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SEITE1 - 148 x210 mm - 44000763522/02 - GRUN (Pantone 575c) • SCHWARZ - 14-222 (sr) SEITE3 - 148 x210 mm - 44000763522/02 - GRUN (Pantone 575c) • SCHWARZ - 14-222 (sr)

PACKAGE LEAFLET:    g

INFORMATION FOR THE PATIENT    g

Xylestesin" with Adrenaline 20 mg/ml +12.5 micrograms/ml solution for injection

Lidocaine hydrochloride/

Adrenaline (epinephrine)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, dentist or pharmacist.

-    If you get any side effects talk to your doctor, dentist or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

1.    What Xylestesirf" with Adrenaline 20 mg/ml +12.5 micrograms/ml is and what it is used for

2.    What you need to know before you use this medicine

3.    How to use this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

2. WHAT YOU NEED TO KNOW BEFORE YOU USE XYLESTESIN WITH ADRENALINE 20 MG/ML +12.5 MICROGRAMS/ML Do not use this medicine

•    if you are allergic to lidocaine hydrochloride, adrenaline (epinephrine) sodium sulfite, or any of the other ingredients of this medicine (listed in section 6) or to local anaesthetics of the amide type

•    if you have an impairment of the cardiovascular system in particular: disturbance of heart rhythm (arrhythmia),

unstable angina pectoris (e.g. severe chest-pairi), recent heart attack (heart infarction), recent heart surgery,

severe forms of Tow or high blood pressure acute heart failure

•    if you have any blood disorders known as haemorrhagic diatheses

•    if you have an inflammation at the site where the injection is to be given

•    if you have recently been given or are taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants (medicines for treating depression)

•    if you have severe bronchial asthma

•    This medicine must not be used at the end of extremities Warnings and precautions

Talk to your doctor, dentist or pharmacist before using this medicine

•    if you have any lung disorders particularly allergic asthma

•    if you have any liver or kidney problems

•    if you have angina pectoris

•    if you have hardening of the arteries

•    if you have any thyroid problems

•    if you have diabetes mellitus

•    if you have any blood disorders including a tendency to bleed or bruise easily

•    if you have an eye condition known as narrow-angle glaucoma

•    if you have pheochrornocytoma (a form of cancer that effects the adrenal gland)

•    if you have impaired cardiovascular function

•    if you have a history of epilepsy

•    if you have any blood disorders known as methaemoglobinaemia

•    There is a possibility that this medicine may show up as positive in routine blood screening tests on athletes.

Other medicines and Xylestesin with Adrenaline 20 mg/ml +

12.5 micrograms/ml

Tell your doctor, dentist or pharmacist if you are taking, have recently taken or might take any other medicines.

•    Monoamine oxidase (MAO) inhibitors or tricyclic antidepressants (drugs for treating depression), as the cardiovascular impact of this medicine (e.g. increased blood pressure) might be intensified

•    Phenothiazines (medicines for treating severe mental disorders) might cause a drop in blood pressure, if this medicine is applied simultaneously; particular caution is advised in case of preexisting low blood pressure

•    Nori-selective beta-blockers (medicines for treating high blood pressure), as the simultaneous application of this medicine might cause an increased blood pressure

•    Inhalatiorial anaesthetics (chemical compound possessing general anaesthetic properties that can be delivered via inhalation) like halothane may induce irregular heart rhythm (arrhythmia) following administration of this medicine

•    Vasopressor drugs (medicines used to elevate blood pressure) and ergot type oxytocic drugs (medicines used to induce labour in pregnant women) as the concomitant use of this medicine may cause severe, prolonged increased blood pressure

•    Local anaesthetics (agent which reduces or abolishes sensation, affecting a particular region) as a concurrently use with this medicine may additive negative effects like adverse drug reaction of local anaesthetics.

•    Oral antidiabetics (drugs for treating diabetes mellitus), as this medicine might weaken their effects; if necessary, the dose has to be increased for avoiding excessive blood glucose levels

Children:

There is no significant different effect expected between adults and children when taking other medicines in conjunction with this medicine.

Xylestesin with Adrenaline 20 mg/ml +12.5 micrograms/ml with food

Do not eat until the anaesthesia is totally worn off and normal function returns to avoid inadvertent trauma to the lips, tongue, cheek mucosa or soft palate.

Pregnancy

Caution should be exercised when this medicine is administered to pregnant women. Therefore ask your doctor or dentist for advice before taking this

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

SUMMARY OF PRODUCT CHARACTERISTICS

Xylestesin" with Adrenaline 20 mg/ml +12.5 micrograms/ml solution for injection

Lidocaine hydrochloride/

Adrenaline (epinephrine)

1 NAME OF THE MEDICINAL PRODUCT

Xylestesin¹'”¹ with Adrenaline 20 mg/mi +12.5 micrograms/ml solution for injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

	1 mi solution	1 cartridge with
	for injection	1.7 mi solution for
	contains	injection contains
Lidocaine hydrochloride	20 mg	34 mg
Adrenaline (Epinephrine)	12.5 micrograms	21.25 micrograms
Excipients of known effect	(1:80,000)	(1:80,000)
Sodium sulphite (E221)	0.6 mg	1.02 mg
Sodium*	1.71 mg	2.91 mg
* Sodium content of sodium sulphite and sodium chloride
For a full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Solution for injection

The solution is a dear, not opalescent, colourless liquid with a pH value of 3.6 to 4.4.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Local anaesthesia (infiltration and nerve-block anaesthesia) in dentistry.

This medicine is indicated in adults, adolescents and children aged more than 4 years.

4.2    Posology and method of administration

This medicine is exclusively recommended for use in dentistry. Posology

The smallest possible volume of solution which will lead to an effective anaesthesia should be used.

Adults:

The dosage should be individually determined from case to case depending on the method used and special characteristics of the particular case.

In oral infiltration and/or mandibular block, initial dosages of 1.0-4.0 ml are usually sufficient.

Special populations:

Elderly population: Increased plasma levels of this medicine can occur in older patients due to diminished metabolic processes and reduced distribution volume. The risk of accumulation of Xylestesin with Adrenaline is increased after repeated administration in particular.

Dosages should be reduced from adult recommendations, taking into consideration any cardiac or liver disease (see section 4.4).

Patients with hepatic Impairment: Lidocaine is metabolized by the liver. Lower doses of lidocaine may be required in patients with hepatic dysfunction due to prolonged effects and systemic accumulation (see section 4.4).

Patients with renal Impairment: Lidocaine and its metabolites are mainly eliminated in urine. Lower doses of lidocaine may be required in patients with severe renal dysfunction due to prolonged effects and systemic accumulation (see section 4.4).

Other relevant special populations: The dose has to be likewise reduced in patients with certain pre-existing diseases (angina pectoris, arteriosclerosis, see section 4.3 and 4.4) and patients taking contemporary medications known to interact with lidocaine and/or see section 4.4 and 4.5).

Dose recommendation for special populations: A lower dosage range is thus recommended in all such cases (i.e. minimum volume of this medicine for sufficient anaesthetic effect).

Paediatric population:

This medicine is indicated in adults, adolescents and children aged more than 4 years. Special care has to be exercised when treating children below 4 years. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The anaesthesia technique should be selected carefully. Painful anaesthesia techniques should be avoided. The behaviour of the child during treatment has to be monitored carefully. The average dose to be used is in the range of 20 mg to 30 mg lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride which can be administered in children may alternatively be calculated from the expression: child's weight (in kilograms) x 1.33.

The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.

Dose recornmendation for chiIdren:

Body weight (kg)	Recommended dosage
	lidocaine hydrochloride/ mg/chiid	anaesthetic/ml/chiid
20—<30	5-20	0.25 ml — 1 ml
30—<40	10-40	0.5ml-2ml
40—<45

Due to the fact that lidocaine diffuses rapidly into tissues and the density of bones is lower in children compared to adults, infiltration anaesthesia instead of conduction anaesthesia can be preferred in paediatric population.

Maxi rn u rn Reco rn men d ed D osa q e:

Adults:

For healthy adults, the maximum dose of the active ingredient lidocaine hydrochloride with vasoconstrictor admixture is 7 mg/kg body weight. Example: The maximum dose for a 70 kg patient is 500 mg. However, due to the addition of epinephrine 12.5 pg/ml, the maximum administered quantity of 16 ml solution for injection or 9 cartridges (equivalent to 0.2 mg epinephrine, maximum dose) must not be exceeded.

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 5 mg lidocaine hydrochloride/kg bodyweight or 0.250 ml this medicine/kg bodyweight.

4.4 Special warnings and precautions for use Special warnings

This medicine must be used with particular caution iri the event of

-    severe impairment to the renal function,

-    angina pectoris (see section 4.2 and 4.3),

-    arteriosclerosis,

-    considerably impaired blood coagulation or ariticoagulatory treatment,

-    uncontrolled or untreated hyperthyroidism,

-    narrow-angle glaucoma,

-    diabetes meiiitus,

-    lung diseases - particularly allergic asthma bronchiale,

-    pheochrornocytorna,

-    methemoglobinemia.

Dental practitioner who employ local anaesthetic agents should be well versed iri diagnosis and management of emergencies which may arise from their uses.

Inadvertent intravascular application must be avoided (see section 4.2). Accidental intravascular injection or accidental overdose may be associated with convulsions, followed by central nervous system depression or cardiorespiratory arrest (see section 4.9). Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

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 which might be caused by these drugs.

Since amide-type local anaesthetics are also metabolised by the liver, this medicine 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 to patients with history of epilepsy, particularly high doses should be avoided.

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.

There is a possibility of positive results on doping tests performed on sportsmen. Lidocaine is not listed on the current WADA list, and the listed epinephrine is not forbidden if used as vasoconstrictor iri local anaesthetics. Iri patients taking anticoagulants or platelet aggregation inhibitors (e.g. heparin or acetylsalicylic acid) the overall risk of bleeding is increased.

An inadvertent vasopuncture when administering the local anaesthetic can lead to serious bleeding.

This medicinal product contains less than 1 mmol (23 mg) sodium per 1.7 ml i.e. essentially "sodium free".

E221 sodium sulphite: May rarely cause severe hypersensitivity reactions and bronchospasm.

Information to the patients: The patient should be advised to exert caution to avoid inadvertent trauma to the lips, tongue, cheek mucosae or soft palate when these structures are anesthetized. The ingestion of food should therefore be postponed until normal function returns.

Precautions for use:

Each time a local anaesthetic is used the following medicinal products/ therapy as well asari indwelling i.v. catheter set should be available:

-    Anti-convulsant medicines (benzodiazepines e.g. diazepam), myorelaxants, glucocorticoids, atropine and vasopressors or adrenaline as well as an electrolyte solution 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 patients 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

Interactions affecting the use of this medicinal product:

•    Contraindicated combinations:

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).

•    Concomitant use is not recommended:

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 non-selective beta-biockers The concomitant administration of non-cardioseiective (3-blockers can lead to an increase in blood pressure due to the epinephrine in this medicine.

Inhaiational anaesthestics

Certain inhaiational anaesthetics, such as halothane, can sensitise the heart to catecholamines and therefore induce arrhythmias following administration of this medicine.

Vasopressor and ergot-type oxytocic drugs Lidocairie hydrochloride with epinephrine 1:80,000 or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur.

•    Precaution including dose adjustment:

Local anaesthetics

Caution is advised if lidocaine with epinephrine is used concurrently with other local anaesthetics. The toxic effects of local anaesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravasai administration, slow metabolic degradation or overdosing.

Interactions resulting iri clinically relevant changes on the use of other medicinal products:

•    Concomitant use is not recommended:

Patients taking oral anti diabetics

Epinephrine can inhibit insulin release in the pancreas and thus diminish the effect of oral antidiabetics.

Paediatric population

No significant differences can be expected regarding drug interactions between adult and paediatric population.

4.6    Fertility, pregnancy and lactation Pregnancy

For this medicine no clinical data on exposed pregnancies are available. Lidocaine animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at doses 6.6 times the human dose (see section 5.3). Animal studies carried out with epinephrine have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women. This medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Breast-feeding

Lidocairie is excreted iri breast milk with a rni!k:p!asma ratio of 0.4.

No information is available on the use of epinephrine during breast feeding. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with this medicine should be made taking into account the benefit of breast-feeding to the child and the benefit of this medicine therapy to the women. Therefore, nursing mothers should milk and discard the first mother's milk following anaesthesia with lidocairie.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.qov.uk/vellowcard

4.9 Overdose

Acute emergencies from local anaesthetics are generally related to high plasma levels encountered during therapeutic use or unintended and fast iritravasal administration of local anaesthetics. Symptoms of overdose may appear either immediately, caused by accidental 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 probably caused by lidocairie:

Cardiovascular symptoms (S0C Cardiac disorders, Vascular disorders, Investigations): blood pressure decreased, bradycardia, cardiac arrest, conduction disorder.

Central nervous symptoms (S0C Psychiatric disorders, Nervous system disorders, Ear and labyrinth disorders, Gastrointestinal disorders, Musculoskeletal and connective tissue disorders, Investigations): anxiety, coma, confusional state, dizziness, dysgeusia, grand mal convulsion, muscle twitching, nausea, respiratory paralysis, respiratory rate increased, restlessness, somnolence, tinnitus, tremor, vomiting.

The most dangerous symptoms regarding the outcome of such an event are: blood pressure decreased, cardiac arrest, conduction disorder, grand mal convulsion, respiratory paralysis, and somnolence/coma.

Syrnptorns probabIv caused by epi nephrine fadrenaline):

Pressure symptoms (SOC Vascular disorders, Investigations): blood pressure systolic increased, blood pressure diastolic increased, venous pressure increased, pulmonary arterial pressure increased, hypotension.

Cardiac symptoms (SOC Cardiac disorders): bradycardia, tachycardia, arrhythmia (e.g. atrial tachycardia, atrioventricular block, ventricular tachycardia, premature ventricular contractions).

These symptoms can result in life threatening situations as well as pulmonary oedema, cardiac arrest, kidney failure, and metabolic acidosis.

Therapy

If symptoms of overdose arise the application of the local anaesthetic has to be stopped.

General basic measures:

Diagnostics (respiration, circulation, consciousness), resuscitation and/or maintenance of the vital functions (respiration and circulation), administration of oxygen, intravenous access.

Elevation of the upper body, if necessary sublingual nifedipine.

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

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

Atropine iv.

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 B52 Mechanism of action:

This medicine contains lidocairie which is a local anaesthetic of the amide type for dentistry arid 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 action of lidocaine.

Epinephrine leads locally to vasoconstriction and reduced blood supply, whereby the absorption of lidocairie is delayed. The result is a higher concentration of the local anaesthetic at the site of action over a longer period, as well as the reduction of systemic adverse side effects.

Pharmacodynamic effects:

Onset of local anaesthetic effects of this medicine occurs after a short latency period of 1-3 min with infiltration and after somewhat longer latency period after injection with nerve block anaesthesia (2 to 4 minutes after injection). The duration of complete anaesthesia with this medicine iri pulpal anaesthesia is 30 to 60 minutes, and iri soft-tissue anaesthesia 120 to 180 minutes.

Clinical efficacy and safety:

Success rates of anaesthesia with this medicine differ, depending on the kind of anaesthesia arid the factors already mentioned before. Iri general, success rates of about 90% or higher may be expected after single use if the drug is administered as indicated. The inferior alveolar nerve block has the greatest failure rate. Repeated or supplementary injections may be necessary iri the event of failure or in the event of prolonged dental procedures and surgery. Special conditions, e.g. acute irreversible pulpitis of mandibular molars, may require special or alternative anaesthetic techniques. Articaine 4% with epinephrine may provide better clinical efficacy iri such cases as reported by different authors, this medicine is usually tolerated well however, adverse reactions cannot be fully excluded (see section 4.8), in the event of overdose in particular (see section 4.9).

Paediatric population:

The use of this medicine iri paediatric population is considered for routine treatment. Dosages in paediatric population should be reduced considering age, body weight, physical condition arid the magnitude of the treatment (see section 4.2), together with complex measures to prevent painful experience arid to reduce anxiety, including sedation.

Since paediatric patients suffer relatively often traumatic injury to their still (residual) anaesthetized soft tissue following local anaesthesia administration in the dental office (reportedly 13%), local anaesthesia providing the appropriate duration of efficacy should be used.

5.2    Pharmacokinetic properties

Absorption:

Lidocaine is rapidly and extensively absorbed. The maximum plasma level of lidocaine from intraoral injection is achieved approximately after 10-20 minutes.

Distribution:

Lidocairie is bound up to 60 to 80% in the serum to plasma proteins. Lidocairie is widely distributed within the organism. The elimination half-life is 1.5 to 2 hours.

Biotrarisformatiori arid elimination:

Lidocairie is largely metabolised iri the liver and any alteration iri liver function or hepatic blood flowcari have a significant effect ori its pharmacokinetics and dosage requirements. Metabolism iri the liver is rapid and about 90% of the given dose is dealkylated to form mono-ethyiglycinexylidide and glycinexylidide. Less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.

Lidocaine crosses the blood-brain and placental barriers.

Epinephrine is rapidly catabolized iri the liver and other tissues. The metabolites are excreted renally.

medicine if you are pregnant, think you may be pregnant or you are planning to have a baby.

Breast-feeding

If you are breast-feeding ask your doctor or dentist for advice before taking this medicine.

• Following anaesthesia with this medicine nursing mothers should milk and discard this first milk before resuming breast-feeding.

Driving and using machines

Although this medicine 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 30 minutes after the injection.

Xylestesin with Adrenaline 20 mg/ml +12.5 micrograms/ml contains sodium sulfite

Anhydrous sodium sulfite (one of the ingredients of this medicine) may rarely cause severe hypersensitivity 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 1.7 ml, i.e. essential "sodium-free".

3.    HOW TO USE XYLESTESIN WITH ADRENALINE 20 MG/ML +

12.5 MICROGRAMS/ML

The medicinal product is only used by a dentist Dosage

The dentist will choose the dose of this medicine that is appropriate for you. In any case your dentist will use the smallest possible volume of solution which will lead to an effective anaesthesia. For uncomplicated procedures your dentist will administer 0.5 to 1.7 ml solution for injection.

Use in adults:

The maximum recommended dosage for healthy adults is 0.350 ml of solution per kg/body weight Due to the maximum dose of adrenaline (epinephrine)

(0.2 mg) 16 ml solution should not be exceeded. A lower dosage range is recommended in case of angina pectoris, reduced general condition, older patients, severe impaired renal and liver function and arteriosclerosis.

Use in children and adolescents:

The dentist has to exercise special care when treating children below 4 years. The quantity which the dentist has to inject should be determined by the age and weight of the child and the magnitude of the operation. The dentist will select the anaesthesia techriigue carefully to avoid painful injection. During the treatment the dentist will monitor the behavior of the child carefully The average dose to be used is in the range of 1 ml to 1.5 ml of this medicine per session. The maximum recommended dosage of 0.250 ml of solution per kg body weight should not be exceeded.

Method and route of administration:

The medicinal product is for dental use only This medicine will be administered to you as an injection into your oral cavity by the dentist.

Generally treatment with this medicine is a single treatment.

If you have any further questions on the use of this product, ask your doctor, dentist or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe Allergic Reactions (Frequency not known)

If you notice one of the following signs within a day of the dental procedure, tell your dentist immediately as they may be the signs of a severe allergic reaction: Swelling of your face, lips, tongue or throat.

Difficulty breathing or wheezing due to throat tightness, bronchospasm; respiratory failure cannot be excluded Itching, rash, inflammation of skin or mucosa Hypersensitivity testing is strongly recommended to avoid such events in the future.

Nerve Disturbances (Frequency not known)

If you feele.g. numbness, tingling, stinging, taste problems or double vision within one day of the dental procedure please contact your dentist. Nerve disturbances can persist for longer time, but in most cases these symptoms disappear within a few months. The signs may include:

-    Face numbness, facial paralysis

-    Eye disorders, e.g. double vision, blurred vision, eye swelling, transient blindness, disturbed focusing

Other side effects

The following adverse events were recorded in clinical studies or during postmarketing surveillance.

Very common (may affect more than 1 in 10 people)

-    Prolonged numbness of the mouth due to the anaesthesic lasting longer than expected

Common (may affect up to 1 in 10 people)

-    Insufficient anaesthesia which results in some pain during the procedure Uncommon (may affect up to 1 in 100 people)

-    Dizziness, feeling sick

-    Infections of the mouth area (e.g. oral herpes)

-    Injury to mouth caused by accidental biting while the mouth is still numb

-    Bruise or swelling at injection site

-    Toothache

Rare (may affect up to 1 in 1,000 people)

-    Headache

-    Drowsiness

-    Abnormal heartbeat

-    Bruise, bleeding beneath the skin Frequency not known

-    Fainting

-    Confusion, pallor, vomiting, increased or irregular heart rate. These may also be signs before fainting

Additional side effects in children and adolescents

Neither data from clinical studies nor postmarked rig observations revealed differences in safety between adults and children and adolescents.

Reporting of side effects

If you get any side effects, talk to your doctor, dentist or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.rnhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.rn. to 2 p.rn. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE XYLESTESIN WITH ADRENALINE 20 MG/ML +

12.5    MICROGRAMS/ML

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottom of the tin and the cartridge after EXP. The expiry date refers to the last day of that month.

Do not store above 25° C. Do not refrigerate. Store in the original package (tin) in order to protect from light.

Do not use this medicine if you notice particulate matter, discoloration or damage of container prior to administration.

The product is for single use only. Any unused product should be discarded immediately after first use.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Xylestesin™ with Adrenaline 20 mg/ml +12.5 micrograms/ml contains

The active substances are Lidocaine hydrochloride and Adrenaline (epinephrine).

-    1 ml solution for injection contains 20 mg Lidocaine hydrochloride and

12.5    micrograms Adrenaline (epinephrine).

-    1 cartridge with 1.7 ml solution for injection contains 34 mg Lidocaine hydrochloride and 21.25 micrograms Adrenaline (epinephrine).

-    The other ingredients are anhydrous sodium sulphite (E221), sodium chloride, and water for injections as well as hydrochloric acid 14% for adjusting the pH-value.

What Xylestesin“with Adrenaline 20 mg/ml +12.5 micrograms/ml 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 Authorisation Holder

3M Health Care Limited 3M House, Morley Street Loughborough, Leicestershire LE 11 1EP, UK

Manufacturer

3M Deutschland GmbH

Carl-Schurz-Strasse 1, D-41453 Neuss, Germany This leaflet was last approved in

October 2014

1

WHAT XYLESTESIN WITH ADRENALINE 20 MG/ML +

12.5 MICROGRAMS/ML IS AND WHAT IT IS USED FOR

Xylestesin"'with Adrenaline 20 mg/mi +12.5 micrograms/ml contains the active substances lidocaine hydrochloride and adrenaline (epinephrine). This medicine is a local anaesthetic (agent which reduces or abolishes sensation, affecting a particular region). This medicine is used for local anaesthesia (loss of feeling or sensation in a part of the body) in dentistry. This medicine is used in adults, children and adolescents.