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ESPESTESIN 4% ARTICAINE WITH 1/100 000 ADRENALINE (EPINEPHRINE) SOLUTION FOR INJECTION

Active substance(s): ADRENALINE HYDROCHLORIDE / ARTICAINE HYDROCHLORIDE

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SEITE 1 - 148 x 210 mm - 44000734531/03 - BRAUN (Pantone 469u) • SCHWARZ - 11-359 (kn)

44000734531/03

In this leaflet:
1. What Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
is and what it is used for
2. Before you use Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine)
3. How to use Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine)
4. Possible side effects
5. How to store Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine)
6. Further information



Espestesin
4% articaine
with1/100 000
adrenaline
(epinephrine)
Solution for Injection
Articaine hydrochloride/
Epinephrine (adrenaline)
Oromucosal use
FOR USE IN DENTAL ANAESTHESIA ONLY
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 doctor, dentist or
pharmacist.

1. WHAT ESPESTESIN 4% ARTICAINE WITH 1/100 000 ADRENALINE
(EPINEPHRINE) IS AND WHAT IT IS USED FOR
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) is a local
anesthetic (agent which reduces or abolishes sensation, affecting a
particular region). The medicine is used for local anesthesia (loss of feeling
or sensation in a part of the body) in dentistry during more complicated
procedures requiring prolonged anesthesia dentistry.
2. BEFORE YOU USE ESPESTESIN 4% ARTICAINE WITH
1/100 000 ADRENALINE (EPINEPHRINE)
Do not use Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine)
• if you are hypersensitive (allergic) to articaine hydrochloride, epinephrine
hydrochloride, sodium sulfite, or any of the other ingredients of
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) or to
local anaesthetics of the amide type
• if you had a heart failure or a recent heart attack
• if you have low or high blood pressure
• if you have a deficiency in plasma cholinesterase activity (a naturally
occurring chemical in the body)
• if you have any blood disorders including a tendency to bleed or bruise
easily
• if you have an infection at the site where the injection is to be given
• if you have any heart problems in particular an irregular heartbeat, or
angina or have you had recent heart surgery
• if you have recently been given or are taking medicines for treating
depression such as monoamine oxidase (MAO) inhibitors or tricyclic
antidepressants
• Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) must
not be used with children aged under 4 years.
Take special care with Espestesin 4% articaine with
1/100 000 adrenaline (epinephrine)
• if you have any lung disorders particularly severe bronchial asthma or
allergic asthma
• if you have any liver or kidney problems
• if you have hardening of the arteries
• if you have any thyroid problems
• if you have diabetes mellitus
• if you have an eye condition known as narrow-angle glaucoma
• if you have pheochromocytoma (a form of cancer that effects the
adrenal gland)
• if you have a history of epilepsy
Taking other medicines
Please tell your dentist or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
• Medicines for treating depression such as monoamine oxidase (MAO)
inhibitors or tricyclic antidepressants
• Oral antidiabetics (drugs for treating diabetes mellitus)
• Non-selective beta-blockers (medicines for treating high blood pressure)
• Phenothiazines (medicines for treating severe mental disorders)
• Blood coagulation inhibitors (drugs which prevent blood clotting)

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- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor, dentist or pharmacist.

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The following information is intended for
medical or healthcare professionals only:



Espestesin
4% articaine
with1/100 000
adrenaline
(epinephrine)
Solution for Injection
Articaine hydrochloride/
Epinephrine (adrenaline)
Oromucosal use
FOR USE IN DENTAL ANAESTHESIA ONLY
1. NAME OF THE MEDICINAL PRODUCT
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution
for injection
contains
Articaine hydrochloride
Epinephrine (adrenaline) as
epinephrine (adrenaline)
hydrochloride

1 cartridge with
1.7 ml solution
for injection
contains

40 mg

68 mg

10 micrograms

17 micrograms

0.6 mg

1.02 mg

0.443 mg

0.753 mg

Excipients
Sodium sulphite (E 221)
Sodium

For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
The solution is a clear, not opalescent, colourless liquid

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Local anaesthesia (infiltration and nerve-block anaesthesia) in dentistry.
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) is
especially indicated for complicated procedures requiring prolonged
anaesthesia.
4.2 Posology and method of administration

The following dosage instructions apply:
The smallest possible volume of solution which will lead to an effective
anaesthesia should be used.
For extraction of maxillary teeth, 1.7 ml Espestesin 4% articaine with
1/100 000 adrenaline (epinephrine) per tooth suffices in most cases; painful
palatal injections can thus be avoided. In the case of serial extractions of
neighbouring teeth, a reduction of the injection volume is often possible.
If a cut or suture is required in the palate, a palatal injection of approx
0.1 ml per puncture is indicated.
For smooth extractions of mandibular premolar teeth, infiltration
anaesthesia of 1.7 ml Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine) per tooth is mostly sufficient; in single cases a buccal
re-injection of 1 to 1.7 ml is required. An injection into the mandibular
foramen can be indicated in rare cases.
Vestibular injections of 0.5-1.7 ml Espestesin 4% articaine with 1/100 000
adrenaline (epinephrine) per tooth enable cavity and crown-stump preparations.
Nerve-block anaesthesia should be used in the treatment of mandibular
molar teeth.
In surgical procedures Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine) should be dosed individually depending on the extent and
duration of the operation and factors relating to the patient.
Generally, in children weighing about 20-30 kg, doses of 0.25-1 ml are
sufficient; in children weighing 30-45 kg, 0.5-2 ml.
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) must not
be used with children aged under 4 years (see section 4.3).
Increased plasma levels of Espestesin 4% articaine with 1/100 000
adrenaline (epinephrine) can occur in older patients due to diminished
metabolic processes and lower distribution volume. The risk of accumulation of Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
is increased in particular after repeated application (e.g. re-injection).
A similar effect can ensue from the reduced general condition of the
patient, as well as severely impaired hepatic and renal function (see also
section 4.4).
A lower dosage range is thus recommended in all such cases (minimum
quantity for sufficient anaesthetic depth).
The dose has to be likewise reduced in patients with certain pre-existing
diseases (angina pectoris, arteriosclerosis) (see also section 4.4).
Maximum Recommended Dosage:
Adults:
For healthy adults, the maximum dose is 7 mg/kg body weight articaine
(500 mg for a 70 kg patient), equivalent to 12.5 ml Espestesin 4% articaine
with 1/100 000 adrenaline (epinephrine).
The maximum dose represents 0.175 ml of solution per kg.
Children:
The quantity to be injected should be determined by the age and weight of
the child and the magnitude of the operation. Do not exceed the equivalent
of 7 mg articaine/kg (0.175 ml Espestesin 4% articaine with 1/100 000
adrenaline (epinephrine)/kg) of body weight.
Espestesin 4% articaine with 1/200 000 adrenaline (epinephrine) is also
available and may be more appropriate for short procedures and/or where
control of bleeding in the operative field is not relevant (see section 5.1 for
more information on duration of analgesia).
Method of administration
For injection/oromucosal use
FOR USE IN DENTAL ANAESTHESIA ONLY

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To avoid intravascular injection, aspiration control at least in two planes
(rotation of the needle by 180°) must always be carefully undertaken,
although a negative aspiration result does not safely rule out an
unintentional and unnoticed intravascular injection.
The injection rate should not exceed 0.5 ml in 15 seconds, i.e. 1 cartridge
per minute.
Major systemic reactions as a result of accidental intravascular injection
can be avoided in most cases by an injection technique - after aspiration
slow injection of 0.1-0.2 ml and slow application of the rest - not earlier
than 20-30 seconds later.
Opened cartridges must not be used in other patients. Residues must be
discarded.
4.3 Contraindications
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) is not
allowed to be used in the event of
- children under 4 years of age
- hypersensitivity to the active substances, sodium sulphite (E221) or to
any of the other excipients

Due to the local anaesthetic ingredient articaine, Espestesin 4% articaine
with 1/100 000 adrenaline (epinephrine) is not allowed to be used in the
event of
- known allergy or hypersensitivity to local anaesthetics of the amide
type
- severe impairment of the impulse initiation and conduction system of
the heart (e.g. grade II and III AV block, pronounced bradycardia)
- acutely decompensated cardiac insufficiency
- severe hypotension
- patients who are known to have a deficiency in plasma cholinesterase
activity
- haemorrhagic diatheses - particularly with nerve-block anaesthesia
- injection into an inflamed area
Due to the content of epinephrine as a vasoconstrictor admixture,
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) is not
allowed to be used in the event of
- Heart diseases such as:
- unstable angina pectoris
- recent myocardial infarction
- recent coronary artery bypass surgery
- refractory arrhythmias and paroxysmal tachycardia or high-frequency,
continuous arrhythmia
- untreated or uncontrolled severe hypertension
- untreated or uncontrolled congestive heart failure
- concomitant treatment with monoamine oxidase (MAO) inhibitors or
tricyclic antidepressants (see section 4.5)
Due to the content of sulphite as excipient, Espestesin 4% articaine with
1/100 000 adrenaline (epinephrine) is not allowed to be used in the event of
- allergy or hypersensitivity to sulphite
- severe bronchial asthma
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) can provoke
acute allergic reactions with anaphylactic symptoms (e.g. bronchospasm).
4.4 Special warnings and precautions for use

Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) must be
used with particular caution in the event of
- severe impairment to the renal function
- angina pectoris (see section 4.2 and 4.3)
- arteriosclerosis
- considerably impaired blood coagulation (see section 4.5)
- thyrotoxicosis
- narrow-angle glaucoma
- diabetes mellitus
- lung diseases - particularly allergic asthma
- pheochromocytoma

Accidental injection may be associated with convulsions, followed by
central nervous system or cardiorespiratory arrest. Resuscitative
equipment, oxygen, and other resuscitative drugs should be available for
immediate use.
Since amide-type local anaesthetics are also metabolised by the liver,
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) should
be used with caution in patients with hepatic diseases. Patients with
severe hepatic diseases are at greater risk of developing toxic plasma
concentration.
The product should be administered with caution in patients with impaired
cardiovascular function since they may be less able to compensate for
functional changes associated with the prolongation of A-V conduction
produced by these drugs.
The product should be administered with caution to patients with history
of epilepsy.
There is a possibility of positive results on doping tests performed on
sportsmen.
It should be taken into consideration that during treatment with blood
coagulation inhibitors (e.g. heparin or acetylsalicylic acid), an inadvertent
vasopuncture when administering the local anaesthetic can lead to serious
bleeding, and that in general the hemorrhagic tendency is increased (see
section 4.5).
Inadvertant intravascular application must be avoided (see section 4.2)
The lower blood flow in the pulp tissue due to the content of epinephrine
and thus the risk to overlook an opened pulp has to be taken into account
regarding cavity or crown preparations.
The medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml,
i.e. essentiall “sodium-free”.

Precautions for use:
Each time a local anaesthetic is used the following drugs/therapy should
be available:
- Anti-convulsant medicines (benzodiazepines or barbiturates),
myorelaxants, atropine and vasopressors or adrenaline for a severe
allergic or anaphylactic reaction.
- Resuscitating equipment (in particular a source of oxygen) enabling
artificial ventilation if necessary.
- Careful and constant monitoring of cardiovascular and respiratory
(adequacy of ventilation) vital signs and the patient's state of
consciousness should be monitored after each local anaesthetic
injection. Restlessness, anxiety, tinnitus, dizziness, blurred vision,
tremors, depression, or drowsiness may be early warning signs of
central nervous system toxicity (see section 4.9).
4.5 Interaction with other medicinal products and other forms of
interaction
Patients taking MAO inhibitors or tricyclic antidepressants
The sympathomimetic effect of epinephrine can be intensified by the
simultaneous intake of MAO inhibitors or tricyclic antidepressants.
(see also section 4.3).
Patients taking oral antidiabetics
Epinephrine can inhibit insulin release in the pancreas and thus diminish
the effect of oral antidiabetics.
Patients taking non-selective beta-blockers
The concomitant administration of non-cardioselective β-blockers can
lead to an increase in blood pressure due to the epinephrine in Espestesin
4% articaine with 1/100 000 adrenaline (epinephrine).
Patients taking phenothiazines
Phenothiazines may reduce or reverse the pressor effect of epinephrine.
Concurrent use of these agents should generally be avoided. In situations
when concurrent therapy is necessary, careful patient monitoring is
essential.
Patients taking blood coagulation inhibitors
During treatment with blood coagulation inhibitors, the hemorrhagic
tendency is increased (see also section 4.4).

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4.6 Pregnancy and lactation
For Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) no
clinical data on exposed pregnancies are available. In regard of articaine
animal studies do not indicate direct or indirect harmful effects with respect
to pregnancy, embryonal/foetal development, parturition or postnatal
development (see section 5.3).
Animal studies carried out with epinephrine have shown reproductive
toxicity (see section 5.3). The potential risk for humans ist unknown.
Caution should be exercised when prescribing to pregnant women.
It is unknown whether articaine and epinephrine is excreted in human
breast milk. The excretion of articaine and epinephrine in milk has not
been studied in animals. A decision on whether to continue/discontinue
breast-feeding or to continue/discontinue therapy with Espestesin 4%
articaine with 1/100 000 adrenaline (epinephrine) should be made taking in
to account the benefit of breast-feeding to the child and the benefit of
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) therapy to
the women. Therefore, nursing mothers should milk and discard the first
mother’s milk following anaesthesia with articaine.
4.7 Effects on ability to drive and use machines
Although test patients have shown no impairment of their normal reactions
when driving a vehicle, the dentist has to assess in each case the possible
impairment of safety when operating a motor vehicle or machinery. The
patient should not leave the dental office earlier than at least 30 minutes
after the injection.
4.8 Undesirable effects

Due to the local anaesthetic ingredient articaine, the following adverse
effects can occur.
Cardiovascular disorders
Rare ( ≥ 1/10,000 to ≤ 1/1,000)
Decrease in heart rate, hypotension.
Drop in blood pressure, cardiac impulse conduction disorders, bradycardia,
asystolia, cardiovascular arrest.
Nervous system disorders
Rare ( ≥ 1/10,000 to ≤ 1/1,000)
Metallic taste, tinnitus, dizziness, nausea, vomiting, restlessness, anxiety,
yawning, shaking, nervousness, nystagmus, logorrhoea, headache, increase
in respiratory rate. Paresthesias (loss of sensation, burning, tingling) of the
lip, tongue, or both.
When these signs appeared rapid corrective measures are required to
prevent possible worsening:
Drowsiness, confusion, tremor, muscle twitching, tonic-clonic seizures,
coma and respiratory paralysis.
Respiratory disorders
Rare ( ≥ 1/10,000 to ≤ 1/1,000)
Tachypnea, then bradypnea, which could lead to apnoea.
Allergic reactions
Very rare ( ≤ 1/10,000)
One may observe manifestation of hypersensitivity to articaine as rash,
pruritus edema, pruritus, and erythema as well as nausea, diarrhea,
wheezing or anaphylaxis. Cross-reactivity to articaine has been reported in
a patient with delayed hypersensitivity to prilocaine.
In general, patients with demonstrated hypersensitivity to articaine or other
amides should receive an ester-group local anaesthetic for subsequent
procedures.
The administration of large doses of articaine may produce
methaemoglobinemia in patients with subclinical methaemoglobinemia.

Due to the content of epinephrine as a vasoconstrictor admixture,
the following undesirable effects can occur
Cardiovascular disorders
Rare ( ≥ 1/10,000 to ≤ 1/1,000)
Heat sensation, sweating, heart racing, migrainelike headache, blood
pressure increase, angina pectoris disorders, tachycardias, tachyarrhythmias
and cardiovascular arrest and acute oedematous thyroid swelling.

Due to the content of sulphite as excipient, the following undesirable
effects can occur in very rare cases:
Allergic reactions or hypersensitivity reactions, particularly in bronchial
asthmatics, which are manifested as vomiting, diarrhoea, wheezing, acute
asthma attack, clouding of consciousness or shock.
Due to the content of both articaine and epinephrine, the following
undesirable effects can occur
Nervous system disorders
2 weeks delayed onset of facial nerve paralysis has been described with
articaine/epinephrine, the event still occur 6 months later.
Interferences in the clinical picture can result from the simultaneous
occurrence of various complications and side effects.
Within each frequency grouping, undesirable effects are presented in
order of decreasing seriousness.
4.9 Overdose
Undesirable effects (showing an abnormally high concentration of local
anaesthetic in the blood) may appear either immediately, caused by
accidential intravascular injection or abnormal absorption conditions, e.g.
in inflamed or intensive vascularised tissue, or later, caused by true overdose following an injection of excessive quantity of anaesthetic solution,
and manifest themselves as central nervous and/or vascular symptoms.

Symptoms caused by the local anaesthetic ingredient articaine:
Milder central nervous symptoms involve metallic taste, tinnitus, dizziness,
nausea, vomiting, restlessness, anxiety, initial increase in respiratory rate.
More severe symptoms are drowsiness, confusion, tremor, muscular
twitching, tonic-clonic seizures, coma and respiratory paralysis.
Severe cardiovascular episodes are seen in the form of a drop in blood
pressure, cardiac impulse conduction disorders, bradycardia, cardiovascular
arrest.
Symptoms caused by epinephrine as a vasoconstrictor:
Cardiovascular symptoms such as heat sensation, sweating, heart racing,
migrainelike headache, blood pressure increase, angina pectoris disorders,
tachycardias, tachyarrhythmias, cardiovascular arrest and acute oedematous
thyroid swelling.
Interferences in the clinical picture can result from the simultaneous
occurrence of various complications and side effects.
Therapy
If adverse reaction arise the application of the local anaesthetic has to be
stopped.
General basic measures:
Diagnostics (respiration, circulation, consciousness), maintenance/
restoration of the vital functions of respiration and circulation, oxygen
administration, intravenous access.

Anaphylactic shock: Contact emergency physician, in the meantime
shock positioning, generous infusion of a whole
electrolyte solution, if necessary epinephrine iv,
cortisone iv.
Cardiovascular arrest: Immediate cardiopulmonary resuscitation, contact
emergency physician.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anaesthetics, local, ATC code N01B B58
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) contains
articaine which is a local anaesthetic of the amide type for dentistry and
leads to a reversible inhibition of the irritability of vegetative, sensory and
motor nerve fibres. The blocking of voltage dependent Na+ channels on the
membrane of the nerve fibre is supposed to be the mechanism of effect of
articaine.
The rapid onset of anaesthesia - latency period of 1-3 minutes - the
reliable effect with strong analgesic effect and good local tolerability
are characteristic. The duration of effect of Espestesin 4% articaine with
1/100 000 adrenaline (epinephrine) in pulpal anaesthesia lasts at least
75 minutes, and in soft-tissue anaesthesia 120 to 240 minutes.
Epinephrine leads locally to vasoconstriction, whereby the absorption
of articaine is delayed. The result is a higher concentration of the local
anaesthetic at the site of effect over a longer period, as well as the
reduction in the occurrence of systemic adverse side effects.
5.2 Pharmacokinetic properties
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) is rapidly
and almost completely absorbed.
The maximum plasma level of articaine from intraoral injection is achieved
approximately after 10-15 minutes (Tmax). The distribution volume is
1.67 l/kg and the elimination half-life is approximately 20 minutes.
Articaine is bound up to 95% in the serum to plasma proteins.
Articaine is rapidly hydrolysed by plasma cholinesterases to its primary
metabolite articainic acid which is further metabolised to articainic acid
glucuronide. Articaine and its metabolites are mainly eliminated in urine.
Epinephrine is rapidly catabolized in the liver and other tissues. The
metabolites are excreted renally.
5.3 Preclinical safety data
Symptoms of articaine toxicity were independent of the route of administration (IV, IM, SC and PO) and of the animal species and included trembling,
vertigo, and tonic and clonic convulsions. The duration and intensity of
these symptoms were dose-dependent; at high doses (single dose of approx
50-100 mg/kg) the convulsions resulted in death and at low doses all
symptoms dissipated in 5 to 10 minutes. Lethal doses of articaine resulted
in pulmonary oedema in mice (IV and SC) and in rats (IV, IM, SC and PO).
In rats, rabbits and cats, articaine showed no effect on embryo or fetal
development in utero and no skeletal or organ abnormalities. Cups of
lactating rats receiving articaine in high doses (80 mg/kg/day) causing
maternal toxicity showed delayed eye opening and increased likelihood of
failure in the passive avoidance test.
Epinephrine was potentially teratogenic in rats albeit at doses 25 times the
human therapeutic dose.
Following IV administration, the presence of 1:100 000 epinephrine
increased the toxicity of articaine in the rat, mouse, but not in the rabbit.
6. PHARMACEUTICAL PARTICULARS

Special measures:
Hypertension:

Elevation of the upper body, if necessary sublingual
nifedipine.

Convulsions:

Protect patients from concomitant injuries,
if necessary benzodiazepins (e.g. diazepam iv).

Hypotension:

Horizontal position, if necessary intravascular
infusion of a whole electrolyte solution, vasopressors
(e.g. etilefrine iv).

Bradycardia:

Atropine iv.

6.1 List of excipients
Anhydrous sodium sulphite (E221)
Sodium chloride
Hydrochloric acid 14% (for pH adjustment)
Sodium hydroxide solution 9% (for pH adjustment)
Water for injections
6.2 Incompatibilities
Not applicable.

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6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect
from light.
6.5 Nature and contents of container
Cartridge made of colourless neutral glass I.
Stopper and rubber disc are made of bromobutyl rubber.
Aluminium cap made of aluminium-iron-silicon-alloy.
Tin with 50 cartridges of 1.7 ml each.
6.6 Special precautions for disposal
The product should be inspected visually for particulate matter, discoloration or damage of container prior to administration. The product should not
be used if such defects are observed.
The product is for single use only. Any unused product should be discarded
immediately after first use.
7. MARKETING AUTHORISATION HOLDER
3M Deutschland GmbH
Carl-Schurz-Straße 1
41453 Neuss
Germany
8. MARKETING AUTHORISATION NUMBER(S)
PL 40356/0002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 17/06/2003
Date of last renewal: 17/07/2006
10. DATE OF REVISION OF THE TEXT
August 2012

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Inhalational anesthestics
Certain inhalational anaesthetics, such as halothane, can sensitise the
heart to catecholamines and therefore induce arrhythmias following
administration of Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine).

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Pregnancy
If you are pregnant, think you may be pregnant or you are planning on
becoming pregnant tell your dentist as Espestesin 4% articaine with
1/100 000 adrenaline (epinephrine) should only be used during pregnancy
on the advice of your dentist.
Breast-feeding
Ask your dentist for advice before taking any medicine.
Following anaesthesia with Espestesin 4% articaine with 1/100 000
adrenaline (epinephrine) nursing mothers should milk and discard this first
milk before resuming breast-feeding.
Driving and using machines
Although Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
should not impair your ability to drive, the dentist should assess you, for
your individual safety, after treatment and you should not leave the dental
office until at least 30 minutes after the injection.
Important information about some of the ingredients of Espestesin
4% articaine with 1/100 000 adrenaline (epinephrine).
Anhydrous sodium sulphite (one of the ingredients of Espestesin 4%
articaine with 1/100 000 adrenaline (epinephrine)) can cause allergic-type
reactions including anaphylactic symptoms and bronchospasm in
susceptible people, especially those with a history of asthma or allergy.
The medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml,
i.e. essential “sodium-free”.
There is a possibility that Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine) may show up as positive in routine blood screening tests on
athletes.
3. HOW TO USE ESPESTESIN 4% ARTICAINE WITH
1/100 000 ADRENALINE (EPINEPHRINE):
Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) will be
administered to you as an injection into your oral cavity by the dentist.
The dentist will choose the dose of Espestesin 4% articaine with 1/100 000
adrenaline (epinephrine) that is appropriate for you. Generally treatment
with Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) is a
single treatment.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine) can cause side effects, although not everybody gets them.
Frequencies of side effects are defined as:
very common (more than 1 out of 10 persons)
common (more than 1 out of 100 persons and less than 1 out of 10 persons)
uncommon (more than 1 out of 1,000 persons and less than 1 out of
100 persons)
rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons)
very rare (less than 1 out of 10,000 persons, including isolated reports)
Cardiovascular disorders
Rare
Decrease in heart rate, an abnormal heart rate (irregular heart rate, slow
heart rate, racing of the heart or fast heart rate), low blood pressure, a fall
or rise in blood pressure, cardiac arrest, sensation of heat, sweating,
migraine-like headache, tightness of the chest, and swelling of the thyroid.
Nervous system disorders
Rare
Other rare effects that you may experience are metallic taste, ringing in
the ears, dizziness, nausea, vomiting, restlessness, anxiety, yawning,
shaking, nervousness, tremble of the eyes, compulsive talking, headache,
and an increase in your breathing rate. You may also experience a loss of
sensation and a burning, tingling feeling of the lip, tongue, or both.
If you experience any of the following symptoms inform your dentist/doctor
immediately in order to avoid possible worsening of the symptoms:
Drowsiness, confusion, tremor, muscle twitching, convulsion, coma and
severe breathing difficulties which may result in your breathing stopping.

Allergic reactions
Very rare
Very rare cases of allergic reactions have been reported following
administration of Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine). You should inform your dentist or doctor immediately if you
experience any of the following side effects:
Rash, itching, itchy swelling, and redness of the skin as well as nausea,
vomiting, diarrhoea, wheezing, acute asthma attack, effects on consciousness, shock or anaphylaxis.
If you have the condition effecting the blood known as a subclinical
methaemoglobinaemia you should inform the dentist as the administration
of Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine) may
cause a condition called methaemoglobinaemia.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your dentist or doctor.
5. HOW TO STORE ESPESTESIN 4% ARTICAINE WITH 1/100 000
ADRENALINE (EPINEPHRINE)
Keep out of the reach and sight of children.
Do not use Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
after the expiry date witch is stated on the bottom of the tin and the
cartridge after EXP. The expiry date refers to the last day of the month.
Do not store above 25 °C.
Store in the original package in order to protect from light.
The product should be inspected visually for particulate matter, discoloration
or damage of container prior to administration. Do not use Espestesin
4% articaine with 1/100 000 adrenaline (epinephrine) if such defects are
observed.
The product is for single use only. Any unused product should be discarded
immediately after first use.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
contains
- The active substances are Articaine hydrochloride and Epinephrine
(adrenaline) (as epinephrine (adrenaline) hydrochloride).
- 1 ml solution contains 40 mg Articaine hydrochloride and 10 micrograms
Epinephrine (adrenaline) (as epinephrine (adrenaline) hydrochloride).
- 1 cartridge with 1.7 ml solution for injection contains 68 mg Articaine
hydrochloride and 17 micrograms Epinephrine (adrenaline) (as Epinephrine
(adrenaline) hydrochloride).
- The other ingredients are anhydrous sodium sulphite (E221), sodium
chloride, and water for injections as well as hydrochloric acid 14% and
sodium hydroxide 9% for adjusting the pH-value.
What Espestesin 4% articaine with 1/100 000 adrenaline (epinephrine)
looks like and contents of the pack
Solution for injection
The solution is a clear, not opalescent, colourless liquid
Tin with 50 cartridges of 1.7 ml each
Marketing Authorization Holder
3M Deutschland GmbH
Carl-Schurz-Straße 1
41453 Neuss
Germany
Manufacturer:
3M Deutschland GmbH, Carl-Schurz-Straße 1, 41453 Neuss, Germany
This medicinal product is authorised in the Member States of the
EEA under the following names:
Germany:
Espestesin 1/100 000 solution for injection
United Kingdom:
Espestesin 4% articaine with 1/100 000 adrenaline
(epinephrine), solution for injection

This leaflet was last approved in August 2012

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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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