DENTISPRAY 50 mg/ml DENTAL SOLUTION

Introduction

Leaflet: information for the user

dentispray 50 mg/ml dental solution

Benzocaine

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

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 2 days of treatment.

Contents of the leaflet:

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

1. What is Dentispray and what is it used for

It is a topical anesthetic that acts by suppressing pain when applied externally to the area of the mouth to be treated.

This medication is used for the symptomatic relief of mouth, tooth, dental, and gum pain until they can be properly treated by a dentist in adults and children over 2 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 2 days of treatment.

2. What you need to know before starting to use Dentispray

Do not use Dentispray

If you are allergic to benzocaine, other local anesthetics derived from para-aminobenzoic acid, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dentispray.

• If you do not tolerate other local anesthetics like para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component).
• If you have any severe or extensive injury in the mouth.
• Do not take doses higher than recommended in section 3 (How to use Dentispray).
• Elderly or debilitated patients should consult their doctor before using this medication, as they are more sensitive to its possible adverse reactions.
• Avoid spraying into the eyes.
• Do not inhale or ingest.
• Do not eat or drink while the numbness of the mouth persists, due to the risk of biting your tongue or the oral mucosa and choking.
• Keep away from fire or flames. Do not smoke during application.

Using Dentispray with other medications

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

This medication may interact with:

• Sulfonamides (medication for treating infections): they should not be used at the same time as benzocaine, as it may decrease the antibacterial effect of sulfonamides.
• Medications containing hyaluronidase: they should not be used at the same time as benzocaine, as it may increase the adverse effects of benzocaine.
• Other local anesthetics.
• In people sensitive to benzocaine, hair dyes of the paraphenylenediamine type may cause severe contact dermatitis.

Using Dentispray with food and drinks

Do not use this medication before meals or before drinking (see section Warnings and precautions).

Pregnancy and breastfeeding

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

Do not use benzocaine during pregnancy.

It is unknown whether benzocaine is excreted in breast milk, so breastfeeding women should not use this medication.

Driving and using machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

3. How to use Dentispray

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents

1 application. Apply to the affected area 3 or 4 times a day. Do not apply more than 4 times a day.

Each spray is equivalent to approximately 3 mg of benzocaine.

• Use in children

Children 6-12 years: only under adult supervision, apply as in the previous case.

Children 2-6 years: under medical control.

Children under 2 years: under strict medical control.

Method of administration

This medication is for administration in the mouth.

Do not inhale or ingest.

Remove the cap from the bottle and place the sprayer, with the applicator nozzle incorporated, over the tube of the dosing pump. Press the sprayer several times until the pump is filled. Then, the medication can be applied, either directly by pressing the sprayer and directing the nozzle towards the painful area, or by soaking a cotton swab with several sprays and applying it to the area for a short period. Once the treatment is finished, it is recommended to rinse the nozzle with water, dry it, and store it.

If symptoms worsen or persist after 2 days of treatment, you should consult a dentist.

If you use more Dentispray than you should

Signs of overdose may be: bluish discoloration of the skin, slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. It may also decrease blood pressure.

In case of overdose or accidental ingestion, consult a doctor immediately or go to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of benzocaine, the following side effects have occurred, whose frequency could not be established with precision:

Hives, edema, anaphylactoid reaction (contact dermatitis). Cross-reactions with other local anesthetics of the ester type. Photosensitivity, bad taste in the mouth, dehydration of the mucous membranes, and difficulty swallowing.

Burning sensation in the mouth.

Methemoglobinemia, whose symptoms are: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia.

Prolonged contact of benzocaine with the mucous membranes of the mouth may cause dehydration of the epithelium and hardening of the mouth mucosa.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 contribute to providing more information on the safety of this medication.

5. Storage of Dentispray

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box and packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Dentispray

• The active ingredient is benzocaine. Each milliliter of dental solution contains 50 mg of benzocaine.
• The other components (excipients) are: polyethylene glycol 400, purified water, sodium saccharin, thymol, menthol, peppermint oil, disodium phosphate dodecahydrate, and ethanol 96º.

Appearance of the product and package contents

Dentispray is presented in 5 ml aluminum bottles of dental solution, with a dosing pump and a sprayer with the applicator nozzle incorporated. The solution is a clear, colorless liquid with a characteristic odor.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Viñas, S.A.

Provenza, 386

08025- Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrente vidalet, 29

08012 Barcelona

Spain

Laboratorios Viñas, S.A.

Polígono Industrial Can Rosés, Avenida Can Rosés, s/n,

08191 Rubí

Spain

Date of the last revision of this leaflet: July 2025

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