Bucomax with lidocaine lozenges for sucking honey and lemon flavour

Patient Information Leaflet

Introduction

Patient Information Leaflet

bucomax with lidocaine lozenges with honey and lemon flavour

lidocaine hydrochloride / amylmetacresol / 2,4-dichlorobenzyl alcohol

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

Follow exactly the instructions for use provided in this leaflet or those given 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 should consult a doctor if your condition worsens or does 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 are suspected of having 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 as if choking) while eating or drinking. 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 alter 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 should consult your doctor.

Do not exceed the maximum recommended dose.

Children and adolescents

This medicine is contraindicated in children under 12 years of age. bucomax with lidocaine is intended for use in adults and adolescents aged 12 years and older.

Taking bucomax with lidocaine with other medicines

Inform your doctor or pharmacist if you are 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 dosage adjustments may be necessary:

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

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

Taking bucomax with lidocaine with food, drinks, and alcohol

This medicine should not be used 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 or 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 is no available data on fertility.

Driving and use of machines

Observe how you react to the medicine. At the recommended doses, drowsiness or reduced reaction ability is 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; therefore, it is essentially "sodium-free".

bucomax with lidocaine contains sunset yellow

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

3. How to take bucomax with lidocaine

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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.

Slowly dissolve one lozenge 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 increased or irregular heart rate, elevated 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 occur.

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 for more than 5 days is not recommended, as it may alter the natural microbial balance of the throat.

Prolonged use at high doses 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 can 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 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, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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 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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to 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 lozenge contains the following active substances:

Lidocaine hydrochloride 2.00 mg.

Amylmetacresol 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 dye (E-110), lemon flavouring, and honey aroma.

Appearance of the product and contents of the pack

bucomax with lidocaine is presented as cylindrical, biconvex yellow lozenges with honey and lemon flavour.

Each pack 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 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/