HURRICAINE 200 mg/g BUCAL GEL

2. What you need to know before you start using Hurricaine gel

Do not use Hurricaine gel

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Hurricaine gel

• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).

• If you have any severe or extensive injury in the mouth.
• Do not take doses higher than those recommended in section 3 (How to take Hurricaine gel).
• If you have asthma, bronchitis, or emphysema.
• Stop taking the medicine and consult your doctor immediately if you notice: headache,

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

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

medicine 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 the oral mucosa and choking.

Using Hurricaine gel with other medicines

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

This medicine may interact with:

• Sulfonamides (medicines for treating infections): they should not be used at the same time as benzocaine, as it may decrease the antibacterial effect of sulfonamides
• Medicines containing hyaluronidase: they should not be used at the same time as benzocaine, as it may increase the adverse effects of benzocaine
• Medicines containing cholinesterase, used to treat diseases such as Alzheimer's, myasthenia gravis, or glaucoma, because when used at the same time, the metabolism of benzocaine is inhibited
• Other local anesthetics.
• In people sensitive to benzocaine, hair dyes of the paraphenylenediamine type may cause severe contact dermatitis.

Using Hurricaine gel with food and drinks

Do not use this medicine before meals or before drinking (see warnings and precautions section).

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 medicine.

Do not use benzocaine during pregnancy.

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

Use in people over 65 years old

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 using machines

It does not affect driving or using machines.

3. How to use Hurricaine gel

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

This medicine is for administration in the mouth. Do not ingest.

The recommended dose is:

Adults and adolescents:

Apply to the area to be treated, a small amount of the medicine, with small touches, up to a maximum of 3 or 4 times a day.

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

Children from 2-6 years old: under medical control

Children under 2 years old: under strict medical control.

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

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

Wash your hands after applying the medicine.

If you use more Hurricaine gel than you should

The 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 your doctor immediately or go to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Hurricaine gel can cause side effects, although not everybody gets them.

During the period of use of benzocaine, the following side 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 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 can cause dehydration of the epithelium and hardening of the mucous membranes.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hurricaine gel

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

Do not use this medicine 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. Keep in the packaging, perfectly closed to protect it from light.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Hurricaine gel

• The active ingredient is: Benzocaine.
• The other ingredients are: Polyethylene glycol, Saccharin, Cherry flavor.

Appearance of the product and contents of the pack

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

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

1 ml of gel corresponds to 1.06 grams.

Marketing authorization holder

Laboratorios Clarben S.A.

Av. Valdelaparra 27

28108 Alcobendas, Spain.

Manufacturer

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 package leaflet was approved inMay 2021.

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