Bucomax with lidocaine orange-flavoured pastilles for sucking

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

bucomax with lidocaine oral lozenges, orange flavour

lidocaine hydrochloride / amylmetacresol / 2,4-dichlorobenzyl alcohol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine 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 any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.
• You must consult a doctor if you worsen or do not improve after 2 days of treatment.

Leaflet contents

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 adverse effects.
5. How to store bucomax with lidocaine.
6. Contents of the pack and other information.

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

Bucomax with lidocaine belongs to a group of medicines called antiseptics.

Bucomax with lidocaine is a combination 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 associated with pain and without fever in adults and adolescents aged 12 years and older.

You should consult a doctor if symptoms worsen or do not improve after 2 days.

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

Do not take bucomax with lidocaine:

• If you are allergic to 2,4-dichlorobenzyl alcohol, amylmetacresol, lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• If you are under 12 years of age.
• If you have had an allergic reaction to local anesthetics.
• If you have suffered from or suspect you have methemoglobinemia.
• If you have experienced asthma attacks or bronchospasm.

Warnings and precautions

Talk to your doctor or pharmacist before taking bucomax with lidocaine:

• If you suffer from asthma.
• The anesthesia caused by this medicine in the throat area may increase the risk of aspiration (coughing during meals, feeling like choking) while eating. This medicine should not be used before meals or before drinking.
• Prolonged use of this medicine for more than 5 days is not recommended, as it may disrupt the natural microbial balance of the throat.
• Do not exceed the maximum recommended dose. If taken in large amounts or repeatedly, this medicine may enter the bloodstream and affect the heart and nervous system, potentially causing seizures.
• Elderly, ill, or weakened individuals should consult their doctor before taking this medicine, as they may be more sensitive to possible adverse reactions.

If your symptoms do not improve, worsen after 2 days of treatment, or if you develop high fever, headache, nausea, or vomiting, you must consult your doctor.

Do not exceed the maximum recommended dose.

Children and adolescents

Children under 12 years of age must not take this medicine, as it is contraindicated. This medicine is intended for adults and adolescents aged 12 years and older.

Taking bucomax with lidocaine with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

In particular, inform them if you are taking any of the following medicines, as it may be necessary to adjust the dose of one or more of them:

• Beta-blockers (used to treat heart conditions or arterial diseases) and medicines such as cimetidine (used to treat stomach ulcers).
• Other local anesthetics (amide-type).
• Medicines used for heart rhythm disorders, such as mexiletine or procainamide.
• Medicines such as fluvoxamine (used to treat depression).
• Antibiotics such as erythromycin and itraconazole.

Do not take other oropharyngeal antiseptics (medicines for mild throat infections like bucomax with lidocaine) while taking this medicine, although interactions are not expected.

Taking bucomax with lidocaine with food, drinks, and alcohol

Do not use this medicine before meals or before drinking.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

The use of this medicine during pregnancy is not recommended.

Breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Fertility:

There are no data available regarding fertility.

Driving and using machines

Observe how you react to the medication. At the recommended doses, drowsiness or reduced reaction ability are not expected; however, if such effects occur, do not drive or operate dangerous machinery.

bucomax with lidocaine contains isomalt and maltitol

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

bucomax with lidocaine contains sodium

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

bucomax with lidocaine contains sunset yellow and cochineal red

This medicine may cause allergic reactions as it contains sunset yellow (E-110) and cochineal red (E-124). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take bucomax with lidocaine

Follow exactly the dosage instructions for the medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 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 medicine is contraindicated in children under 12 years of age.

How to take bucomax with lidocaine:

Oropharyngeal use, to be dissolved in the mouth.

Allow one lozenge to dissolve slowly in the mouth. Do not swallow, chew, or bite it.

If symptoms do not improve, worsen after 2 days of treatment, or if you develop high fever, headache, nausea, or vomiting, you must consult your doctor.

If you take more bucomax with lidocaine than you should

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

In case of accidental ingestion of large amounts, gastrointestinal discomfort, blurred vision, tinnitus (ringing in the ears), and drowsiness may be experienced.

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

Prolonged use of this medicine, beyond 5 days, is not recommended, as it may alter the natural microbial balance of the throat.

The use of high doses over long periods in children may cause seizures.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Adverse effects with unknown frequency (cannot be estimated from the available data): abdominal pain, nausea, or oral discomfort.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of bucomax with lidocaine

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of bucomax with lidocaine

Each pastille contains the following active substances:

Hydrochloride lidocaine 2.00 mg.

Amylmetacresol 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 colour (E-110), carmine red colour (E-124), citric acid monohydrate (E-330) and orange flavour.

Appearance of the product and contents of the pack

bucomax with lidocaine is presented as cylindrical, biconvex pastilles, orange in colour and with an orange flavour.

Each pack contains 8 or 24 pastilles.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 most recent review of this leaflet: December 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/