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.    What Lidocaine Injection is and what it is used for

2.    Before Lidocaine Injection is given

3.    How Lidocaine Injection is given

4.    Possible side effects

5.    How to store Lidocaine Injection

6.    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

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

Aurum

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom