Prospecto: information for the user

Hurricaine spray 200mg/ml oral spray

Benzocaine

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

Follow exactly the administration instructions for the medicine contained in this prospect or those indicated by your doctor, or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

1. What isHurricaine sprayand for what it is used

2. What you need to know before starting to useHurricaine spray

3. How to useHurricaine spray

4. Possible adverse effects

5. Conservation ofHurricaine spray

6. Contents of the package and additional information

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

It is indicated for local relief of dental or mouth pain, such as that caused by the rubbing of prostheses, extractions, small oral wounds, mouth ulcers, and small sores in adults and children aged 6 years and above.

Consult a doctor if it worsens or does not improve after 2 days of treatment.

Do not use Hurricane spray

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Hurricane spray

• 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 take Hurricane spray).
• If you have asthma, bronchitis, or emphysema.
• Stop taking the medication and consult your doctor immediately if you notice: headache,

dizziness, shallow breathing, nausea, fatigue, or tachycardia.

• Older, sick, or debilitated individuals should consult with their doctor before taking this

medication as they are more sensitive to its possible adverse reactions.

• Do not ingest, do not inhale.
• Avoid contact and/or spraying in the eyes.

• Do not eat or drink while the numbness of the mouth persists, due to the risk of

biting the tongue or buccal mucosa and choking.

Use of Hurricane spray with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take 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

because 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.
• Medications containing cholinesterase, used to treat diseases such as Alzheimer's, myasthenia gravis, or glaucoma, because using them at the same time inhibits the metabolism of benzocaine
• Other local anesthetics.
• In individuals sensitive to benzocaine, hair dyes of the paraphenylenediamine type may

cause severe contact dermatitis.

Use of Hurricane spray with food and beverages

Do not use this medication before meals or before drinking (See warnings and precautions).

Pregnancy and Lactation

If you are pregnant or breastfeeding, or 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.

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

Use in individuals over 65 years

Individuals over 65 years old and debilitated patients may be more sensitive to the adverse effects of benzocaine, so they should consult with their doctor.

Driving and operating machinery

No effect on driving and operating machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is for use in the mouth. Do not ingest.

The recommended dose is:

Adults and adolescents:

Press the valve for half a second on the area to be anesthetized, or soak a cotton ball and keep it applied to the area for a few minutes. Apply a maximum of 3 or 4 times a day.

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

Children aged 2-6 years: under medical supervision.

Children under 2 years: Due to the fact that it is a spray, its use is not recommended.

Remove the cap and apply to the area to be anesthetized, pressing the valve for half a second or soaking a cotton ball with several presses and keeping it applied to the area for several minutes.

Do not apply this medication more than 3 or 4 times a day.

If it worsens or if the pain persists after 2 days of treatment, consult a doctor.

Wash your hands after applying the medication.

If you use more Hurricaine spray 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. It may also lower blood pressure.

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, Hurricaine spray may produce adverse effects, although not everyone will experience them.

During the period of benzocaine use, the following adverse effects have occurred, but their 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, mucous membrane dehydration, 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 mucous membranes may cause epithelial dehydration and mucous membrane hardening.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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.

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

Do not store at a temperature above 30 °C

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines 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 the medicines you no longer need. By doing so,

you will help protect the environment.

Composition of Hurricaine spray

• The active ingredient is: Benzocaína.
• The other components are: Polietilénglicol, Sacarina sódica, Cherry aroma.

Appearance of the product and contents of the packaging

Hurricaine spray is a buccal spray solution, of a cinnamon color, with a cherry odor and taste.

It is presented in 5 and 60 ml aluminum flasks.

Holder of the marketing authorizationandResponsible for manufacturing

Laboratorios Clarben S.A.

C/ Asura 111 local 1 y 4

28043 Madrid, Spain.

This leaflet has been approved in

November 2013

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