BUCOSIL 5 MG/5 MG LOZENGES ORANGE FLAVORED

Introduction

Leaflet: information for the user

BUCOSIL 5mg/5mg Orange Flavored Lozenges

Chlorhexidine Dihydrochloride/Benzocaine

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you

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

• Keep this 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 or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the leaflet:

1. What BUCOSIL is and what it is used for
2. What you need to know before taking BUCOSIL
3. How to take BUCOSIL
4. Possible side effects
5. Storage of BUCOSIL
6. Package contents and additional information

1. What BUCOSIL is and what it is used for

Chlorhexidine and benzocaine, the active ingredients of this medication, act by combining the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medication is indicated for the symptomatic and temporary relief of mild infectious processes of the mouth and throat, such as oral aphthae and throat irritation, which occur with pain and 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 BUCOSIL

Do not use BUCOSIL

• If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).

• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component).

Warnings and precautions

Consult your doctor or pharmacist before starting to use BUCOSIL:

• if you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component),
• if you have any severe or extensive injury in the mouth,
• if you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus (tartar that appears above the gums),
• if you have asthma,
• if you have fillings on your incisors and if the surface of the filling or its edges are rough, as chlorhexidine can cause a permanent discoloration.
• Do not use before eating or drinking.
• Do not use more than the recommended amounts in section 3 (How to take BUCOSIL).

Maintain good oral hygiene to reduce the accumulation of tartar and possible tooth discoloration that may be caused by chlorhexidine.

Interference with analytical tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are using this medication, as it may alter the results.

This medication may interact with pancreatic function tests that use bentiromide. Do not use this medication at least 3 days before the test and inform your doctor.

Children

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

Between 6 and 12 years, children can only use it under adult supervision.

Use in people over 65 years of age

People over 65 years of age and debilitated patients may be more sensitive to benzocaine.

Other medications and BUCOSIL

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Cholinesterase inhibitors (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Anionic compounds and suspending agents (common components of toothpastes) reduce the effectiveness of chlorhexidine, so the mouth should be rinsed well after using toothpaste.

Using BUCOSIL with food and drinks

This medication cannot be used immediately before eating or drinking.

Pregnancy and breastfeeding

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

No effects on the ability to drive or use machines have been described.

BUCOSIL contains glucose

This medication contains glucose (in maltodextrin from potato and corn). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause cavities.

3. How to take BUCOSIL

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

The recommended dose is:

Adults and children over 6 years:Dissolve slowly in the mouth 1 lozenge every 2 or 3 hours, if necessary, up to a maximum of 8 lozenges per day.

Use in children

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

Between 6 and 12 years, children can only use it under adult supervision.

Elderly patients

People over 65 years of age and debilitated patients should consult their doctor, as they may be more sensitive to the effects of benzocaine.

The recommended dose is:

BUCOSIL is a medication for buccopharyngeal use, so the lozenges should be dissolved slowly in the mouth without chewing or swallowing, as its action is local and only manifests when the product is in direct contact with the affected area.

You should consult a doctor if it worsens or does not improve after 2 days of treatment.

If you notice that after 2 days of starting treatment you have a fever, headache, nausea, or vomiting, you should consult your doctor as soon as possible.

If you take more BUCOSIL than you should

Signs of overdose are: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, increased sweating, and/or low blood pressure.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The side effects that may occur, whose frequency has not been determined with precision, are:

Possible tooth discoloration. This pigmentation or discoloration can occur especially in people who have tartar buildup. This alteration of tooth color is not permanent and can be eliminated through a dental cleaning. The color of fillings can also be altered, in which case this discoloration can be permanent.

Some people may develop alterations in taste perception.

In some cases, BUCOSIL can cause irritation in the mouth or on the tip of the tongue, which are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of BUCOSIL

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

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6. Package contents and additional information

BUCOSIL composition

• The active ingredients are: Chlorhexidine Dihydrochloride 5 mg and Benzocaine 5 mg.
• The other components (excipients) are: Mannitol (E 421), Microcrystalline Cellulose (E 460), Povidone, Magnesium Stearate, Sodium Cyclamate, Sodium Saccharin (E 954), Menthol Flavor (contains Maltodextrin from Potato and Corn and Gum Arabic) and Orange Flavor (contains Maltodextrin from Corn).

Appearance of the product and package contents:

They are orange-flavored lozenges. This medication is presented in packages of 20 lozenges packaged in aluminum blisters coated with PVDC and layered with PVC/PE/PVDC.

Marketing authorization holder:

Medical, S.A.

Pol. Ind. Las Quemadas, Parcela 87

14014 - Córdoba

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last revision of this leaflet: September 2020

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/