressing.

5. Remove the plastic backing.
Smooth down the edges of
the dressing carefully. Then
leave it in place for at least
60 minutes.

6. 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):
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.
• 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 on adults and
adolescents over 12 years only.
• 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 on adults and adolescents
over 12 years only.
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
• 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 your doctor, pharmacist or
nurse has 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 the 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.
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 or
pharmacist. 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. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. How to store 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 Macrogolglycerol
hydroxystearate, 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 April 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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