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REXOCAINE

Active substance(s): ADRENALINE ACID TARTRATE / LIDOCAINE HYDROCHLORIDE / ADRENALINE ACID TARTRATE / LIDOCAINE HYDROCHLORIDE / ADRENALINE ACID TARTRATE / LIDOCAINE HYDROCHLORIDE

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Solution for injection



Lidocaine hydrochloride and adrenaline
PATIENT INFORMATION LEAFLET

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 dentist.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your dentist, doctor or pharmacist.
In this leaflet:
1. What REXOCAINE is and what it is used for
2. Before you use REXOCAINE
3. How to use REXOCAINE
4. Possible side effects
5. How to store REXOCAINE
6. Further information
1.What REXOCAINE is and what it is used for
REXOCAINE is given by injection to cause loss of feeling
before and during dental procedures.
It contains two active ingredients:
• lidocaine hydrochloride, a local anaesthetic, which
prevents pain,
• adrenaline tartrate, a vasoconstrictor which makes the
effect last longer. Adrenaline narrows the blood vessels
at the site of injection, which keeps the anaesthetic
where needed for a longer time. It also controls the
bleeding during the surgery.
REXOCAINE isis for
for adults,
childrenchildren
over 4 years
old and adults.
REXOCAINE
and adolescents.
Only a dentist can administer this product.
2.Before you use REXOCAINE
Do not use REXOCAINE
• if you are allergic (hypersensitive) to one of the active
ingredients (lidocaine hydrochloride or adrenaline
tartrate) or to any of the other ingredients (refer to
section 6)
• if you are allergic to local anaesthetics called amide type
anaesthetics,
• if you are asthmatic or have suffered difficulty with your
breathing as a result of taking medicines which contain
ingredients called sulphites or metabisulphites,
• if you have a high blood pressure (arterial hypertension),
• if you have particular heart or blood vessels disease
(coronary or valvular cardiac disease),

• if you are taking or have taken medicines for depression
in the last two weeks,
• in children under 4 years old.
Take special care with REXOCAINE
Take
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REXOCAINE
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tell your dentist if:
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Using other medicines
Please tell your dentist if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.
• Do not use REXOCAINE if you are taking or have taken
medicines for depression in the last two weeks.
Your dentist should take special attention if you are taking
the following medicines:
• medicines used to reduce your blood pressure (e.g.
betablockers like propranolol or vasopressor drugs like
dihydroergotamine),
• medicines used to reduce patient apprehension (e.g.
sedatives). In this case, the dosage of anaesthetic should
be reduced.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
If you experience side effects, including dizziness or blurred
vision, you should not drive or operate machinery until
these effects have disappeared.
Important information about some ingredients of
REXOCAINE
REXOCAINE contains
• less than 1 mmol (23mg) sodium per cartridge, i.e.
essentially "sodium free".
• potassium metabisulphite: it may rarely cause severe
allergic reactions and difficulty in breathing
(bronchospasm).
3.How to use REXOCAINE
Your dentist will explain to you why you are being treated
with REXOCAINE. He or she will adjust the dosage according
to your age, your health and the dental procedure.
One cartridge is usually sufficient but your dentist may give
you a greater quantity. REXOCAINE is injected between two
teeth.
If your dentist uses more REXOCAINE than he or
she should
If you think you may have been given too much
of this injection and feel unwell (see section 4.
Possible side effects), tell your dentist.
4. Possible side effects
Like all medicines, REXOCAINE can cause side
effects, although not everybody gets them.
While you are in your dentist’s office, your
dentist will carefully follow the effects of
REXOCAINE.



Rexocaine



Administration of REXOCAINE may cause high
plasma levels in active substances (lidocaine
and/or adrenaline), especially overdose or
unintended injection. Symptoms include: effects
on your senses (hearing, sight, behaviour), effects
on your heart and blood vessels, effects on your
immune defences (diminished tolerance).
As complications to the manifestations of
progressive cerebral hypoxia (decrease below
normal levels of oxygen in tissue) and seizure or
cardiovascular problem, sweating, feeling of
faintness, changes in pulse or sensorium,
vasovagal reaction might occur.

Allergic (hypersensitivity) reactions may occur when using
this medicine. Symptoms of these reactions might include:
rash, itching, swelling of the throat and difficulty breathing.
Inform your dentist, doctor or pharmacist immediately if
one of these effects applies to you.
The following common side effects affect between 1 and 10
of every 100 patients treated:
• Failure of cardiac circulation (cardiovascular collapse)
which may lead to cardiac arrest, loss or abnormality of
rhythm (arrhythmia), conduction disorders, drop in blood
pressure (hypotension), convulsions, feeling of well-being
commonly exaggerated (euphoria), unconsciousness,
malaise, confusion, dizziness, headache. If you are in an
upright position, a vasovagal reaction (relating to the
action of the nerve upon the blood vessels) may develop,
slow or rapid heartbeats (bradycardia or tachycardia),
irregular pulsation of heart (palpitations),
lightheadedness, feeling nervous (nervousness),
apprehension, agitation, drowsiness, buzzing in the ears
(tinnitus), blurred or double vision, nausea, vomiting,
sensations of heat, cold or numbness, uncontrolled eye
movement (twitching), trembling.

6. Further information
What REXOCAINE contains
• Active substances: each ml of solution for injection
contains:
- 20 mg of lidocaine hydrochloride,
- 12.5 micrograms of adrenaline (epinephrine).
• The other ingredients are: potassium metabisulphite
(E224), sodium chloride, sodium edetate, sodium
hydroxide solution and water for injection.
What REXOCAINE looks like and content of the pack
It is a solution for injection.
REXOCAINE is available in boxes containing 50 cartridges of
2.2 ml.
Marketing authorisation holder
Septodont Ltd, Units R & S
Orchard Business Centre
St Barnabas Close
Allington, Maidstone
Kent ME16 0JZ - UK
Manufacturer
Septodont
58 rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France
Distributor
Henry Schein UK Holdings Ltd – Medcare House
Centurion Close – Gillingham Business park – Gillingham,
Kent
ME8 0SB - UK
April 2013.2012.
This leaflet was last approved on: November
If more PILs are necessary, call free number 0800435155.

The following very rare side effects affect 1 of 10,000
patients treated:
• severe allergic reactions (anaphylactoid reactions)
characterized by swelling of the face, lips and/or tongue,
difficulty breathing.
• allergic reactions characterized by skin rash (cutaneous
lesions), eruption of itching wheals (urticaria), swelling
(edema)

5. How to store REXOCAINE
Keep out of the reach and sight of children.
It is most unlikely that you will be asked to look after this
medicine.
Your dentist will not use this medicine after the expiry date
which is stated on the package. The expiry date refers to the
last day of that month.
Your dentist will keep it up to 25° C, stored in the original
container (protected from light). It should not be frozen.



If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your dentist,
doctor or pharmacist.

Expand Transcript

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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