Patient leaflet - Xylonor spray 150 mg / g + 1.5 mg / g Oromucosal spray solution
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) before performing dental procedures.
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 6 years old and adults. Only a dentist or stomatologist can administer this product.
2. What you need to know before you use XYLONOR SPRAY
For professional use by dentists and stomatologists only.
Do not use XYLONOR SPRAY
if you are allergic to lidocaine or cetrimide or to any of the
other ingredients of this medicine (listed in section 6). ▪ if you are allergic to other local anaesthetics called amide
type anaesthetics.
- in children under 6 years old.
Warning and precautions
Before receiving this medicine, tell your dentist or stoma‐
tologist if you have severe infection or an inflammation in the area to be treated.
- The dentist should avoid spraying the back of the throat.
Children
This medicinal product should not be used below 6 years old.
Other medicines and XYLONOR SPRAY
Tell your dentist if:
- you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
- you have injuries in your mouth because lidocaine may be released into the blood and interact with other medicines.
Xylonor with food
After using this medicine, avoid chewing gum or eating until normal sensation is restored, otherwise you risk biting your lips, cheeks or tongue.
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 dentist, doctor or pharmacist for advice before taking this medicine. XYLONOR SPRAY can be used during pregnancy and breastfeeding without any risk to the foetus or to the breastfed child, provided that it is used as prescribed.
No effects on fertility are anticipated.
Driving and using machine
XYLONOR SPRAY has no or negligible influence on the ability to drive and use machines.
XYLONOR SPRAY contains alcohol (ethanol 96%)
This medicine contains 606 mg of alcohol (ethanol 96%) in a maximum daily dose of 1.3 g of product which is equivalent to 45.45% (w/w). It may cause a slight burning sensation when exposed to open wounds.
3. How to use XYLONOR SPRAY
Only dentists and stomatologists are trained 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.
The minimum effective anaesthetic dose should be used. Your dentist will spray it onto the buccal mucosa. XYLONOR SPRAY should not be sprayed in the back of throat.
Use in children and adolescents
Particular care should be taken when treating children and adolescents.
Your dentist will adjust the dosage according to the child’s age and weight.
If your dentist or stomatologist use more XYLONOR SPRAY than they should
Under normal conditions of use in dentistry, no overdose effects are to be expected with a product for local use only. However, the following symptoms may be signs of toxicity due to excessive doses or rapid absorption of the product: burning, pricking, tingling sensations around the mouth with no apparent physical cause, dizziness, nervousness, anxiety, apprehension, euphoric mood, confusion, drowsiness, oversensitivity of hearing, ringing in the ears, blurred vision, vomiting, nausea, feeling hot, cold or numbed, muscle twitching, tremors, fits, loss of consciousness, abnormally slow breathing or suspension of breathing, abnormally slow or irregular heartbeat, low blood pressure.
09/23 05 06 033 15 00 Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
ͳ Keep this leaflet. You may need to read it again. ͳ If you have any further questions, ask your dentist, doc‐
tor or pharmacist.
ͳ If you get any side effects, talk to your dentist, doctor or
pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you experience any of these, talk to your dentist, doctor or pharmacist.
If you swallow a lot of the solution, or if you think your child has swallowed any of the solution, tell your dentist. If you have any further questions on the use of this medicine, ask your dentist, doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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.
Inform your dentist, doctor or pharmacist immediately if you experience one of the following serious side effects, which might be symptoms of a hypersensitivity reaction (aller-gic / allergic‐like reaction):
skin rash, hives or itching, skin irritation and occasionally
sensitisation.
swelling of the face, lips, gums, tongue and/or throat, diffi‐
culty breathing, wheezing, asthma.
These side effects happen rarely (they may affect up to 1 in 1,000 people).
Other side effects may also occur in some patients (frequency not known (cannot be estimated from the available data):
- Rash, redness,
- Itching,
- Exfoliation and ulceration of the gums,
- Abnormal sensation in and around the mouth,
- Swelling of the application site, application site burn.
Reporting of side effects
If you get any side effects, talk to your dentist, doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system 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 XYLONOR SPRAY
Keep this medicine out of the sight and reach 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 after EXP. The expiry date refers to the last day of that month.
Your dentist will keep it up to 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your dentist or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What XYLONOR SPRAY contains
The active substances are Lidocaine 10 mg per dose and
Cetrimide 0.10 mg per dose
- The other ingredients are: saccharin, spearmint flavour, dipropylene glycol and ethanol 96%.
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