Lidocaine Hydrochloride Injection 2%W/V
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 anesthetist
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 Injection is a local anaesthetic.
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 suffer from heart problems
• you have porphyria (a blood disorder).
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 potssium levels
• you have epilepsy
• you have breathing problems.
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:
• diuretics (medicines used to treat water retention)
• quinupristin or dalfopristin (medicines used to treat bacterial infections)
• medicines used to treat high blood pressure or an irregular heartbeat (e.g. beta blockers such as propranolol)
• cimetidine (a medicine used to treat heartburn and stomach ulcers)
• suxamethonium (a medicine used to relax muscles)
• phenytoin and barbituates (medicines used to treat epilepsy)
• reboxetine (a medicine used to treat depression)
• procainamide (a medicine used to treat heart problems).
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 (2.5 - 5ml) 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:
Not recommended.
The elderly and ill:
Lower doses are necessary.
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.
As can happen with any medicine, a few people may develop an allergic reaction. If you experience the following, tell your doctor or nurse immediately:
• sores, hives, swelling, itching
• a blocked nose, and breathing difficulties.
Possible side effects include:
• drowsiness, dizziness
• a ring or buzzing in the ears (tinnitus)
• feeling confused
• blurred vision
• slowed breathing
• twitching, shaking or convulsions (fits)
• unconsciousness
• involuntary eye movements
• 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 2%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
RM38UG
United Kingdom
Manufacturer
Federa SC
Avenue Jean Jaureslaan, 71 B-1030 Brussels Belgium
This leaflet was last approved in Jan/2008.
PL 12064/0049
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