XYLOCAINA 20 mg /Ml Injectable Solution

Зміст інструкції

1. XYLOCAINA 20 mg/ml injectable solution
   1. What is Xylocaine and what is it used for
   2. What you need to know before you are given Xylocaine
   3. How Xylocaina will be administered to you
   4. Possible side effects
   5. How to store Xylocaina
   6. Contents of the pack and other information
2. XYLOCAINA 20 mg/ml injectable solution
   1. What is Xylocaine and what is it used for
   2. What you need to know before you are given Xylocaine
   3. How Xylocaina will be administered to you
   4. Possible side effects
   5. How to store Xylocaina
   6. Contents of the pack and other information

XYLOCAINA 20 mg/ml injectable solution

lidocaine hydrochloride
Read this leaflet carefully before you are given this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Xylocaina is and what it is used for
• 2. What you need to know before you are given Xylocaina
• 3. How you will be given Xylocaina
• 4. Possible side effects
• 5. How to store Xylocaina
• 6. Contents of the pack and other information

1. What is Xylocaine and what is it used for

Xylocaine contains lidocaine hydrochloride, a medicine belonging to the group of local anesthetics.
Xylocaine is used to numb (anaesthetize) parts of the body in adults and adolescents
aged 12 years and over.
Xylocaine is used for local anesthesia, i.e. to eliminate pain in a specific area of the body
without loss of consciousness.

2. What you need to know before you are given Xylocaine

You will not be given Xylocaine

• if you are allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other local anesthetics and/or similar substances.

Warnings and precautions
Talk to your doctor or nurse before you are given Xylocaine.
Tell your doctor, who will monitor you carefully:

• if the part of the body chosen for the injection shows signs of infection or inflammation;
• if you have nerve diseases;
• if you suffer from high blood pressure (hypertension)
• if you suffer from advanced liver disease or severe kidney disease;
• if you suffer from a heart condition (partial or complete heart block);
• if you are elderly or in poor general condition;
• if you are taking class III antiarrhythmic drugs (e.g. amiodarone) to treat irregular heartbeat (see section “Other medicines and Xylocaine”). The doctor may

subject you to an ECG monitoring (electrocardiogram, an examination to assess the
functionality of the heart);

• if you are taking MAOIs (monoamine oxidase inhibitors) or tricyclic antidepressants, used to treat depression (see section “Other medicines and Xylocaine”);
• if you suffer from porphyria, an inherited disease that interferes with the production of certain blood cells, red blood cells.
• if you are pregnant (see section “Pregnancy and breastfeeding”);

Children and adolescents
The use of Xylocaine is not recommended:

• to numb parts of the body during surgery (local anesthesia) in children under 12 years of age. In pediatric patients from 1 to 12 years of age, a less concentrated solution is recommended.

Other medicines and Xylocaine
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking:

• other local anesthetics or similar substances;
• medicines such as mexiletine and tocainide or class III antiarrhythmics (e.g. amiodarone), used to treat heart rhythm disorders;
• medicines such as cimetidine, used to treat some stomach disorders or beta-blockers, used to treat some heart disorders.
• MAOIs (monoamine oxidase inhibitors) or tricyclic antidepressants, used to treat depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before you are given this medicine.

Pregnancy
Xylocaine will only be given during pregnancy if necessary and under direct medical supervision.

Breastfeeding
If you are breastfeeding, ask your doctor for advice before you are given this
medicine.
Like other local anesthetics, lidocaine may be excreted in breast milk.

Driving and using machines
Lidocaine impairs the ability to drive and use machines.
Local anesthetics can have a very mild effect on mental function and coordination, and
can temporarily negatively affect motor skills and alertness.

Xylocaine contains sodium
This medicine contains approximately 1 mmol (24 mg) of sodium per vial.
To be taken into consideration in people with reduced kidney function or who are following a low-sodium
diet.

3. How Xylocaina will be administered to you

The dose will be established by the doctor based on your weight and your state of health.
Xylocaina will be administered to the part of the body affected by a doctor specialized in the use of
this type of medicine, in adequately equipped facilities.
If a large part of your body needs to be anesthetized or if you are administered a high dose of
medicine, the doctor will insert a small tube into a vein (catheter) before administering
Xylocaina.

Use in children and adolescents
The dosage depends on the age, physical condition and weight of the patient and will be determined by the anesthesiologist.
In pediatric patients from 1 to 12 years of age, a less concentrated solution is recommended.

If you are given more Xylocaina than you should
It is very unlikely that you will be given more solution than necessary as your doctor will monitor you
during treatment.
Accidental injection of local anesthetics into a blood vessel can cause immediate generalized adverse effects
(ranging from a few seconds to a few minutes). In case of overdose, however, the adverse effects
manifest later (15-60 minutes after the injection) (see section 4).
The doctor will determine which rescue techniques or medications will be necessary in case you are
given more solution than necessary.

If you stop treatment with Xylocaina
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The immediate availability of suitable equipment, medicines and personnel for emergency treatment must be ensured, as rare cases of severe allergic reactions, sometimes fatal, have been reported following the use of local anesthetics, even in the absence of a known allergy.
Possible side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• low blood pressure (hypotension);
• increased blood pressure (hypertension);
• nausea, vomiting;
• numbness (paresthesia), dizziness;
• decreased heart rate (bradycardia).

Uncommon (may affect up to 1 in 100 people)

• uncontrolled body movements (convulsions);
• numbness around the mouth (paresthesia in the circumoral region);
• tongue numbness;
• increased sensitivity to sounds (hyperacusis);
• visual disturbances;
• tremor;
• ringing in the ears (tinnitus);
• difficulty speaking (dysarthria);
• reduction of central nervous system activity (CNS depression).

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

• cardiac arrest;
• heart rhythm disturbances (cardiac arrhythmias);
• allergic reactions, anaphylactic shock (severe allergic reaction);
• respiratory depression;
• nerve disease (neuropathy);
• nerve damage;
• inflammation of a meninges, the lining of the brain (arachnoiditis);
• double vision (diplopia).

Other reported side effects include:

Allergic reactions

• swelling and pain (edema);
• urticaria;
• itching.

Effects on the nervous system

• excitement (which may manifest as initial drowsiness);
• depression;
• anxiety;
• tremors followed by changes in consciousness;
• respiratory arrest.

Effects on the heart and circulation

• decreased heart activity (myocardial depression).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Xylocaina

Do not store at a temperature above 25°C. Do not freeze.
The solutions do not contain preservatives and must be used immediately after opening the vial.
Any residual medicine must be discarded.
Restérilization of Xylocaina is not recommended.
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 pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Xylocaina contains

• The active ingredient is lidocaine hydrochloride 20 mg
• The other ingredients are sodiumchloride (see section 2 “Xylocaina contains sodium”), sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster), water for injections.

Description of the appearance of Xylocaina and contents of the pack
Xylocaina is presented as a clear and colourless injectable solution.
Xylocaina 20 mg/ml injectable solution is available in packs of
5 ampoules of 5 ml.

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: +39 0687 502 429

Manufacturer
CENEXI, 52 Rue Marcel et Jacques Gaucher, 94120 Fontenay sous Bois, France
-----------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:
Precautions for use
Regional anaesthesia techniques must always be performed in adequately equipped areas and by
qualified personnel. Immediate availability of equipment and drugs necessary for monitoring and emergency resuscitation must be ensured.
In patients undergoing major block or receiving high doses of the drug, an intravenous catheter must be inserted before
administration of the local anaesthetic. The doctor must have received complete and adequate training in the type of technique to be used and must be experienced in the diagnosis and
treatment of adverse effects, systemic toxicity or other complications (see Adverse Effects and
Overdose).
The safety of lidocaine use depends on appropriate dosage, correct technique
and the adoption of precautionary measures. The product should therefore be used at the minimum effective dosage, which must be determined taking into account the age, physical condition and weight of patients
such as the elderly and acutely ill patients.
Use with extreme caution in patients with cardiovascular conditions and especially in case of shock or
atrioventricular conduction disturbances.
The solution must be injected slowly and with frequent aspirations; repeated injections of
lidocaine can cause significant increases in its plasma levels due to accumulation of the substance or
its metabolites. Drowsiness is the first sign of high plasma levels, which can also occur in case of too rapid absorption or accidental intravenous injection.
Loco-regional anaesthesia methods must be performed with caution when the tissue or the region
chosen for the injection shows signs of infection or inflammation. Particular precautions must be
necessarily adopted depending on the areas involved.
Epidural or caudal anaesthesia must be performed with extreme caution in patients with
neurological diseases, spinal deformities, septic states or hypertension.

Special warnings
Some local anaesthesia techniques may be associated with severe adverse reactions, regardless of
the local anaesthetic used, such as:
o central nervous block which can cause cardiovascular depression especially in the presence of
hypovolaemia. Epidural anaesthesia should be used with caution in patients with reduced
cardiovascular function;
o retrobulbar injections: may, in very rare cases, reach the cerebral subarachnoid space
causing temporary blindness, cardiovascular collapse, apnea, convulsions, etc. These reactions
must be diagnosed and treated immediately;
o retro- and peribulbar injections of local anaesthetics carry a low risk of persistent eye muscle dysfunction. Primary causes include trauma and/or local toxic effects on muscles and/or nerves. The severity of these reactions on the tissues is related to the extent of trauma, the concentration of local anaesthetic and the duration of tissue exposure to the local anaesthetic. As
with all local anaesthetics, it is therefore necessary to use the lowest doses and concentrations that
can allow to obtain the desired effect. Vasoconstrictors may worsen tissue reactions and should be used only if indicated;
o accidental intra-arterial injections in the cranial and cervical region can cause severe symptoms
even at low doses;
o paracervical block may sometimes cause fetal bradycardia/tachycardia. Careful monitoring of fetal heart rate is therefore necessary;
o Continuous intra-articular infusion is not an approved indication for Xylocaina. However, cases of chondrolysis in patients who
received post-operative continuous intra-articular infusion of local anaesthetics have been reported exclusively in North America. The
majority of chondrolysis cases reported have involved the shoulder joint. No causal link has been
established.

Dosage, method and duration of administration
The maximum recommended dose is 10 ml. This dose should be appropriately reduced in adolescents
and in patients in poor condition. In adolescents with a high body weight, a gradual reduction
of the dose is often necessary and must be based on ideal body weight. The total dose should not exceed
5 mg/kg of lidocaine ideal body weight. The correct dose and concentration will be determined by
the doctor.
Reference texts should be consulted regarding both aspects that affect specific block techniques and individual patient needs.
The dose to be administered must be calculated based on the doctor's experience and knowledge
of the patient's clinical condition. The lowest doses that can allow to obtain adequate anaesthesia must be used (see Precautions for use). However, individual variations may occur
regarding the onset and duration of action.
In general, surgical anaesthesia requires the use of higher concentrations and dosages. Lower concentrations are indicated when a block of lesser intensity is required. The volume of the drug used
influences the extent and speed of anaesthesia.
To prevent intravascular injection, aspiration should be performed before and during the administration
of the main dose, which should be injected slowly or in increasing doses. During the procedure
carefully monitor the patient's vital functions and maintain verbal contact.
An accidental intravascular injection can be recognised by a temporary increase in heart rate; an accidental intrathecal injection is recognised by signs of spinal block. Stop administration immediately at the first sign of
toxicity.
When performing prolonged blocks, for example through repeated administrations, the risk of reaching toxic plasma concentrations or inducing local neuronal damage must be considered.
Caution: the ampoules do not contain parasympathomimetic excipients and must be used for a single administration.
Any remaining contents should be discarded.
The solution in the ampoules does not contain preservatives and must be used immediately after opening
the container. Any residual drug must be eliminated.
Resterilization of Xylocaina is not recommended.
The solubility of lidocaine at pH higher than 6.5 is limited. This should be taken into consideration when
adding alkaline solutions, such as carbonates, which can cause the solution to precipitate.

Paediatric population
In paediatric patients from 1 to 12 years of age, a less concentrated solution is recommended.

Further information relating to possible adverse effects
The profile of adverse reactions of Xylocaina is similar to that of other local anaesthetics of the amidic type. Drug adverse reactions are difficult to distinguish from the physiological effects resulting
from nerve conduction block (such as decreased blood pressure, bradycardia) and from events
caused directly by the injection (e.g. nerve fibre trauma) or indirectly (e.g. epidural abscess).
The side effects of lidocaine are represented by hypersensitivity reactions or high plasma levels due to excessive dosage, rapid absorption or accidental intravascular injection. Hypersensitivity reactions include: oedema, urticaria, itching and anaphylactic reactions that must be treated with
conventional means. Reactions from high plasma levels involve primarily the CNS and the cardiovascular system. Involvement of the CNS can manifest as excitation or depression with
dizziness, visual disturbances, anxiety, tremors followed by changes in consciousness, convulsions
and respiratory arrest. The excitatory signs preceding the depressive phase may be brief or
completely absent and drowsiness may be the first manifestation. Involvement of the cardiovascular system
is characterised by bradycardia, hypotension, myocardial depression, up to cardiac arrest.
Acute systemic toxicity
Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system (SCV). These reactions are caused by a high blood concentration of local anaesthetic
which can be caused by an accidental intravascular injection, overdose or exceptionally rapid absorption from a highly vascularised area (see Overdose). CNS reactions are
similar for all amidic-type local anaesthetics, while cardiac reactions are more
dependent on the drug, both in quantitative and qualitative terms. The signs of CNS toxicity generally precede the toxic cardiovascular effects, except in cases where the patient
has undergone general anaesthesia or has been deeply sedated with drugs such as benzodiazepines
or barbiturates.

Toxicity affecting thecentral nervous systemmanifests gradually, with symptoms and signs of increasing severity. The first symptoms are paraesthesia in the circumoral region, numbness of the tongue, feeling of
head emptiness, hyperacusis and tinnitus and visual disturbances. Dysarthria, muscle contractions and tremors are
more serious manifestations and precede the onset of generalised convulsions. These signs should not
be confused with erotic behaviours. Unconsciousness and convulsions may follow, which can last from a few seconds to several minutes. After the convulsions, due to increased muscle activity,
interference with normal breathing and the lack of airway patency, hypoxemia and hypercapnia develop rapidly. In severe cases, apnea may occur. Hyperkalaemic acidosis,
hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.
Return of the patient to initial clinical conditions is due to redistribution of the local anaesthetic
from the central nervous system and metabolism and excretion. Recovery can be rapid if large amounts of drug have not been administered.
In severe cases, toxic effects on thecardiovascular systemmay occur, which are
generally preceded by signs of CNS toxicity.
In patients undergoing general anaesthesia or deeply sedated, the prodromal symptoms of the central
nervous system may be absent. As a result of high systemic concentrations of local anaesthetics,
hypotension, bradycardia, arrhythmias and even cardiac arrest can occur. Cardiac arrest, in
rare cases, has occurred without the appearance of prodromal CNS effects.

Treatment of acute toxicity
Administration of the local anaesthetic must be stopped immediately if signs of
acute systemic toxicity appear and the symptoms of the central nervous system (convulsions, depression of the nervous system) must be promptly treated with appropriate support of ventilation/respiration
and administration of anticonvulsants.
If circulatory arrest occurs, cardiopulmonary resuscitation must be performed immediately. It is vital to ensure adequate oxygenation, ventilation, support the
circulation and treat acidosis.
In case of cardiovascular depression (hypotension, bradycardia), treatment with intravenous fluids, vasoconstrictors, chronotropes and or inotropes should be considered.

XYLOCAINA 20 mg/ml injectable solution

lidocaine hydrochloride
Read this leaflet carefully before you are given this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Xylocaina is and what it is used for
• 2. What you need to know before you are given Xylocaina
• 3. How Xylocaina will be given to you
• 4. Possible side effects
• 5. How to store Xylocaina
• 6. Contents of the pack and other information

1. What is Xylocaine and what is it used for

Xylocaine contains lidocaine hydrochloride, a medicine belonging to the group of local anaesthetics.
Xylocaine is used to numb (anaesthetize) parts of the body in adults and adolescents
aged 12 years and over.
Xylocaine is used for local anaesthesia, i.e. to eliminate pain in a specific area of the body
without loss of consciousness.

2. What you need to know before you are given Xylocaine

You will not be given Xylocaine

• if you are allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other local anaesthetics and/or similar substances.

Warnings and precautions
Talk to your doctor or nurse before you are given Xylocaine.
Tell your doctor, who will monitor you carefully:

• if the part of the body chosen for the injection shows signs of infection or inflammation;
• if you have nerve diseases;
• if you suffer from high blood pressure (hypertension)
• if you suffer from advanced liver disease or severe kidney disease;
• if you suffer from a heart condition (partial or complete heart block);
• if you are elderly or in poor general condition;
• if you are taking Class III antiarrhythmic drugs (e.g. amiodarone) to treat irregular heartbeat (see section “Other medicines and Xylocaine”). The doctor may

subject you to an ECG (electrocardiogram, a test to assess the
functionality of the heart);

• if you are taking MAO inhibitors (monoamine oxidase inhibitors) or tricyclic antidepressants, used to treat depression (see section “Other medicines and Xylocaine”);
• if you suffer from porphyria, an inherited disease that interferes with the production of certain blood cells, red blood cells.
• if you are pregnant (see section “Pregnancy and breastfeeding”);

Children and adolescents
The use of Xylocaine is not recommended:

• to numb parts of the body during surgery (local anaesthesia) in children under 12 years of age. In paediatric patients aged 1 to 12 years, a less concentrated solution is recommended.

Other medicines and Xylocaine
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking:

• other local anaesthetics or similar substances;
• medicines such as mexiletine and tocainide or Class III antiarrhythmics (e.g. amiodarone), used to treat heart rhythm disorders;
• medicines such as cimetidine, used to treat some stomach disorders or beta-blockers, used to treat some heart disorders.
• MAO inhibitors (monoamine oxidase inhibitors) or tricyclic antidepressants, used to treat depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before you are given this medicine.

Pregnancy
Xylocaine will only be given during pregnancy if necessary and under direct medical supervision.

Breastfeeding
If you are breastfeeding, ask your doctor for advice before you are given this
medicine.
Like other local anaesthetics, lidocaine can be excreted in breast milk.

Driving and using machines
Lidocaine impairs the ability to drive and use machines.
Local anaesthetics can have a mild effect on mental function and coordination, and
can temporarily negatively affect movement ability and alertness.

Xylocaine contains sodium
This medicine contains approximately 1 mmol (24 mg) of sodium per vial.
To be taken into consideration in people with reduced kidney function or who are following a low-sodium
diet.

3. How Xylocaina will be administered to you

The dose will be established by the doctor based on your weight and state of health.
Xylocaina will be administered to the part of your body affected by a doctor specialized in the use of
this type of medicine, in adequately equipped facilities.
If a large part of your body needs to be anesthetized or if you are administered a high dose of
medicine, the doctor will insert a small tube into a vein (catheter) before administering
Xylocaina.

Use in children and adolescents
The dosage depends on the age, physical condition and weight of the patient and will be determined by the anesthesiologist.
In pediatric patients from 1 to 12 years of age, a less concentrated solution is recommended.

If you are given more Xylocaina than you should
It is very unlikely that you will be given more solution than necessary, as your doctor will monitor you
during treatment.
Accidental injection of local anesthetics into a blood vessel can cause immediate generalized adverse effects
(ranging from a few seconds to a few minutes). In case of overdose, however, the adverse effects
manifest later (15-60 minutes after the injection) (see section 4).
The doctor will determine which rescue techniques or medications will be necessary in case you are
given more solution than necessary.

If you stop treatment with Xylocaina
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The immediate availability of suitable equipment, medicines and personnel for emergency treatment must be ensured, as rare cases of severe allergic reactions, sometimes fatal, have been reported following the use of local anesthetics, even in the absence of a known allergy.
Possible side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• low blood pressure (hypotension);
• increased blood pressure (hypertension);
• nausea, vomiting;
• numbness (paresthesia), dizziness;
• decreased heart rate (bradycardia).

Uncommon (may affect up to 1 in 100 people)

• uncontrolled body movements (convulsions);
• numbness around the mouth (paresthesia in the circumoral region);
• tongue numbness;
• increased sensitivity to sounds (hyperacusis);
• visual disturbances;
• tremor;
• ringing in the ears (tinnitus);
• difficulty speaking (dysarthria);
• reduction of central nervous system activity (CNS depression).

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

• cardiac arrest;
• heart rhythm disturbances (cardiac arrhythmias);
• allergic reactions, anaphylactic shock (severe allergic reaction);
• respiratory depression;
• nerve disease (neuropathy);
• nerve damage;
• inflammation of a meninges, the lining of the brain (arachnoiditis);
• double vision (diplopia).

Other reported side effects include:

Allergic reactions

• swelling and pain (edema);
• urticaria;
• itching.

Effects on the nervous system

• excitation (which may manifest as initial drowsiness);
• depression;
• anxiety;
• tremors followed by changes in consciousness;
• respiratory arrest.

Effects on the heart and circulation

• decreased heart activity (myocardial depression).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Xylocaina

Do not store at a temperature above 25°C. Do not freeze.
The solutions do not contain preservatives and must be used immediately after opening the vial.
Any residual medicine must be discarded.
Restérilization of Xylocaina is not recommended.
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 pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Xylocaina contains

• The active ingredient is lidocaine hydrochloride 20 mg
• The other ingredients are sodiumchloride (see section 2 “Xylocaina contains sodium”), sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster), water for injections.

Description of the appearance of Xylocaina and contents of the pack
Xylocaina is presented as a clear and colourless injectable solution.
Xylocaina 20 mg/ml injectable solution is available in packs of
5 ampoules of 5 ml.

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland

Manufacturer
CENEXI, 52 Rue Marcel et Jacques Gaucher, 94120 Fontenay sous Bois, France
-----------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:
Precautions for use
Regional anaesthesia techniques must always be performed in adequately equipped areas and by
qualified personnel. Immediate availability of equipment and drugs necessary for monitoring and emergency resuscitation must be ensured.
In patients undergoing major block or receiving high doses of the drug, an intravenous catheter must be inserted before
administration of the local anaesthetic. The doctor must have undergone complete and adequate training in the type of technique to be used and must be experienced in the diagnosis and
treatment of adverse effects, systemic toxicity or other complications (see Adverse Effects and
Overdose).
The safety of lidocaine use depends on appropriate dosage, correct technique and the adoption of precautionary measures. The product should therefore be used at the minimum effective dosage, which should be determined taking into account the age, physical condition and weight of patients, such as the elderly and acutely ill patients.
Use with extreme caution in patients with cardiovascular conditions and especially in cases of shock or atrioventricular conduction disturbances.
The solution should be injected slowly and with frequent aspirations; repeated injections of
lidocaine may cause significant increases in its plasma levels due to accumulation of the substance or
its metabolites. Drowsiness is the first sign of high plasma levels, which may also occur in case of too rapid absorption or accidental intravenous injection.
Loco-regional anaesthesia techniques should be performed with caution when the tissue or the region
chosen for the injection shows signs of infection or inflammation. Particular precautions must be
necessarily adopted depending on the areas involved.
Epidural or caudal anaesthesia must be performed with extreme caution in patients with
neurological diseases, spinal deformities, septic states or hypertension.

Special warnings
Some local anaesthesia techniques may be associated with severe adverse reactions, regardless of
the local anaesthetic used, such as:
o central nervous block which may cause cardiovascular depression especially in the presence of
hypovolaemia. Epidural anaesthesia should be used with caution in patients with reduced
cardiovascular function;
o retrobulbar injections: may, in very rare cases, reach the cerebral subarachnoid space
causing temporary blindness, cardiovascular collapse, apnoea, convulsions, etc. Such reactions
must be diagnosed and treated immediately;
o retro and peribulbar injections of local anaesthetics involve a low risk of persistent ocular muscle dysfunction. Primary causes include trauma and/or local toxic effects on muscles and/or nerves. The severity of such reactions to the tissues is correlated with the extent of trauma, the concentration of local anaesthetic and the duration of tissue exposure to the local anaesthetic. As
with all local anaesthetics, it is therefore necessary to use the lowest doses and concentrations that
can allow to obtain the desired effect. Vasoconstrictors may worsen reactions
to the tissues and should be used only if indicated;
o accidental intra-arterial injections in the cranial and cervical region can cause severe symptoms
even at low doses;
o paracervical block may sometimes cause fetal bradycardia/tachycardia. Careful monitoring of fetal heart rate is therefore necessary;
o Continuous intra-articular infusion is not an approved indication for Xylocaina. However, cases post-marketing have been reported exclusively in North America of chondrolysis in patients who
received post-operative continuous intra-articular infusion of local anaesthetics. The
majority of chondrolysis cases reported have involved the shoulder joint. No causal relationship has been established.

Dosage, method and duration of administration
The maximum recommended dose is 10 ml. This dose should be appropriately reduced in adolescents
and in patients in poor condition. In adolescents with a high body weight, a gradual reduction
of the dose is often necessary and should be based on ideal body weight. The total dose should not exceed
5 mg/kg of lidocaine of ideal body weight. The correct dose and concentration will be determined by
the doctor.
Reference texts should be consulted both regarding aspects that affect specific block techniques and regarding individual patient needs.
The dose to be administered must be calculated based on the doctor’s experience and knowledge
of the patient’s clinical condition. It is necessary to use the lowest doses that can allow to obtain
adequate anaesthesia (see Precautions for use). However, individual variations may occur
regarding the onset and duration of action.
In general, surgical anaesthesia requires the use of higher concentrations and dosages. Lower concentrations are indicated when a block of lesser intensity is required. The volume of the drug used
influences the extent and speed of anaesthesia.
To prevent intravascular injection, aspiration should be performed before and during administration
of the main dose, which should be injected slowly or in increasing doses. During the procedure
carefully monitor the patient's vital functions and maintain verbal contact.
An accidental intravascular injection can be recognised by a temporary increase in heart rate; an accidental intrathecal injection is recognised by signs of spinal block. At the first sign of
toxicity, immediately stop administration.
When performing prolonged blocks, for example through repeated administrations, the risk of reaching toxic plasma concentrations or inducing local neuronal damage must be considered.
Caution: ampoules do not contain parasympathomimetic excipients and must be used for a single administration.
Any remaining contents should be discarded.
The solution in the ampoules does not contain preservatives and should be used immediately after opening
the container. Any residual drug must be discarded.
Resterilization of Xylocaina is not recommended.
The solubility of lidocaine at pH higher than 6.5 is limited. This should be taken into consideration when
adding alkaline solutions, such as carbonates, which may cause the solution to precipitate.
The solution should not be kept in contact with metals, for example cannulae and syringes with metal parts.
Metal ions may be released, which may cause swelling at the injection site.

Paediatric population
In paediatric patients from 1 to 12 years of age, a less concentrated solution is recommended.

Further information relating to possible adverse effects
The profile of adverse reactions of Xylocaina is similar to that of other local anaesthetics of the amidic type. Drug adverse reactions are difficult to distinguish from the physiological effects resulting
from nerve conduction block (such as decreased blood pressure, bradycardia) and from events
caused directly by the injection (e.g. nerve fibre trauma) or indirectly (e.g. epidural abscess).
The side effects of lidocaine are represented by hypersensitivity reactions or by high plasma levels due to excessive dosage, rapid absorption or accidental intravascular injection. Hypersensitivity reactions include: oedema, urticaria, itching and anaphylactic reactions that must be treated with
conventional means. Reactions from high plasma levels involve primarily the CNS and the cardiovascular system. Involvement of the CNS may manifest as excitation or depression with
dizziness, visual disturbances, anxiety, tremors followed by changes in consciousness, convulsions
and respiratory arrest. The excitatory signs preceding the depressive phase may be brief or
completely absent and drowsiness may be the first manifestation. Involvement of the cardiovascular system
is characterised by bradycardia, hypotension, myocardial depression, up to cardiac arrest.

Acute systemic toxicity
Systemic toxic reactions involve primarily the central nervous system (CNS) and the cardiovascular system (SCV). These reactions are caused by a high blood concentration of local anaesthetic
which may be caused by an accidental intravascular injection, overdose or exceptionally rapid absorption from a highly vascularized area (see Overdose). The CNS reactions are
similar for all local anaesthetics of the amidic type, while the cardiac reactions are more
dependent on the drug, both in quantitative and qualitative terms. The signs of CNS toxicity generally precede the toxic cardiovascular effects, except in cases where the patient
has undergone general anaesthesia or has been deeply sedated with drugs such as benzodiazepines
or barbiturates.

Toxicity affecting thecentral nervous systemmanifests gradually, with symptoms and signs of increasing severity. The first symptoms are paraesthesia in the circumoral region, numbness of the tongue, a feeling of
emptiness in the head, hyperacusis and tinnitus and visual disturbances. Dysarthria, muscle contractions and tremors are
more serious manifestations and precede the onset of generalised convulsions. These signs should not
be confused with erotic behaviours. Unconsciousness and convulsions may follow, which can last from a few seconds to several minutes. After the convulsions, due to increased muscle activity,
interference with normal breathing and lack of airway patency, hypoxemia and hypercapnia develop rapidly. In severe cases, apnoea may occur. Hyperkalemic acidosis,
hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.
Return of the patient to initial clinical conditions is consequent to redistribution of the local anaesthetic
from the central nervous system and to metabolism and excretion. Recovery may be rapid if large amounts of the drug have not been administered.
In severe cases, toxic effects on thecardiovascular systemmay occur, which are
generally preceded by signs of CNS toxicity.
In patients undergoing general anaesthesia or deeply sedated, the prodromal symptoms of the central nervous system may be absent. As a result of high systemic concentrations of local anaesthetics,
hypotension, bradycardia, arrhythmias and even cardiac arrest may occur. Cardiac arrest, in
rare cases, has occurred without the appearance of prodromal CNS symptoms.

Treatment of acute toxicity
Administration of the local anaesthetic must be stopped immediately if signs of
acute systemic toxicity appear and the symptoms of the central nervous system (convulsions, depression of the central nervous system) must be promptly treated with appropriate support of ventilation/respiration
and with the administration of anticonvulsants.
If circulatory arrest occurs, cardiopulmonary resuscitation must be performed immediately. It is vital to ensure optimal oxygenation, ventilation, support the
circulation and treat acidosis.
In case of cardiovascular depression (hypotension, bradycardia), treatment with intravenous fluids, vasoconstrictors, chronotropes and/or inotropes should be considered.