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    XYLONOR-SPRAY-UK PIL APP en 201811

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    Izat Izat
    Xylonor Spray is a local anesthetic and antiseptic oromucosal spray solution containing lidocaine and cetrimide that is administered by a dentist. It is used to numb the lining of the mouth for dental procedures. Common side effects are numbness, tingling, and irritation of the mouth. Rare but serious side effects include allergic reactions that can potentially cause swelling of the face/throat and difficulty breathing. The dentist monitors patients closely during use and is prepared to treat any side effects.

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    XYLONOR-SPRAY-UK PIL APP en 201811

    Uploaded by

    Izat Izat
    23 views4 pages
    Xylonor Spray is a local anesthetic and antiseptic oromucosal spray solution containing lidocaine and cetrimide that is administered by a dentist. It is used to numb the lining of the mouth for dental procedures. Common side effects are numbness, tingling, and irritation of the mouth. Rare but serious side effects include allergic reactions that can potentially cause swelling of the face/throat and difficulty breathing. The dentist monitors patients closely during use and is prepared to treat any side effects.

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    XYLONOR-SPRAY-UK_PIL_APP_en_201811

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    Xylonor Spray is a local anesthetic and antiseptic oromucosal spray solution containing lidocaine and cetrimide that is administered by a dentist. It is used to numb the lining of the mouth for dental procedures. Common side effects are numbness, tingling, and irritation of the mouth. Rare but serious side effects include allergic reactions that can potentially cause swelling of the face/throat and difficulty breathing. The dentist monitors patients closely during use and is prepared to treat any side effects.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    23 views4 pages

    XYLONOR-SPRAY-UK PIL APP en 201811

    Uploaded by

    Izat Izat
    Xylonor Spray is a local anesthetic and antiseptic oromucosal spray solution containing lidocaine and cetrimide that is administered by a dentist. It is used to numb the lining of the mouth for dental procedures. Common side effects are numbness, tingling, and irritation of the mouth. Rare but serious side effects include allergic reactions that can potentially cause swelling of the face/throat and difficulty breathing. The dentist monitors patients closely during use and is prepared to treat any side effects.

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    of 4

    Package leaflet: Information for the user

    Xylonor Spray, 150 mg/g + 1.5mg/g, oromucosal spray solution

    Lidocaine/ Cetrimide

    Read all of this leaflet carefully before you start using this medicine because it contains
    important information for you.
    - Keep this leaflet. You may need to read it again.
    - If you have any further questions, ask your dentist, doctor or pharmacist.
    - 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.

    In this leaflet:
    1. What Xylonor Spray is and what it is used for
    2. What you need to know before you use Xylonor Spray
    3. How to use Xylonor Spray
    4. Possible side effects
    5. How to store Xylonor Spray
    6. Contents of the pack and other 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. What you need to know 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 of this medicine (listed in section 6).
     if you are allergic to local anaesthetics called amide type anaesthetics.
     in children under 4 years old.

    Warning and precautions


     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.
    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.

    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


    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask
    your dentist for advice before taking this medicine.

    Driving and using machine


    If you experience side effects, including dizziness or blurred vision, do not drive or use machines
    until these symptoms have disappeared.

    Xylonor Spray contains small amounts of ethanol (alcohol), less than 100mg per 20 actuations
    (maximum recommended dose) may be absorbed in the blood.

    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 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:
    - skin rash, hives or itching in the mouth, skin irritation and occasionally sensitisation: these might
    be symptoms of an allergic (hypersensitivity) reaction
    - swelling of the face, lips, tongue and/or throat, difficulty breathing: these might be symptoms of a
    severe allergic (anaphylactoid) reaction.
    These side effects happen very rarely (they may affect up to 1 in 10,000 people).

    Other side effects not listed above may also occur in some patients.
    The 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).

    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

    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. The expiry
    date refers to the last day of that month.

    Your dentist will keep it up to 25°C.

    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

    This leaflet was last revised in October 2018.

    If more PILs are necessary, call free number 0800435155.

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