Lidocaine Aguettant

Package leaflet: Information for the patient

Lidocaine Aguettant 10 mg/ml injectable solution in pre-filled syringe, 20 mg/ml injectable solution in pre-filled syringe

Lidocaine hydrochloride
Read this leaflet carefully before using this medicine because it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Lidocaine Aguettant is and what it is used for
2. What you need to know before using Lidocaine Aguettant
3. How to use Lidocaine Aguettant
4. Possible side effects
5. How to store Lidocaine Aguettant
6. Contents of the pack and other information

1. What Lidocaine Aguettant is and what it is used for

Lidocaine Aguettant contains the active substance lidocaine hydrochloride.
Lidocaine Aguettant is a local anaesthetic. It is used to anaesthetize parts of the body during surgical procedures. It prevents nerves from transmitting pain signals to the brain and therefore prevents the sensation of pain.

2. What you need to know before using Lidocaine Aguettant

Do not use Lidocaine Aguettant:

• if you are allergic to lidocaine, to amide-type local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lidocaine Aguettant:

• if you suffer from epilepsy. Your doctor will closely monitor you for the appearance of any symptoms.
• if you have kidney or liver disease.
• if you have a condition causing muscle weakness (myasthenia gravis).
• if you have heart problems, including conduction disorders or slow heart rate.
• if you have respiratory depression (difficulty breathing, with slow and shallow breathing).
• if you are elderly or in poor general health.
• if you have, or are being treated for, disorders affecting blood clotting.

Furthermore, your doctor is aware that injecting this medicine into inflamed tissue may increase absorption of the active substance into the bloodstream, thereby reducing the local effect of the active substance.
Your doctor will assess the potential increased risk of nervous system-related side effects when this medicine is administered in the head and neck area.

Children and adolescents
Lidocaine Aguettant 10 mg/ml must not be used in children under 2 years of age.
Lidocaine Aguettant 20 mg/ml must not be used in children and adolescents under 18 years of age.

Other medicines and Lidocaine Aguettant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Lidocaine Aguettant may affect, or be affected by, other medicines.
In particular, inform your doctor if you are taking any of the following:

• medicines used to treat high blood pressure, such as diuretics;
• medicines used to treat heart conditions, including irregular heartbeat, such as beta-blockers (e.g. metoprolol, propranolol) or calcium channel blockers (e.g. amiodarone);
• medicines that constrict blood vessels (vasoconstrictors, e.g. epinephrine, norepinephrine);
• medicines used to relax muscles during general anaesthesia (e.g. suxamethonium);
• sleeping pills and medicines that reduce consciousness levels (sedatives);
• medicines that increase the risk of seizures or convulsive episodes (e.g. tramadol, bupropion);
• medicines that reduce the risk of seizures or convulsive episodes (e.g. diazepam);
• cimetidine, a medicine used to treat heartburn;
• antiviral medicines (e.g. ritonavir), macrolide antibiotics (e.g. erythromycin), or antifungals (e.g. ketoconazole, itraconazole);
• ciprofloxacin (an antibiotic);
• medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine, or primidone);
• fluvoxamine, a medicine used in the treatment of mental disorders;
• medicines used to reduce intraocular pressure (e.g. acetazolamide);
• other anaesthetics, including local anaesthetics.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you may use this medicine.
Pregnancy
Your doctor will administer this medicine during pregnancy only if considered necessary. The dose should be as low as possible.
Breastfeeding
Lidocaine passes into breast milk in small amounts. Use of lidocaine at recommended doses is not expected to have effects on the breastfed newborn. Breastfeeding can therefore be continued during treatment with lidocaine.

Driving and using machines
Lidocaine Aguettant may affect your ability to drive or operate machinery. Consult your doctor to find out when it is safe for you to drive or use machines.

Lidocaine Aguettant contains sodium
Lidocaine Aguettant 10 mg/ml
This medicine contains 32 mg of sodium (the main component of table salt) per syringe. This corresponds to 1.6% of the maximum daily dietary intake recommended for an adult.
Lidocaine Aguettant 20 mg/ml
This medicine contains 23 mg of sodium per syringe. This corresponds to 1.2% of the maximum daily dietary intake recommended for an adult.

3. How to use Lidocaine Aguettant

Administration will be performed by a healthcare professional with adequate training and
experience in this field.
The doctor will determine the most appropriate dosage for your specific condition based on
your age and medical status, as well as the injection site, route of administration, and
response to the injection.
Use in children and adolescents
Lidocaine Aguettant 10 mg/ml must not be used in children under 2 years of age.
Lidocaine Aguettant 20 mg/ml must not be used in children and adolescents under 18 years
of age.
Method of administration
Lidocaine Aguettant will be administered by infiltration injection (intradermal, subcutaneous,
or submucosal use) near peripheral nerves.
If you use more Lidocaine Aguettant than you should
Since this medicine is administered by an experienced healthcare professional, it is unlikely
that you will receive an excessive dose of Lidocaine Aguettant.
Whether or not you experience symptoms of overdose depends on the level of this medicine
in your blood. The higher the amount of lidocaine in your blood and the faster it is absorbed,
the more frequent and severe the symptoms of overdose may be.
A minor overdose mainly affects the central nervous system. In most cases, adverse effects
resolve after discontinuation of lidocaine administration.
However, if you think you have been given too much of the medicine, or if you start to feel
dizziness or lightheadedness, numbness of the tongue, ringing in the ears, vomiting, or
chills, you must inform immediately the person who administered the injection. The doctor
will know how to manage these symptoms and, if necessary, will provide you with the
required treatment.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious. Seek immediate medical help if you experience an allergic reaction causing:

• swelling of the hands, feet, face, lips, mouth, tongue or throat
• difficulty breathing
• itchy rash
• fever
• drop in blood pressure and shock

These side effects are rare (may affect up to 1 in 1,000 people).

Other side effects may include:
Very common (may affect more than 1 in 10 people)

• nausea

Common (may affect up to 1 in 10 people)

• tingling, burning, itching or numbness sensation (paraesthesia)
• loss of consciousness
• pain or chills caused by injections
• slow heartbeat
• low or high blood pressure
• vomiting

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

• altered sensation or muscle weakness (neuropathy)
• seizures (convulsive fits)
• partial paralysis
• headache associated with ringing or buzzing in the ears (tinnitus) and abnormal sensitivity to light (photophobia)
• hearing loss (deafness)
• damage to cranial nerves
• drooping eyelid/s accompanied by pupil constriction and, occasionally, reduced sweating (Horner’s syndrome). This occurs after administration in the head/neck region
• asymmetric sweating and hot flushes affecting the upper chest, neck or face (Harlequin syndrome)
• irregular heartbeat
• cardiac arrest
• double vision
• slow or interrupted breathing
• skin rash or hives

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lidocaine Aguettant

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the syringe label, on the blister, and on the carton. The expiry date refers to the last day of that month.
Store the pre-filled syringe in its original sealed blister until the time of use.
Do not freeze. After opening, the medicine must be used immediately.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lidocaine Aguettant contains
The active substance is lidocaine hydrochloride.
Lidocaine Aguettant 10 mg/ml:

• Each ml of injectable solution contains 10 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).
• Each 10 ml pre-filled syringe contains 100 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate). Lidocaine Aguettant 20 mg/ml:
• Each ml of injectable solution contains 20 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).
• Each 10 ml pre-filled syringe contains 200 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).

The other components are: sodium chloride, sodium hydroxide, concentrated hydrochloric acid (for pH adjustment) and water for injections.
Description of the appearance of Lidocaine Aguettant and pack contents
Lidocaine Aguettant is a clear, colourless injectable solution (for injection). Lidocaine Aguettant is available in a 10 ml pre-filled syringe made of polypropylene, individually packaged in a transparent blister. Carton box containing 1 or 10 pre-filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

The following information is intended for healthcare professionals only:

Prepare the pre-filled syringe carefully as follows
The pre-filled syringe is for single patient use only. Discard the pre-filled syringe after use. Do not reuse.
The contents of an unopened and undamaged blister are sterile and should be opened only immediately before use.
Visually inspect the medicinal product for the presence of particles and discoloration prior to administration. Use only clear, colorless solutions without particles or precipitates.
The medicinal product must not be used if the tamper-evident seal on the syringe is broken.
The outer surface of the pre-filled syringe is sterile until the blister is opened.
If handled under aseptic conditions, this medicinal product can be used in a sterile environment.

1. Remove the pre-filled syringe from the sterile blister.

2. Push the plunger of the syringe to dislodge the rubber stopper.
   The sterilization process may have caused the stopper to adhere to the barrel of the pre-filled syringe.

3. Twist the terminal cap to break the seal. Do not touch the exposed Luer connection to avoid contamination.

4. Check that the seal at the tip of the pre-filled syringe has been completely removed. If not, replace the cap and twist again.

5. Expel air by gently pressing the plunger.
6. Connect the pre-filled syringe to the access device or needle. Push the plunger slowly to inject the required volume.