2% Xylocaine DENTAL with Adrenaline 1:80,000

Main information

  • Trade name:
  • 2% Xylocaine DENTAL with Adrenaline 1:80,000 Solution for injection
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Cartridge, glass, 2.2mL auto asp, 100 dose units
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Boehringer Ingelheim Pharma GmbH & Co KG

Documents

Localization

  • Available in:
  • 2% Xylocaine DENTAL with Adrenaline 1:80,000 Solution for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • The product is indicated for the production of local nerve anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. Lidocaine solutions with adrenaline are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 1526
  • Authorization date:
  • 31-12-1969
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Xylocaine

Dental

1(3)

2% XYLOCAINE

DENTAL with

Adrenaline 1:80,000

Lignocaine hydrochloride

Adrenaline acid tartrate

___________________________________________________________________________

Consumer Medicine Information

Name of consumer

Address of consumer

__________________

What is in this leaflet

___________________________________________________________________

Xylocaine and lignocaine are

different names for the same

medicine which is used as to stop

pain during dental procedures. It is

only called Xylocaine Dental in

this leaflet. The information about

them is the same.

This leaflet answers some of the

common questions people ask about

Xylocaine Dental. It does not

contain all the information that is

known about Xylocaine Dental.

It does not take the place of talking

to your dentist or pharmacist.

All medicines have risks and

benefits. Your dentist will have

weighed the risks of you being

given Xylocaine Dental against the

benefits they expect it will have for

you.

If you have any concerns about

being given this medicine, ask

your dentist or pharmacist.

Keep this leaflet. You may need to

read it again.

__________________

What XYLOCAINE

DENTAL is for

___________________________________________________________________

Xylocaine Dental is used to prevent

or relieve pain during dental

procedures, but it will not put you

to sleep.

Xylocaine Dental belongs to a

group of medicines called local

anaesthetics. It is injected into the

mouth where it makes the nerves

unable to pass messages to the

brain.

Depending on the amount used,

Xylocaine Dental will either totally

stop pain or will cause a partial loss

of feeling.

Xylocaine Dental is often used

with adrenaline to make it last

longer. Adrenaline makes the blood

vessels at the site of injection

narrower, which means you bleed

less and it is easier for your dentist

to see what is happening.

Your dentist will have explained

why you are being treated with

Xylocaine Dental. Follow all

directions given to you by your

dentist carefully. They may differ

from the information contained in

this leaflet. Ask your dentist if you

want more information.

Xylocaine Dental is not addictive

__________________________

Before you are given

XYLOCAINE DENTAL

___________________________________________________________________

When you must not be

given it

Do not use Xylocaine Dental if

you are pregnant or breastfeeding

unless your doctor and dentist say

so. Ask your doctor or dentist

about the risks and benefits

involved.

Xylocaine Dental has been widely

used during pregnancy and there

have been no reports of any ill

effects on the baby. It can be used

during childbirth.

Your baby can take in very small

amounts of Xylocaine Dental from

breast milk if you are breastfeeding,

but it is unlikely that the amount

available to the baby will do any

harm.

Xylocaine Dental will only be

used if the solution is clear, the

package is undamaged and the

use by (expiry) date marked on

the pack has not been passed.

Xylocaine

Dental

2(3)

Before you are given it

You must tell your dentist if:

1. you have any allergies to

other local anaesthetics

any other substances

ingredients listed at the end of

this leaflet

If you have an allergic reaction, you

may get a skin rash, hayfever,

asthma or feel faint.

2. you have any of these medical

conditions

problems with your blood

pressure or circulation

blood poisoning

problems with the clotting of

your blood

nerve problems

heart problems

liver problems

kidney problems

malignant hyperthermia

It may not be safe for you to be

given Xylocaine Dental if you have

any of these conditions.

Taking other medicines

Tell your dentist if you are taking

any other medicines, including

mexilitene

medicines that you buy at the

chemist, supermarket or health

food shop.

These medicines may affect the way

Xylocaine Dental works.

Your dentist or pharmacist can tell

you what to do if you are taking any

of these medicines.

If you have not told your dentist

about any of these things, tell them

before you are given any Xylocaine

Dental.

__________________________

How XYLOCAINE

DENTAL is given

___________________________________________________________________

Xylocaine Dental will be injected

by your dentist into the gum inside

your mouth near a single nerve, or

into an area which contains a large

number of nerves.

This will result in an area of

numbness at the site or near the site

of injection.

Xylocaine Dental should not be

injected directly into the blood.

The dosage you will be given will

depend on your body size, age and

the type of dental work you will be

having done.

Your dentist will have had a lot of

experience injecting Xylocaine

Dental or other local anaesthetics

and will choose the best dose for

you. They will be willing to discuss

this decision with you.

Overdose

The dentist giving you Xylocaine

Dental will be experienced in the

use of local anaesthetics, so it

unlikely that you will be given an

overdose.

However, if you are particularly

sensitive to Xylocaine Dental, or

the dose is accidently injected

directly into your blood, you may

develop problems for a short time.

You may get a numb feeling in or

around the mouth, feel dizzy or

stiff, or have twitchy muscles. If

Xylocaine Dental with adrenaline

is being used and this happens, you

will feel alarmed and your heart

will beat very rapidly.

Whenever you are given Xylocaine

Dental, equipment will be available

to care for you if an overdose

happens.

__________________________

While you are using it

___________________________________________________________________

Things you must not do

Do not eat or drink anything until

the feeling has returned to your

mouth. You may burn or bite

yourself.

Things to be careful of

Be careful driving or operating

machinery until you know how

Xylocaine Dental affects you.

You may be drowsy and your

reflexes may be slow.

Do not drink alcohol immediately

before or after you are given

Xylocaine Dental. If you drink

alcohol while you are being given

Xylocaine Dental your blood

pressure may drop making you feel

dizzy and faint.

Please talk to your dentist or

pharmacist about these possibilities

if you think they may bother you.

__________________________

Side effects

___________________________________________________________________

Tell your dentist or pharmacist as

soon as possible if you do not feel

well while you are taking

Xylocaine Dental.

Xylocaine Dental helps most

people have pain free visits to the

dentist, but it may have unwanted

side-effects in a few people.

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.

Ask your dentist or pharmacist to

answer any questions you may

have.

(continued over)

Xylocaine

Dental

3(3)

Tell your dentist if you notice any

of the following:

nervousness

dizziness

blurred vision

drowsiness

ringing in the ears

numbness

feeling strange (disoriented)

nausea

vomiting

These are all mild side effects of

Xylocaine Dental.

Tell your dentist immediately if

you notice any of the following:

feeling of alarm

rapid heart beat (palpitations)

These are serious side effects. You

may need urgent medical attention

Serious side effects are rare.

If Xylocaine Dental is given

wrongly, or you are very sensitive

to it, it sometimes causes

fits

unconsciousness

breathing problems

low blood pressure

slow heart beat

collapse

These are very serious side effects.

If you have them, you may have

had a serious (allergic) reaction to

Xylocaine Dental. You may need

urgent medical attention or

hospitalisation.

All of these side effects are very

rare.

Tell your dentist if you notice

anything else that is making you

feel unwell.

Some people may get other side

effects while using Xylocaine

Dental.

__________________________

After using it

___________________________________________________________________

Storage

Xylocaine Dental will be stored by

your dentist under the

recommended conditions.

It should be kept in a fridge

where the temperature stays at

2˚C to 8˚C (Refrigerate. Do not

freeze) and it is protected from

light.

Once removed from refrigeration

for use, store below 25

C and use

within 4 weeks. Do not return to

refrigerator.

Excursions outside the

recommended storage temperature

are permitted during transport.

______________________

Disposal

____________________________________________________________

Any Xylocaine Dental from a

single dose which is not used, will

be disposed of in a safe manner

by your dentist.

__________________________

Product description

___________________________________________________________________

Xylocaine Dental is a clear

colourless solution and is available

under the following name:

2% XYLOCAINE Dental with

adrenaline 1:80,000

The active ingredients are lignocaine

hydrochloride 20 mg/mL and

adrenaline 12.5 mcg/mL.

Lignocaine is known as lidocaine

and adrenaline as epinephrine in the

USA.

These are available as 2.2 mL

dental cartridges in packs of 50 and

100 cartridges.

Not all pack sizes/presentations are

being distributed.

__________________________

Supplier/Sponsor

___________________________________________________________________

Xylocaine Dental is supplied in

Australia by:

DENTSPLY (Australia) Pty Ltd

11 – 21 Gilby Road

Mount Waverley, VIC 3149

Australia

Tel: 1300 55 29 29

Name and address of New Zealand

Sponsor:

Dentsply (N.Z.) Limited

11 Marshall Road

Katikati 3129

New Zealand

Tel: 0800 DENTSPLY (33 68 77)

This leaflet was prepared on

5 August 2015

Australian Registration Number

12024

® Trade Mark herein is the property of the

AstraZeneca group

13-12-2018

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