TOPIGEL 200 mg/g BUCAL GEL

2. What you need to know before starting to use Topigel

Do not use Topigel

• 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 Topigel

• 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 injury in the mouth.
• Do not take doses higher than recommended in section 3 (How to take Topigel).
• 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.

• Elderly or debilitated patients should consult their doctor before taking this medication, as they are more sensitive to its possible adverse reactions.

Interaction with Other Medications

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

This medication may interact with:

• Sulfonamides (medication to treat infections): should not be used at the same time as benzocaine, as it may decrease 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 when used at the same time, it inhibits the metabolism of benzocaine
• Other local anesthetics.
• In people sensitive to benzocaine, hair dyes of the paraphenylenediamine type can cause severe contact dermatitis.

Use of Topigel with Food and Drinks

Do not use this medication 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 medication.

Do not use benzocaine during pregnancy.

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

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 Topigel

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

This medication is for administration in the mouth. Do not swallow.

The recommended dose is:

Adults and adolescents:

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

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

Children 2-6 years old: under medical control

Children under 2 years old: under strict medical control.

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 Topigel Than You Should

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 can also decrease blood pressure.

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

4. Possible Side Effects

Like all medications, Topigel can cause side effects, although not all people experience them.

During the use of benzocaine, the following side effects have occurred, whose frequency cannot be established with certainty:

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 mucous membranes can cause dehydration of the epithelium and hardening of the mucous membranes.

Reporting Side Effects

If you experience any type of side effect, 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 Medication Surveillance System website:

www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Topigel

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

Do not use this medication after the expiration date shown 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 the packaging perfectly closed to protect it from light.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications 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 medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Topigel

? The active ingredient is: Benzocaine.

? The other components are: Polyethylene glycol, Saccharin, Cherry flavor.

Appearance of the Product and Package Contents

Topigel is a viscous gel with a cinnamon color and cherry flavor.

It comes in a polyethylene tube of 11.25g and 33.75g of gel.

Marketing Authorization Holder

Laboratorios Clarben S.A.

Av Valdelaparra 27

28108 Alcobendas, Spain.

Manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

28923 Alcorcón (Madrid), Spain

This Package Leaflet was Approved in

December 2013

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