Leaflet: information for the user

dentispray 50 mg/ml dental solution

Benzocaine

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.

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

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

You should consult a doctor if it worsens or does not improve after 2 days of treatment.

Do not use Dentispray

If you are allergic to benzocaine, to other local anesthetics derived from para-aminobenzoic acid or to 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 such as para-aminobenzoic acid (PABA), parabens or paraphenylenediamine (a hair dye component).
• If you have any severe or extensive injuries in the mouth.
• Do not take doses higher than the recommended in section 3 (How to use Dentispray).
• Older, sick or weakened individuals should consult with their doctor before using this medication as they are more sensitive to its possible adverse reactions.
• Avoid spraying on the eyes.
• Do not inhale or ingest.
• Do not eat or drink while numbness of the mouth persists, due to the risk of biting the tongue or buccal mucosa and choking.
• Keep away from fire or flames. Do not smoke during application.

Use of Dentispray with other medications

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

This medication may interact with:

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

Use of Dentispray with food and beverages

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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use benzocaine during pregnancy.

The excretion of benzocaine in breast milk is unknown, so women breastfeeding should not use this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 pulse is approximately equivalent to 3 mg of benzocaine.

• Use in children

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

Children aged 2-6 years: under medical supervision.

Children under 2 years: under strict medical supervision.

Administration method

This medication is for administration in the mouth.

Do not inhale or ingest.

Remove the cap and place the actuator, with the applicator cannula incorporated, over the outlet tube of the dosing pump. Press the actuator several times until the pump is filled. Then, the medication can be applied, either by pressing the actuator and directing the cannula towards the painful area, or by soaking a cotton swab with several pulses and applying it to the area for a brief period of time. Once the treatment is finished, it is recommended to rinse the cannula 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

The signs of overdose may be: blue discoloration of the skin, slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. Blood pressure may also decrease.

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

Like all medications, this medication may produce adverse effects, although not everyone experiences them.

During the period of use of benzocaine, the following adverse effects have occurred whose frequency has not been 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 mucous membranes, and difficulty swallowing.

Burning sensation in the mouth.

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

The prolonged contact of benzocaine with the mucous membranes of the mouth may cause dehydration of the epithelium and hardening of the mucous membranes of the mouth.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use website: 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.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 dodecahydrate phosphate, and 96° ethanol.

Appearance of the product and contents of the packaging

Dentispray is presented in 5 ml aluminum flasks of dental solution, with a dosing pump and a trigger with the applicator cannula incorporated. The solution is a transparent, colorless, and characteristic-smelling liquid.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Viñas, S.A.

Provenza, 386

08025- Barcelona

Last review date of this leaflet: May 2014

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