BUCOMAX WITH LIDOCAINE LOZENGES HONEY & LEMON FLAVOR

Introduction

Leaflet: Information for the user

bucomax with lidocaine lozenges with honey and lemon flavor

lidocaine hydrochloride / amylmetacresol / 2,4-dichlorobenzyl alcohol

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

Follow exactly the administration instructions of 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 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 of age.

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 of age.
• If you have suffered an allergy to local anesthetics.
• If you have had or are suspected of having methemoglobinemia.
• If you have suffered 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 the 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 of age should not take this medication; it is contraindicated. This medication is indicated for adults and adolescents from 12 years of age.

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 stomach ulcer treatment).
• Other local anesthetics (amido type).
• Medications for cardiac rhythm disorders, such as mexiletine or procainamide.
• Medications such as fluvoxamine (for depression treatment).
• 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, you should avoid consuming alcoholic beverages.

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, it is not expected to cause drowsiness or a decrease in reaction capacity, but if it does, 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; that is, it is essentially "sodium-free".

bucomax with lidocaine contains yellow-orange colorant

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

3. How to take bucomax with lidocaine

Follow exactly the administration instructions of 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 of age: 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 of age.

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 notice 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 ingested.

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

The 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 may 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 the 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 the sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be thrown away in drains or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of 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 bucomax with lidocaine

Each lozenge contains the active ingredients:

Lidocaine hydrochloride 2.00 mg.

Amymetacresol 0.60 mg.

2,4-Dichlorobenzyl alcohol 1.20 mg.

The other components (excipients) are: peppermint essential oil, quinoline yellow (E-104), sodium saccharin (E-954), tartaric acid (E-334), isomalt (E-953), maltitol (E-965), yellow-orange colorant (E-110), lemon essence, and honey flavor.

Appearance of the product and package contents

bucomax with lidocaineis presented in the form of cylindrical, biconvex lozenges, yellow in color, and with a honey and lemon 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/