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LIDOCAINE HYDROCHLORIDE INJECTION 1%W/V

Active substance(s): LIDOCAINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lidocaine Injection 1% w/v
Prefilled Syringe
Lidocaine Hydrochloride
(Referred to as Lidocaine Injection in this leaflet)
Read this leaflet carefully before you are given Lidocaine
Injection
• Keep this leaflet, you may need to read it again
• If you have any further questions, please ask your doctor, nurse
or anaesthetist
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
anaesthetist

In this leaflet:
1.
2.
3.
4.
5.
6.

What Lidocaine Injection is and what it is used for
Before Lidocaine Injection is given
How Lidocaine Injection is given
Possible side effects
How to store Lidocaine Injection
Further information

This leaflet contains a summary of the information available for this
medicine. You should ask your doctor or nurse if you are unsure
about any aspect of this medicine.

1. What Lidocaine Injection is and what it is used
for
Lidocaine is one of a group of medicines known as antiarrythmics
which are used to regulate the heartbeat.
Lidocaine Injection is used to treat an irregular heartbeat,
particularly following a heart attack.

2. Before Lidocaine Injection is given
You should not be given Lidocaine Injection if:
• you are allergic (hypersensitive) to Lidocaine Hydrochloride or
other local anaesthetics, or to any of the other ingredients of the
injection listed in section 6 of this leaflet
• you have porphyria (a blood disorder)
• you have been told you have low levels of blood in your body or
you have recently suffered from severe diarrhoea or sickness, or
lost a lot of blood
• you have been told you suffer from conduction disorders of the
heart such as severe heart block, severe myocardial depression
or cardiac decompensation.
Take special care with Lidocaine Injection
Tell your doctor if:
• you have palpitations (irregular heart beat)
• you have liver or kidney problems
• you have any conditions which make your heart beat too slowly
• you have low blood pressure
• you have low blood potassium levels
• you suffer from epilepsy (fits)
• you are suffering from breathing difficulties
• you are suffering from heart failure
If any of the above applies to you, please tell your doctor or nurse.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have recently
taken, any other medicines, including medicines obtained without
prescription.
Tell your doctor if you are taking any of the following:
• beta blockers e.g. propranolol (medicines used to treat high
blood pressure)
• cimetidine (a medicine used to treat heartburn and stomach
ulcers)
• suxamethonium (a medicine used as a muscle relaxant during
surgery)
• medicines used to treat bacterial infections such as quinupristin
and dalfopristin
• medicines used to treat an irregular heartbeat
• medicines that make you pass more urine such as
acetazolamide, loop diuretics and thiazides
• medicines used to treat depression such as reboxetine
• medicines used to treat epilepsy such as phenytoin or
barbiturates
Pregnancy and breast-feeding
If you are pregnant or are breast-feeding, your doctor will advise you
whether you can be given Lidocaine Injection.
Driving and using machines
Lidocaine Injection may affect your ability to drive or use machines.
If you feel it has affected you do not drive or use machinery.
Continued overleaf

3. How Lidocaine Injection is given
This medicine is an injection which will be given to you by a doctor.
Your doctor will determine the dose you require. It will be given
under the skin, into a vein or into a muscle.
Adults:
• The usual dose is 1mg per kilogram of body weight
• This is around 50 - 100mg (5- 10ml) and is given by intravenous
injection
• When necessary the injection can be repeated once or twice at
5 - 10 minute intervals
• The usual maximum dose is 200-300mg in any one hour period.
Children:
Lidocaine Injection is not recommended for children.
The elderly and ill:
If you are elderly or ill you will be given a reduced dose.
If you think you have been given too much Lidocaine Injection
This medicine will be given to you by your doctor so it is unlikely
you will receive too much. If you are concerned about your
treatment, please talk to your doctor.

4. Possible side effects
Like all medicines, Lidocaine Injection can cause side effects,
although not everybody gets them.
If any of the following symptoms occur tell your doctor or nurse
immediately. These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other possible side effects include:
• drowsiness, dizziness
• a ring or buzzing in the ears (tinnitus)
• feeling confused
• blurred vision
• slowed breathing
• shaking or convulsions (fits)
• unconsciousness
• feeling of tingling, pricking or numbness.
Rare side effects
• low blood pressure
• slow heart beat
• cardiac arrest.
If any of these side effects get serious, or you notice any other
side effects not listed in this leaflet, please tell your doctor or
nurse immediately.

5. How to store Lidocaine Injection
Keep out of the reach and sight of children.
You should not be given this medicine if it has passed the expiry
date shown on the label. The expiry date refers to the last day of that
month. The doctor or nurse will check that the product has not
passed this date.
Store below 25°C. Keep in outer box.

6. Further Information
What Lidocaine Injection contains
Lidocaine Injection contains 1%w/v of the active Lidocaine
Hydrochloride.
The other ingredients are sodium chloride, dilute hydrochloric acid,
sodium hydroxide solution and water for injections.
What Lidocaine Injection looks like and contents of the pack
Lidocaine Injection is a clear, colourless solution supplied in 5ml and
10ml prefilled syringes. Each box contains one prefilled syringe.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
Manufacturer
Federa SC
Avenue Jean Jaureslaan, 71
B-1030 Brussels
Belgium
This leaflet was last approved in 12/2008
PL 12064/0056

C*****

If you would like more information, or would like the leaflet in a
different format, please contact Medical Information at the
above address.

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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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