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SCANDONEST 2% SPECIAL SOLUTION (CARTRIDGES FOR INJECTION)

Active substance(s): ADRENALINE / MEPIVACAINE HYDROCHLORIDE

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Transcript
Solution for injection



Mepivacaine 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 SCANDONEST 2% SPECIAL is and what it is used for
2.Before you use SCANDONEST 2% SPECIAL
3.How to use SCANDONEST 2% SPECIAL
4.Possible side effects
5.How to store SCANDONEST 2% SPECIAL
6.Further information
1.What SCANDONEST 2% SPECIAL is and what it is used for
SCANDONEST 2 % SPECIAL is given by injection to cause loss
of feeling before and during dental procedures.
It contains two active ingredients:
• mepivacaine hydrochloride, a local anaesthetic which
prevents pain,
• adrenaline, 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.
SCANDONEST 2 % SPECIAL is for children over 34 years old
and adults.
Only a dentist can administer this product.
2.Before you use SCANDONEST 2% SPECIAL
Do not use SCANDONEST 2% SPECIAL
• if you are allergic (hypersensitive) to one of the active
ingredients (mepivacaine hydrochloride or adrenaline) 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 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
3 years old.
07/10

05 06 117 22 00

Take special care with SCANDONEST 2% SPECIAL
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 problems with your kidneys,
• you have a severe infection or an inflammation in the
area where the injection will be done,
• you are epileptic,
• you have troubled breathing.
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 SCANDONEST 2% SPECIAL 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 that case, the dosage of anaesthetic should
be reduced.
• medicines used to treat some psychiatric disorders called
phenothoazines.
• medicines used for anaesthesia (e.g. chloroform,
halothane, cyclopropane, trichloroethylene).
Pregnancy and breast-feeding
This medicine should be used with caution during pregnancy
or 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
SCANDONEST 2% SPECIAL
SCANDONEST 2% SPECIAL 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 SCANDONEST 2% SPECIAL
Your dentist will explain to you why you are
being treated with SCANDONEST 2 % SPECIAL.
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.
SCANDONEST 2% SPECIAL is injected between
two teeth.



Scandonest 2% Special



If your dentist uses more SCANDONEST 2%
SPECIAL 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, SCANDONEST 2% SPECIAL 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
SCANDONEST 2% SPECIAL.

Administration of SCANDONEST 2% SPECIAL
may cause high plasma levels in active substances
(mepivacaine and/or adrenaline), especially overdose or
unintended injection. Symptoms include: effects on your
senses (hearing, sight, behaviour), effects on your heart or
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.The stimulation of the senses
due to adrenaline appears by increasing fear and anxiety,
tension, restlessness, throbbing, headache, tremor,
weakness, pallor, respiratory difficulty.
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 or dysrhythmia), conduction disorders, drop in
blood pressure (hypotension), convulsions, feeling of wellbeing 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 rare side effects affect between 1 and 1000
of every 10,000 patients treated:

• 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.How to store SCANDONEST 2% SPECIAL
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 SCANDONEST 2% SPECIAL contains
• Active substances: each ml of solution for injection
contains:
- 20 mg of mepivacaine hydrochloride,
- 10 micrograms of adrenaline (epinephrine).
• The other ingredients are: potassium metabisulphite (E
224), sodium chloride, hydrochloric acid, sodium
hydroxide and water for injection.
What SCANDONEST 2% SPECIAL looks like and content of
the pack
It is a solution for injection.
SCANDONEST 2% SPECIAL is available in boxes containing
50 cartridges of 1.8 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: 05/2010.
04/2013
If more PILs are necessary, call free number 0800435155.



• Abnormality of rhythm of ventricle (ventricular fibrillation)
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. These allergic-type reactions may
occur in patients with bronchial asthma due to
hypersensitivity to sulphites (see section “Important
information about some ingredients of Scandonest 2%
Special).

SEPTODONT
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés - France

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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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