Prospect: information for the user

Bucomax with lidocaine lozenges for orange flavor

Lidocaine hydrochloride / amylmetacresol / 2,4-dichlorobenzoic alcohol

Read this prospect carefullybefore starting to take thismedicine, because it contains important informationforyou.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• Ifyou experience adverse effects, consult your doctor, pharmacist or nurse,even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improveafter 2 days of treatment.

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

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

3. How to take bucomax with lidocaine.

4. Possible adverse effects.

5. Storage of bucomax with lidocaine.

6. Contents of the package and additional information.

bucomax with lidocaine belongs to the group of medications known as antiseptics.

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

It is used for the local symptomatic relief of mild infections of the mouth and throat that are accompanied by pain and without fever in adults and adolescents 12 years of age and older.

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

Do not takebucomax with lidocaína:

• If you are allergic to alcohol 2,4-diclorobencílico, amilmetacresol, lidocaína hydrochloride, or any of the other components of this medication(including in section 6).
• If you are under 12 years old.
• If you have had an allergy to local anesthetics.
• If you have had or suspect you have metaglobinemia.
• If you have had an asthma attack or bronchospasm.

Warnings and precautions

Consult your doctororpharmacist before starting to take bucomax with lidocaína:

• If you have asthma.
• The anesthesia caused by this medication at the level of the throat may favor false ways (coughing during a meal, having the impression of choking), while eating food. Do not use this medication before meals or before drinking.
• The prolonged use of this medication for more than 5 days is not recommended because it may 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, when it passes into the bloodstream, may act on the heart and the nervous system with the possibility of seizures occurring.
• Older, sick, or weakened 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 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 12 years old and above.

Taking bucomax with lidocaína with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have 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 one of them:

• Beta-blockers (to treat the heart or to treat arterial diseases) and medications such as cimetidine (to treat stomach ulcers).
• Other local anesthetics (type amida).
• Medications indicated for cardiac rhythm disorders such as mexiletine or procainamide.
• Medications such as fluvoxamine (to treat depression).
• Antibiotics such as erythromycin and itraconazole.

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

Taking bucomax with lidocaína with food, drinks, and alcohol

You should not use this medication 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 intend 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 is available on fertility.

Driving and operating machinery

Observe your response to the medication. At the recommended doses, drowsiness or a decrease in reaction capacity is not expected, but if so, do not drive or operate hazardous machinery.

bucomax with lidocaína contains isomalta and maltitol

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

bucomax with lidocaína contains sodium

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

bucomax with lidocaína contains yellow orange and red cochineal

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

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

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

The recommended dose is:

Adults and adolescents 12 years and older: 1 tablet every 2 or 3 hours, as needed, up to a maximum of 8 tablets in 24 hours.

Use in children

This medication is contraindicated in children under 12 years.

How to take bucomax with lidocaine:

Oral buccal use, to dissolve in the mouth.

Leave a tablet to 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 has high fever, headache, nausea, or vomiting; you must consult the doctor.

If you take morebucomax with lidocainethan you should

You may experience 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 seizures (symptoms of central nervous system depression or stimulation). 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 Toxicological 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 may modify the natural microbial balance of the throat.

The use of large doses and prolonged periods of time in children may cause seizures.

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

Like all medications,this medicationmay cause adverse effects, although not all people will 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, consultyour doctororpharmacist,even if they are adverse effects not listed 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 not listed 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 about the safety of this medication.

Keepthis medicationout of sightand out of reachof children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and unused medications at the SIGREcollection pointat the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment..

Composition of bucomax with lidocaine

Each lozenge contains the active principles

Lidocaine hydrochloride2.00 mg.

Amilmetacresol0.60 mg.

2,4-Dichlorobenzoic alcohol1.20 mg.

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

Appearance of the product and content of the packaging

bucomax with lidocaineis presented in the form of cylindrical, biconvex lozenges, orange in color and orange flavored.

Each package contains 8 or 24 lozenges.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

LOZY'S PHARMACEUTICALS, S.L.

Business Campus s/n

31795 Lekaroz (Navarra)

SPAIN

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

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/