Lidocaine Aguettant 20 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

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

Hydrochloride lidocaine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 numb parts of the body during surgical procedures. It temporarily prevents nerves from sending pain signals to the brain in the area where it has been injected.

Lidocaine Aguettant 20 mg/ml can be used in adults.

2. What you need to know before using Lidocaine Aguettant

Do not use Lidocaine Aguettant:

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

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before being administered Lidocaine Aguettant:
• if you have epilepsy. Your doctor will closely monitor for symptoms.
• if you have kidney or liver disease.
• if you have a condition causing muscle weakness (myasthenia gravis).
• if you have heart disorders, such as conduction disorders or slow heart rate.
• if you have respiratory depression (difficulty breathing with slow and shallow breathing).
• if you are elderly or have poor general health.
• if you have bleeding disorders or are receiving treatment for them.

Additionally, your doctor knows that injecting this medicine into inflamed tissue may increase absorption of the active substance into the circulation, thereby weakening its effect in your body.

Your doctor will take into account that there is an increased risk of nervous system adverse effects if this medicine is administered in the head and neck area.

Children and adolescents

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

Use of Lidocaine Aguettant with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Lidocaine Aguettant may affect other medicines or be affected by them.

Specifically, 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 disorders, including irregular heartbeats, such as beta-blockers (e.g., metoprolol, propranolol) or calcium antagonists (e.g., amiodarone);
• medicines that constrict blood vessels (vasoconstrictors, e.g., epinephrine, norepinephrine);
• medicines used to relax muscles during general anesthesia (e.g., suxamethonium);
• hypnotics and medicines that reduce consciousness levels (sedatives);
• medicines that increase the risk of seizures and convulsions (e.g., tramadol, bupropion);
• medicines that reduce the risk of seizures and convulsions (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 (antibiotics);
• medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine, or primidone);
• fluvoxamine, a medicine used in the treatment of mental illness;
• medicines used to reduce intraocular pressure (e.g., acetazolamide);
• other anesthetics, including local anesthetics.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will then decide whether this medicine should be administered to you.

Pregnancy

Your doctor will only administer this medicine during pregnancy if considered necessary. The dose should be as low as possible.

Breastfeeding

Lidocaine passes into human breast milk in small amounts. Use of lidocaine at recommended doses is unlikely to affect the breastfed infant. Therefore, breastfeeding can be continued during treatment with lidocaine.

Driving and use of machinery

Lidocaine Aguettant may affect your ability to drive or operate machinery. Ask your doctor when it would be safe to drive or use machinery.

Lidocaine Aguettant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml or 10 ml pre-filled syringe, i.e., essentially "sodium-free".

3. How to use Lidocaína Aguettant

Administration will be performed by a healthcare professional with appropriate training and experience.

Your doctor will determine the most suitable dose for your particular case, based on your age and health status, as well as the injection site, the method used, and your response to the injection.

Use in children and adolescents

Lidocaína Aguettant 20 mg/ml should not be used in children and adolescents under 18 years of age.

Route of administration

Lidocaína Aguettant will be administered to you by intravenous injection (intravenous route) or by infiltration (intradermal, subcutaneous, or submucosal route) into areas surrounding peripheral nerves.

If you use more Lidocaína Aguettant than you should

Since this medicine is administered by a trained healthcare professional, it is unlikely that you will receive too much Lidocaína Aguettant.

If you develop symptoms of overdose or not depends on the level of the drug present in your blood. The higher the amount of lidocaine in your blood and the faster it is administered, the more frequently and intensely you may experience overdose symptoms.

A minor overdose mainly affects your central nervous system. Adverse effects that occur will disappear in most cases after discontinuation of lidocaine administration.

Nevertheless, if you think you have received too much of the medicine, or if you begin to experience dizziness or lightheadedness, tongue numbness, tinnitus, vomiting, or chills, you must inform the person who administered the injection immediately. The doctor will know how to manage these symptoms and will provide any necessary treatment.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious. Seek immediate medical help if you experience an allergic reaction causing:

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

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

Other adverse effects may include:

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

• nausea

Common (may affect up to 1 in 10 people)

• tingling, prickling, burning, stabbing sensations or numbness (paraesthesia)
• loss of consciousness
• pain or chills due to injections
• slow heart rate
• low blood pressure or high blood pressure
• vomiting

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

• changes in sensation or muscle weakness (neuropathy)
• seizures
• partial paralysis
• headache accompanied by ringing or crackling sounds in the ears (tinnitus) and abnormal intolerance to light (photophobia)
• hearing loss (deafness)
• damage to cranial nerves
• drooping eyelids combined with pupil constriction and, occasionally, reduced sweating (Horner’s syndrome). This occurs after administration in the head/neck region.
• asymmetric sweating and flushing of the upper chest, neck or face (Harlequin syndrome)
• irregular heartbeats
• cardiac arrest
• double vision
• slowed or interrupted breathing
• rash or hives

Frequency not known (cannot be estimated from available data)

• bluish discoloration of the skin, headache, difficulty breathing and fatigue due to abnormal levels of methaemoglobin (a form of haemoglobin with reduced oxygen-binding capacity) in the blood (methaemoglobinaemia)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label, blister pack, and cardboard box of the syringe. The expiry date refers to the last day of the month indicated.

Keep the pre-filled syringe in its sealed blister pack until ready for use. Do not freeze.

Once opened, the medicine should be used immediately.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lidocaine Aguettant 20 mg/ml solution for injection in a pre-filled syringe

The active substance is lidocaine hydrochloride.

• Each ml of the solution for injection contains 20 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).
• Each 5 ml pre-filled syringe contains 100 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), water for injections.

Appearance of the product and contents of the pack

Lidocaine Aguettant 20 mg/ml solution for injection in a pre-filled syringe is a clear, colourless, injectable solution (injection). Lidocaine Aguettant is available in a 5 ml or 10 ml polypropylene pre-filled syringe, graduated at 0.5 ml intervals from 0 to 10 ml, individually packed in a transparent blister. Carton pack containing 1 or 10 pre-filled syringes. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer

Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Laboratoire Aguettant
Lieu-Dit Chantecaille
07340 Champagne
France

Local representative:

Aguettant Ibérica S.L.
Parc Científic de Barcelona
Baldiri Reixac, 4-8 (Torre I)
08028 Barcelona
Spain

Date of the most recent review of this leaflet: 12/2025

This information is intended for healthcare professionals only:

Prepare the pre-filled syringe carefully as described below

The pre-filled syringe is intended for use in a single patient only. Discard the pre-filled syringe after use. Do not reuse.

The contents of an unopened and undamaged package are sterile and must not be opened until the time of use.

The medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if it is clear, colourless, and no particles or precipitates are observed.

The medicine must not be used if the syringe's tamper-evident seal is broken.

The outer surface of the pre-filled syringe is sterile until the blister is opened.

When handled using an aseptic technique, this medicinal product may be placed in a sterile area.