Hurricane 200 mg/g oral gel

Patient Information Leaflet

Introduction

Patient Information Leaflet

Hurricaine 200 mg/g oral gel

Benzocaine

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

Follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of this leaflet

1. What Hurricaine gel is and what it is used for
2. What you need to know before using Hurricaine gel
3. How to use Hurricaine gel
4. Possible side effects
5. How to store Hurricaine gel
6. Contents of the pack and other information

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

It is a topical anesthetic that works by suppressing pain when applied externally to the affected area of the mouth.

It is indicated for the local relief of dental or mouth pain, such as that caused by denture irritation, tooth extractions, minor mouth injuries, canker sores, and small mouth ulcers in adults and children aged 6 years and older.

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

2. What you need to know before using Hurricaine gel

Do not use Hurricaine gel

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Hurricaine gel if:

• You are intolerant to other local anaesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).

• You have a severe or extensive injury in the mouth.

• Do not exceed the recommended dose stated in section 3 (How to use Hurricaine gel).

• You have asthma, bronchitis, or emphysema.

• Stop taking the medicine and contact your doctor immediately if you experience: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia.

• Elderly or debilitated patients should consult their doctor before using this medicine, as they may be more sensitive to potential adverse reactions.

• Do not swallow.

• Avoid contact with the eyes.

• Do not eat or drink while the mouth remains numb, due to the risk of biting the tongue or oral mucosa and of choking.

Using Hurricaine gel with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This medicine may interact with:

• Sulfonamides (medicines used to treat infections): should not be used at the same time as benzocaine, as it may reduce the antibacterial effect of sulfonamides.
• Medicines containing hyaluronidase: should not be used at the same time as benzocaine, as it may increase the adverse effects of benzocaine.
• Medicines containing cholinesterase inhibitors, used to treat conditions such as Alzheimer's disease, myasthenia gravis, or glaucoma, because their simultaneous use may inhibit the metabolism of benzocaine.
• Other local anaesthetics.
• In individuals sensitive to benzocaine, hair dyes containing paraphenylenediamine may cause severe contact dermatitis.

Using Hurricaine gel with food and drinks

Do not use this medicine before eating or drinking (see section Warnings and precautions).

Pregnancy and breastfeeding

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

Benzocaine should not be used during pregnancy.

It is unknown whether benzocaine is excreted in breast milk; therefore, women who are breastfeeding should not use this medicine.

Use in people aged 65 years and older

People aged 65 years and older and debilitated patients may be more sensitive to the adverse effects of benzocaine; therefore, you should consult your doctor.

Driving and using machines

Hurricaine gel has no effect on the ability to drive or operate machinery.

3. How to use Hurricaine gel

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is for administration in the mouth. It must not be swallowed.

The recommended dose is:

Adults and adolescents:

Apply a small amount of the medicine to the affected area by gentle touches, up to 3 or 4 times a day.

Children aged 6–12 years: only under adult supervision, as in the case above.

Children aged 2–6 years: under medical supervision.

Children under 2 years: under strict medical supervision.

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

If your condition worsens or if 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

Signs of overdose may include: bluish discoloration of the skin, slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, and 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 Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Hurricaine gel can cause adverse effects, although not everyone will experience them.

During the period of use of benzocaine, the following adverse effects have been reported, although their frequency cannot be precisely determined:

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

Sensation of oral burning.

Methemoglobinemia (symptoms include: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia).

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es.

By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required. Keep the container tightly closed to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Hurricaine gel

• The active substance is: Benzocaine.
• The other components are: Polyethylene glycol, Saccharin, Cherry flavour.

Appearance of the product and contents of the pack

Hurricaine gel is a viscous, cinnamon-coloured gel with a cherry scent.

It is available in 6 ml polyethylene tubes and in 30 ml and 50 ml polyethylene bottles with polypropylene caps (clinical pack) of gel.

1 ml of gel corresponds to 1.06 g.

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 leaflet was approved in May 2021.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/