Xylonor spray

Metered aerosol Lidocaine and cetrimide

PATIENT INFORMATION LEAFLET

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    If more PILs are necessary, call free number 0800435155.

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

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 Creteil 94100 Saint-Maur-des-Fosses France