Lidocaine Aguettant 10 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Lidocaína Aguettant 10 mg/ml solution for injection in pre-filled syringe

Hydrochloride lidocaine

Read the entire leaflet carefully before you start using this medicine, as 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 Lidocaína Aguettant is and what it is used for
2. What you need to know before using Lidocaína Aguettant
3. How to use Lidocaína Aguettant
4. Possible adverse effects
5. How to store Lidocaína Aguettant
6. Contents of the pack and other information

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

Lidocaína Aguettant contains the active substance lidocaine hydrochloride.

Lidocaína Aguettant is a local anaesthetic. It is used to numb areas 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.

Lidocaína Aguettant 10 mg/ml can be used in adults and children over 2 years of age, or in adults only, depending on the intended use.

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 of the other components 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 conditions, such as conduction disorders or slow heart rate.
• if you have respiratory depression (difficulty breathing with slow, shallow breathing).
• if you are elderly or have generally poor 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, and the effect of the active substance in your body may be reduced.

Your doctor will take into account that there is an increased risk of nervous system adverse 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 10 mg/ml may be used in children over 2 years of age or only in adults, depending on the intended use.

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 conditions, including irregular heartbeats, 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 anesthesia (e.g., suxamethonium);
• sleeping pills and medicines that reduce consciousness (sedatives);
• medicines that increase the risk of seizures (e.g., tramadol, bupropion);
• medicines that reduce the risk of seizures (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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will then decide whether you should be given 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 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 using machines

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

Lidocaine Aguettant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml pre-filled syringe, which is essentially “sodium-free”.

This medicine contains 28 mg of sodium (main component of table/cooking salt) in each 10 ml pre-filled syringe. This corresponds to 1.4% of the maximum daily intake of 2 g of sodium recommended by the WHO for adults.

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 10 mg/ml must not be used in children under 2 years of age. Lidocaína Aguettant 10 mg/ml may be used in children over 2 years of age or only in adults, depending on the intended use.

Method of administration

Lidocaína Aguettant will be administered to you by intravenous injection (intravenous route) or by infiltration (intradérmic, subcutaneous, or submucosal route) in the 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 medicine 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 symptoms of overdose.

A small 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 immediately the person who administered the injection. 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 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
• 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 sensitivity 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 can 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lidocaine Aguettant 10 mg/ml solution for injection in a pre-filled syringe

The active substance is lidocaine hydrochloride.

• Each ml of the solution for injection contains 10 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).
• Each 5 ml pre-filled syringe contains 50 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate).
• Each 10 ml pre-filled syringe contains 100 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 10 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 Authorisation 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 revision 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 single-patient use only. Discard the pre-filled syringe after use. Do not reuse.

The contents of an unopened and undamaged container are sterile and must not be opened before use.

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

The medicinal product 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.