Farbucal 5 mg/5 mg lozenges for sucking
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Farbucal 5mg/5mg lozenges
Benzocaine/chlorhexidine dihydrochloride
Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 2 days.
Leaflet contents
- What Farbucal 5mg/5mg is and what it is used for
- What you need to know before using Farbucal 5mg/5mg
- How to take Farbucal 5mg/5mg
- Possible adverse effects
- Storage of Farbucal 5mg/5mg
- Contents of the pack and other information
1. What Farbucal 5mg/5mg is and what it is used for
Chlorhexidine and benzocaine, the active substances in this medicine, exert their effect 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 conditions of the mouth and throat, such as mouth ulcers and sore throat, which are accompanied by pain and not by fever, in adults and children aged 6 years and older.
You should consult a doctor if symptoms worsen or do not improve after 2 days.
2. What you need to know before using 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 are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
Warnings and precautions:
Consult your doctor or pharmacist before starting to use Farbucal 5mg/5mg
- if you have a severe or extensive oral lesion,
- if you suffer from periodontitis (gum disease), since chlorhexidine may increase supragingival calculus (tartar buildup above the gum line),
- if you have asthma,
- if you have fillings in your incisor teeth and the filling surface or its margins are rough, as they may acquire permanent discoloration with chlorhexidine.
- Do not use immediately before eating or drinking.
- Do not use more than the recommended doses described in section 3 (How to use Farbucal 5mg/5mg).
Maintain adequate oral hygiene to reduce tartar buildup and possible tooth discoloration that chlorhexidine may cause.
This medicine contains glucose (in maltodextrin derived from corn and potato). If your doctor has advised you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Interference with diagnostic tests:
If you are due to undergo any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter test results.
This medicine may interfere with pancreatic function tests using bentiromide. Do not use this medicine at least 3 days before such a test and inform your doctor.
Children:
This medicine must not be used in children under 6 years of age.
Children between 6 and 12 years of age may only use it under adult supervision.
Elderly people:
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 taking, have recently taken, or might need to take any other medicines.
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 ingredients in toothpastes) reduce the effectiveness of chlorhexidine; therefore, rinse your mouth thoroughly after using toothpaste.
Taking Farbucal 5mg/5mg with food and drink:
This medicine must not be used immediately before eating or drinking.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines:
No effects on the ability to drive or operate machinery have been reported.
Farbucal 5 mg/5 mg contains mannitol and sodium
May have a mild laxative effect due to the presence of mannitol.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is considered essentially "sodium-free".
3. How to take Farbucal 5mg/5mg
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Farbucal 5mg/5mg is a buccopharyngeal medication; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing them, as its action is local and only becomes evident when the product is in direct contact with the affected area.
The recommended dose is:
Adults and children over 12 years of age: Slowly dissolve 1 lozenge in the mouth every 2 or 3 hours, if necessary, up to a maximum of 8 lozenges per day.
Children from 6 to 12 years of age: Use only under adult supervision. Slowly dissolve 1 lozenge in the mouth every 4 or 5 hours, if necessary, up to a maximum of 6 lozenges per day.
Use in children:
This medicine must not be used in children under 6 years of age.
Children between 6 and 12 years of age should only use this medicine under adult supervision.
Use in people over 65 years of age:
People over 65 years of age and patients who are debilitated should consult their doctor, as they may be more sensitive to the effects of benzocaine.
You should consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
If, after 2 days of starting treatment, you develop 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 include 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The possible adverse effects, whose frequency has not been precisely established, are:
Possible tooth staining. This pigmentation or discoloration mainly occurs in individuals who have accumulations of dental plaque and tartar. This tooth discoloration is not permanent and can be removed by professional oral cleaning. The color of dental fillings may also be altered; in such cases, this discoloration may be permanent.
Some individuals may develop disturbances in taste perception.
In some cases, Farbucal 5mg/5mg may cause irritation in the mouth or on the tip of the tongue, which is usually temporary, as well as allergic reactions to chlorhexidine or benzocaine.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide 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 °C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Farbucal 5mg/5mg
Each lozenge contains:
- Active substances: chlorhexidine dihydrochloride 5 mg and benzocaine 5 mg.
- Other components (excipients): mannitol (E 421), microcrystalline cellulose (E 460), povidone, magnesium stearate, sodium cyclamate, sodium saccharin (E 954), menthol flavour (contains maltodextrin from potato, gum arabic E414, modified starch E1450) and orange flavour (contains maltodextrin from maize, modified starch E1450).
Appearance of the medicine and contents of the pack:
These are orange-flavoured lozenges. This medicine is available in packs of 20 lozenges, packed in blisters made of PVDC-coated aluminium laminated 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 most recent revision of this leaflet: July 2018
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/