BUCOMAX WITH LIDOCAINE ORANGE FLAVORED LOZENGES

Introduction

Package Leaflet: Information for the User

bucomax with lidocaine orange flavor lozenges

lidocaine hydrochloride / amylmetacresol / 2,4-dichlorobenzyl alcohol

Read this entire leaflet carefullybefore starting to take thismedication, as it contains important informationforyou.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience 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 it worsens or does not improve after 2 days of treatment.

Contents of the Package Leaflet

1. What bucomax with lidocaine is and what it is used for.
2. What you need to know before taking bucomax with lidocaine.
3. How to take bucomax with lidocaine.
4. Possible side effects.
5. Storage of bucomax with lidocaine.
6. Package Contents and Additional Information.

1. What bucomax with lidocaine is and what it is used for

bucomax with lidocaine belongs to the group of medications called antiseptics.

bucomax with lidocaine is an association of two antiseptics, 2,4-dichlorobenzyl alcohol and amylmetacresol, and a local anesthetic for the throat, lidocaine hydrochloride.

It is used for the local symptomatic relief of mild mouth and throat infections with pain and without fever in adults and adolescents from 12 years old.

You should consult a doctor if it worsens or does not improve after 2 days.

2. What you need to know before taking bucomax with lidocaine

Do not takebucomax with lidocaine:

• If you are allergic to 2,4-dichlorobenzyl alcohol, amylmetacresol, lidocaine hydrochloride, or any of the other components of this medication (listed in section 6).
• If you are under 12 years old.
• If you have suffered an allergy to local anesthetics.
• If you have had or are suspected of having methemoglobinemia.
• If you have had an asthma attack or bronchospasm.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take bucomax with lidocaine:

• If you have asthma.
• The anesthesia caused by this medication at the throat level can favor false routes (coughing during a meal, feeling like choking), while eating. This medication should not be used before meals or before drinking.
• Prolonged use of this medication for more than 5 days is not recommended because it can modify the natural microbial balance of the throat.
• Do not exceed the maximum recommended dose. If you take it in large quantities or repeatedly, this medication can act on the heart and nervous system, with the possibility of seizures.
• Elderly, sick, or debilitated people should consult their doctor before taking this medication, as they are more sensitive to its possible adverse reactions.

If it does not improve, if it worsens after 2 days of treatment, or if you have a high fever, headache, nausea, or vomiting, you should consult your doctor.

Do not exceed the maximum recommended dose.

Children and Adolescents

Children under 12 years old should not take this medication; it is contraindicated. This medication is indicated for adults and adolescents from 12 years old.

Taking bucomax with lidocaine with other medications

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

And in particular, if you are taking any of the following medications, as it may be necessary to modify the dose of any of them:

• Beta-blocker medications (for heart treatment or for treating arterial diseases) and medications such as cimetidine (for treating stomach ulcers).
• Other local anesthetics (amino amide type).
• Medications for cardiac rhythm disorders, such as mexiletine or procainamide.
• Medications such as fluvoxamine (for treating depression).
• Antibiotics such as erythromycin and itraconazole.

You should not take other buccopharyngeal antiseptics (medications for mild throat infections, such as bucomax with lidocaine) if you are taking this medication, although interactions are not expected.

Taking bucomax with lidocaine with food, drinks, and alcohol

This medication should not be used before meals or before drinking.

During treatment with this medication, consumption of alcoholic beverages should be avoided.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy:

Consult your doctor or pharmacist before using any medication.

The use of this medication during pregnancy is not recommended.

Breastfeeding:

Consult your doctor or pharmacist before using any medication.

Fertility:

No data are available on fertility.

Driving and Using Machines

Observe your response to the medication. At the recommended doses, drowsiness or decreased reaction ability is not expected, but if it occurs, do not drive or use hazardous machinery.

bucomax with lidocaine contains isomalt and maltitol

This medication contains isomalt (E-953) and maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

bucomax with lidocaine contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per lozenge; it is essentially "sodium-free".

bucomax with lidocaine contains orange yellow and cochineal red

This medication may cause allergic reactions because it contains orange yellow (E-110) and cochineal red (E-124). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains terpenes provided by levomenthol, which, in excessive doses, can cause seizures in young children (under 6 years old), although at the doses and route of administration used in this medication, the absorption and activity of the terpenes are very low.

3. How to take bucomax with lidocaine

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

The recommended dose is:

Adults and adolescents from 12 years old: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours.

Use in Children

This medication is contraindicated in children under 12 years old.

How to take bucomax with lidocaine:

Buccopharyngeal use, to dissolve in the mouth.

Let a lozenge dissolve slowly in the mouth. Do not swallow, chew, or bite.

If it does not improve, if it worsens after 2 days of treatment, or if you have a high fever, headache, nausea, or vomiting, you should consult your doctor.

If you take more bucomax with lidocaine than you should

It may cause an increase or alteration of the normal heart rhythm, increased blood pressure, sedation, alteration of breathing during sleep, unconsciousness, cardiovascular collapse, insomnia, hallucinations, tremors, and epileptic seizures (symptoms of depression or stimulation of the central nervous system). Drowsiness may be a symptom of overdose. In children, agitation may appear.

In case of accidental ingestion of large quantities, you may experience gastrointestinal discomfort, blurred vision, ringing in the ears, and drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Prolonged use of this medication, more than 5 days, is not recommended because it can modify the natural microbial balance of the throat.

Use in large doses and for long periods in children can cause seizures.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Very Rare Side Effects(may affect up to 1 in 10,000 people): allergic reactions (hypersensitivity) such as redness, itching, or swelling of the skin (rash), or burning, itching, or swelling of the mouth or throat.

Side Effects with Unknown Frequency(cannot be estimated from available data): abdominal pain, nausea, or oral discomfort.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of bucomax with lidocaine

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of bucomax with lidocaine

Each lozenge contains the active ingredients

Lidocaine hydrochloride 2.00 mg.

Amilmetacresol 0.60 mg.

2,4-Dichlorobenzyl alcohol 1.20 mg.

The other components (excipients) are: levomenthol, sodium saccharin (E-954), isomalt (E-953), maltitol (E-965), orange-yellow coloring (E-110), cochineal red coloring (E-124), citric acid monohydrate (E-330), and orange flavor.

Appearance of the Product and Package Contents

bucomax with lidocaine is presented in the form of orange, cylindrical, biconvex lozenges with an orange flavor.

Each package contains 8 or 24 lozenges.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

LOZY'S PHARMACEUTICALS, S.L.

Campus Empresarial s/n

31795 Lekaroz (Navarra)

SPAIN

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:December 2019

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/