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Rexocaine

Solution for injection

Lidocaine hydrochloride and adrenaline PATIENT INFORMATION LEAFLET

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In this leaflet:

1.    What REXOCAINE is and what it is used for

2.    Before you use REXOCAINE

3.    Howto use REXOCAINE

4.    Possible side effects

5.    Howto 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

REXOCAINE is for adults, children and adolescents.

Only a dentist can administer this product.

2.Beforeyou 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,

Take special care with REXOCAINE

Before receiving this medicine, tell your dentist if:

•    you have problems with your heart or blood vessels,

•    you have problems with your liver,

•    you have a severe infection or an inflammation in the area where the injection will be done,

•    the child being treated is under 4 years old.

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.

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.

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)

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.

5. Howto 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.

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 Creteil 94100 Saint-Maur-des-Fosses France

Distributor

Henry Schein UK Holdings Ltd - Medcare House

Centurion Close - Gillingham Business park - Gillingham,

Kent

ME8 0SB - UK

This leaflet was last approved on: April 2013.

If more PILs are necessary, call free number 0800435155.