Label: information for the user

Hurricaine 200mg/goral gel

Benzocaine

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

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.

1. What is Hurricaine gel and what it is used for

2. What you need to know before starting to use Hurricaine gel

3. How to use Hurricaine gel

4. Possible adverse effects

5. Storage of Hurricaine gel

6. Contents of the package and additional information

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

It is indicated for local relief of dental or mouth pain, such as that caused by the rubbing of prostheses,

extraction, 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 gel

• 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 gel

• If you cannot 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 gel).
• 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.

• People with serious or debilitating illnesses should consult their doctor before taking this

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

• Do not ingest.
• Avoid contact with 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 gel 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
• 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 people sensitive to benzocaine, hair dyes of the paraphenylenediamine type may cause severe contact dermatitis.

Use of Hurricane gel with food and beverages

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

Pregnancy and breastfeeding

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 people over 65 years

People over 65 years old and debilitated patients may be more sensitive to the adverse effects

of benzocaine, so they should consult their doctor.

Driving and operating machinery

Does not affect 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:

Apply to the affected area, a small amount of the medication, by small touches, as 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: under strict medical supervision.

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 gel 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, Hurricaine gel may produce adverse effects, although not all people 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. Store in the packaging perfectly closed to protect it from light.

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

medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your

pharmacist how to dispose of the packaging and the medicines that you do not need. In this way,

you will help to protect the environment.

Composition of Hurricaine gel

• The active ingredient is: Benzocaína.
• The other components are: Polyethylene glycol, Saccharin, Cherry aroma.

Appearance of the product and contents of the packaging

Hurricaine gel is a viscous gel of cinnamon color and cherry aroma.

It is presented in a 6 ml polyethylene tube and polypropylene bottles with polyethylene of 30 ml and 50 ml (clinical packaging) of gel.

1 ml of gel corresponds to 1.06 gr.

Holder of the marketing authorization

Laboratorios Clarben S.A.

C/Asura 111. 28043

Madrid, Spain.

Responsible for Manufacturing

CLARBEN, S.A.

Eduardo Marconi, 2.

Polígono Industrial Codein

Fuenlabrada (Madrid)-Spain

or

B BRAUN MEDICAL S.A.

Ronda de los Olivares, Parcela II,

Polígono Industrial Los Olivares, Jaén – Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

Laguna, 66-68-70. Polígono Industrial Urtinsa II,

Alcorcón, Madrid – Spain

or

LABORATORIUM SANITATIS, S.L.

C/ Leonardo da Vinci, 11 (Parque Tecnológico de Álava),

Miñano (Álava) - Spain

This leaflet has been approved inMay 2021.

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