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Information for Consumers

Revised: 12 June 2015

Consumer Medicine Information

SEPTANEST 1:100,000

WHAT'S IN YOUR MEDICINE

Active ingredients
Cartridge 2.2 mL 1.7 mL
Articaine hydrochloride ....................................................... 88.0 mg 68.0 mg
Adrenaline tartrate (expressed in base) ................................ 22.0 µg 17.0 µg
Other ingredients:

Sodium chloride, sodium metabisulfite, sodium hydroxide solution, water for injections.

Presentation:

Box of 50 cartridges single use, containing each 1.7 mL of solution

Box of 50 cartridges single use, containing each 2.2 mL of solution

WHAT IS YOUR MEDICINE USED FOR, AND HOW DOES IT WORK

SEPTANEST is given by injection to cause loss of feeling before and during dental procedures. It contains two active ingredients:

Articaine hydrochloride, a local anaesthetic to prevent the pain, and adrenaline tartrate, a vasoconstrictor, which makes it last longer (adrenaline narrows the blood vessels at the site of injection, which keeps the anaesthetic where it's needed for a longer time) and controls bleeding during the surgery.

ADVICE BEFORE USING THE MEDICINAL PRODUCT

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your dentist will make before treatment.

This product should not be used if any of the following apply to you:

You must tell your dentist if you have the following conditions:

SEPTANEST MAY INTERACT WITH OTHER MEDICINES

It should not be used if you are taking:

It should be used with caution if you are taking:

Please make sure that you tell your dentist about all medicines which you are taking, whether prescribed or purchased over the counter.

HOW THIS MEDICINE WILL BE USED

Your dentist will explain to you why you are being treated with SEPTANEST and what dose you will be administered. Your dentist will inject Septanest into your oral (mouth) cavity. This will result in an area of numbness at the site of injection. One cartridge is usually sufficient but your dentist may give you a greater quantity. He will adjust the dosage according to your age, your health, your weight and the dental work to be performed. If only a portion of a cartridge is used the remainder must be discarded.

While you are using SEPTANEST

Things you must not do:
Things to be careful of:

SIDE EFFECTS

SEPTANEST like most other medicines may cause side effects in some patients. Although not all of these side effects may occur, if they do occur they may need medical attention. While you are in your dentist's office, your dentist will carefully follow the effects of SEPTANEST. However, some effects may not be noticed or appear later. Check with your dentist if any of the following side effects occur:

Common reactions:
Very rare reactions:

There are some serious unwanted reactions, which may happen if SEPTANEST is given into the veins or you are very sensitive to it, it may cause:

If experiencing any of these, you may have had a serious (allergic) reaction to SEPTANEST. You may need urgent medical attention or hospitalisation.

Tell your dentist if you notice anything else that is making you feel unwell.

Some people may get other side effects while using SEPTANEST.

You may be hypersensitive to sulfites and therefore show allergic symptoms to SEPTANEST such as breathing difficulties and/or skin reactions.

If you have problems with your blood vessels, circulation or have high blood pressure, you may react exaggeratedly to the vasoconstrictor contained in SEPTANEST and develop a small injury at the site of injection.

IN CASE OF OVERDOSE

Your dentist will determine the amount of solution, which is needed to provide pain control during your treatment, and it is very unlikely that you would receive too much

SEPTANEST. However, some persons tolerate articaine and adrenaline less well than others and the signs and symptoms of too much of these substances in your blood include: nervousness, dizziness, blurred vision, nausea, trembling, convulsions, slow or irregular heart beat, troubled breathing.

Tell your dentist immediately if you experience any of these symptoms during or shortly after your treatment.

STORAGE CONDITIONS

It is most unlikely that you will be asked to look after this medicine. Your dentist will keep it below 25°C and protected from light. He will not use this medicine after the expiry date printed on the package.

All medicines must be kept in a safe place out of the reach of children.

FURTHER INFORMATION

Only a dentist can administer this product. This leaflet provides only a summary of the information known about SEPTANEST. If you have any questions, want to know more about this medicine, or have some doubts, ask your dentist.

DISTRIBUTOR: IVOCLAR VIVADENT Ltd - 12 Omega Street - Albany, Auckland - NEW ZEALAND

DATE OF INFORMATION: June 22, 2005
(Registration N°)

SEPTANEST 1:100,000
(Articaine hydrochloride 4% with adrenaline 1:100 000, solution for injection)

MANUFACTURER : Septodont - 58, rue du Pont de Créteil - 94100 Saint Maur des Fossés, Cedex, FRANCE

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