XILONIBSA 10 mg/puff, cutaneous spray solution

Introduction

Leaflet: information for the user

Xilonibsa 10 mg/spray, solution for cutaneous spraying

Lidocaine

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

Contents of the leaflet

1. What Xilonibsa 10 mg/spray is and what it is used for
2. What you need to know before starting to use Xilonibsa 10 mg/spray
3. How to use Xilonibsa 10 mg/spray
4. Possible side effects
5. Storage of Xilonibsa 10 mg/spray
6. Package contents and additional information

1. What Xilonibsa 10 mg/spray is and what it is used for

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

Xilonibsa 10 mg/spray is indicated for superficial anesthesia of the mucosa in surgery, obstetrics, dentistry, and otorhinolaryngology.

2. What you need to know before starting to use Xilonibsa 10 mg/spray

Do not use Xilonibsa 10 mg/spray:

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

Warnings and precautions

Consult your doctor before starting to take Xilonibsa 10 mg/spray:

• 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 impaired respiratory function.
• if you have impaired liver function.
• if you suffer from heart and circulatory failure.
• if you suffer from renal impairment.

Excessive doses should be avoided, as well as the application of the medicine to infected or inflamed tissues, as the absorption of lidocaine is very rapid in these cases, and systemic adverse reactions may occur.

Eye contact with lidocaine should be avoided. In case of eye contact, if necessary, remove the contact lenses from the person. Wash immediately and abundantly with water for 15 minutes, keeping the eyelids apart. Do not let the water flow towards the unaffected eye. Perform immediate complementary treatments with an ophthalmologist.

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

Children

Xilonibsa 10 mg/spray is not recommended for use in children under 6 years of age due to the risk of rapid absorption of the anesthetic and the risk of reflex laryngospasm in the newborn.

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

Taking Xilonibsa 10 mg/spray with other medicines

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

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

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

Using Xilonibsa 10 mg/spray with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Xilonibsa 10 mg/spray is not recommended during pregnancy, as it crosses the placental barrier. However, no evidence of congenital anomalies has been demonstrated.

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

Breastfeeding

Xilonibsa 10 mg/spray is excreted in breast milk, but at therapeutic doses used, no effects are expected in newborns/children during breastfeeding.

Fertility

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

Driving and using machines

The influence of Xilonibsa 10 mg/spray on the ability to drive and use machines is small.

Depending on the dose and place of administration, local anesthetics may affect mental function and temporarily alter locomotion and coordination. When administering this medicine, the doctor should assess each particular case to determine if the reaction capacity is compromised and if the patient can drive or use machines.

Xilonibsa 10 mg/spray may cause dizziness, sedation, blurred vision, and dizziness. If any of these side effects occur after applying Xilonibsa 10 mg/spray, you should wait until they cease before driving or using machinery.

Xilonibsa 10 mg/spray contains ethanol

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

3. How to use Xilonibsa 10 mg/spray

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

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

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

In dentistry

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

In otorhinolaryngology

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).

Keep in mind 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 body weight per day.

Use in children

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

Xilonibsa 10 mg/spray is not recommended for use in children under 6 years of age.

If you use more Xilonibsa 10 mg/spray than you should

As with other local anesthetics, due to excessive dosing or rapid absorption, systemic reactions may occur that can affect the central nervous system and the cardiovascular system. In these cases, treatment will consist of maintaining vital signs, and if convulsions appear, administering short-acting barbiturates (such as thiopental) or benzodiazepines (diazepam) intravenously.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Xilonibsa 10 mg/spray may cause local irritation (coughing, sneezing) at the time of application or immediately after.

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

Rare side effects (may affect up to 1 in 1000 patients).

Cardiac disorders: Hypotension, arrhythmias, bradycardia, cardiovascular arrest.

Nervous system disorders: Metallic taste, tinnitus, dizziness, nausea, vomiting, anxiety, tremors, nystagmus, headache, increased respiratory rate, paresthesia (loss of sensitivity accompanied by burning) of the lip and/or tongue, unconsciousness, and convulsions, coma, and respiratory arrest (in case of overdose).

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

Very rare side 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 side effects

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xilonibsa 10 mg/spray

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

Do not store above 25°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Xilonibsa 10 mg/spray

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

Appearance of the product and package contents

Xilonibsa 10 mg/spray is a clear or practically clear solution with a characteristic odor.

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

Marketing authorization holder and manufacturer

Laboratorios Inibsa, S.A.

Ctra. Sabadell a Granollers, km. 14,5

08185 Lliçà de Vall (Barcelona)

Spain

Telephone: +34 938 609 500

Fax: +34 938 439 695

e-mail: info_medica@inibsa.com

Local representative

LAPHYSAN S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this leaflet: May 2016

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/