Leaflet: information for the user

BUCOSIL 5mg/5mg Lozenges, orange flavor

Dihydrochloride of chlorhexidine/Benzocaine

Read this leaflet carefully before you start taking this medicine, because 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.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

1.What is BUCOSIL and what it is used for

2.What you need to know before starting to use BUCOSIL

3.How to use BUCOSIL

4.Possible side effects

5.Storage of BUCOSIL

6.Contents of the pack and additional information

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

This medication is indicated for the symptomatic relief and temporary treatment of mild infections of the mouth and throat, such as mouth ulcers and throat irritation, which are accompanied by pain and without fever in adults and children aged 6 years and above.

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

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 cannot tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).

Warnings and precautions

Consult your doctor or pharmacist before starting to use BUCOSIL:

-if you cannot tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye),-if you have any severe or extensive injuries in the mouth,

-if you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus (tartar above the gum line),

-if you have asthma,

-if you have fillings in your incisors and if the surface of the filling or its margins are rough, as chlorhexidine may cause permanent discoloration.

-Do not use before eating or drinking.

-Do not use quantities greater than those recommended in section 3 (How to use BUCOSIL).

Maintain good oral hygiene to reduce the accumulation of tartar and the possible discoloration of the teeth that chlorhexidine may cause.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, 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 old.

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

Use in people over 65 years old

People over 65 years old and those who are debilitated may be more sensitive to benzocaine.

Other medications and BUCOSIL

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

This is especially important in the case of:

-Other mouth or throat antisetics.

-Cholinesterase inhibitors (medications for Alzheimer's disease).

-Sulfonamides (used for infections).

Anionic compounds and suspending agents (common components of toothpaste) reduce the effectiveness of chlorhexidine, so you should rinse your mouth well after using toothpaste.

Use of BUCOSIL with food and drinks

This medication cannot be used just before eating or drinking.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects on the ability to drive or operate machinery 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 him before taking this medication. It may cause caries.

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

The recommended dose is:

Adults and children over 6 years old:Slowly dissolve in the mouth1 tablet every 2 or 3 hours, if necessary, up to a maximum of 8 tablets per day.

Use in children

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

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

Geriatric patients

People over 65 years old and those with weakened health should consult their doctor, as they may be more sensitive to the effects of benzocaine.

The recommended dose is:

BUCOSIL is a buccal and pharyngeal medication, so the tablets to suck should be slowly dissolved in the mouth without chewing or swallowing them, as their action is local and only manifests when the product is in direct contact with the affected area.

Consult a doctor if symptoms worsen or do not improve after 2 days of treatment.

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

If you take more BUCOSIL than you should

The signs of overdose are: slurred speech, numbness, unsteady 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Likeall medications, this medication may produce adverse effects, although not all people will experience them.

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

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

Some people may develop alterations in the perception of taste.

In some cases, BUCOSIL may produce irritation in the mouth or at the tip of the tongue that are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.

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

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

Do not store at a temperature above 86°F (30°C).

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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Composition of BUCOSIL

-The active principles are: Dihydrochloride of chlorhexidine 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 aroma (contains maltodextrin from potato and corn and gum arabic) and orange aroma (contains maltodextrin from corn).

Appearance of the product and content of the packaging:

They are orange-flavored lozenges. This medication is presented in packs of 20 lozenges conditioned in aluminum blister packs coated with PVDC and stratified with PVC/PE/PVDC.

Holder of the marketing authorization:

Medical, S.A.

Pol. Ind. Las Quemadas, Parcela 87

14014 - Córdoba

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last review of this leaflet: September 2020

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/