FARBUCAL 5 MG/5 MG LOZENGES

Introduction

Package Leaflet: Information for the User

Farbucal 5mg/5mg Lozenges

Benzocaine/Chlorhexidine Dihydrochloride

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 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 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.

Contents of the Package Leaflet

1. What is Farbucal 5mg/5mg and what is it used for
2. What you need to know before taking Farbucal 5mg/5mg
3. How to take Farbucal 5mg/5mg
4. Possible side effects
5. Storage of Farbucal 5mg/5mg
6. Package Contents and Additional Information

1. What is Farbucal 5mg/5mg and what is it used for

Chlorhexidine and benzocaine, the active ingredients of this medicine, act 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 processes of the mouth and throat, such as oral aphthae and throat irritation, which occur with pain and without fever in adults and children from 6 years of age.

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

2. What you need to know before taking Farbucal 5mg/5mg

Do not take Farbucal 5mg/5mg:

• 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 take Farbucal 5mg/5mg

• if you have any severe or extensive injury in the mouth,
• if you suffer from periodontitis (gum disease), because chlorhexidine may cause an increase in supragingival calculus (tartar that appears above the gums),
• if you have asthma,
• if you have fillings on your incisors and if the surface of the filling or its edges are rough, as chlorhexidine can cause a permanent discoloration.
• Do not use before eating or drinking.
• Do not use more than the recommended amounts in section 3 (How to use Farbucal 5mg/5mg).

Maintain good oral hygiene to reduce the accumulation of tartar and possible tooth discoloration that may be caused by chlorhexidine.

This medicine contains glucose (in maltodextrin from corn and potato). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Interference with analytical tests:

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

This medicine may interact with tests of pancreatic function that use bentiromide. Do not use this medicine at least 3 days before the test and inform your doctor.

Children:

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

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

Elderly:

People over 65 years of age and debilitated patients may be more sensitive to benzocaine.

Taking Farbucal 5mg/5mg with other medicines:

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

This is especially important in the case of:

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

Anionic compounds and suspending agents (common components of toothpastes) decrease the efficacy of chlorhexidine, so the mouth should be rinsed well after using toothpaste.

Taking Farbucal 5mg/5mg with food and drinks:

This medicine cannot be used immediately 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 using this medicine.

Driving and Using Machines:

No effects on the ability to drive or use machines have been described.

Farbucal 5 mg/5 mg contains mannitol and sodium

It may produce a mild laxative effect because it contains mannitol.

This medicine contains less than 23 mg of sodium (1 mmol) per lozenge; this is, essentially "sodium-free".

3. How to take Farbucal 5mg/5mg

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

Farbucal 5mg/5mg is a medicine for buccopharyngeal use, so the lozenges should be dissolved slowly in the mouth without chewing or swallowing, as its action is local and only manifests when the product is in direct contact with the affected area.

The recommended dose is:

Adults and children over 12 years:Dissolve slowly in the mouth 1 lozenge every 2 or 3 hours, if necessary, up to a maximum of 8 lozenges per day.

Children from 6 to 12 years:Use only under adult supervision. Dissolve slowly in the mouth 1 lozenge every 4 or 5 hours, if necessary, up to a maximum of 6 lozenges per day.

Use in Children:

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

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

Use in Elderly:

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

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

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

If you take more Farbucal 5mg/5mg than you should:

Signs of overdose manifest with: slurred speech, numbness, staggering 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

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

Some people may develop alterations in taste perception.

In some cases, Farbucal 5mg/5mg may cause irritation in the mouth or on the tip of the tongue, which are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

Reporting of Side Effects:

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

5. Storage of Farbucal 5mg/5mg

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

Do not store above 25 ºC.

Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Farbucal 5mg/5mg

Each lozenge contains:

• The active ingredients 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 flavor (contains maltodextrin from potato, gum arabic E414, modified starch E1450) and orange flavor (contains maltodextrin from corn, modified starch E1450).

Appearance of the Product and Package Contents:

They are orange-flavored lozenges. This medicine is presented in packages of 20 lozenges, packaged in aluminum blister packs coated with PVDC and layered with PVC/PE/PVDC.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid) Spain

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid) Spain

Date of the Last Revision of this Leaflet:July 2018

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