Lidocaine hydrochloride Intes

Patient Information Leaflet

Lidocaine Hydrochloride INTES 40 mg/ml Eye Drops, Solution

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 yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Lidocaine Hydrochloride INTES is and what it is used for

Lidocaine Hydrochloride INTES contains the active substance lidocaine hydrochloride, which belongs to the group of local anaesthetics that work by temporarily causing loss of sensation in the area where they are applied, without inducing changes in consciousness (surface anaesthesia).
This medicine is an eye drop solution used to facilitate certain eye procedures and examinations that may be particularly uncomfortable in the absence of anaesthesia, such as:

• cataract surgery;
• removal of foreign bodies;
• painful dressings;
• measurement of intraocular pressure (tonometry).

2. What you need to know before using Lidocaine Hydrochloride INTES

Do not use Lidocaine Hydrochloride INTES

• if you are allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if the patient is a child under 12 years of age.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lidocaine Hydrochloride INTES.
This medicine will be administered to you by a doctor or nurse in a facility equipped with the necessary equipment and medicines to manage emergencies.
Rarely, severe reactions may occur, sometimes fatal, even if you have not previously experienced allergies when using this medicine or other similar medicines.
Before administering this medicine, your doctor will check your circulatory condition. During treatment with this medicine, you will be closely monitored by the doctor. Administration of this medicine must be immediately stopped if you experience changes in sensitivity (altered sensation) or drowsiness.
Additionally, inform your doctor if you are taking other medicines, if you have previously experienced allergic reactions, or if you have previously used this medicine or similar medicines.
Repeated use of anaesthetics in the eye may cause corneal problems and reduced vision.
Inform your doctor and use this medicine with caution if you have liver problems (impaired liver function), heart problems, or circulatory disorders (shock, atrioventricular conduction disturbances, or sinus bradycardia).
Do not touch the eye and protect it from dust or possible bacterial contamination until the anaesthetic effect wears off.
Children and adolescents
This medicine must not be administered to children under 12 years of age.
Other medicines and Lidocaine Hydrochloride INTES
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking:

• cimetidine, a medicine used to treat gastric ulcer;
• beta-blockers, such as propranolol, used to treat various heart conditions and high blood pressure, as they slow down the elimination (hepatic metabolism) of local anaesthetics;
• digitalis medicines, used to treat heart disorders, as they increase the risk of slow heartbeats (bradycardia) and atrioventricular conduction disturbances.

Do not use Lidocaine Hydrochloride INTES if you are taking sodium sulfadiazine, a medicine used to treat bacterial infections, or sodium metocitoxone, a medicine used to induce anaesthesia.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine will not be administered to you if you are known or suspected to be pregnant or if you are breastfeeding.
Driving and using machines
At the recommended doses, this medicine does not significantly or long-lastingly impair your ability to concentrate. However, consult your doctor, who will assess whether you can drive or operate machinery after the procedure.

3. How to use Lidocaine Hydrochloride INTES

This medicine, like all local anaesthetics, will be administered to you by a doctor, only at the time of the procedure and solely when necessary.

Local ocular anaesthesia for cataract surgery
The recommended dose is one to two drops instilled into the eye every 2 minutes, repeated up to 5 times.

Anaesthesia of the ocular surface
The recommended dose is one to two drops instilled into the eye.

Anaesthesia of the ocular surface for tonometry
The recommended dose is one to two drops instilled into the eye.
The dose may be increased at the discretion of the specialist.

If you use more Lidocaine Hydrochloride INTES than you should
This medicine will be administered to you by a doctor; therefore, it is unlikely that you will receive an excessive dose. However, symptoms of an overdose of this medicine may include: tremors, seizures followed by depression, severe breathing difficulty (respiratory failure), coma, cardiovascular alterations with hypotension (heart and circulation disorders associated with decreased blood pressure), slowing of the heartbeat (bradycardia). If you experience these symptoms, inform your doctor immediately, who will take appropriate precautions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Frequency not known (frequency cannot be estimated from the available data):

• burning sensation and/or eye pain, eye redness (conjunctival hyperemia);
• allergic reactions, including severe reactions (anaphylactic shock). When administered as indicated, this medicine is absorbed into the body only to a minimal extent. Nevertheless, the following side effects related to the passage of the medicine into the bloodstream are reported:

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

• depression or excitation associated with dizziness, drowsiness, visual disturbances, anxiety, tremors, followed by altered consciousness, seizures and respiratory depression;
• slowing of heart rate (bradycardia);
• decrease in blood pressure (hypotension);
• reduced heart activity up to cardiac arrest.

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lidocaine Hydrochloride INTES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original container to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lidocaine Hydrochloride INTES contains
The active substance is lidocaine hydrochloride. 1 ml of solution contains 40 mg of lidocaine hydrochloride.
The other components are: sodium hydroxide and purified water.
Description of the appearance of Lidocaine Hydrochloride INTES and package contents
Packaging containing 100 single-dose containers of 0.5 ml each.
Marketing Authorization Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy
MM/YYYY--------------------------------------------------------------------------------------------------------------------

Information intended for the physician or healthcare personnel
Lidocaine Hydrochloride INTES 40 mg/ml eye drops, solution
Therapeutic indications
Local ocular anesthesia for cataract surgery.
Anesthesia of the ocular surface (removal of foreign bodies or painful dressings).
Anesthesia of the ocular surface for tonometry.
Posology and method of administration
Adults and adolescents (12 to 18 years of age).
Local ocular anesthesia for cataract surgery
One to two drops every 2 minutes, repeated up to 5 times.
Anesthesia of the ocular surface
One to two drops.
Anesthesia of the ocular surface for tonometry
One to two drops.
The dose may be increased at the physician's discretion.
The medicinal product must be used immediately after opening the container; after use, the container (and any
remaining medicinal product) must be discarded, even if partially used.
Special warnings and precautions for use
This medicinal product is for exclusive ophthalmic use.
Immediate availability of emergency equipment, medications, and trained personnel is required, as severe,
sometimes fatal, reactions have been reported following the use of local anesthetics, even in the absence of
individual hypersensitivity history.
Prior to administration, the physician must assess the patient's circulatory status and review current therapies
and any history of allergic reactions.
In any case, the lowest effective doses and concentrations should be used to achieve the desired effect. The
patient must be closely monitored, and administration must be stopped immediately at the first sign of
warning (e.g., changes in mental status).
Repeated and uncontrolled use of anesthetics in the eye may cause corneal damage, leading to reduced vision.
Particular caution is required when administering the medicinal product to patients with impaired hepatic and
cardiovascular function.
During the period of anesthesia, the eye must not be touched and must be protected from dust and potential
bacterial contamination.
Incompatibilities
Lidocaine is incompatible with amphotericin, sodium sulfadiazine, sodium cefazolin, sodium phenytoin,
hydrochloride mefentermine, alkalis, heavy metals, oxidizing agents, tannin, air, and light.
Overdose
Due to high systemic levels resulting from rapid absorption or overdose, lidocaine hydrochloride may cause
acute toxic effects.
Symptoms of overdose are characterized by neuroexcitatory manifestations (tremors, seizures followed by
depression, respiratory failure, and coma) and cardiovascular alterations with hypotension and bradycardia.
Treatment is symptomatic. Seizures, if present, may be controlled with intravenous diazepam at a dose of 10–20 mg.
Barbiturates are not recommended, as they may exacerbate bulbar depression.
For further information, consult the Summary of Product Characteristics.