PACKAGE LEAFLET: INFORMATION FOR THE USER    C*****

Lidocaine Hydrochloride Injection BP 0.5% w/v Lidocaine Hydrochloride Injection BP 1% w/v Lidocaine Hydrochloride Injection BP 2% w/v

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 hydrochloride is a local anaesthetic.

Lidocaine Injection is used before surgery to numb the area to be operated on.

It can also be used to treat an irregular heartbeat after heart surgery, 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 a heart condition known as Stokes-Adams syndrome

•    you have a heart condition known as Wolff-Parkinson-White syndrome

•    you have any other heart problems which cause the heart to beat too slowly

•    you have porphyria (a blood disorder)

•    you have low levels of blood or plasma.

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 fast

•    you have any other heart problems such as congestive heart failure

•    you or someone in your family has malignant hyperthermia (a muscle disorder that can be triggered by local anaesthetics)

•    you are in shock.

If any of the above applies to you, please tell your doctor or nurse. Taking with 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:

•    acetozolamide (a medicine used to treat glaucoma)

•    diuretics (medicines used to treat water retention)

•    tubocurarine (an anaesthetic)

•    polymyxin B or quinupristin/dalfopristin (medicines used to treat bacterial infections)

•    beta blockers e.g. propranolol and metoprolol (medicines used to treat high blood pressure)

•    cimetidine (a medicine used to treat heartburn and stomach ulcers)

•    succinylcholine (a medicine used to relax muscles)

•    phenytoin (a medicine used to treat epilepsy)

•    reboxetine (a medicine used to treat depression)

•    procainamide (a medicine used to treat heart problems).

Pregnancy and breast-feeding

This medicine should not be given to you if you are pregnant unless your doctor has specifically recommended it.

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.

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:

For the treatment of an irregular heartbeat:

•    50 - 100mg by slow intravenous injection followed by infusion (drip) at 2 - 4mg per minute

•    the usual maximum dose is 200-300mg in any one hour period.

For numbing on the surface of the skin:

•    by injection of a 0.25 - 1% injection into the appropriate tissue

•    the dose is 5 - 300mg.

To numb deeper areas:

•    by injection of a 1 - 2% injection into or around the appropriate nerve

•    the dose is 30 - 300mg.

The elderly and children:

Lower doses are necessary in the elderly and in children.

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:

•    light-headedness, drowsiness, dizziness

•    low blood pressure, excess fluid in the blood

•    blood clots

•    a ring or buzzing in the ears (tinnitus)

•    feeling nervous or confused

•    feeling high

•    blurred or double vision

•    fever

•    being sick

•    slowed breathing, slowed heart beat

•    infection in the injection site

•    soreness or weeping of fluid at the injection site

•    feelings of heat, cold or numbness

•    twitching, shaking and convulsions (fits), unconsciousness.

If any of these side effects get serious, or you notice any other side effects not listed in this leaflet, please tell your doctor 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 ampoule 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.

6.    Further Information

What Lidocaine Injection contains

Lidocaine Injection contains either 0.5, 1 or 2% w/v of the active ingredient Lidocaine Hydrochloride.

The other ingredients are Sodium Chloride BP and Water for Injection BP.

What Lidocaine Injection looks like and contents of the pack

Lidocaine Injection is a clear, colourless solution supplied in clear, colourless glass ampoules containing sufficient solution to permit the removal of 2, 5, 10 or 20ml. Each carton contains 10 ampoules.

Marketing Authorisation Holder and manufacturer:

Martindale Pharmaceuticals Ltd., Bampton Road, Harold Hill, Romford Essex RM3 8UG Product Licence Number:

Lidocaine Hydrochloride Injection BP 0.5% w/v PL 1883/0036 Lidocaine Hydrochloride Injection BP 1% w/v PL 1883/0037 Lidocaine Hydrochloride Injection BP 2% w/v PL 1883/0038

Date of Revision: January 2008

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

MARTINDALE

Pharmaceuticals

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

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