LIDOCAINE / EPINEPHRINE AGUETTANT 20 mg/mL + 0.005 mg/mL INJECTABLE SOLUTION

2. What you need to know before you use Lidocaine/Adrenaline Aguettant

Do not use Lidocaine/Adrenaline Aguettant:

• if you are allergic to lidocaine, to other local anesthetics similar to lidocaine, to adrenaline or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfite.
• for anesthesia through the membranes surrounding the spinal cord (epidural anesthesia) if you have very low blood pressure, for example, in case of shock after heart failure (cardiogenic shock) or a significant reduction in blood circulation in the body after significant blood or fluid loss (hypovolemic shock).
• to anesthetize fingers of the hands, feet, nose, ears, or penis.

Warnings and precautions

Consult your doctor or nurse before starting to use Lidocaine/Adrenaline Aguettant:

• if you have heart disorders, including disorders in the electrical conduction system of the heart, slow or irregular heartbeat (heart block) and chest pain (angina)
• if you are an elderly patient or are in a state of general weakness
• if you have severe or untreated hypertension
• if you have porphyria (a disease based on a disorder in the production of the pigment of red blood cells)
• if you have severely reduced liver or kidney function
• if you have an overactive thyroid gland
• if you have diabetes
• if you have reduced blood supply to the brain
• if you have been treated with a local anesthetic before and did not respond well at that time
• if you are being treated with certain medications for heart rhythm disorders, such as amiodarone.

Children and adolescents

Lidocaine/Adrenaline Aguettant 10 mg/ml + 0.005 mg/ml must not be used in children under 1 year of age.

Lidocaine/Adrenaline Aguettant 20 mg/ml + 0.005 mg/ml must not be used in children under 12 years of age.

Other medicines and Lidocaine/Adrenaline Aguettant

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

The following medicines may influence the effect of Lidocaine/Adrenaline Aguettant.

In particular, tell your doctor if you are using any of the following:

• medicines used to treat heart disorders, including irregular heartbeats, hypertension, and chest pain (angina), such as beta-blockers (e.g., metoprolol, propranolol) or calcium channel blockers (e.g., amiodarone);
• medicines used to relax muscles during general anesthesia (e.g., suxamethonium);
• medicines that reduce your level of consciousness, such as sleeping pills and medicines to treat anxiety (sedatives);
• tricyclic antidepressants (medicines to treat depression) or ergotamine, as this may cause persistent hypertension;
• 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 stomach acidity;
• antiviral medicines (e.g., ritonavir), macrolide antibiotics (e.g., erythromycin), or antifungal medicines (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 illnesses;
• other anesthetics, including local anesthetics;
• diuretics (medicines to eliminate fluids) (acetazolamide, loop diuretics, or thiazides);
• general anesthesia by inhalation, such as halothane, as this may cause severe cardiac arrhythmias.
• antipsychotic medicines (e.g., phenothiazines, butyrophenones), as they reduce the effect of adrenaline on blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Pregnancy

Lidocaine crosses the placenta and reaches the fetus. However, there is no evidence that lidocaine causes negative effects on the fetus, although the risk is not fully known.

Adrenaline may potentially reduce uterine blood flow and make contractions during childbirth more difficult, especially after an accidental injection into the mother's blood vessels.

Your doctor will weigh the benefits against the risks of using this medicine for short-term treatment during pregnancy. If this medicine is used in the cervix, the doctor will closely monitor the baby's heart rate.

Breastfeeding

Lidocaine and adrenaline pass into breast milk, but it is unlikely to have any effect on breastfed babies. However, when deciding whether you can breastfeed, your doctor will weigh your need for treatment and the benefits of breastfeeding against the potential risks to the baby.

Driving and using machines

This medicine may affect your ability to drive or use machines. After receiving this medicine, you may experience an impact on your motor skills and mobility. Do not drive or use machines until these effects have disappeared.

Lidocaine/Adrenaline Aguettant contains sodium and sodium metabisulfite (E223).

This medicine contains 2.48 mg of sodium (main component of table/cooking salt) per ml. This is equivalent to 1.24% of the maximum recommended daily intake of sodium for an adult.

The presence of sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Lidocaine/Adrenaline Aguettant

This medicine will be administered to you by your doctor or nurse, who will decide on the correct dose based on the type of anesthesia you need, the area to be anesthetized, and the required duration of anesthesia. It will also depend on your weight, age, and physical condition. You will be given the lowest concentration and the smallest dose possible to achieve the desired effect.

This medicine will be administered to you by injection. The part of the body where it will be used will depend on the reason why you are being given this medicine.

Use in children and adolescents

Lidocaine/Adrenaline Aguettant 10 mg/ml + 0.005 mg/ml must not be used in children under 1 year of age.

Lidocaine/Adrenaline Aguettant 20 mg/ml + 0.005 mg/ml must not be used in children under 12 years of age for safety reasons.

If you use more Lidocaine/Adrenaline Aguettant than you should

Since this medicine will be administered to you by a trained healthcare professional, it is unlikely that you will be given too much of this medicine.

However, if you think you have been given too much of this medicine or start to experience dizziness or drowsiness, headache, numbness of the tongue, ringing in the ears, nausea, vomiting, or chills, you should tell the person administering the injection immediately. Your doctor will know how to manage these symptoms and provide you with the necessary treatment.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious. Seek medical attention immediately if you have an allergic reaction that causes:

• swelling of hands, feet, face, lips, mouth, tongue, or throat
• difficulty breathing
• skin rash with itching
• fever
• low 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)

• feeling of tingling, numbness, burning, pricking, or stabbing (paresthesia)
• loss of consciousness
• slow heartbeat
• low or high blood pressure
• vomiting.

Uncommon(may affect up to 1 in 100 people)

• signs of toxicity in the central nervous system, such as tingling or numbness around the mouth, numbness of the tongue, increased sensitivity to sound, difficulty speaking

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

• changes in sensations or muscle weakness (neuropathy)
• seizures (fits)
• partial paralysis
• persistent anesthesia
• headache accompanied by a buzzing or clicking sound in your ears (tinnitus) and an abnormal intolerance to light (photophobia)
• hearing loss (deafness)
• damage to the nerves of the brain
• drooping of the eyelid(s), combined with constriction of your pupils and, sometimes, decreased sweating (Horner's syndrome). This may occur after application in the head/neck region.
• asymmetric sweating and flushing of the upper chest, neck, or face (Harlequin syndrome).
• irregular heartbeats
• reduced heart function, cardiac arrest (the heart stops suddenly)
• double vision
• slow or stopped breathing
• skin rash or hives
• swelling due to fluid accumulation.

Frequency not known(cannot be estimated from the available data)

• bluish discoloration of the skin, headache, difficulty breathing, and fatigue due to abnormal amounts of methemoglobin (a form of hemoglobin with reduced ability to bind oxygen) in the blood (methemoglobinemia).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidocaine/Adrenaline Aguettant

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 carton and on the label of the ampoule after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Keep the ampoule in the outer packaging to protect it from light.

This medicine may be stored at temperatures not exceeding 25°C for a maximum period of 3 months. In any case, once initially removed from refrigerated storage, the medicine must be discarded after 3 months.

Once opened, the medicine should be used immediately. Any unused solution should be discarded.

Do not use this medicine if you notice visible signs of deterioration. Only clear and colorless solutions, free from precipitated particles, should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lidocaine/Adrenaline Aguettant

• The active substances are lidocaine hydrochloride and epinephrine (adrenaline).

Lidocaine/Adrenaline Aguettant 10 mg/ml + 0.005 mg/ml:

Each ml of injectable solution contains lidocaine hydrochloride monohydrate equivalent to 10 mg of lidocaine hydrochloride and epinephrine (adrenaline) tartrate equivalent to 5 micrograms of epinephrine (adrenaline).

Each 10 ml ampoule contains lidocaine hydrochloride monohydrate equivalent to 100 mg of lidocaine hydrochloride and epinephrine (adrenaline) tartrate equivalent to 50 micrograms of epinephrine (adrenaline).

Lidocaine/Adrenaline Aguettant 20 mg/ml + 0.005 mg/ml:

Each ml of injectable solution contains lidocaine hydrochloride monohydrate equivalent to 20 mg of lidocaine hydrochloride and epinephrine (adrenaline) tartrate equivalent to 5 micrograms of epinephrine (adrenaline).

Each 10 ml ampoule contains lidocaine hydrochloride monohydrate equivalent to 200 mg of lidocaine hydrochloride and epinephrine (adrenaline) tartrate equivalent to 50 micrograms of epinephrine (adrenaline).

• The other ingredients are sodium chloride, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), sodium metabisulfite (E223), water for injections (see section "Lidocaine/Adrenaline Aguettant contains sodium and sodium metabisulfite (E223)").

Appearance and packaging

This medicine is a clear and colorless aqueous solution for injection, practically free from particles. The solution is contained in a 10 ml colorless glass ampoule. Each pack contains 10 ampoules.

Marketing authorization holder

Laboratoire Aguettant

1 rue Alexander Fleming

69007 Lyon

France

Manufacturers

Delpharm Tours

Rue Paul Langevin

37170 Chambray-lès-Tours

France

Delpharm Dijon

6 Boulevard de l’Europe

21800 Quetigny

France

Laboratoire Aguettant

1 Rue Alexander Fleming

69007 Lyon

France

Local representative:

AGUETTANT Ibérica S.L.

Phone: +34 93 403 37 80

This medicine is authorized in the Member States of the European Economic Area (EEA) under the following names:

AT, DE: Lidocain / Adrenalin Aguettant

BE, NL, LU: Lidocaïne/Adrenaline Aguettant

DK, FI, IS, NO, SE: Lidokain/Adrenalin Aguettant

IE: Lidocaine/Adrenaline (Epinephrine)

IT: Lidocaina e Adrenalina Aguettant

PT, ES: Lidocaína/Adrenalina Aguettant

Date of last revision of this leaflet 03/2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).