Leaflet: information for the user

Xilonibsa 10 mg/pulse, skin spray solution

Lidocaína

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. What isXilonibsa 10 mg/pulseand for what it is used

2. What you need to know before starting to useXilonibsa 10 mg/pulse

3. How to useXilonibsa 10 mg/pulse

4. Possible side effects

5. Storage ofXilonibsa 10 mg/pulse

6. Contents of the pack and additional information

Xilonibsa 10 mg/pulsecontains lidocaine and belongs to the group of local anesthetics of the amide type.

Xilonibsa 10 mg/pulseis indicated for superficial anesthesia of the mucosa in surgery, obstetrics, dentistry, and otolaryngology.

No use Xilonibsa 10 mg/pulsación:

• if you are allergic to lidocaine or to amide-type anesthetics or to any of the other components of this medication (listed in section 6).

Advertencias y precauciones

Consult your doctor before starting to takeXilonibsa 10 mg/pulsación:

• if you are an elderly and debilitated person.
• if you suffer from epilepsy, hypovolemia, atrioventricular block or other conduction disorders.
• if you have bradycardia or deteriorated respiratory function.
• if you have deteriorated liver function.
• if you suffer from heart and circulatory failure.
• if you suffer from renal deterioration.

Administration of excessive doses should be avoided, as well as application of the medication on infected or inflamed tissues, since in these cases the absorption of lidocaine is very rapid, and systemic adverse reactions may occur.

Lidocaine should be avoided from coming into contact with the eyes. In case of eye contact, if necessary, remove contact lenses from the person. Immediately and abundantly rinse with water for 15 minutes, keeping the eyelids separated. Do not let the water flow towards the unaffected eye. Perform immediate complementary treatments with an ophthalmologist.

Patients treated with class III antiarrhythmic medications (e.g., amiodarone) should be closely monitored and ECG monitoring should be considered, as the cardiac effects may be additive.

Children

The use of Xilonibsa 10 mg/pulsación is not recommended in children under 6 years of age due to the risk of very rapid absorption of the anesthetic and the risk of laryngeal spasm in newborns.

Lidocaine should be used with caution in children over 6 years of age, not exceeding the recommended maximum dose.

Use of Xilonibsa 10 mg/pulsación with other medications

Inform your doctor if you are using, have used recently or may have to use any other medication.

In particular, inform your doctor if you have used recently or have received treatment with any of the following medications:

• Medications used to treat epilepsy, such as phenytoin.
• Medications used to treat HIV/AIDS (atazanavir, darunavir).
• Other local or general anesthetics (halothane).
• Diuretics (acetazolamide, loop diuretics and thiazides).
• Cimetidine or beta-blockers.

Use of Xilonibsa 10 mg/pulsación with food and beverages

It is recommended not to ingest food or liquids until sensitivity is regained to prevent the risk of biting the tongue.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

The use of Xilonibsa 10 mg/pulsación is not recommended during pregnancy due to the fact that it crosses the placental barrier. However, there is no evidence of congenital anomalies.

The use of Xilonibsa 10 mg/pulsación during pregnancy will be reserved only for cases where the potential benefit justifies possible risks to the fetus.

Lactation

Xilonibsa 10 mg/pulsación is excreted in breast milk, but at therapeutic doses usedno effects are expected in newborns/infants in the lactation period.

Fertility

No effects on fertility have been reported with Xilonibsa 10 mg/pulsación.

Driving and operating machinery

The influence of Xilonibsa 10 mg/pulsación on the ability to drive and operate machinery is small.

Depending on the dose and site of administration, local anesthetics can affect mental function and temporarily alter locomotion and coordination. When this medication is administered, the doctor should assess in each case whether the reaction capacity is compromised and whether the patient can drive or operate machinery.

Xilonibsa 10 mg/pulsación may cause dizziness, sedation, blurred vision, and vertigo. If any of these adverse effects occur after the application of Xilonibsa 10 mg/pulsación, you should wait until these symptoms subside before driving or operating machinery.

Xilonibsa 10 mg/pulsación contains ethanol

This medication contains 241 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

Xilonibsa 10 mg/pulse will be administered by your doctor.

The lowest dose that provides the required anesthetic effect should be used, avoiding excessive doses.

No more than 20 pulses should be applied to produce the desired anesthesia in adults.

In dentistry

It is recommended to administer from 1 to 5 applications on the mucosa.

In otolaryngology

When used for maxillary sinus puncture, it is recommended to apply 3 sprays.

In gynecology-obstetrics

It is recommended to apply approximately 20 sprays (equivalent to 200 mg).

Please note that the maximum dose in 24 hours for an adult weighing approximately 70 kg is 200 mg (corresponding to 20 applications with the dosing valve). No more than 20 applications should be administered per adult patient.If dosing is based on patient weight, the dose should not exceed 3 mg/kg of body weight per day.

Use in children

The lidocaine dose in children should be adjusted according to the nature of the procedure and the patient's characteristics. In children over 6 years old, the maximum dose will be calculated based on body weight, taking the dose of 3 mg/kg of body weight per day as the recommended maximum daily dose.

Xilonibsa 10 mg/pulse is not recommended for use in children under 6 years old.

If you use moreXilonibsa 10 mg/pulsethan you should

As with other local anesthetics, due to excessive dosing or rapid absorption, systemic reactions may occur that can affect the CNS and cardiovascular system. In these cases, treatment will consist of maintaining vital signs, and if seizures occur, administering barbiturates of short action (e.g. thiopental) or benzodiazepines (diazepam) intravenously.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Xilonibsa 10 mg/heartbeatmay produce local irritation (cough, sneezing) at the time of application or immediately after.

Other adverse reactions that may be observed with the use of this medication are:

Adverse effects that are rare (may affect up to 1 in 1000 patients).

Cardiovascular Disorders: Hypotension, arrhythmias, bradycardia, cardiovascular arrest.

Nervous System Disorders: Metallic taste, tinnitus, sensation of dizziness, nausea, vomiting, anxiety, tremors, nystagmus, headache, increased respiratory rate, paresthesias (loss of sensation accompanied by burning) of the lip and/or tongue, unconsciousness, and seizures, coma, and respiratory arrest (in case of overdose).

Respiratory Disorders: Tachypnea followed by bradypnea, which may cause apnea.

Very rare adverse effects (may affect up to 1 in 10,000 patients).

General Disorders and Administration Site Conditions:Allergic reactions, skin rash, erythema, pruritus, edema of the tongue, mouth, lips, or throat, and, in severe cases, anaphylactic shock.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above25°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Xilonibsa 10 mg/pulse

• The active ingredient is lidocaine.
• The other excipients are 96% ethanol, menthol, saccharin, macrogol 400, banana flavor, and purified water.

Appearance of the product and contents of the packaging

Xilonibsa 10 mg/pulse is a transparent or almost transparent solution, with a characteristic odor.

Xilonibsa 10 mg/pulse is presented in a 50 ml bottle that contains approximately 500 pulses. Each bottle contains a dosing valve that provides a dose of 10 mg of lidocaine per pulse.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Inibsa, S.A.

Ctra. Sabadell to Granollers, km. 14.5

08185 Lliçà de Vall (Barcelona)

Spain

Telephone: +34 938 609 500

Fax: +34 938 439 695

e-mail: [email protected]

Local representative

LAPHYSAN S.A.U.

Anabel Segura, 11 Building A, 4th Floor, Door D

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: May 2016

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/