Consumer medicine information

XYLOCAINE® 4% TOPICAL SOLUTION

Lignocaine Hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about Xylocaine 4% Topical Solution (Xylocaine Topical) . It does not contain all the information that is known about Xylocaine Topical.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Xylocaine Topical against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What XYLOCAINE TOPICAL is for

Xylocaine Topical is used to produce temporary loss of sensation in a part of the body before certain types of examination and instrumentation are performed by your doctor, such as an examination of your throat or lungs. It may also help prevent coughing or gagging during these procedures.

Xylocaine Topical belongs to a group of medicines called local anaesthetics. It works by making the pain nerves unable to send messages to the brain.

Ask your doctor or pharmacist if you have any questions about why Xylocaine Topical is being used for you. Your doctor may be using it for another reason.

Xylocaine Topical is not addictive.

Before you use XYLOCAINE TOPICAL

When you must not use it

Do not use Xylocaine Topical if you have an allergy to:

  • the active ingredient, lignocaine
  • any other local anaesthetics
  • para aminobenzoic acid (PABA)
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body,
  • rash itching or hives on the skin.

Xylocaine Topical should not be used after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Xylocaine Topical should not be used on open wounds or infected areas.

If you are not sure that you should be using this medicine talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor or pharmacist if you have any allergies to any other medicines, foods preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any of the following medical conditions:

  • epilepsy
  • heart problems
  • liver problems
  • kidney problems
  • open wounds or infection where the solution will be used
  • dangerously high body temperature or if you have a family history of dangerously high body temperature
  • porphyria ( a rare metabolic disorder characterised by excessive levels of porphyrin in the blood and urine) Symptoms of acute porphyria include:
    – muscle pain or paralysis
    – seizures
    – disorientation
    – hallucination
    – bloody (red) urine
    – hypertension
    – abdominal pain
    – constipation
    – vomiting.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breast-feeding or plan to breast-feed. Your doctor can discuss the risks and benefits involved.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines that you get without a prescription from your pharmacy supermarket or health food shop.

Some medicines and Xylocaine Topical may interfere with each other. These include:

  • medicines used to treat irregular heart beat
  • cimetidine, a medicine used to help reduce the amount of acid produced by the stomach
  • medicines used to treat epilepsy such as, phenytoin, phenobarbitone, primodone and carbamazepine.

These medicines may be affected by Xylocaine Topical or may affect how well it works. You may need different amounts of your medicines or you may need to use different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

If you have not told your doctor or pharmacist about any of these things, tell them before you are given any Xylocaine Topical.

Using XYLOCAINE TOPICAL

How to use it

Xylocaine Topical will usually be administered by your doctor.

The dose of Xylocaine Topical depends on the procedure that your doctor will be performing. Your doctor will use the dose that is suitable for you. The dose normally used in adults is 1-5mL of Xylocaine Topical solution (40 – 200mg lignocaine hydrochloride).

Children are given a lower dose, depending on the age and weight of the child. The usual maximum dose does not exceed 3 mg/kg of bodyweight.

Xylocaine Topical can be applied with a cotton swab or pack, or directly onto the area.

Xylocaine Topical is sometimes used as a spray during procedures involving the throat and windpipe.

Overdose

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anybody else may have used too much Xylocaine Topical even if there are no signs of discomfort or poisoning.

The first signs that too much Xylocaine Topical has been used are light headedness, drowsiness, dizziness, and sometimes blurred vision. In the event of a serious overdosage, trembling, seizures or unconsciousness may occur.

While you are using it

Things to be careful of

Be careful driving or operating machinery after you have been given Xylocaine Topical. You may be drowsy and your reflexes may be slow. If you have any of these symptoms, do not drive, operate machinery or do anything else that may be dangerous.

Things you must not do

Do not eat or drink anything for at least 1 hour after you have been given Xylocaine Topical in the mouth or throat area. You may swallow your food the wrong way, or burn or bite your mouth. Eating, chewing or drinks should be avoided while the mouth or throat is numb.

Do not use Xylocaine Topical as a gargle.

Contact with Xylocaine Topical and your eyes should be avoided. If any of the solution does go in your eye, rinse immediately with lots of water for at least 15 minutes and call your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after you have been given Xylocaine Topical. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • skin rash or irritation

These side effects are usually mild.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • dizziness, lightheadedness
  • drowsiness, confusion
  • blurred vision, ringing in the ears
  • tremor
  • wheezing or difficulty breathing
  • chest pain
  • severe rash or itching
  • increased sweating
  • fits
  • unconsciousness
  • low blood pressure
  • slow heart beat
  • collapse.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

All of these side effects are rare.

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some people.

Storage

Keep your Xylocaine Topical in the bottle until it is time to use it.

Keep it in a cool place where the temperature is kept below 25 degrees C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Ask your pharmacist what to do with any solution you have left over if your doctor tells you to stop using it, or you find that the expiry date has passed.

Product description

Xylocaine Topical is a clear, colourless solution in bottles of 30mL.

Each mL of solution contains 40 mg lignocaine hydrochloride (anhydrous) and the following inactive ingredients:

  • Methyl hydroxybenzoate (E 218)
  • Sodium hydroxide or hydrochloric acid (for pH adjustment)
  • Purified water .

Lignocaine is known as lidocaine in some other countries.

Sponsor

AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113

This leaflet was prepared in
March 2009

Customer service line:
Tel: 1 800 805 342

Australian Registration Number
Xylocaine 4% Topical Solution –
AUST R 124858

Xylocaine is a registered trade mark of the AstraZeneca Group of companies.

Published by MIMS November 2009