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LIDOCAINE 4% M/V OROMUCOSAL SOLUTION

Active substance(s): LIDOCAINE HYDROCHLORIDE

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LIDOCAINE 4% m/v OROMUCOSAL SOLUTION

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 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 pharmacist.
IN THIS LEAFLET:
1. What Lidocaine Solution is and what it is used for
2. Before you use Lidocaine Solution
3. How to use Lidocaine Solution
4. Possible side effects
5. How to store Lidocaine Solution
6. Further information
1.

WHAT LIDOCAINE SOLUTION IS AND WHAT IT IS USED FOR

Lidocaine is a medicine called a local anaesthetic. 'Oromucosal' means that the solution is for use in
the mouth area. It may be applied to parts of the body to relieve pain or discomfort.
Lidocaine is used:

in the examination of the airways

for taking tissue samples from the mouth

for removal of tonsils or polyps

for other minor surgical procedures and in dentistry.

2.

BEFORE YOU USE LIDOCAINE SOLUTION

Do NOT use Lidocaine Solution if you:
 are allergic (hypersensitive) to lidocaine, other local anaesthetics or any of the other
ingredients of this medicine.
Take special care with Lidocaine Solution
 Lidocaine Solution is not intended to be used as an injection.
Taking other medicines
Talk to your doctor if you are taking any of the following:
 cimetidine or propranolol, as they may enhance the effects of Lidocaine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.

Pregnancy and breast-feeding


Lidocaine Solution should not be used in early pregnancy unless under the supervision of your doctor

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if you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice
before using this medicine.

Driving and using machines
 if absorbed into the bloodstream Lidocaine can cause drowsiness
 application of the solution is not expected to affect your ability to drive or operate machinery,
but if affected do not drive or operate machinery.
Important information about some of the ingredients of Lidocaine Solution
 E123 may cause allergic reactions.

3.

HOW TO USE LIDOCAINE SOLUTION

A nurse, midwife, or your doctor or dentist will usually apply this solution and they are fully
instructed in its use.
If you are given Lidocaine Solution to take home, you must follow the instructions given by your
doctor or dentist on how much to use and how often.
Wash your hands before and after applying Lidocaine.
If you are not sure how to use the solution, check with your doctor or dentist.
The treatment guidelines for the following procedures are: Biopsy:
Apply 3 to 4 ml by swab or spray to the area a few minutes beforehand (0.05 ml of a 1:1,000
solution of adrenaline may be added to 5 ml of Lidocaine solution to localise the effect).


Bronchoscopy and Bronchography:
Apply 2 to 3 ml by a suitable spray to the mouth, pharynx, larynx, and trachea.



Puncture Of Maxillary Sinus or Polypectomy:
Apply a saturated swab for 2 to 3 minutes. The addition of adrenaline as described above is
recommended.

The usual maximum dose is:
 Adults
Maximum daily dose 200 mg (5 ml).


The elderly or debilitated patients:
Reduce maximum dose.



Children
Your doctor will decide on the appropriate dose for your child based on the child’s body weight.

If you apply more Lidocaine Solution than you should
 wipe off the excess with a paper towel or similar.

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If you (or someone else) accidentally swallow any of the solution, or if you think a child has
swallowed any of the solution contact your nearest hospital casualty department or your doctor
immediately.
An overdose is likely to cause low blood pressure and heart problems.
Please take this leaflet, any remaining solution, and the container with you to the hospital or doctor
so that they know which solution has been consumed.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Lidocaine Solution can cause side effects, although not everybody gets them.
If the following happens, stop using the solution and tell your doctor immediately or go to the
casualty department at your nearest hospital:
 an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing;
skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Most patients using Lidocaine will have no problems when used in the correct amount for the
prescribed time.
 using Lidocaine Solution for a prolonged period (longer than prescribed) can cause an allergic
reaction.
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 pharmacist.
5.

HOW TO STORE LIDOCAINE SOLUTION

Keep out of the reach and sight of children.
Lidocaine Solution should be stored below 25º C in a safe place.
Once opened, Lidocaine Solution may not be considered sterile and should be thrown away after
use.
Do not use Lidocaine Solution after the expiry date that is stated on the outer packaging. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. If your doctor has stopped
your treatment, DO NOT STORE any unused Lidocaine solution. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Lidocaine Solution contains:
 The active ingredient is lidocaine hydrochloride 4% m/v.
 The other ingredients are water for injections and the colouring agent, amaranth (E123).
What Lidocaine Solution looks like and contents of the pack:
 Lidocaine Solution is a sterile aqueous solution in an amber coloured glass bottle fitted with an
aluminium cap and neoprene liner. The cap is sealed to the bottle with a viskring.
 The pack size is 25 ml.

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Marketing Authorisation Holder and Manufacturer
Authorisation Holder and company responsible for manufacture: TEVA UK Limited, Eastbourne,
BN22 9AG England.
This leaflet was last revised: February 2010
PL 00289/0766

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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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