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XYLOCAINE 1% WITH ADRENALINE 1:200 000

Active substance(s): ADRENALINE / LIDOCAINE HYDROCHLORIDE ANHYDROUS

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Possible side effects seen with other local anaesthetics which might also be
caused by Xylocaine with adrenaline include:
• Damaged nerves which may cause permanent problems.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

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5. How to store Xylocaine with adrenaline
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the vial and
container after EXP. The expiry date refers to the last day of that month.
• Store between 2 and 8°C in a fridge.
• Your doctor or the hospital will normally store Xylocaine with adrenaline and they are
responsible for the quality of the product when it has been opened if it is not used
immediately. They are also responsible for disposing of any unused Xylocaine with
adrenaline correctly.
6. Contents of the pack and other information
What Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 contains
The active ingredients are lidocaine and adrenaline (epinephrine). Each millilitre (ml) of
solution contains 10 milligrams or 20 milligrams of lidocaine hydrochloride anhydrous
as the monohydrate and 5 micrograms of adrenaline (epinephrine) as the acid tartrate.
The other ingredients are sodium chloride, sodium metabisulphite, methyl
hydroxybenzoate, sodium hydroxide, hydrochloric acid and water for injections.
What Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 looks like
and contents of the pack
Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 is a solution for
injection. It comes in multi-dose vials of 20 ml.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Xylocaine 1% and 2% with adrenaline (epinephrine)
1:200,000 are held by AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.
Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 is manufactured by
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.

Package leaflet: Information for the user

Xylocaine® 1% and 2% with adrenaline (epinephrine)
1:200,000 Solution for Injection

lidocaine, adrenaline (epinephrine)
Read all of this leaflet carefully before this medicine is given to you 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 doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. See section 4.
What is in this leaflet:
1. What Xylocaine with adrenaline is and what it is used for
2. What you need to know before Xylocaine with adrenaline is given to you
3. How Xylocaine with adrenaline is given to you
4. Possible side effects
5. How to store Xylocaine with adrenaline
6. Contents of the pack and other information

1. What Xylocaine with adrenaline is and what it is used for
The name of your medicine is ‘Xylocaine 1% with adrenaline (epinephrine) 1:200,000’
or ‘Xylocaine 2% with adrenaline (epinephrine) 1:200,000’. It is referred to as ‘Xylocaine
with adrenaline’ in the rest of this leaflet.
Xylocaine with adrenaline is used to numb (anaesthetise) part of the body for surgical
operations or to provide pain relief.
Xylocaine 1% with adrenaline is used in adults and children above 1 year of age to:
• numb (anaesthetise) the area of the body where surgery is to be performed.
• provide pain relief in labour, after surgery or after acute injury.
• treat certain types of chronic pain.
Xylocaine 2% with adrenaline is used in adults and children above 12 years to:
• numb (anaesthetise) the area of the body where surgery is to be performed.
• provide pain relief in labour, after surgery or after acute injury.
• treat certain types of chronic pain.
Xylocaine with adrenaline contains two different medicines: lidocaine and adrenaline
(epinephrine). Each of these works in a different way.
• Lidocaine belongs to a group of medicines called local anaesthetics. These
medicines numb (anaesthetise) parts of the body.
• Adrenaline (epinephrine) belongs to a group of medicines called vasoconstrictors.
These medicines make the blood vessels where the injection is given narrower. This
means you will bleed less and the effects of the medicine will last longer.

To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Reference
number
Xylocaine 1% with Adrenaline (epinephrine) 17901/0174
Xylocaine 2% with Adrenaline (epinephrine) 17901/0175
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in November 2014.
© AstraZeneca 2014.
Xylocaine is a trade mark of the AstraZeneca group of companies.
PAI 14 0001a

2. What you need to know before Xylocaine with adrenaline is given to you
You must not be given Xylocaine with adrenaline:
• if you are allergic to lidocaine, adrenaline or any of the other ingredients of this
medicine (listed in section 6).
• if you are allergic to any other local anaesthetics.
You must not be given Xylocaine with adrenaline if any of the above apply to you. If you
are not sure, talk to your doctor or nurse before you are given it.

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Warnings and precautions
Talk to your doctor or nurse before having Xylocaine with adrenaline:
• if you have high blood pressure or heart problems such as a slow heart beat.
• if you have been told that you have hypovolaemia (decreased volume of blood).
• if you have liver or kidney problems.
• if you have difficulty breathing.
• if you have epilepsy.
• if you have diabetes.
• if you have thyroid problems.
• if you have ever had a stroke.
• if you have an infection or inflammation at the site where the injection is to be given.
• if you have ever been told that you have a rare disease of the blood pigment called
‘porphyria’ or anyone in your family has it.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before
having Xylocaine with adrenaline.
Other medicines and Xylocaine with adrenaline
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This includes medicines that you buy without a prescription and herbal medicines. This
is because Xylocaine with adrenaline can affect the way some medicines work and
some medicines can have an effect on Xylocaine with adrenaline.
In particular, tell your doctor if you are taking any of the following medicines:
• Other local anaesthetics.
• Other medicines that contain adrenaline.
• Halothane (a general anaesthetic).
• Medicines used to treat an uneven heart beat (arrhythmia) such as amiodarone.
• Beta-blockers medicines such as propranolol.
• Butyrophenone medicines for sickness, such as domperidone.
• Other butyrophenone medicines for mental problems, such as haloperidol.
• Phenothiazine medicines for mental problems, such as chlorpromazine.
• Medicines for depression such as monoamine oxidase inhibitors (MAOIs) and
tricyclic antidepressants.
• Medicines that induce labour.
• Cimetidine.
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 doctor for advice before you are given Xylocaine with adrenaline
Driving and using machines
Xylocaine with adrenaline may make you feel sleepy and affect the speed of your
reactions. After you have been given Xylocaine with adrenaline, you should not drive or
use tools or machines until the next day.
Xylocaine with adrenaline contains sodium, methyl hydroxybenzoate and sodium
metabisulphite
• Xylocaine with adrenaline contains 2.49 mg of sodium per millilitre (ml), equivalent
to 49.8 mg per 20 ml. To be taken into consideration by patients on a controlled
sodium diet.
• Xylocaine with adrenaline contains methyl hydroxybenzoate (E218). This may cause
allergic reactions (possibly delayed), and exceptionally, bronchospasm.
• Xylocaine with adrenaline contains sodium metabisulphite. This may rarely cause
severe hypersensitivity reactions and bronchospasm.
3. How Xylocaine with adrenaline is given to you
Xylocaine with adrenaline will be given to you by a doctor. It will be given to you as an
injection. The dose that your doctor gives you will depend on the type of pain relief that
you need. It will also depend on your body size, age, physical condition and the part of
your body that the medicine is being injected into. You will be given the smallest dose
possible to produce the required effect.
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Xylocaine with adrenaline will usually be given near the part of the body to be operated
on. It stops the nerves from being able to pass pain messages to the brain. It will stop
you feeling pain. It will start to work a few minutes after being injected and will slowly
wear off when the medical procedure is over.
If you have been given too much Xylocaine with adrenaline
Serious side effects from getting too much Xylocaine with adrenaline need special
treatment and the doctor treating you is trained to deal with these situations. The first
signs of being given too much Xylocaine with adrenaline are usually as follows:
• Feeling dizzy or light-headed.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Problems with your sight (vision).
To reduce the risk of serious side effects, your doctor will stop giving you Xylocaine
with adrenaline as soon as these signs appear. This means that if any of these happen
to you, or you think you have received too much Xylocaine with adrenaline, tell your
doctor immediately.
More serious side effects from being given too much Xylocaine with adrenaline
include problems with your speech, irrational behaviour, twitching of your muscles, fits
(seizures), effects on your heart and blood vessels, loss of consciousness, coma and
stopping breathing for a short while (apnoea).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
If you have a severe allergic reaction, tell your doctor immediately. The signs may
include sudden onset of:
• Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.
• Severe or sudden swelling of your hands, feet and ankles.
• Difficulty breathing.
• Severe itching of the skin (with raised lumps).
Other possible side effects:
• Numbness where the injection is given. This will go away slowly.
Common (may affect up to 1 in 10 people)
• Low blood pressure. This might make you feel dizzy or light-headed.
• High blood pressure.
• Feeling sick (nausea) or being sick (vomiting).
• Pins and needles.
• Feeling dizzy.
• Slow heart beat.
Uncommon (may affect up to 1 in 100 people)
• Ringing in the ears (tinnitus) or being sensitive to sound.
• Difficulty in speaking.
• Numbness of the tongue or around the mouth.
• Fits (seizures).
• Feeling sleepy.
• Shakiness.
• Blurred vision.
Rare (may affect up to 1 in 1,000 people)
• Uneven heart beat (arrhythmias).
• Nerve damage that may cause changes in sensation or muscle weakness
(neuropathy). This may include peripheral nerve damage.
• A condition called arachnoiditis (inflammation of a membrane that surrounds the
spinal cord). The signs include a stinging or burning pain in the lower back or legs
and tingling, numbness or weakness in the legs.
• Double vision.
• Slowed or stopped breathing or stopped heart beat.
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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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