Leaflet: information for the user

BUCOMETASANA lozenges

Chlorhexidine hydrochloride, benzocaine, and thymol

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist, or nurse.

-Keep this leaflet, as you may need to read it again.

-Consult your pharmacist if you need advice or more information.

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

-Consult a doctor if your symptoms worsen or do not improve after 2 days.

Bucometasana is a medicationthat combines in its formulation the antisepsis action of chlorhexidine and tyrothricin with the local anesthetic action of benzocaine.

While antisepsis agents provide disinfection of the buccal and pharyngeal area, the local anesthetic relieves pain.

Bucometasanais indicated in adults for symptomatic relief of mild infections of the mouth and throat that cause pain but not fever, such as throat irritation, hoarseness, and small mouth ulcers.

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

Do not take Bucometasana

• If you are allergic to chlorhexidine, benzocaine, or tyrothricin or any of the other components of this medication (listed in section 6).
• If you are allergic to other local anesthetics of the ester type such as para-aminobenzoic acid, parabens, or paraphenylenediamine (a component of hair dye).

Warnings and precautions

• Children cannot take this medication due to the dose of benzocaine, which could lead to methemoglobinemia (an abnormally high level of hemoglobin in the blood).
• People with congenital defects, including glucose-6-phosphatase deficiency, hemoglobin-M disease, ADH-methemoglobin reductase deficiency, and pyruvate kinase deficiency, have an increased risk of developing methemoglobinemia.
• Seek immediate medical attention if you experience symptoms and signs of methemoglobinemia, which are: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia.

• If it worsens, if symptoms persist for more than 2 days, or if other symptoms such as high fever, headache, nausea, or vomiting appear, seek medical attention.

• If you take high doses or take the medication more frequently than recommended, there is a possibility of seizures.

• In exceptional cases, local hypersensitivity and generalized hypersensitivity may occur. If this happens, discontinue treatment.

The use of this medication may cause alteration of the pigmentation of oral surfaces (teeth, tongue, dental fillings, dentures, and other oral appliances). This discoloration may be visible after a week of starting treatment. The discoloration of teeth, like that of the tongue, disappears spontaneously and is not harmful and can be removed by oral hygiene. The discoloration of fillings may be permanent.

Consult your doctor or pharmacist before starting to take Bucometasana.

• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).
• If you have asthma, bronchitis, or emphysema.
• Stop taking the medication and seek immediate medical attention if you notice: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia.
• If you are an elderly patient, suffering from an acute phase of any disease, or debilitated, as you are more sensitive to the toxicity of benzocaine, and lower concentrations of this medication may be needed.
• If you have a local infection in the treatment area, as the pH is altered, reducing the local anesthetic effect.
• If you have severe mucosal trauma, as it increases the adsorption of the anesthetic.
• If you have periodontitis, as chlorhexidine causes an increase in supragingival calculus. You will need to maintain good oral hygiene with a special anti-plaque toothpaste to reduce the accumulation of plaque and the discoloration of teeth caused by chlorhexidine.

Interference with diagnostic tests:

Inform your doctor if you are to undergo any diagnostic tests while taking Bucometasana.

Children and adolescents

Children cannot take this medication due to the dose of benzocaine. They are more sensitive to the systemic toxicity of benzocaine and may develop a blood disorder, methemoglobinemia.

Use of Bucometasana with other medications

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

• Do not use other buccal and pharyngeal antiseptics without consulting your doctor.

This medication may interact with:

• Sulfonamides (a type of antibiotic) as benzocaine may decrease the antibacterial activity of sulfonamides.
• Medications containing hyaluronidase: should not be used at the same time as benzocaine, as it may increase the adverse effects of benzocaine.
• Medications containing cholinesterase inhibitors (medications used in myasthenia gravis and Alzheimer's disease) as they inhibit the metabolism of benzocaine and increase the risk of general toxicity.
• Other local anesthetics.
• Medications containing proteolytic enzymes such as clostridiopeptidase or combinations, as they are inhibited by the antisepsis action of tyrothricin.

Use of Bucometasana with food

Do not take this medication before eating or drinking.

Pregnancy and lactation

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

This medication is not recommended for use during pregnancy or lactation as its safety has not been established in this population.

Driving and operating machinery

The effect on driving or operating machinery is negligible or insignificant.

Bucometasana containsaspartame and sorbitol.

This medication may be harmful to people with phenylketonuria as it contains aspartame, which is a source of phenylalanine.

Bucometasana contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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: 1 tablet every 6-8 hours if necessary. Do not take more than 4 tablets a day.

How to Take

Oral-Buccal Use

The tablet must be sucked. Do not break it with your teeth, or chew or swallow it, as its action is local and will only be effective if there is direct contact with the affected area.

Do not take before eating or drinking.

If it worsens or symptoms persist for more than 2 days or you have high fever, headache, nausea, or vomiting, consult your doctor as soon as possible.

Use in Children and Adolescents

This medication is for adults.Children cannot take this medication due to the dose of Benzocaine. They are more sensitive to systemic toxicity of benzocaine and may develop a blood disease, methemoglobinemia.

If You Take More Bucometasana Than You Should

If you have taken more Bucometasana than you should, consult your doctor or pharmacist immediately.

The signs of overdose may be:alcohol intoxication symptoms (slurred speech, sleep, and staggering gait),blue discoloration of the skin, mumbling speech, numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. Blood pressure may also decrease.

If you take high doses or take it more frequently than appropriate, there is a possibility of convulsions.

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

Like all medications, Bucometasana can produce adverse effects, although not all people may experience them.

During the period of use of medications containing chlorhexidine, tyrothricin, and benzocaine, the following adverse effects have been reported, whose frequency has not been established with precision:

• Alteration of the pigmentation of oral surfaces (teeth, tongue, dental fillings, dentures, and other oral appliances), which may be visible a week after starting treatment. The coloration of the teeth, like that of the tongue, disappears spontaneously and is not harmful and can be removed by oral hygiene. The coloration of fillings may be permanent.
• Increased tartar buildup on teeth.
• Burning sensation in the mouth.
• Dehydration of the epithelium, hardening of the mucous membranes, alteration of taste, bad taste in the mouth, and difficulty swallowing, usually due to prolonged use.
• Methemoglobinemia, mainly due to prolonged use and also in cases of overdose. People with congenital defects, including glucose-6-phosphate dehydrogenase deficiency, hemoglobin-M disease, ADH-metahemoglobin reductase deficiency, and pyruvate kinase deficiency, have an increased risk of developing methemoglobinemia.
• In some cases, urticaria, edema, anaphylactoid reaction (contact dermatitis), cross-reactions with other local anesthetics of the ester type, and photosensitivity have been reported.
• In exceptional cases, local hypersensitivity and generalized hypersensitivity may appear. In this case, discontinue treatment immediately and consult a doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This product does not require special conditions for conservation.

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

Do not use Bucometasana after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Bucometasana

The active principles arechlorhexidine hydrochloride, benzocaine and tyrothricin.

Each lozenge contains 5 mg of chlorhexidine hydrochloride, 15 mg of benzocaine and 1 mg of tyrothricin

The other components (excipients) are sorbitol (E420), aspartame (E951), colloidal silica, mannitol (E421), magnesium stearate and peppermint aroma.

Appearance of the product and contents of the packaging

White, round lozenges with a peppermint flavor.

Carton packaging of 20 or 30 lozenges in a blister pack of 10 lozenges.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible manufacturer:

Recipharm Parets, S.L.

Ramón y Cajal, 2

08150 Parets del Vallés (Barcelona)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Last review date of this leaflet: May 2016

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