Xylonor gel

Gingival gel

Lidocaine and cetrimide

PATIENT INFORMATION LEAFLET

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 Creteil 94100 Saint-Maur-des-Fosses France