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XYLONOR SPRAY

Active substance(s): CETRIMIDE / LIDOCAINE

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Xylonor spray
Metered aerosol

Lidocaine and cetrimide

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this
medicine.
‐ Keep this leaflet. You may need to read it again.
‐ If you have any further questions, ask your dentist.
‐ If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
dentist, doctor or pharmacist.
In this leaflet:
1. What XYLONOR SPRAY is and what it is used for
2. Before you use XYLONOR SPRAY
3. How to use XYLONOR SPRAY
4. Possible side effects
5. How to store XYLONOR SPRAY
6. Further information
1. What XYLONOR SPRAY is and what it is used for
XYLONOR SPRAY is used to obtain a local anaesthesia of the
lining of the inside of the mouth (buccal mucosa).
It contains two active ingredients:
• lidocaine, a local anaesthetic, which numbs the painful
area temporarily,
• cetrimide, an antiseptic, which kills any micro‐organisms
that are present.
XYLONOR SPRAY is for children over 4 years old and adults.
Only a dentist can administer this product.
2. Before you use XYLONOR SPRAY
Do not use XYLONOR SPRAY
• if you are allergic (hypersensitive) to one of the active
ingredients (lidocaine or cetrimide) or to any of the other
ingredients (refer to section 6).
• if you are allergic to local anaesthetics called amide type
anaesthetics.
• in children under 4 years old.
Take special care with XYLONOR SPRAY
• Before receiving this medicine, tell your dentist if you
have severe infection or an inflammation in the area to be
treated.
• The dentist will adapt the dosage to your age and general
condition.
• The dentist should have available resuscitation equipment
for effects on heart.
• The dentist should avoid spraying the back of the throat.

Using other medicines
Please tell your dentist if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Your dentist should take special attention if you are taking the
following medicines:
• medicines used to reduce your blood pressure (e.g.
betablockers),
• medicines used to treat ulcers (e.g. cimetidine).
Pregnancy and breast‐feeding
Ask your dentist for advice before taking any medicine.
Important information about some ingredients of XYLONOR
SPRAY
XYLONOR SPRAY contains dipropylene glycol which may
cause skin irritation.
3. How to use XYLONOR SPRAY
Your dentist will explain to you why you are being treated
with XYLONOR SPRAY.
He or she will adjust the dosage according to your age, your
health and the treatment you are having.
One to two metered doses are usually sufficient to achieve
anaesthesia on a particular site. Your dentist will spray it onto
the buccal mucosa.
XYLONOR SPRAY should not be sprayed in the back of throat
or mouth.
If your dentist uses more XYLONOR SPRAY than he or she
should
If you swallow a lot of the solution, or if you think your child
has swallowed any of the solution, tell your dentist.
4. Possible side effects
Like all medicine, XYLONOR SPRAY can cause side effects,
although not everybody gets them.
While you are in your dentist’s office, your dentist will
carefully follow the effects of XYLONOR SPRAY.
Administration of XYLONOR SPRAY may cause high plasma
levels in active substances (lidocaine and/or cetrimide),
especially excessive dosage or rapid absorption. Symptoms
include: effects on your senses (hearing, sight, behaviour),
effects on your heart and blood vessels, effects on your
immune defences (diminished tolerance).
Allergic (hypersensitivity) reactions may occur when using
this medicine. Symptoms of these reactions might include:
rash, itching, swelling of the throat and difficulty breathing.
Inform your dentist, doctor or pharmacist immediately if one
of these effects applies to you.
You may develop more severe reactions such as convulsions
and reduced level of consciousness with possible arrest
of breathing or heart. Emergency medical help should
immediately be called.

The following side effects may be observed:
• Effects on your heart and blood vessels: low blood
pressure, slow or irregular heartbeats, which may lead to
cardiac arrest,
• Effects on your lungs: abnormally slow and shallow
respiration, which may lead to respiratory arrest,
• General effects: unconsciousness, convulsions, dizziness,
drowsiness, feeling nervous,
• Effects on your senses: blurred vision, trembling

This leaflet was last approved on: 12/2012.
If more PILs are necessary, call free number 0800435155.

The following very rare side effects affect 1 of 10,000
patients treated:
• Effects on your skin: - severe allergic reactions (anaphylactoid
reactions) characterized by swelling of the face, lips and/
or tongue, difficulty breathing.

- skin rash, hives or itching in the mouth,
skin irritation and occasionally sensitisation.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your dentist,
doctor or pharmacist.
5. How to store XYLONOR SPRAY
Keep out of the reach and sight of children.
It is most unlikely that you will be asked to look after this
medicine.
Your dentist will not use this medicine after the expiry date
which is stated on the package. The expiry date refers to the
last day of that month.
Your dentist will keep it up to 25°C.
6. Further information
What XYLONOR SPRAY contains
• Active substances: 1 dose contains:

‐ 10 mg of lidocaine,

‐ 0.10 mg of cetrimide.
• The other ingredients are: saccharin, natural mint flavour,
dipropylene glycol and ethylic alcohol 95 %.
What XYLONOR SPRAY looks like and content of the pack
It is a clear, colourless to slightly yellow liquid with an odour
of mint.
XYLONOR SPRAY is available in metered dose aerosol
containing 36 g of solution.
Marketing authorisation holder
Septodont Ltd, Units R & S
Orchard Business Centre
St Barnabas Close
Allington, Maidstone
Kent ME16 0JZ ‐ UK
Manufacturer
Septodont
58, rue du Pont de Créteil
94100 Saint‐Maur‐des‐Fossés
France

SEPTODONT
58, rue du Pont de Créteil
94107 Saint‐Maur‐des‐Fossés Cedex - France

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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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