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fA Henry Schein

Isonest 1:100,000 Isonest 1:200,000

Solution for injection Articaine hydrochloride and adrenaline

PATIENT INFORMATION LEAFLET

In this leaflet:

1.    What ISONEST is and what it is used for

2.    Before you use ISONEST

3.    How to use ISONEST

4.    Possible side effects

5.    How to store ISONEST

6.    Further information

1. What ISONEST is and what it is used for

ISONEST is given by injection to cause loss of feeling before

and during dental procedures.

It contains two active ingredients:

•    articaine hydrochloride, a local anaesthetic which prevents pain,

•    and 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.

Depending on the kind of dental procedure performed,

your dentist will choose:

•    ISONEST 1:200,000 is usually used for simple and short dental procedure or

•    ISONEST 1:100,000 is more adapted to procedures lasting longer or with possible significant bleeding.

ISONEST is for children over 4 years old and adults.

Only a dentist can administer this product.

2. Before you use ISONEST

Do not use ISONEST

• if you are allergic (hypersensitive) to one of the active ingredients (articaine hydrochloride or adrenaline tartrate) or to any of the other ingredients (refer to section 6)

•    if you are allergic to local 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 problems in the way your muscles work by not having enough of a substance called cholinesterase in your body

•    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 ISONEST

Before receiving this medicine, tell your dentist if:

•    you have problems with your heart, your blood vessels or your heart rhythm

•    you have problems with your liver

•    you are epileptic

•    you have diabetes

•    you have an overactive thyroid gland

If you have problems with the blood supply to your arms and/or legs or high blood pressure this medicine may result in a small injury at the site of injection.

Patients who already have a condition of the blood called methaemoglobinaemia may find they become worse.

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 ISONEST 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 treat irregular heartbeats (e.g. cardiac glycosides like digoxin)

Pregnancy

This medicine should be used with caution during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

You should not breast-feed for 48 hours following the use of ISONEST.

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 ISONEST

ISONEST contains

•    less than 1 mmol (23mg) sodium per cartridge, i.e. essentially "sodium free".

• sodium metabisulphite: it may rarely cause severe allergic reactions and difficulty in breathing (bronchospasm).

3. Howto use ISONEST_

Your dentist will explain to you why you are being treated with ISONEST. He or she will choose the formula and 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. ISONEST is injected between two teeth.

If your dentist uses more ISONEST 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 medicine, ISONEST 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 ISONEST.

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.

Administration of ISONEST may cause the following side effects, which require rapid corrective measures to prevent possible worsening:

•    Effects on your heart and blood vessels: slow heartbeats, drop in blood pressure.

•    Effects on your lung: slow or fast breathing which could lead to temporarily stopping breathing.

•    Effects on your senses: trembling, shaking, uncontrolled eye movement, buzzing in the ears, problems with speech, yawning.

•    General effects: headache, nausea, feeling nervous, apprehension.

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:

•    Effects on your senses: loss of sensation and muscle function following the injection of ISONEST. Resolution occurs generally within eight weeks.

•    Effects on your skin: facial swelling or inflammation of gums.

•    General effects: headache

The following very rare side effects affect 1 of 10,000 patients treated:

•    Severe allergic reaction including swelling of the face, lips and/or tongue, difficulty breathing.

•    Allergic reactions including skin rash, hives or itching.

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 ISONEST

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.

Before giving you ISONEST, your dentist will check if its colour is not pinkish or darker than slightly yellow or if it does not contain a precipitate.

6. Further information_

What ISONEST contains

•    Active substances: each ml of solution for injection contains 40 mg of articaine hydrochloride and

-    18.2 micrograms of adrenaline (epinephrine) for ISONEST 1:100,000.

-    9.1 micrograms of adrenaline (epinephrine) for ISONEST 1:200,000.

•    The other ingredients are: sodium metabisulphite, sodium chloride, sodium hydroxide and water for injections.

What ISONEST looks like and content of the pack

It is a clear and colourless solution. ISONEST is available in boxes containing 50 cartridges of 1.7 ml or 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

This leaflet was last approved on: 01/2012.

If more PILs are necessary, call free number 0800435155.

The following uncommon side effects affect less than 1 of every 100 patients treated:

• General effects: nausea