Leaflet: information for the user

Bucomax lozenges, peppermint flavor

Amilmetacresol / 2,4-dichlorobenzoic alcohol

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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.
• Ifyou 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 you get worse or do not improveafter 2 days of treatment.

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

2. What you need to know before starting to take bucomax.

3. How to take bucomax.

4. Possible side effects.

5. Storage of bucomax.

6. Contents of the pack and additional information.

bucomaxbelongs to a group of medicines called antiseptics.

It is used for the local symptomatic relief of mild infections of the mouth and throat that do not cause fever in adults and children aged 6 years and above.

Consult a doctor if it worsens or does not improve after 2 days.

Do not take bucomax

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take bucomax.

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

Do not exceed the maximum recommended dose.

Children

It should not be used in children under 6 years.

Taking bucomax with other medications

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

Do not take other buccal and pharyngeal antiseptics (medications for mild throat infections such as bucomax) while taking this medication, although interactions are not expected.

Pregnancy, breastfeeding, and fertility

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.

Driving and operating machines

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

Bucomax lozenges with peppermint 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 with peppermint 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, at excessive doses, may cause convulsions in young children (under 6 years), although at the doses and administration route used in this medication, the absorption and activity of the terpenes are very low.

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

The recommended dose is:

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

Children

Children aged 6 years and above: 1 tablet every 2 or 3 hours, as needed, up to a maximum of 4 tablets in 24 hours.

Not recommended for children under 6 years.

How to take bucomax

Buccal use, to dissolve in the mouth.

Leave a tablet to dissolve slowly in the mouth. Do not swallow, chew, or bite.

If symptoms persist for more than 2 days, worsen, or are accompanied by high fever, headache, nausea, or vomiting, you must consult your 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 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 all people may experience them.

Very Rare Adverse 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, stinging, or swelling of the mouth or throat.

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

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of sightand out of reachof children.

This medication does not require special conditions for conservation.

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 disposed of through drains or inthe trash. Disposeof the packaging and medications you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition of bucomax chewing tablets, peppermint flavor

• The active principles are:

Amilmetacresol 0.60 mg

2,4-Dichlorobenzoic alcohol 1.20 mg

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

Appearance of the product and content of the packaging

bucomax chewing tablets, peppermint flavor are cylindrical tablets, green in color with a peppermint flavor.

Each package contains 8 or 24 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

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

Last review date of this leaflet: December 2019

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