BUCOMAX LOZENGES MINT FLAVOR

Introduction

Package Leaflet: Information for the User

bucomax lozenges for sucking mint flavor

amilmetacresol / 2,4-dichlorobenzyl alcohol

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

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

• Keep this package 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 side effects not listed in this package 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 is and what it is used for.
2. What you need to know before taking bucomax.
3. How to take bucomax.
4. Possible side effects.
5. Storage of bucomax.
6. Package contents and additional information.

1. What bucomax is and what it is used for

bucomaxbelongs to the group of medications called antiseptics.

It is used for the local symptomatic relief of mild mouth and throat infections that occur without fever in adults and children from 6 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

Do not takebucomax

• If you are allergic to amilmetacresol, 2,4-dichlorobenzyl alcohol, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take bucomax.

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

Do not exceed the recommended maximum dose.

Children

It should not be used in children under 6 years of age.

Taking bucomax with other medications

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

Do not take other buccal antiseptics (medications for mild throat infections like bucomax) if you are taking this medication, although interactions are not expected.

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.

Driving and using machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

bucomax lozenges for sucking mint flavor contain sodium.This medication contains less than 23 mg of sodium (1 mmol) per lozenge; that is, it is essentially "sodium-free".

bucomax lozenges for sucking mint flavor contain isomalt and maltitol.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains terpenes provided by levomenthol, which, in excessive doses, can cause convulsions in small children (under 6 years of age), 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

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.

The recommended dose is:

Adults:1 lozenge every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours.

Children

Children from 6 years of age: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 4 lozenges in 24 hours.

It is not recommended for children under 6 years of age.

How to take bucomax

Buccal use, to dissolve in the mouth.

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

If the discomfort persists for more than 2 days, worsens, or is accompanied by high fever, headache, nausea, or vomiting, you should consult a doctor as soon as possible.

If you take morebucomaxthan you should

In case of ingestion of large quantities, you may experience gastrointestinal discomfort.

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.

If you have any other questions 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 the available data): abdominal pain, nausea, or oral discomfort.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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

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 "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or 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 lozenges for sucking mint flavor

• The active ingredients are:

Amilmetacresol 0.60 mg

2,4-Dichlorobenzyl alcohol 1.20 mg

• The other ingredients are: peppermint essential oil, star anise essential oil, levomenthol, carmine indigo colorant (E-132), quinoline yellow (E-104), sodium saccharin (E-954), tartaric acid (E-334), isomalt (E-953), and maltitol (E-965).

Appearance of the product and package contents

bucomaxlozenges for sucking mint flavor are cylindrical lozenges, green in color with a mint flavor.

Each package contains 8 or 24 lozenges.

Only some package sizes may be marketed.

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.

Campo 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 package 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