BUCOMETASANA lozenges

Introduction

Package Leaflet: Information for the User

BUCOMETASANA Lozenges

Chlorhexidine hydrochloride, benzocaine, tyrothricin

Read all of 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 as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, 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, pharmacist, or nurse, 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.

Contents of the Package Leaflet:

1. What is Bucometasana and what is it used for
2. What you need to know before taking Bucometasana
3. How to take Bucometasana
4. Possible side effects
5. Storage of Bucometasana
6. Contents of the pack and further information

1. What is Bucometasana and what is it used for

Bucometasana is a medicine that combines in its formulation the antiseptic action of chlorhexidine and tyrothricin with the local anesthetic action of benzocaine.

While antiseptics provide disinfection of the buccopharyngeal area, the local anesthetic relieves pain.

Bucometasana is indicated in adults for the symptomatic relief of mild mouth and throat infections 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.

2. What you need to know before taking Bucometasana

Do not take Bucometasana

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

Warnings and precautions

• Children cannot take this medicine due to the dose of benzocaine, as it could produce methemoglobinemia (abnormally high level of hemoglobin in the blood).
• People with congenital defects, including glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, ADH-methemoglobin reductase deficiency, and pyruvate kinase deficiency, have an increased risk of developing methemoglobinemia.
• You should consult your doctor immediately 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 appear, such as high fever, headache, nausea, or vomiting, you should consult your doctor.

• If you take high doses or take the medicine more frequently than appropriate, 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 medicine may cause alteration of the pigmentation of oral surfaces (teeth, tongue, dental fillings, dentures, and other oral appliances). This discoloration may be visible within a week of starting treatment. The discoloration of teeth, like that of the tongue, disappears spontaneously and is not dangerous and can be eliminated by oral hygiene. The discoloration of fillings may be permanent.

Consult your doctor or pharmacist before taking Bucometasana.

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

Interference with analytical tests:

If you are going to undergo any diagnostic test, inform your doctor that you are taking Bucometasana.

Children and Adolescents

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

Taking Bucometasana with other medicines

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

• Do not use other buccopharyngeal antiseptics without consulting your doctor.

This medicine may interfere with:

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

Taking Bucometasana with food

Do not take this medicine 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 taking this medicine.

The use of this medicine is not recommended during pregnancy or breastfeeding, as its safety in this population has not been established.

Driving and Using Machines

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

Bucometasana containsaspartame and sorbitol.

This medicine may be harmful to people with phenylketonuria because 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 medicine.

3. How to take Bucometasana

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

The recommended dose is:

Adults: 1 lozenge every 6-8 hours if necessary. Do not take more than 4 lozenges per day.

How to take

Buccopharyngeal use

The lozenge should be sucked. Do not break it with your teeth, chew, or swallow, as its action is local and will only take effect 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 if you have a high fever, headache, nausea, or vomiting, consult your doctor as soon as possible.

Use in Children and Adolescents

This medicine is for adults. Children cannot take this medicine due to the dose of benzocaine. They are more sensitive to the 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: symptoms of alcohol intoxication (slurred speech, drowsiness, and stumbling gait), bluish discoloration of the skin, slurred speech, numbness, stumbling gait, blurred or double vision, dizziness, excitement, or seizures, ringing in the ears, increased sweating. It may also decrease blood pressure.

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

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

4. Possible Side Effects

Like all medicines, Bucometasana can cause side effects, although not everybody gets them.

During the use of medicines with chlorhexidine, tyrothricin, and benzocaine, the following side effects have occurred, whose frequency could not be established with accuracy:

• Alteration of the pigmentation of oral surfaces (teeth, tongue, dental fillings, dentures, and other oral appliances), this discoloration may be visible within a week of starting treatment. The discoloration of teeth, like that of the tongue, disappears spontaneously and is not dangerous and can be eliminated by oral hygiene. The discoloration of fillings may be permanent.
• Increased dental plaque.
• 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 case of overdose. People with congenital defects, including glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, ADH-methemoglobin 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 occurred.
• In exceptional cases, local hypersensitivity and generalized hypersensitivity may occur. In this case, discontinue treatment immediately and consult your doctor.

Reporting of Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bucometasana

No special storage conditions are required.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Bucometasana

The active ingredients are chlorhexidine hydrochloride, benzocaine, and tyrothricin.

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

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

Appearance of the Product and Contents of the Pack

White, round lozenges with a peppermint flavor.

Carton packs of 20 or 30 lozenges in blisters of 10 lozenges.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer:

Recipharm Parets, S.L.

Ramón y Cajal, 2

08150 Parets del Vallés (Barcelona)

You can request more information about this medicine from the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 - Barcelona

Spain

Date of the Last Revision of this Leaflet: May 2016

Detailed and updated information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/