FARINGESIC 5 mg/5 mg LOZENGES LEMON FLAVORED

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Faringesic 5 mg/5 mg Lemon Flavor Lozenges

Chlorhexidine dihydrochloride/Benzocaine

Read all of this leaflet carefully because it contains important information for you.

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 2 days, you should consult a doctor.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is Faringesic and what is it used for
2. Before taking Faringesic
3. How to take Faringesic
4. Possible side effects
5. Storage of Faringesic
6. Additional information

1. What is Faringesic and what is it used for

The active ingredients of this medication work by combining the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medication is used for the symptomatic local and temporary relief of mild mouth and throat infections that occur with pain and without fever, such as: throat irritation, hoarseness, small mouth ulcers.

2. Before taking Faringesic

Do not take Faringesic

• If you are allergic (hypersensitive) to chlorhexidine, benzocaine, or any of the other components of Faringesic.

Be careful with Faringesic

• If you do not tolerate other local anesthetics like para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).
• If you have any severe or extensive injury in the mouth.
• If you suffer from periodontitis (gum disease), because chlorhexidine may produce an increase in supragingival calculus.
• It is recommended to maintain good oral hygiene to reduce the accumulation of tartar and the possible discoloration of teeth that may be caused by chlorhexidine.
• Do not take doses higher than those recommended in section 3 (How to take Faringesic).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Although they are not described in the recommended conditions of use, do not use with other medications for mouth or throat application without consulting your doctor or pharmacist.

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Cholinesterase inhibitor medications (medications 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.

Interference with diagnostic tests

This medication may interact with the test for determining pancreatic function that uses bentiromide. Do not take this medication at least three days before the test and inform your doctor.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Benzocaine should not be used during pregnancy, unless the woman's clinical situation requires treatment with benzocaine.

It is unknown whether benzocaine is excreted in breast milk, so breastfeeding women should not use this medication without consulting their doctor.

Use in people over 65 years old

Older people and debilitated patients may be more sensitive to benzocaine.

Use in children

This medication should not be administered to children under 6 years old without consulting a doctor first. Children may be more sensitive to benzocaine, just like older people and debilitated patients.

Driving and using machines

No cases have been reported that affect the ability to drive or operate machinery.

3. How to take Faringesic

Follow the administration instructions of Faringesic indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults and children over 6 years old:

1 lozenge every 2 or 3 hours, dissolving slowly in the mouth.

Do not take more than 8 lozenges in 24 hours (1 day).

Dissolve the lozenge slowly in the mouth without chewing or swallowing.

If you think the action of Faringesic is too strong or too weak, inform your doctor or pharmacist.

This medication is 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.

Always use the smallest effective dose.

If you notice that symptoms worsen or persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting appear, you should consult a doctor as soon as possible.

If you take more Faringesic than you should

If you have taken more than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

The signs of overdose manifest with: slurred speech, numbness, stumbling gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, increased sweating and/or low blood pressure.

If you forget to take Faringesic

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Faringesic can produce side effects, although not all people suffer from them.

The most characteristic adverse reactions due to benzocaine are:

Teeth discoloration may appear, especially in people who have tartar buildup on their teeth. This alteration of tooth color is not permanent and can be eliminated through oral cleaning. The color of fillings can also be altered, in which case this discoloration can be permanent.

Alteration in taste perception may appear.

In some cases, Faringesic may present irritation in the mouth or irritation of the tip of the tongue, which are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Faringesic

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Faringesic 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 thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of FARINGESIC

Each lozenge contains:

• The active ingredients are chlorhexidine dihydrochloride, benzocaine.
• The other components are: mannitol (E-421), microcrystalline cellulose, povidone, magnesium stearate, sodium cyclamate, sodium saccharin, menthol flavor, and lemon flavor.

Appearance of the product and packaging content

They are lemon-flavored lozenges. This medication is presented in packages of 20 lozenges.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat (Barcelona) Spain

Date of the last revision of this leaflet: March 2007

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