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XYLONOR GEL

Active substance(s): CETRIMIDE / LIDOCAINE

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Xylonor gel
Gingival gel

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 GEL is and what it is used for
2. Before you use XYLONOR GEL
3. How to use XYLONOR GEL
4. Possible side effects
5. How to store XYLONOR GEL
6. Further information
1. What XYLONOR GEL is and what it is used for
XYLONOR GEL is used to obtain a local anaesthesia of the
lining of the inside of the mouth (buccal mucosa) before
performing dental procedures.
It contains two active ingredients:
• lidocaine, a local anaesthetic, which numbs the painful
area temporarily,
• cetrimide, an antiseptics, which kills any microorganisms
that are present.
XYLONOR GEL is for children over 4 years old and adults.
Only a dentist can administer this product.
2. Before you use XYLONOR GEL
Do not use XYLONOR GEL
• 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 GEL
• Soaps should be used with caution when you receive
XYLONOR GEL, as they can decrease the efficiency of the
active substance cetrimide.
• If you have a severe infection or an inflammation in the
area to be treated.
• Avoid chewing gums or any type of food as long as the
anaesthesia persists, as there is a risk of biting.
• The dentist will adapt the dosage to your age and general
condition.
• The dentist should have available resuscitation equipment
for effects on heart.

Using other medicines
Please tell your dentist if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast‐feeding
Ask your dentist for advice before taking any medicine.
Using XYLONOR GEL and sport
There is a possibility of positive results on doping tests
performed on sportsmen.
3. How to use XYLONOR GEL
Your dentist will explain to you why you are being treated
with XYLONOR GEL.
He or she will adjust the dosage depending on the treatment
you are having.
The usual dose of XYLONOR GEL is 100 to 500 mg (about 2 to
10 mm of gel).
Your dentist will apply it with a cotton pellet to the buccal
mucosa.
A lower dose than usual may be used in patients who are ill
or weak and in children or the elderly.
If your dentist uses more XYLONOR GEL than he or she
should
If you swallow a lot of gel, or if you think your child has
swallowed any of the gel, tell your dentist.
4. Possible side effects
Like all medicine, XYLONOR GEL 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 GEL.
Administration of XYLONOR GEL 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 very rare side effects affect 1 of 10,000
patients treated:
• 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
• 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 GEL
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 in a dry place, and tightly
closed after use.
6. Further information
What XYLONOR GEL contains
• Active substances: 100 g of gel contains 5 g of lidocaine
and 0.15 g of cetrimide.
• The other ingredients are: spearmint oil, saccharin and
macrogol.
What XYLONOR GEL looks like and content of the pack
It is a white clear gel with an odour of mint.
XYLONOR GEL is available in tube of 15 g.
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
This leaflet was last approved on: 12/2012.
If more PILs are necessary, call free number 0800435155.

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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