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BARTINEST 1:100 000

Active substance(s): ADRENALINE TARTRATE / ARTICAINE HYDROCHLORIDE

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Bartinest 1:100,000
Bartinest 1:200,000
Solution for injection

Articaine 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.

In this leaflet:
1. What BARTINEST is and what it is used for
2. Before you use BARTINEST
3. How to use BARTINEST
4. Possible side effects
5. How to store BARTINEST
6. Further information

1. What BARTINEST is and what it is used for

BARTINEST 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:
• BARTINEST 1:200,000 is usually used for simple and
short dental procedure or
• BARTINEST 1:100,000 is more adapted to procedures
lasting longer or with possible significant bleeding.

BARTINEST is for children over 4 years old and adults.
Only a dentist can administer this product.
2. Before you use BARTINEST

Do not use BARTINEST
• 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 BARTINEST
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 BARTINEST 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 BARTINEST.

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 BARTINEST
BARTINEST 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. How to use BARTINEST

Your dentist will explain to you why you are
being treated with BARTINEST. 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. BARTINEST is injected between
two teeth.

If your dentist uses more BARTINEST 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, BARTINEST 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 BARTINEST.

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 BARTINEST 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 BARTINEST.
Resolution occurs generally within eight weeks.
• Effects on your skin: facial swelling or inflammation of
gums.
• General effects: headache

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

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. How to store BARTINEST

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 BARTINEST, 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 BARTINEST contains
• Active substances: each ml of solution for injection
contains 40 mg of articaine hydrochloride and
- 18.2 micrograms of adrenaline (epinephrine) for
BARTINEST 1:100,000.
- 9.1 micrograms of adrenaline (epinephrine) for
BARTINEST 1:200,000.
• The other ingredients are: sodium metabisulphite,
sodium chloride, sodium hydroxide and water for
injections.

What BARTINEST looks like and content of the pack
It is a clear and colourless solution. BARTINEST 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 Créteil
94100 Saint-Maur-des-Fossés - France

This leaflet was last approved on: 01/2012.

If more PILs are necessary, call free number
0800435155.

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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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