Lidocaine and adrenaline Aguettant

Package leaflet: Information for the patient

Lidocaine and Adrenaline Aguettant 10 mg/mL + 5 micrograms/mL injectable solution, 20 mg/mL + 5 micrograms/mL injectable solution

lidocaine hydrochloride/adrenaline
equivalent medicine
Please read all of this leaflet carefully before this medicine is administered to you 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

Lidocaine and Adrenaline Aguettant contains the active substance lidocaine hydrochloride, a local anaesthetic,
and the active substance adrenaline, which prolongs the effect of lidocaine. This medicinal product is used
to anaesthetize parts of the body during surgical procedures. It temporarily prevents the nerves
in the area where it is injected from transmitting pain signals to the brain and therefore prevents
the sensation of pain.
Lidocaine and Adrenaline Aguettant 10 mg/mL + 5 mcg/mL can be used in adults and children above 1 year of age.
Lidocaine and Adrenaline Aguettant 20 mg/mL + 5 mcg/mL can be used in adults and adolescents above 12 years of age.

2. What you need to know before being administered Lidocaine and Adrenaline Aguettant

Do not receive Lidocaine and Adrenaline Aguettant:

• if you are allergic to lidocaine, to other local anaesthetics 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 anaesthesia through the membranes surrounding the spinal cord (epidural anaesthesia) if you have very low blood pressure, for example due to shock following heart failure (cardiogenic shock) or significant reduction in blood circulation in the body following substantial blood or fluid loss (hypovolemic shock);
• for anaesthetizing fingers, toes, nose, ears, or penis.

Warnings and precautions
Talk to your doctor or nurse before receiving Lidocaine and Adrenaline Aguettant:

• if you have heart problems, including electrical conduction disorders, irregular or slow heartbeat (heart block), or chest pain (angina);
• if you are elderly or in a generally weakened condition;
• if you have severe high blood pressure or untreated high blood pressure;
• if you suffer from porphyria (a disorder affecting the production of red blood cell pigments);
• if liver or kidney function is severely impaired;
• if you have an overactive thyroid gland;
• if you have diabetes;
• if you have reduced blood supply to the brain;
• if you were previously treated with a local anaesthetic and did not respond well at that time;
• if you are being treated with certain medicines for heart rhythm disorders, such as amiodarone.

Children and adolescents
Lidocaine and Adrenaline Aguettant 10 mg/mL + 5 mcg/mL must not be used in children under 1 year of age.
Lidocaine and Adrenaline Aguettant 20 mg/mL + 5 mcg/mL must not be used in adolescents under 12 years of age.

Other medicines and Lidocaine and Adrenaline Aguettant
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The following medicines may affect the action of Lidocaine and Adrenaline Aguettant.
In particular, inform your doctor if you are taking any of the following:

• medicines used to treat heart conditions, including irregular heartbeat, high blood pressure, 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 anaesthesia (e.g. suxamethonium);
• medicines that reduce consciousness, such as sleeping pills and medicines for anxiety (sedatives);
• tricyclic antidepressants (medicines used to treat depression) or ergotamine, as these may cause persistent high blood pressure;
• medicines that increase the risk of seizures or convulsions (e.g. tramadol, bupropion);
• medicines that reduce the risk of seizures or 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 (antibiotic);
• medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine, or primidone);
• fluvoxamine, a medicine used to treat mental disorders;
• other anaesthetics, including local anaesthetics;
• diuretics ("water pills" to increase urination) (acetazolamide, loop diuretics, or thiazide diuretics);
• inhaled general anaesthetics, such as halothane, as these may cause severe cardiac arrhythmias;
• antipsychotic medicines (e.g. phenothiazines, butyrophenones); as they may reduce the effect of adrenaline on blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before receiving this medicine.

Pregnancy
Lidocaine crosses the placenta and reaches the fetus. However, there is no evidence that lidocaine causes harmful effects on the fetus, although the risk is not entirely known.
Adrenaline may potentially reduce uterine blood flow and interfere with contractions during labour, especially following accidental injection into the mother's blood vessels.
Your doctor will assess the benefits versus the risks of using this medicine for short-term treatment during pregnancy. If the medicine is used in the cervix, your doctor will closely monitor the baby's heart rate.

Breastfeeding
Lidocaine and adrenaline pass into breast milk, but it is unlikely they will affect breastfed infants. However, when deciding whether you can breastfeed, your doctor will evaluate your need for treatment and the benefits of breastfeeding against the potential risks to the infant.

Driving and using machines
This medicine may affect your ability to drive or operate machinery. After receiving this medicine, your motor skills and mobility may be impaired.
Do not drive or operate machinery until these effects have worn off.

For athletes: Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Lidocaine and Adrenaline Aguettant contains sodium and sodium metabisulfite (E223)
Lidocaine and Adrenaline Aguettant contains 2.48 mg of sodium (the main component of table salt) per mL. This corresponds to 1.24% of the maximum recommended daily dietary intake of sodium for an adult.
The presence of sodium metabisulfite may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm.

3. How Lidocaine and Adrenaline Aguettant is administered to you

This medicine will be administered to you by a doctor or a nurse, who will decide the correct dose based on the type of anaesthesia you require, the area to be anaesthetized, and the duration of anaesthesia needed. The dose will also depend on your weight, age, and physical condition. You will be given the lowest possible concentration and the smallest dose necessary to achieve the desired effect.
This medicine will be administered by injection. The part of the body where it will be used depends on the reason for which this medicine is being administered to you.
Use in children and adolescents
Lidocaine and Adrenaline Aguettant 10 mg/mL + 5 mcg/mL must not be used in children under 1 year of age.
Lidocaine and Adrenaline Aguettant 20 mg/mL + 5 mcg/mL must not be used in adolescents under 12 years of age due to safety concerns.
If you are given more Lidocaine and Adrenaline Aguettant than you should
Since this medicine is administered by a trained healthcare professional, it is unlikely that you will receive an excessive dose.
However, if you think you have been given too much of the medicine, or if you start experiencing dizziness or lightheadedness, headache, numbness of the tongue, ringing in the ears, nausea, vomiting, or shivering, you must immediately inform the person who administered the injection. The doctor will know how to manage these symptoms and, if necessary, will provide the required treatment.
If you have any doubts about the use of this medicine, consult 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 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, numbness, burning, itching or pins and needles sensation (paraesthesia)
• loss of consciousness
• slow heartbeat
• low or high blood pressure
• vomiting

Uncommon (may affect up to 1 in 100 people)

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

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

• altered sensation or muscle weakness (neuropathy)
• seizures (convulsive fits)
• partial paralysis
• persistent anaesthesia
• headache accompanied by ringing or buzzing in the ears (tinnitus) and abnormal sensitivity to light (photophobia)
• hearing loss (deafness)
• damage to cranial nerves
• drooping of the eyelid(s) associated with pupil constriction and, sometimes, 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 heartbeat
• reduced heart function, cardiac arrest (heart suddenly stops)
• double vision
• slow or interrupted 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, shortness of breath and fatigue due to abnormal levels of methaemoglobin (a form of haemoglobin with reduced oxygen-binding capacity) in the blood (methaemoglobinaemia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lidocaine and Adrenaline Aguettant

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Keep the vial in the outer carton to protect the medicine from light.
This medicine may be stored at temperatures not exceeding 25 °C for a maximum period of 3 months. In any case, once removed from refrigerated storage conditions, the medicine must be discarded after 3 months.
After opening, the medicine should be used immediately. Any unused solution must be disposed of.
Do not use this medicine if you notice any visible signs of deterioration. Use only a clear, colourless solution without particles or precipitates.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What Lidocaina e Adrenalina Aguettant contains

• The active substances are lidocaine hydrochloride and adrenaline.
  Lidocaina e Adrenalina Aguettant 10 mg/mL + 5 microgrammi/mL: Each mL of injectable solution contains lidocaine hydrochloride monohydrate equivalent to 10 mg of lidocaine hydrochloride and adrenaline (epinephrine) tartrate equivalent to 5 micrograms of adrenaline (epinephrine). Each 10 mL vial contains lidocaine hydrochloride monohydrate equivalent to 100 mg of lidocaine hydrochloride and adrenaline (epinephrine) tartrate equivalent to 50 micrograms of adrenaline (epinephrine).

Lidocaina e Adrenalina Aguettant 20 mg/mL + 5 microgrammi/mL
Each mL of injectable solution contains lidocaine hydrochloride monohydrate equivalent to 20 mg of lidocaine hydrochloride and adrenaline (epinephrine) tartrate equivalent to 5 micrograms of adrenaline (epinephrine).
Each 10 mL vial contains lidocaine hydrochloride monohydrate equivalent to 200 mg of lidocaine hydrochloride and adrenaline (epinephrine) tartrate equivalent to 50 micrograms of adrenaline (epinephrine).

• The other components are sodium chloride, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), sodium metabisulfite (E223), water for injections (see section 2 “Lidocaina e Adrenalina Aguettant contains sodium and sodium metabisulfite (E223)”).

Description of the appearance of Lidocaina e Adrenalina Aguettant and pack contents
This medicine is a clear, colourless aqueous injectable solution (injection), practically free from visible particles. The solution is contained in a colourless glass vial filled with 10 mL. Each pack contains 10 vials.

Marketing Authorisation Holder and Manufacturer
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer
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

This medicine is authorised in the Member States of the European Economic Area under the following names:
Lidocain / Adrenalin Aguettant
BE, LU, NL: Lidocaïne/Adrenaline Aguettant
DK, FI, IS, NO, SE: Lidokain/Adrenalin Aguettant
Lidocaína/Adrenalina Aguettant
IT: Lidocaina e Adrenalina Aguettant
IE: Lidocaine/Adrenaline (Epinephrine)