Ecocain

Package leaflet: Information for the user

ECOCAIN 10 g/100 ml oral mucosa spray

Lidocaine hydrochloride
Please 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Ecocain Spray is and what it is used for
  2. What you need to know before using Ecocain Spray
  3. How to use Ecocain Spray
  4. Possible side effects
  5. How to store Ecocain Spray
  6. Contents of the pack and other information

1. What Ecocain Spray is and what it is used for

Ecocain Spray contains the active substance lidocaine hydrochloride, which belongs to a group of medicines called local anaesthetics, that reduce sensitivity in a part of the body by blocking the transmission of pain.

In dentistry, Ecocain Spray is used exclusively by the dentist to eliminate pain at the injection site before performing:

• conservative procedures;
• dental and gingival (periodontal) surgery;
• tooth extractions.

In particular, Ecocain Spray is indicated to anaesthetize specific areas of the mouth during the following procedures:

• incision of superficial abscesses;
• minor surgical procedures, removal of bone splinters, soft root remnants, etc.;
• extraction of deciduous (milk) teeth and loose teeth;
• preparation of small cavities;
• removal of tartar (dental scaling) and treatment of gum disease (periodontosis);
• suppression of gag reflex when taking impressions or performing radiographs;
• use of fast-hardening plastic materials and painless fitting of prostheses;
• application of bridges and crowns.

In pharyngeal anaesthesia during the initial phase of patient preparation for procedures involving insertion of instruments and catheters into the respiratory tract, Ecocain Spray is used exclusively by medical personnel to provide superficial anaesthesia of oropharyngeal and hypopharyngeal areas, to reduce reflex activity and facilitate the insertion of the tube or passage of instruments used for endotracheal intubation, laryngoscopy, and bronchoscopy.

In pharyngeal anaesthesia for patient preparation prior to procedures involving insertion of instruments and catheters into the digestive tract, Ecocain Spray is used exclusively by medical personnel to provide superficial anaesthesia of oropharyngeal and hypopharyngeal areas, to reduce reflex activity, increase tolerance, and facilitate the insertion of the tube or passage of instruments used for oesophagoscopy and gastroscopy.

In otorhinolaryngology, Ecocain Spray is used exclusively by medical personnel to reduce pain sensation (e.g. to perform anaesthesia prior to minor non-invasive procedures in the nasal cavity, pharynx, and epipharynx, including rhinoscopy and laryngoscopy).

2. What you should know before using Ecocain Spray

Do not use Ecocain Spray if:

• you are allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or think you might be pregnant (See section “Pregnancy and breastfeeding”);
• the person to whom the medicine is to be administered is a child under 14 years of age (See sections “Children” and “Use in children”).

Warnings and precautions
Talk to your doctor before using Ecocain Spray.
Ecocain Spray will be administered by your doctor, who will determine the appropriate dose and method of administration.
This medicine is intended for local application (topical use).
For safe and effective use of the medicine, the doctor must:

• avoid administering excessive amounts of the medicine (overdose);
• use the lowest possible dose needed to achieve the desired effect;
• keep you under close observation;
• immediately discontinue administration at the first sign of warning (burning, tingling, electric shock sensation).

Ecocain Spray is not indicated for procedures requiring aseptic conditions.
Effects on anti-doping tests
For individuals engaged in sports activities, the use of medicines containing ethyl alcohol may lead to a positive result in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Children
Do not use this medicine in children under 14 years of age (See section “Do not use Ecocain Spray”).
Other medicines and Ecocain Spray
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Ecocain Spray must not be administered if you are pregnant or think you might be pregnant (See section “Do not use Ecocain Spray”).
Driving and using machines
Ecocain Spray does not affect, or affects negligibly, the ability to drive vehicles and operate machinery.

3. How to use Ecocain Spray

Ecocain Spray will be administered only by your dentist or other specialist medical personnel. If
you have any doubts, consult your doctor or nurse.
Recommended dose:

How to use the spray
The bottle must be held in an upright position during spraying.
The medicine must not be sprayed into the eyes.
Ecocain Spray does not contain gas (propellant).
It is recommended not to use the same single-use applicator for more than one patient in order to avoid the risk of contamination and infections, and to adopt appropriate measures to prevent cross-contamination in healthcare settings, including hand hygiene before use, wearing disposable gloves during applicator replacement and administration, and ensuring proper disposal of each applicator after use.
Before each use (and upon each applicator replacement), perform 3 test sprays into the air (priming) to ensure the pump delivers the spray correctly.

Use in children
This medicine must not be administered to children under 14 years of age.

If you use more Ecocain Spray than you should
This medicine will be administered to you by a dentist, therefore overdose is unlikely.
However, if you are administered an excessive amount of this medicine, the following effects may occur:

• excitement;
• tremors;
• disorientation;
• dizziness;
• pupil dilation (mydriasis);
• increased metabolism and body temperature;
• difficulty opening the mouth (trismus), if a very high dose is administered;
• seizures;
• sweating;
• changes in heart rhythm (arrhythmias);
• increased blood pressure (hypertension);
• rapid breathing (tachypnea);
• breathing problems (bronchodilation);
• nausea;
• vomiting;
• reduced heart rate (bradycardia);
• circulatory problems (vasodilation).

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of this medicine are dose-dependent and may be caused by administration of an excessive amount of this medicine (overdose) (see section “If you use more Ecocain Spray than you should”), by rapid absorption of the medicine, or may be due to allergy (hypersensitivity), intolerance (idiosyncrasy), or reduced tolerance to the medicine by the patient.

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 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 Ecocain Spray

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.".
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 Ecocain Spray contains

• The active substance is lidocaine hydrochloride. 100 ml of solution contain 10 g of lidocaine hydrochloride.
• The other components are: cetylpyridinium chloride, sodium saccharinate, polyethylene glycol 400, ethanol 95°, monobasic sodium phosphate, sodium hydroxide 1 M, purified water.

Description of the appearance of Ecocain Spray and contents of the pack
60 ml bottle with an integrated single-use applicator dispenser. Additional single-use applicator dispensers are
available separately.
Marketing Authorization Holder
Molteni Dental srl, Via Barontini 8, Loc. Granatieri 50018 Scandicci (FI)
Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018
Scandicci (FI)
ITC Production S.r.l., via Pontina km 29, Pomezia (RM)

Package leaflet: information for the user

ECOCAIN 20 mg/ml + 10 micrograms/ml injectable solution with adrenaline, 20 mg/ml + 12.5 micrograms/ml injectable solution with adrenaline, 20 mg/ml + 20 micrograms/ml injectable solution with adrenaline

Lidocaine hydrochloride and adrenaline
Please 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Ecocain is and what it is used for
2. What you need to know before using Ecocain
3. How to use Ecocain
4. Possible side effects
5. How to store Ecocain
6. Package contents and other information

1. What Ecocain is and what it is used for

Ecocain with adrenaline is a combination of two active substances:

• lidocaine hydrochloride, which belongs to a group of medicines called local anaesthetics that reduce sensitivity in a specific part of the body by blocking the transmission of pain;
• adrenaline, which belongs to a group of medicines called vasoconstrictors that reduce blood flow at the injection site (minimizing bleeding). Ecocain is used exclusively by dentists to anaesthetize certain areas of the mouth before performing:
  • conservative treatments;
  • dental and gingival (periodontal) surgery;
  • tooth extractions.

Ecocain with adrenaline is particularly indicated when a prolonged anaesthetic effect is desired.

2. What you need to know before using Ecocain

Do not use Ecocain if:

• you are allergic to lidocaine hydrochloride, adrenaline, or any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or think you might be pregnant (See section “Pregnancy and breastfeeding”);
• you have heart problems (cardiopathies), severe arterial problems (arteriopathies), or high blood pressure (hypertension);
• you have experienced ischemic events (inadequate blood supply) of any kind;
• you suffer from headaches (essential migraine);
• your thyroid gland is overactive (hyperthyroidism);
• you have diabetes;
• you have an enlarged prostate (prostatic hypertrophy);
• you have a disease of the eye caused by increased pressure inside the eye (acute angle-closure glaucoma);
• you have severe kidney problems (nephropathies).

Warnings and precautions
Talk to your doctor before Ecocain is administered to you.
Ecocain will be administered by your dentist, who will determine the appropriate dose and method of administration.
This medicine should be administered with caution if:

• you are taking medicines for depression, such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants (See section “Other medicines and Ecocain”);
• you have circulation problems.

Other medicines and Ecocain
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
Ecocain with adrenaline should be administered with extreme caution if you are taking:

• medicines used to treat depression, such as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, as they may cause a severe increase in blood pressure;
• medicines used to treat certain mental disorders, such as phenothiazines and butyrophenones, as they may alter the effect of adrenaline.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Ecocain must not be administered if you are pregnant or think you might be pregnant (See section “Do not use Ecocain”).

Driving and using machines
Ecocain does not affect, or affects only negligibly, the ability to drive and use machinery.

Ecocain contains sodium and sodium metabisulfite
Ecocain with adrenaline 10 or 12.5 micrograms/ml contains 3.24 mg of sodium (main component of table salt) per cartridge. This corresponds to 0.16% of the maximum recommended daily dietary intake for an adult.
Ecocain with adrenaline 20 micrograms/ml contains less than 1 mmol (23 mg) of sodium per cartridge, i.e. it is essentially ‘sodium-free’.
Ecocain contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Ecocain

Ecocain will be administered to you only by your dentist. If you have any doubts, consult your doctor or nurse.
This medicine will be administered by injection.
The recommended dose is 1–2 ml or more, depending on the type of procedure.
If you use more Ecocain than you should
Since this medicine will be administered by a dentist, overdose is unlikely.
However, if you are given an excessive amount of this medicine or if the medicine is accidentally injected into a blood vessel (intravascular injection), the following effects may occur:

• excitation;
• tremors;
• disorientation;
• dizziness;
• pupil dilation (mydriasis);
• increased metabolism and body temperature;
• difficulty opening the mouth (trismus), if a very high dose is administered;
• seizures;
• sweating;
• changes in heart rhythm (arrhythmias);
• increased blood pressure (hypertension);
• rapid breathing (tachypnea);
• breathing problems (bronchodilation);
• nausea;
• vomiting;
• reduced heart rate (bradycardia);
• circulation problems (vasodilation).

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of this medicine depend on the dose of the medicine (dose-dependent) and may be caused by administration of an excessive amount of this medicine (overdose) (see section “If you use more Ecocain than you should”), by rapid absorption of the medicine, by accidental administration of the medicine into a blood vessel (intravascular injection), or may be due to allergy (hypersensitivity), intolerance (idiosyncrasy), or reduced tolerance to the medicine by the patient.
Adrenaline may cause, in subjects with cardiovascular disorders: anxiety, sweating, breathing difficulties, disturbances in heart rhythm (arrhythmias), increased blood pressure (hypertension), particularly if suffering from high blood pressure or thyroid dysfunction, headache (acute cephalalgia), excessive sensitivity to light (photophobia), chest pain, vomiting.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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 Ecocain

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.".
Store Ecocain with adrenaline at a temperature not exceeding 25°C and in the original packaging 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 Ecocain 20 mg/ml + 10 microgram/ml solution for injection with adrenaline contains

• The active substances are: lidocaine hydrochloride and adrenaline. Each ml of solution for injection contains 20 mg of lidocaine hydrochloride and adrenaline bitartrate equivalent to 10 µg of adrenaline.
• The other components are: sodium chloride, sodium metabisulfite and water for injections.

What Ecocain 20 mg/ml + 12.5 microgram/ml solution for injection with adrenaline contains

• The active substances are: lidocaine hydrochloride and adrenaline. Each ml of solution for injection contains 20 mg of lidocaine hydrochloride and adrenaline bitartrate equivalent to 12.5 µg of adrenaline.
• The other components are: sodium chloride, sodium metabisulfite and water for injections.

What Ecocain 20 mg/ml + 20 microgram/ml solution for injection with adrenaline contains

• The active substances are: lidocaine hydrochloride and adrenaline. Each ml of solution for injection contains 20 mg of lidocaine hydrochloride and adrenaline bitartrate equivalent to 20 µg of adrenaline.
• The other components are: sodium chloride, sodium metabisulfite and water for injections.

Description of the appearance of Ecocain and contents of the pack
Pack sizes of 10 or 50 cartridges of 1.8 ml.
Marketing Authorization Holder
Molteni Dental srl, Via Barontini 8, Loc. Granatieri 50018 Scandicci (FI)
Manufacturers
Laboratorios Normon S.A., Ronda de Valdecarrizo 6, Tres Cantos, 28760 Madrid (Spain)

Package leaflet: Information for the user

ECOCAIN 20 mg/ml injectable solution

Lidocaine hydrochloride
Please 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

1. What Ecocain is and what it is used for

Ecocain contains the active substance lidocaine hydrochloride, which belongs to a group of medicines called local anaesthetics that reduce sensitivity in a specific part of the body by blocking the transmission of pain.
Ecocain is used exclusively by dentists to anaesthetize certain areas of the mouth before performing:

• conservative dental procedures;
• dental and gingival (periodontal) surgery;
• tooth extractions.

2. What you should know before using Ecocain

Do not use Ecocain if:

• you are allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or think you might be pregnant (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking Ecocain.
Ecocain will be administered to you by your dentist, who will determine the appropriate dose and method of administration of the medicine.
This medicine should be administered to you with caution if you have problems with blood circulation.

Other medicines and Ecocain
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
Ecocain should be administered to you with extreme caution if you are taking:

• medicines used for depression such as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, as they may cause a severe increase in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Ecocain should not be administered to you if you are pregnant or think you might be pregnant (See section “Do not use Ecocain”).

Driving and using machines
Ecocain does not affect or affects negligibly the ability to drive vehicles and use machinery.

Ecocain contains sodium
Ecocain contains 4.25 mg of sodium (the main component of table salt) per cartridge. This corresponds to 0.21% of the maximum daily recommended dietary intake for an adult.

3. How to use Ecocain

Ecocain will be administered to you only by your dentist. If you have any doubts, consult your doctor or nurse.
This medicine will be given to you by injection.
The recommended dose is 1–2 ml or more, depending on the type of procedure.

If you use more Ecocain than you should
Since this medicine will be administered by a dentist, it is unlikely that an overdose will occur.
However, if you are given an excessive amount of this medicine or if the medicine is accidentally injected into a vein (intravascular injection), the following effects may occur:

• excitation;
• tremors;
• disorientation;
• dizziness;
• dilation of the pupils (mydriasis);
• increased metabolism and body temperature;
• difficulty opening the mouth (trismus), especially if a very high dose is administered;
• seizures;
• sweating;
• changes in heart rhythm (arrhythmias);
• increased blood pressure (hypertension);
• rapid breathing (tachypnea);
• breathing problems (bronchodilation);
• nausea;
• vomiting;
• decreased heart rate (bradycardia);
• circulatory problems (vasodilation).

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects of this medicine are dose-dependent and may be caused by administration of an excessive
amount of this medicine (overdose) (see section “If you use more Ecocain than you should”), by rapid absorption
of the medicine, by accidental administration of the medicine into a blood vessel (intravascular injection), or
may be due to allergy (hypersensitivity), intolerance (idiosyncrasy), or reduced patient tolerance to the medicine.

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 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 Ecocain

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.".
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 Ecocain contains

• The active substance is lidocaine hydrochloride. Each ml of injectable solution contains 20 mg of lidocaine hydrochloride.
• The other components are: sodium chloride and water for injections.

Description of the appearance of Ecocain and package contents
Pack sizes of 10-50 cartridges of 1.8 ml.
Marketing Authorization Holder
Molteni Dental srl, Via Barontini 8, Loc. Granatieri 50018 Scandicci (FI)
Manufacturers
Laboratorios Normon S.A., Ronda de Valdecarrizo 6, Tres Cantos, 28760 Madrid (Spain)