Leaflet: information for the user

BUCOSPRAY 15 mg/ml + 0,5 mg/ml oral spray solution

Chlorhexidine gluconate / Benzocaine

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

Follow exactly the administration instructions for 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 your condition worsens or does not improve after 2 days of treatment.

This medication combines the antiseptic action of chlorhexidine with the local anesthetic action of benzocaine. While the antiseptic provides disinfection in the buccal-pharyngeal area, the local anesthetic relieves pain and calms discomfort.

Indicated in adults and children aged 6 years and above for symptomatic relief of mild mouth and throat infections that are not accompanied by fever and are characterized by pain as: throat irritation, hoarseness, small wounds, and aphthae.

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

Do not use BUCOSPRAY

• If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).
• If you are not tolerant of other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or para-phenylenediamine (a component of hair dye).

Warnings and precautions

Consult your doctor or pharmacist before starting to use BUCOSPRAY

• 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.
• Do not take doses higher than recommended in section 3 (How to use BUCOSPRAY).
• If you have asthma
• Do not use before eating or drinking.
• If you have fillings on your incisors and the surface of the filling or its margins are rough, chlorhexidine may cause permanent discoloration.
• It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and the possible discoloration of the teeth that chlorhexidine may cause.

Interference with diagnostic tests

If you are to undergo any diagnostic tests (including blood, urine, skin tests using 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 take this medication at least 3 days before the test and inform your doctor.

NChildren

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

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

Use of BUCOSPRAY with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Although not described in the recommended conditions of use, it should not be used with other mouth or throat antiseptics without consulting your doctor or pharmacist.

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Medications that inhibit cholinesterase (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Anionic compounds and suspending agents, common components of toothpaste, reduce the effectiveness of chlorhexidine, so it is recommended to rinse your mouth well after using toothpaste.

Pregnancy and Breastfeeding

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

Driving and operating machines

The use of this medication does not affect your ability to drive or operate machines.

Use in people over 65

Older people and those with weakened health may be more sensitive to the adverse effects of benzocaine.

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

The recommended dose is:

Adults and adolescents over 12 years:

2 sprays every 2 or 3 hours, increasing the time between applications as the discomfort decreases. In no case should more than 16 sprays be used per day.

Children from 6 to 12 years:

1 spray every 2 or 3 hours. In no case should more than 8 sprays be used per day.

How to Use

This medication is for buccal and pharyngeal use.

The medication has a local action, so it should be avoided being swallowed or inhaled.

Do not use this medication before meals or before drinking.

Before using the bottle for the first time, it is advisable to perform 2 or 3 sprays into the air to prime the dosing valve.

Always use the smallest effective dose.

You should consult a doctor if you worsen or do not improve after 2 days of treatment.

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

If you use more BUCOSPRAY than you should

If you use more BUCOSPRAY than you should, you may notice slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. You may also experience a decrease in blood pressure.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

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

Discoloration of the teeth may appear, especially in people who have accumulations of tartar on their teeth. 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.

Alteration in the perception of taste may occur.

In some cases, BUCOSPRAY may produce irritation in the mouth or irritation of the tip of the tongue, which are usually temporary.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.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 25°C.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of BUCOSPRAY

• The active principles are chlorhexidine gluconate and benzocaine. Each milliliter of solution contains 0.5 mg of chlorhexidine gluconate (each 0.05 ml pulse contains 0.025 mg) and 15 mg of benzocaine (each 0.05 ml pulse contains 0.75 mg).
• The other components (excipients) are: sodium saccharin, 96° ethanol, glycerol, ammonium glycyrrhizinate, and strawberry essence.

Appearance of the product and contents of the packaging

BUCOSPRAY is presented in a nebulizer bottle containing 25 ml of solution provided with a dosing valve.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia), ITALY

Date of the last review of this leaflet: July 2014

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