Lidocaine hydrochloride FisioPharma

Package leaflet: Information for the user

LIDOCAINE HYDROCHLORIDE FISIOPHARMA 10 mg/ml injection solution, 20 mg/ml injection solution

Lidocaine hydrochloride
Generic medicine
Read this leaflet carefully before using this medicine 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What LIDOCAINE HYDROCHLORIDE FISIOPHARMA is and what it is used for
2. What you need to know before using LIDOCAINE HYDROCHLORIDE FISIOPHARMA
3. How to use LIDOCAINE HYDROCHLORIDE FISIOPHARMA
4. Possible side effects
5. How to store LIDOCAINE HYDROCHLORIDE FISIOPHARMA
6. Contents of the pack and other information

1. What LIDOCAINE HYDROCHLORIDE FISIOPHARMA is and what it is used for

LIDOCAINE HYDROCHLORIDE FISIOPHARMA contains the active substance lidocaine hydrochloride, which belongs to a group of medicines called local anesthetics, that work by blocking sensitivity and pain in the area where they are applied.
LIDOCAINE HYDROCHLORIDE FISIOPHARMA is indicated to eliminate pain sensation:

• during dental procedures (extractions, tooth smoothing for crowns and bridges, cavity preparation, vital extirpations, abscess incisions, apicectomies);
• during minor skin procedures (e.g., removal of cysts);
• during procedures on the jaw.

2. What you need to know before using LIDOCAINE HYDROCHLORIDE FISIOPHARMA

Do not use LIDOCAINE HYDROCHLORIDE FISIOPHARMA

• if you are allergic to lidocaine, to other similar medicines (amide-type local anesthetics), or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant;
• if the patient is a child under 4 years of age.

Do not use LIDOCAINE HYDROCHLORIDE FISIOPHARMA for direct intravenous administration.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LIDOCAINE HYDROCHLORIDE FISIOPHARMA.
This medicine will be administered to you by a doctor or nurse in a medical facility equipped with the necessary equipment and medicines to manage emergencies. Serious adverse reactions, sometimes fatal, have rarely occurred after the use of this medicine, even in patients who previously did not show allergic reactions when using this medicine or other similar medicines.
Before administering this medicine, your doctor must check your blood circulation. Also, inform your doctor if you are taking other medicines or if you have previously experienced allergic reactions.
Your doctor will administer this medicine at the lowest possible dose that achieves the desired effect, using slow injections with continuous aspiration, avoiding direct injection into a vein.
During treatment with this medicine, your doctor will closely monitor you. Use LIDOCAINE HYDROCHLORIDE FISIOPHARMA with caution and inform your doctor if you have received another anesthetic less than 24 hours ago, as two maximum doses of this medicine must never be administered unless at least 24 hours have passed between administrations.
Administration of this medicine must be immediately stopped if you experience sensory disturbances (changes in consciousness) or drowsiness.
If this medicine is administered during dental procedures, keep in mind that you will temporarily lose mouth sensation; therefore, avoid chewing until sensation returns to normal.
Administration of LIDOCAINE HYDROCHLORIDE FISIOPHARMA should be performed cautiously when the tissue or area selected for injection is highly vascularized or shows signs of infection or inflammation.
Children and adolescents
LIDOCAINE HYDROCHLORIDE FISIOPHARMA must not be used in children under 4 years of age.
Other medicines and LIDOCAINE HYDROCHLORIDE FISIOPHARMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use LIDOCAINE HYDROCHLORIDE FISIOPHARMA with caution and inform your doctor if you are taking the following medicines:

• cimetidine, a medicine used to treat stomach acidity and stomach or intestinal lesions, because concomitant use may cause accumulation of the medicine (due to reduced liver metabolism of local anesthetics);
• medicines used to treat high blood pressure or heart problems (beta-blockers), because concomitant use may cause accumulation of the medicine (due to reduced liver metabolism of local anesthetics);
• medicines used to treat heart disorders (digitalis), because concomitant use may cause slow heart rate (bradycardia) and other disturbances in heart contraction (atrioventricular conduction disturbances);
• medicines for depression (MAOIs or tricyclic antidepressants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are pregnant or suspect you may be pregnant.
Driving and using machines
This medicine may affect your ability to drive or operate machinery. Therefore, ask your doctor whether you can drive or use machinery after the procedure.
LIDOCAINE HYDROCHLORIDE FISIOPHARMA injectable solution contains sodium
The 5 ml vial contains less than 23 mg (1 mmol) of sodium per dose, i.e., it is practically 'sodium-free'.
The 10 ml vial contains 23.61 mg (1.03 mmol) of sodium per dose.

3. How to use LIDOCAINE HYDROCHLORIDE FISIOPHARMA

This medicine will be administered to you by a doctor or trained healthcare professional under close supervision.
Your doctor will administer this medicine through small subcutaneous injections (infiltration) or via injection into the spinal cord (peripheral nerve block).
The recommended dose is 10–40 mg; the doctor will adjust the administration rate accordingly.
If you have not received other sedative medicines, the maximum dose is 300 mg, either as a single administration or divided into repeated doses within a 2-hour period.
Use in children
The doctor will reduce the dose according to the child's weight and age.
If you use more LIDOCAINE HYDROCHLORIDE FISIOPHARMA than you should
Since this medicine is administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much, inform your doctor or another healthcare provider immediately.
In case of overdose, certain adverse effects may occur (see section 4 “Possible side effects”).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects are more likely to occur in the following cases:

• if an excessive dose is administered;
• if the medicine is absorbed very rapidly by your body;
• if administration is inadequate;
• if you suffer from allergic-type conditions (hypersensitivity, idiosyncrasy, reduced tolerance).

The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• skin irritation (rash, urticaria), itching, severe allergic reactions (anaphylactic shock, anaphylactoid reaction), breathing difficulties (bronchospasm), swelling of the throat due to fluid accumulation (laryngeal edema), cessation of heart and respiratory activity (cardiorespiratory collapse);
• excitation or depression associated with dizziness, drowsiness, visual disturbances, tremors followed by changes in consciousness, seizures, difficulty opening the mouth due to muscle contraction (trismus);
• anxiety, disorientation;
• slowing of the heartbeat (bradycardia), irregular heartbeats (arrhythmias, myocardial depression) up to cessation of cardiac activity;
• dilation of the pupil (mydriasis);
• nausea, vomiting;
• increased breathing rate (tachypnea), bronchial dilation (bronchodilation), respiratory arrest;
• sweating;
• dilation of blood vessels (vasodilation), decrease or increase in blood pressure (hypotension, hypertension);
• increased metabolism and body temperature.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIDOCAINE HYDROCHLORIDE FISIOPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month, provided the product remains unopened
and stored correctly.
Store below 30 °C.
Keep in the original packaging to protect the medicine from light.
Use this medicine immediately after opening the container; after use, discard the container (and
any remaining medicine), even if partially used.
The solution should be clear, colourless, and free from visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What LIDOCAINA CLORIDRATO FISIOPHARMA 10 mg/ml injectable solution contains

• The active substance is lidocaine hydrochloride. Each 5 ml vial contains 50 mg of lidocaine hydrochloride.
• The other components are: sodium chloride, water for injections.

What LIDOCAINA CLORIDRATO FISIOPHARMA 20 mg/ml injectable solution contains

• The active substance is lidocaine hydrochloride. Each 10 ml vial contains 200 mg of lidocaine hydrochloride.
• The other components are: sodium chloride, water for injections.

Description of the appearance of LIDOCAINA CLORIDRATO FISIOPHARMA and contents of the
pack LIDOCAINA CLORIDRATO FISIOPHARMA 10 mg/ml injectable solution
Pack containing 5, 10, 50 or 100 vials of 5 ml.
LIDOCAINA CLORIDRATO FISIOPHARMA 20 mg/ml injectable solution
Pack containing 5, 10, 50 or 100 vials of 10 ml.
Marketing Authorization Holder and Manufacturer
Fisiopharma Srl – Nucleo Industriale 84020 Palomonte (SA) Italy
Package leaflet: information for the physician

LIDOCAINE HYDROCHLORIDE FISIOPHARMA 10 mg/ml injectable solution, 20 mg/ml injectable solution

Lidocaine hydrochloride
Equivalent medicinal product

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
As a local anesthetic
10–40 mg or more, depending on the requirements of the procedure, by infiltration or peripheral nerve block.
The anesthetic solution must be injected slowly in small increments, at an administration rate of approximately 1 ml/minute, with prior adequate aspiration.
In healthy adults not pre-treated with sedatives, the maximum doses, either as a single administration or repeated administrations within less than 120 minutes, must not exceed a total of 300 mg of lidocaine hydrochloride.
In pediatric patients, reduce the dose proportionally according to body weight and age.

Special warnings and precautions for use
The efficacy and safety of lidocaine in dental practice depend on appropriate dosing, proper administration technique, and adequate precautions.
The solution must be injected slowly and in small amounts, with caution, approximately 10 seconds after prior aspiration. Especially when infiltrating highly vascularized areas, it is advisable to wait about 2 minutes before proceeding with the actual loco-regional block. Direct intravenous administration must be absolutely avoided.
Repeated injections of lidocaine may lead to significant increases in plasma levels due to accumulation of the drug or its metabolites. Drowsiness represents the first sign of elevated plasma levels, which may also occur following excessively rapid absorption or accidental intravenous injection.
Loco-regional anesthetic techniques must be performed with caution when the tissue or the injection site shows signs of infection or inflammation.

Overdose
Emergencies associated with the use of local anesthetics are generally related to high plasma levels caused by accidental intravenous injection.
At the first sign of alarm, administration must be stopped immediately, the patient placed in a horizontal position, and airway patency ensured, providing oxygen in case of severe dyspnea or performing artificial ventilation if necessary.
The use of bulbar analeptics should be avoided, as they may worsen the condition by increasing oxygen consumption. Any seizures may be controlled by administering diazepam 10–20 mg intravenously; barbiturates are not recommended, as they may exacerbate bulbar depression.
The circulation may be supported by intravenous administration of appropriate doses of corticosteroids; diluted solutions of alpha-beta adrenergic agents with vasoconstrictor action (methyphenitamine, metaraminol, and others) or atropine sulfate may be added. Sodium bicarbonate, in appropriate concentrations, may be used intravenously as an antiacidotic agent.

Incompatibilities
Lidocaine is incompatible with amphotericin, sodium metexitone, sodium sulfadiazine, methyphenitamine hydrochloride, alkalis, heavy metals, oxidizing agents, tannin, air, and light.

For further information, please refer to the Summary of Product Characteristics.