Leaflet: information for the user

Farbucal 5mg/5mg chewable tablets

Benzocaine/chlorhexidine dihydrochloride

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 it worsens or does not improve after 2 days.

1. What isFarbucal 5mg/5mgand what it is used for

2. What you need to know before starting to useFarbucal 5mg/5mg

3. How to takeFarbucal 5mg/5mg

4. Possible side effects

5. Storage ofFarbucal 5mg/5mg

6. Contents of the pack and additional information

Thechlorhexidine and benzocaine,active ingredients of this medication, act by combiningthe antisepticanddisinfectant action of chlorhexidinewiththe local anesthetic action of benzocaine.

This medication is indicated for the symptomatic relief and temporary treatment of mild oral and throat infections such as, mouth ulcers and throat irritation, which are accompanied by pain and without fever in adults and children aged 6 years and above.

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

Do not take Farbucal 5mg/5mg:

• If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).
• If you cannot 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 injuries in the mouth,
• If you have periodontitis (gum disease),due to the fact that chlorhexidine may cause an increase in supragingival calculus (tartar that appears above the gums),
• If you have asthma,
• If you have fillings in your incisors and if the surface of the filling or its margins are rough, as chlorhexidine may cause permanent discoloration.
• Do not use before eating or drinking.
• Do not use quantities greater than those recommended in section 3 (How to use Farbucal 5mg/5mg).

Maintain good oral hygiene to reduce the accumulation of tartar and the possible discoloration of the teeth that chlorhexidine may cause.

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

Interference with diagnostic tests:

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

Children:

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

Between 6 and 12 years old, children can only use it under the supervision of an adult.

Older adults:

People over 65 years old and those who are debilitated may be more sensitive to benzocaine.

Use of Farbucal 5mg/5mg with other medications:

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

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Cholinesterase inhibitors (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 necessary to rinse the mouth well after using toothpaste.

Use of Farbucal 5mg/5mg with food and drinks:

This medication cannot be used just before eating or drinking.

Pregnancy and breastfeeding:

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

Driving and operating machinery:

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

Farbucal 5 mg/5 mg contains mannitol and sodium

It may cause a mild laxative effect because it contains mannitol

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Farbucal 5mg/5mg is a buccal-pharyngeal medication, so the chewable tablets must be dissolved slowly in the mouth without chewing or swallowing them, as their 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 old: Dissolve slowly in the mouth 1 tablet every 2 or 3 hours, if necessary, up to a maximum of 8 tablets per day.

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

Use in children:

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

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

Use in people over 65 years old:

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

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

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

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

The signs of overdose are: slurred speech, numbness, unsteady 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 S ervicio de I nformación T oxicológica, telephone 91 562 04 20, indicating the medication and the amount ingested.

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

The adverse effects that may occur whose frequency has not been determined with exactness are:

Possible tooth discoloration. This pigmentation or discoloration may occurespecially in people who have accumulations of plaqueofplaque.This alteration of tooth color is not permanent and can be eliminated through a dental cleaning. Tooth color may also be altered in fillings, in which case, this discoloration may be permanent.

Some people may develop a change in the perception of taste.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usehttps://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 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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Farbucal 5mg/5mg

Each lozenge contains:

• The active principles are: dihydrochloride of chlorhexidine 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 (containsmaltodextrin from potato, gum arabic E414, modified starch E1450)and orange flavor (containsmaltodextrin from corn, modified starch E1450).

Appearance of the product and contents of the packaging:

They are orange-flavored lozenges. This medication is presented in packs of 20 lozenges acondicionados in blister packs ofaluminum coated with PVDC and stratified PVC/PE/PVDC.

Holder of the authorization and responsible for the manufacturing:

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid)Spain

Responsible for the manufacturing:

Alcalá Farma, S.L. Laboratories

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)Spain

Last review date of this leaflet:July 2018

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