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XYLOCAINE 2% W/V WITH ADRENALINE (EPINEPHRINE) 1:80 000 DENTAL SOLUTION FOR INJECTION

Active substance(s): ADRENALINE TARTRATE / LIGNOCAINE

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PATIENT INFORMATION LEAFLET FOR THE USER
Xylocaine® 2% w/v with Adrenaline (epinephrine) 1:80,000
DENTAL
Solution for injection
Lidocaine Hydrochloride Anhydrous 2% w/v
Adrenaline (epinephrine) 1:80,000
What you should know about your medicine.
Please read all of this leaflet before you are given this medicine

Keep this leaflet. You may need to read it again.

If you have any further questions ask your dentist or doctor.

This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if
their symptoms are the same as yours.

Normally a dentist or dental hygienist will use this product on you in the dental surgery. It is unlikely
that you will be permitted to take this medicine home.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your dentist or doctor.
In this leaflet:
1. What Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL is and what it is used for
2. Before being given Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL
3. How Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL will be given
4. Possible side effects
5. Storing Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL
6. Further information
1. What Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL is and what it is used for
Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL is a solution for injection. It contains
lidocaine and adrenaline.
Lidocaine is a type of medicine called a local anaesthetic (anaesthetics are medicines which numb
an area of the body). Adrenaline is a type of medicine called a vasoconstrictor (these are medicines which
make the blood vessels at the site of injection narrower) which means that you will bleed less and
the effects of the medicine will last longer.
What this medicine is used for
It is used to stop pain during dental procedures.
2. Before being given Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL
Do not use Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL

if you are allergic (hypersensitive) to Xylocaine or any of the ingredients of Xylocaine 2% with
Adrenaline (epinephrine) 1:80,000 DENTAL (see section 6 – Further Information)

if you have ever had an allergic reaction to another local anaesthetic

to numb the fingers, toes, nose, ear lobes or penis as an injection directly into the vein.
Tell your dentist or doctor if any of the following apply to you:

if you have high blood pressure or any heart problems, in particular a slow heartbeat

if you have anaemia or other blood disorder

if you have epilepsy

if you have ever had a stroke

if you have problems with your liver

if you have problems with your thyroid

if you have breathing problems

if you are pregnant or think you might be pregnant

if you are breast feeding

if you have an infection at the site where the injection is to be given

Using other medicines
Make sure your dentist or doctor knows if you are taking any of the medicines listed here:

anti depressants (MAOI’s) monoamine oxidase inhibitors (for example, phenelzine and
isocarboxazid)

tricyclic anti depressants (for example, imipramine, amitriptyline, doxepin, mianserin, trazodone and
lofepramine)

any other anaesthetics
Tell your dentist or doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are breast-feeding, ask your dentist or doctor
for advice before being given Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL
Important Information about some of the ingredients of Xylocaine® 2% with Adrenaline (epinephrine)
1:80,000 DENTAL

Sodium metabisulfite (E223) may rarely cause severe hypersensitivity reactions and bronchospasm.
This may be manifested as a rash, swelling, low blood pressure and breathlessness and may be more
prevalent in people with a history of allergies and asthma.


This product contains less than 1 mmol sodium (23mg) per ml. i.e. essentially “sodium free”

3 . How Xylocaine ® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL will be given
You will be given Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL as an injection by
your dentist.
You may have this injection inside your mouth before having your dental treatment. Your dentist will wait
a few minutes for the area to go numb before starting the treatment, so that you will feel less pain. The
numbness will last until the treatment is finished and for a while afterwards.



Your dentist will decide what dose is right for you
The maximum dose is 500mg (25ml)

Adults

The usual dose is between 1 to 2ml.
Children, the elderly and unwell patients

A smaller dose should be given depending on age and how unwell they are

In all cases, the smallest dose that is needed should be used
After the injection, your mouth may feel numb for some time. Take care not to accidentally bite your
tongue or cheek. Also, avoid drinking very hot drinks and eating very hot food until the feeling fully returns.
The numbness will slowly go away.
If you feel you have been given too much or too little Xylocaine 2% with Adrenaline (epinephrine) 1:80,000
DENTAL, talk to your dentist or doctor immediately.
Xylocaine Injection will be given to you by the dentist or doctor.
If you have any further questions on the use of this product, ask your dentist or doctor.
4. Possible side effects
Like all medicines, Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL can cause side
effects, as well as the effects that are needed. These side effects are rare and usually only occur with
high doses.
If you have any of the following rare side effects while taking your medicine tell your dentist
immediately, or go straight to the hospital if you have left the dental surgery.

Severe allergic reaction may include a red and lumpy skin rash, difficulty in breathing, lowered
blood pressure, swelling of the face, mouth, lips or eyelids.

Rare side effects (affecting fewer that 1 in 1,000 people)

Feelings of nervousness, dizziness, blurred vision, shakiness, sounds/ringing in the ears, and
occasionally drowsiness and loss of consciousness.

Fits

Low blood pressure

Nausea, headache, or a faster heartbeat.

A slow (rarely stopped) heart beat or breathing
If any of these side effects become serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or dentist.
5. How to store Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL
You will not normally be asked to store your medicine as it will be given to you by a healthcare professional.
Keep out of the sight and reach of children.
Do not store above 25ºC. Do not freeze.
Keep the container in the outer carton in order to protect from light.
Do not use Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL after the expiry date which is
printed on the container after EXP. The expiry date refers to the last day of the month.
Do not use if there is any appearance of cloudiness or colour.
6. Further information
What Xylocaine® 2% with Adrenaline (epinephrine)1:80,000 DENTAL contains



Each ml of solution contains Lidocaine Hydrochloride equivalent to lidocaine hydrochloride
anhydrous 20 mg (44 mg per 2.2 ml cartridge), and Adrenaline (Epinephrine) tartrate equivalent to
adrenaline (epinephrine) 12.5 micrograms (27.5 micrograms per 2.2 ml cartridge).
The other ingredients are: sodium chloride, sodium metabisulfite (E223), sodium hydroxide,
hydrochloric acid and water for injections.

What Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL looks like and contents of the
pack
A clear, colourless, aqueous sterile solution.
Solution for injection for dental use.
Each glass cartridge contains 2.2ml of Xylocaine® 2% with Adrenaline (epinephrine) 1:80,000 DENTAL.
Each pack contains 50 or 100 cartridges.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DENTSPLY Limited
Building 3, The Heights
Weybridge, Surrey, KT13 0NY
United Kingdom
Manufacturer
Pierrel S.p.A., Strada Statale, Appia 46/48
81043, Capua (CE), Italy

This leaflet was last revised in May 2016

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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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