Prospecto: Information for the Patient

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

Lidocaína hydrochloride

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

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

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

2.What you need to know before starting to use Lidocaína Aguettant

3.How to use Lidocaína Aguettant

4.Possible adverse effects

5.Storage of Lidocaína Aguettant

6.Contents of the package and additional information

Lidocaína Aguettant contains the active ingredient lidocaine hydrochloride.

Lidocaína Aguettant is a local anesthetic. It is used to numb parts of the body during surgical procedures. It prevents nerves from transmitting pain messages to the brain and thus prevents pain from being felt.

No use Lidocaína Aguettant:

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

Warnings and Precautions

Consult your doctor, pharmacist or nurse before Lidocaína Aguettant is administered to you:

• if you have epilepsy. Your doctor will closely monitor the manifestations of symptoms.
• if you have kidney or liver disease.
• if you have a muscle weakness disease (myasthenia gravis).
• if you have heart problems, such as conduction disorders, slow heartbeats.
• if you have respiratory depression (difficulty breathing with slow and shallow breathing).
• if you are an elderly person or have a general state of poor health.
• if you have bleeding disorders or are receiving treatment for them.

In addition, your doctor knows that an injection of this medication in inflamed tissue may cause an increase in the absorption of the active ingredient by the circulation and the effect of the active ingredient in your body will be weakened.

Your doctor will take into account that there is a higher risk of adverse effects on the nervous system if this medication is administered in the head and neck region.

Children and Adolescents

Lidocaína Aguettant 10 mg/ml should not be used in children under 2 years.

Use of Lidocaína Aguettant with other Medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to use any other medication. Lidocaína Aguettant may affect other medications or be affected by them.

In particular, inform your doctor if you are taking any of the following:

• medications used to treat high blood pressure, such as diuretics;
• medications used to treat heart problems, including irregular heartbeats, such as beta-blockers (e.g., metoprolol, propranolol) or calcium channel blockers (e.g., amiodarone);
• medications that constrict blood vessels (vasoconstrictors, e.g., epinephrine, norepinephrine);
• medications used to relax muscles during general anesthesia (e.g., suxamethonium);
• somnifacients and medications that reduce the level of consciousness (sedatives);
• medications that increase the risk of having epileptic seizures and convulsions (e.g., tramadol, bupropion);
• medications that reduce the risk of having epileptic seizures and convulsions (e.g., diazepam);
• cimetidine, a medication used to treat heartburn;
• antiviral medications (e.g., ritonavir), macrolide antibiotics (e.g., erythromycin) or antifungal medications (e.g., ketoconazole, itraconazole);
• ciprofloxacin (antibiotics);
• medications used to treat epilepsy (phenobarbital, phenytoin, carbamazepine or primidone);
• fluvoxamine, a medication used in the treatment of mental illness;
• medications used to reduce intraocular pressure (e.g., acetazolamide);
• other anesthetics, including local anesthetics.

Pregnancy and Lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will then decide whether to administer this medication to you.

Pregnancy

Your doctor will only administer this medication to you while you are pregnant if they consider it necessary. The dose should be as low as possible.

Lactation

Lidocaine passes into human breast milk in small amounts. The use of lidocaine at recommended doses is unlikely to affect the infant. Therefore, breastfeeding can continue during the use of lidocaine.

Driving and Operating Machines

Lidocaína Aguettant may affect your ability to drive or operate machines. Ask your doctor when it would be safe to drive or operate machines.

Lidocaína Aguettant contains sodium

This medication contains 32 mg of sodium (main component of table salt/cooking salt) in each syringe. This is equivalent to 1.6% of the maximum daily intake of 2 mg of sodium recommended by the WHO for an adult.

The administration will be carried out by a healthcare professional with the necessary training and experience.

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

Use in children and adolescents

Lidocaína Aguettant 10 mg/ml should not be used in children under 2 years old.

Administration method

Lidocaína Aguettant will be administered as an infiltration injection (intradermal, subcutaneous, or submucosal) in the areas surrounding the peripheral nerves.

If you use more Lidocaína Aguettant than you should

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

If you develop symptoms of overdose or not, it depends on the level of medication present in your blood. The more lidocaína there is in your blood and the faster it is administered, you may experience symptoms of an overdose more frequently and intensely.

A small overdose mainly affects your central nervous system. The adverse effects that occur will disappear in most cases after interrupting the administration of lidocaína.

Regardless of this, if you consider that you have received too much of the medication, or you begin to experience dizziness or vertigo, tongue numbness, ear buzzing, vomiting, or chills, you must inform the person who administered the injection immediately. Your doctor will know how to control these symptoms and will administer any necessary treatment.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Some side effects can be serious. Seek immediate medical help if you experience an allergic reaction that causes:

• swelling of hands, feet, face, lips, mouth, tongue, or throat
• difficulty breathing
• hives with itching
• fever
• drop in blood pressure and shock.

These side effects are rare (may affect up to 1 in 1000 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, numbness, burning, stinging, or prickling sensation (paresthesia)
• loss of consciousness
• pain or chills due to injections
• slow heart rate
• low or high blood pressure
• vomiting.

Rare (may affect up to 1 in 1000 people)

• neuropathy (changes in sensations or muscle weakness)
• seizures
• partial paralysis
• headache accompanied by a buzzing or crackling sound in the ears (tinnitus) and abnormal intolerance to light (photophobia)
• hearing loss (deafness)
• brain nerve damage
• drooping eyelids combined with pupil constriction and, in some cases, decreased sweating (Horner's syndrome). This occurs after application in the head/neck region.
• asymmetric sweating and shortness of breath in the upper chest, neck, or face (cholinergic urticaria)
• irregular heartbeats
• cardiac arrest
• double vision
• slow or interrupted breathing
• hives or urticaria.

Unknown frequency (cannot be estimated from available data)

• blue discoloration of the skin, headaches, difficulty breathing, and fatigue due to abnormal levels of methemoglobin (a form of hemoglobin with reduced oxygen-carrying capacity) in the blood (methemoglobinemia)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label, the cartridge blister, and the cardboard box of the syringe. The expiration date is the last day of the month indicated.

Keep the preloaded syringe in the closed blister pack until use. Do not freeze.

Once opened, the medication must be used immediately.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of Lidocaína Aguettant 10mg/ml injectable solution in pre-filled syringe

The active ingredient is lidocaína hydrochloride.

• Each ml of the injectable solution contains 10mg of lidocaína hydrochloride (as lidocaína hydrochloride monohydrate).
• Each pre-filled syringe of 5ml contains 50mg of lidocaína hydrochloride (as lidocaína hydrochloride monohydrate).
• Each pre-filled syringe of 10ml contains 100mg of lidocaína hydrochloride (as lidocaína hydrochloride monohydrate).

The other components are: sodium chloride, sodium hydroxide, concentrated hydrochloric acid (for pH adjustment), water for injection

Appearance of the product and contents of the package

Lidocaína Aguettant10mg/ml injectable solution in pre-filled syringeis a colourless transparent injectable solution (injection). Lidocaína Aguettant is available in a pre-filled syringe of polypropylene of 5 or 10ml, packaged individually in a transparent blister. Carton box of 1 or 10 pre-filled syringes. Some package sizes may only be marketed.

Marketing Authorization Holder

Laboratoire Aguettant

1 rue Alexander Fleming

69007 Lyon

France

Responsible for manufacturing

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

Last review date of this leaflet: 06/2024.

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This information is intended solely for healthcare professionals:

Prepare the pre-filled syringe carefully as indicated below

The pre-filled syringe must be used on a single patient. Dispose of the pre-filled syringe after use. Do not reuse it.

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

It should be visually inspected for the presence of particles or colour changes before administration. Only use the solution when it is transparent, colourless and no particles or precipitates are observed.

The medicine should not be used if the tamper-evident safety seal of the syringe is broken.

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

When handled using an aseptic method, this medicine can be placed in a sterile area.

6) Connect the pre-filled syringe to the access device or needle. Push the plunger slowly to inject the required volume.