Patient Information Leaflet

Normobucal 200 mg/ml Oral Solution for Buccal Administration

Benzocaine

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

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

1. What is Normobucal and what it is used for

2. What you need to know before using Normobucal

3. How to use Normobucal

4. Possible side effects

5. Storage of Normobucal

6. Contents of the pack 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 mouth wounds, aphthae, 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.

No use Normobucal

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Normobucal.

• If you do not tolerate other local anesthetics such as p-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 Normobucal).
• 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, frail patients 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 your tongue or buccal mucosa and choking.
• In people over 65 years and in debilitated patients, the risk of developing methemoglobinemia is increased.
• Young children (especially those under 2 years) also have a higher risk of developing methemoglobinemia.

If symptoms worsen, or if they persist after 2 days of treatment, consult your doctor.

Children

The use of this medication is not indicated in children under 6 years, as its efficacy and safety have not been established in this age group.

Use of Normobucal with other medications

Inform your doctor or pharmacist if you are taking, have taken 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, as using them at the same time may inhibit the metabolism of benzocaine.
• Other local anesthetics. There may be cross-reactivity of sensitization, including anaphylaxis (unusual or excessive allergic reaction), between benzocaine and other local anesthetics of the ester type, sulfonamides, thiazides, para-amin colorants, glyceryl p-aminobenzoate (glyceryl PABA), p-aminobenzoic acid, p-aminosalicylic acid, and mepricaine.
• In people sensitive to benzocaine, hair dyes of the paraphenylenediamine type may cause severe contact dermatitis.
• Pancreatic puncture test (diagnostic test): Benzocaine should not be used 72 hours before the pancreatic puncture test with bentiromide, as there may be interference with the test results.

Use of Normobucal 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, think you may be pregnant, or intend 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 and debilitated patients may be more sensitive to the adverse effects of benzocaine, so they should consult with their doctor.

Driving and operating machinery

Normobucal does not affect driving or operating machinery.

Normobucal contains ethanol

This medication contains 47% ethanol (alcohol), which corresponds to 38.8mg/pulse.

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

This medication is to be administered in the mouth. It should not be ingested.

Each pulse is approximately equivalent to 20 mg of benzocaine.

The recommended dose is:

Adults, adolescents, and children aged 6 years and above

Apply one pulse to the area to be anesthetized, or soak a cotton swab and keep it applied to the area for a few minutes. Apply a maximum of 3 or 4 times a day.

In children (6 to under 12 years of age), the administration of this medication should only be performed under the supervision of an adult. The dose is the same as in the previous case.

Weak and elderly patients

The dose should be reduced, as elderly and weakened patients may be more sensitive to the systemic toxicity of benzocaine. Apply to the area to be anesthetized up to 2 or 3 times a day.

Remove the cap and place the applicator cannula on the valve. Press the trigger for half a second, directing the applicator cannula towards the area to be anesthetized, or soak a cotton swab with several pulses and keep it in contact with the area to be anesthetized for several minutes. Wash your hands after each application.

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 your doctor.

If you use more Normobucal than you should

No cases of overdose have been reported.

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.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

During the period of use of benzocaine, the following adverse effects have been reported, 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. Methemoglobinemia is mainly due to prolonged use and also in cases of overdose. The risk of developing methemoglobinemia is increased in people with asthma, bronchitis, and emphysema, as well as in people over 65 years old and young children (especially those under 2 years old), and in people with congenital defects including glucose-6-phosphate dehydrogenase deficiency, hemoglobin-M disease, ADH-metahemoglobin reductase deficiency, and pyruvate kinase deficiency.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require special conservation conditions.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Normobucal

• The active principle is benzocaine, each milliliter contains 200 mg of benzocaine.
• The other components (excipients) are: Sodium saccharin (E-954), Polyethylene glycol 400, 96° ethanol, and Strawberry flavor.

Appearance of the product and contents of the packaging

Normobucal is a transparent, colorless, or light yellow solution.

It is presented in aluminum bottles with 5 ml or 60 ml of oral spray solution, the packaging contains the bottle with a cap, an applicator cannula with a trigger, and a leaflet.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet:May 2018

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