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The product codes for this leaflet are: PL 17901/0174, PL 17901/0175

 

Xylocaine 1% and 2% with Adrenaline

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AstraZeneca UK Limited


Horizon Place600 Capability GreenLutonBedfordshireLU1 3LU
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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 Xylocaine with adrenaline is given to you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1. What Xylocaine with adrenaline is and what it is used for
2. 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. Further information

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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 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.

Xylocaine with adrenaline is used to stop pain happening during medical procedures and surgery (operations).

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2. Before Xylocaine with adrenaline is given to you

You must not be given Xylocaine with adrenaline if:

  • You are allergic (hypersensitive) to lidocaine, adrenaline or any of the other ingredients of Xylocaine with adrenaline (see Section 6: Further information).
  • 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 before you are given it.

Take special care with Xylocaine with adrenaline

Check with your doctor before having Xylocaine with adrenaline if:

  • You have high blood pressure or heart problems such as a slow heart beat.
  • You have been told that you have hypovolaemia (decreased volume of blood).
  • You have liver or kidney problems.
  • You have difficulty breathing.
  • You have epilepsy.
  • You have diabetes.
  • You have thyroid problems.
  • You have ever had a stroke.
  • You have an infection or inflammation at the site where the injection is to be given.
  • 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 before having Xylocaine with adrenaline.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, 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 and breast-feeding

Before you are given Xylocaine with adrenaline, tell your doctor if you are pregnant, planning to get pregnant, or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

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.

Important information about some of the ingredients of Xylocaine with adrenaline

  • Xylocaine with adrenaline contains 2.49 mg of sodium per millilitre (ml), equivalent to 49.8 mg per 20 ml. Your doctor will take this into account if you are on a sodium controlled diet.
  • Xylocaine with adrenaline contains methyl parahydroxybenzoate (E218). This may cause an allergic reaction such as skin rashes. This may happen a while after you have been given the medicine. Rarely, you may have a reaction immediately with a skin rash and breathlessness.
  • Xylocaine with adrenaline contains sodium metabisulphite. This may rarely cause an allergic reaction and breathlessness.
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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.

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).

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4. Possible side effects

Like all medicines, Xylocaine with adrenaline may cause side effects although not everybody gets them.

Severe allergic reactions (rare, affect less than 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 (affects less than 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 (affects less than 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 (affects less than 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.

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.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

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5. How to store Xylocaine with adrenaline

  • Keep out of the reach and sight of children.
  • Do not use 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.
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6. Further 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 parahydroxybenzoate, 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

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.

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Leaflet prepared: August 2012.

© AstraZeneca 2012.

Xylocaine is a trade mark of the AstraZeneca group of companies.

PAI 11 0023


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