Summary for ARTG Entry:
Lignocaine-Claris lidocaine (lignocaine) hydrochloride 50mg/5 mL solution for injection, ampoule
ARTG entry for
Claris Lifesciences Australia Pty Ltd
PO Box 1290,BURWOOD, NSW, 1805
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. Lignocaine-Claris lidocaine (lignocaine) hydrochloride 50mg/5 mL solution for injection, ampoule
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
For production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. Treatment or prophylaxis of
life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular
arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.
Additional Product information
Glass Type I Clear
Store below 30
Child resistant closure
Do Not Use if there is
Pack Size/Poison information
(S4) Prescription Only Medicine
(S4) Prescription Only Medicine
(S4) Prescription Only Medicine
1. Lignocaine-Claris lignocaine hydrochloride 50mg/5 mL solution for injection, ampoule
Route of Administration
Clear colourless or almost colourless solution
lidocaine (lignocaine) hydrochloride monohydrate
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Lignocaine hydrochloride 1% and 2% Solution for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about Lignocaine-Claris. It does not
contain all the information that is known about Lignocaine-Claris. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking
Ligocaine-Claris against the benefits they expect it will have for you.
This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this
leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you
after the medicine has been used.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Lignocaine-Claris is used for
Lignocaine-Claris belongs to two groups of medicines known as local anaesthetics and
antiarrhythmic drugs. Local anaesthetics stop pain and feeling in the area around where it is
injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal.
Lignocaine-Claris may be used for the management of other conditions that are not mentioned
above. Your doctor will be able to tell you about the specific condition for which you have been
This medicine is available only with a doctor's prescription
Ligocaine-Claris will not put you to sleep.
Lignocaine-Claris is also used after surgery to relieve pain. It can also be used to make childbirth less
Depending on the amount used, Lignocaine-Claris will either totally stop pain or will cause a partial
loss of feeling.
Lignocaine hydrochloride is sometimes combined with adrenaline to make it last longer. Adrenaline
makes the blood vessels at the site of injection narrower, which keeps the lignocaine hydrochloride
where it is needed for a longer time.
Lignocaine-Claris is not addictive.
Before you are given it
When you must not be given it:
If you are pregnant or breastfeeding do not use Lignocaine-Claris unless your doctor says so. Ask
your doctor about the risks and benefits of using this medicine while you are pregnant or
Lignocaine-Claris 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 lignocaine from breast milk if you are breastfeeding, but
it is unlikely that the amount available to the baby will do any harm.
Lignocaine-Claris 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.
Before you are given it
You must tell your doctor if:
you have any allergies to
any ingredients listed at the end of this leaflet
other local anaesthetics e.g. bupivacaine
any other medicine
other substances such as foods, preservative or dyes
If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.
you have any of these medical conditions
problems with your blood pressure or circulation
problems with the clotting of your blood
nerve problems, e.g. epilepsy
heart, liver or kidney problems
It may not be safe for you to take Lignocaine-Claris if you have any of these conditions.
Taking other medicines
Tell your doctor if you are taking any other medicines, including
ones to control your heart beat e.g. amiodarone
ones for blood pressure (antihypertensives e.g. propranolol, metoprolol, atenolol)
ones for epilepsy or fits e.g. phenytoin, carbamazepine, primidone, phenobarbitone
ones for depression
warfarin (used to stop blood clots)
aspirin, salicylates or other non-steriodal anti-inflammatory drugs (NSAIDs), medicines to
relieve pain and inflammation
Some medicines that relax the skeletal muscles e.g. suxamethonium
any medicines that you buy at the chemist, supermarket or health food shop.
These medicines may affect the way Lignocaine-Claris works. Your doctor or pharmacist can tell you
what to do if you are taking any of these medicines.
If you have not told your doctor about any of these things, tell them before you are given any
How Lignocaine-Claris is given
Lignocaine-Claris is given by injection into the skin, directly into the blood stream or into an organ. It
must only be given by a doctor or nurse.
Your doctor will decide what dose and how long you will receive Lignocaine-Claris
If you are given too much (overdose)
This rarely happens as Lignocaine-Claris is administered under the care of a highly trained doctor.
However, if you are given too much lignocaine, you may experience some of the effects listed under
"Side Effects" below.
Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have
While you are being given Lignocaine-Claris
Things to be careful of
Be careful driving or operating machinery after you have been given Lignocaine-Claris. You may be
drowsy or your reflexes may be slow.
Do not drink alcohol while you are being given Lignocaine-Claris. If you drink alcohol while you are
being given Lignocaine-Claris, your blood pressure may drop making you feel dizzy and faint.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are
being given Lignocaine-Claris.
Like other medicines, Lignocaine-Claris can cause some side effects. If they occur, most are likely to
be minor or temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions that you may have.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor or nurse if you notice any of the following:
weakness, confusion, nervousness, agitation, drowsiness, disorientation or unconsciousness
nausea, vomiting, difficulty in swallowing
headache, dizziness or light-headedness especially if you get up suddenly from a lying or
ringing in the ears
slurred speech, sensations of heat and cold
numbness, tremors, twitching
slow heartbeat, low blood pressure
blurred or double vision
These are the mild side effects of Lignocaine-Claris.
Serious side effects of Lignocaine-Claris include:
fits or convulsions
skin rash, hives or itching
low blood pressure
slow heart beat
You may need urgent medical attention if you get these side effects.
After an epidural injection you may develop a headache or backache which is not related to the
medicine used. These can, on rare occasions, last for some months after the injection is given.
Other side effects not listed above may also occur in some patients. If you notice any other effects,
check with your doctor. Some side effects may only be seen by your doctor.
Lignocaine-Claris will be stored in the pharmacy or on the ward. The injection is kept in a cool dry
place, where the temperature stays below 30 °C.
Lignocaine-Claris is a clear colourless solution, It is available as:
20 mg/2 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222074
50 mg/5 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222077
200 mg/20 mL, glass vial, packs of 1 vial, AUST R 222076
40 mg/2 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222075
100 mg/5 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222072
400 mg/20 mL, glass vial, packs of 1 vial, AUST R 222073
Lignocaine-Claris contains lignocaine hydrochloride 1% or 2% as the active ingredient. It also
contains sodium chloride and Water for Injections as the excipients. It does not contain a
Claris Lifesciences (Australia) Pty Ltd
Suite 1, Level 1,
127-133 Burwood Road
Date of Preparation
13 April 2015