Bucosil 5 mg/5 mg orodispersible tablets orange flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BUCOSIL 5mg/5mg Orodispersible tablets, orange flavour

Dihydrochloride of chlorhexidine/Benzocaine

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

Follow exactly the instructions for taking this medicine contained in this leaflet or those provided 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 2 days.

Contents of the leaflet:

1. What BUCOSIL is and what it is used for
2. What you need to know before using BUCOSIL
3. How to use BUCOSIL
4. Possible adverse effects
5. How to store BUCOSIL
6. Contents of the pack and other information

1. What BUCOSIL is and what it is used for

Chlorhexidine and benzocaine, the active ingredients in this medicine, work by combining the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medicine is indicated for the symptomatic and temporary relief of mild infectious conditions of the mouth and throat, such as mouth ulcers and sore throat, which are accompanied by pain and without fever, in adults and children aged 6 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 using BUCOSIL

Do not use BUCOSIL

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

• If you do not 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 do not tolerate other local anaesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye),
• if you have a severe or extensive oral lesion,
• if you suffer from periodontitis (gum disease), since chlorhexidine may increase supragingival calculus formation (tartar appearing above the gums),
• if you have asthma,
• if you have fillings in your incisor teeth and the filling surface or its margins are rough, since they may become permanently discoloured with chlorhexidine.
• Do not use immediately before eating or drinking.
• Do not use amounts exceeding those recommended in section 3 (How to use BUCOSIL).

Maintain adequate oral hygiene to reduce tartar buildup and possible tooth discolouration that chlorhexidine may cause.

Interference with diagnostic tests

If you are due to undergo any diagnostic tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter test results.

This medicine may interfere with pancreatic function tests using bentiromide. Do not use this medicine at least 3 days prior to the test and inform your doctor.

Children

This medicine must not be used in children under 6 years of age.

Children between 6 and 12 years of age should only use it under adult supervision.

Use in patients over 65 years of age

Patients over 65 years of age and those who are debilitated may be more sensitive to benzocaine.

Other medicines and BUCOSIL

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

This is especially important in the case of:

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

Anionic compounds and suspending agents (common components of toothpastes) reduce the effectiveness of chlorhexidine; therefore, rinse your mouth thoroughly after using toothpaste.

Use of BUCOSIL with food and beverages

This medicine must not be used immediately before eating or drinking.

Pregnancy and breastfeeding

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.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

BUCOSIL contains glucose

This medicine contains glucose (in maltodextrin derived from potato and maize). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

3. How to take BUCOSIL

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 again.

The recommended dose is:

Adults and children over 6 years of age: Slowly dissolve 1 tablet in the mouth every 2 or 3 hours, if necessary, up to a maximum of 8 tablets per day.

Use in children

This medicine must not be used in children under 6 years of age.

Children between 6 and 12 years of age should only use this medicine under adult supervision.

Elderly patients

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

The recommended dose is:

BUCOSIL is a medicine intended for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing them, since its action is local and only becomes effective when the product is in direct contact with the affected area.

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

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

If you take more BUCOSIL than you should

Signs of overdose may include: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or seizures, 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

The possible adverse effects that may occur, whose frequency has not been accurately determined, are:

Possible tooth staining. This pigmentation or discoloration may occur especially in individuals who have accumulations of plaque or tartar. This change in tooth color is not permanent and can be removed by professional dental cleaning. The color of dental fillings may also be altered; in such cases, this discoloration may be permanent.

Some individuals may develop altered taste perception.

In some cases, BUCOSIL may cause irritation in the mouth or at the tip of the tongue, which is usually temporary, as well as allergic reactions to chlorhexidine or benzocaine.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BUCOSIL

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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 should not be disposed of via wastewater drains or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of BUCOSIL

• The active substances 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 flavour (containing maltodextrin derived from potato and maize and arabic gum) and orange flavour (containing maltodextrin derived from maize).

Appearance of the medicinal product and content of the pack:

They are orange-flavoured lozenges. This medicine is available in packs of 20 lozenges, presented in blisters made of aluminium coated with PVDC and laminated 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 most recent revision of this leaflet: September 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/