PROSPECTO: INFORMATION FOR THE USER

Faringesic 5 mg /5 mg Lozenges with Lemon Flavor

Chlorhexidine dihydrochloride/Benzocaine

Read this prospectus carefully as it contains important information for you.

This medication can be purchased without a prescription. However, for the best results, it should be used properly.

• Keep this prospectus, 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

This medication is used for the symptomatic relief of mild infections of the mouth and throat that are accompanied by pain, but not fever, such as: sore throat, hoarseness, small mouth ulcers.

Do not take Faringesic

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

Be especially careful with Faringesic

• If you do not tolerate other local anesthetics such as 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 have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus.
• It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and the possible discoloration of teeth that chlorhexidine may cause.
• Do not take doses higher than the 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 not described in the recommended conditions of use, it should not be used with other mouth or throat medications without consulting your doctor or pharmacist.

This is especially important in the case of:

• Other mouth or throat antiseptics.
• Medications that inhibit cholinesterase (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Ionogenic compounds and suspending agents, common components of toothpaste, reduce the effectiveness of chlorhexidine, so it is necessary to rinse your mouth well after using toothpaste.

Interference with diagnostic tests

This medication may interact with the test for 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.

The excretion of benzocaine in breast milk is unknown, so women in the lactation period should not use this medication without consulting their doctor.

Use in people over 65 years

Older people and those who are debilitated 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 those who are debilitated.

Driving and operating machinery

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

Follow exactly the administration instructions for Faringesic as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and children over 6 years old:

1 lozenge every 2 or 3 hours, dissolving it 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 estimate that the action of Faringesic is too strong or weak, inform your doctor or pharmacist.

This medication is for buccal use, so the lozenges must 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 lowest effective dose.

If you observe that the symptoms worsen or persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting appear, you must consult your 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 Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

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

If you forgot to take Faringesic

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Faringesic may produce adverse effects, although not all people will experience them.

The most characteristic adverse reactions due to benzocaine are:

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

Alteration in the perception of taste may occur.

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 adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Pharyngesic after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of FARINGESIC

Each tablet contains:

• The active principles are chlorhexidine dihydrochloride, benzocaine.
• The other components are: mannitol (E-421), microcrystalline cellulose, povidone, magnesium stearate, sodium cyclamate, sodium saccharin, peppermint aroma and lime aroma.

Appearance of the product and contents of the package

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

Responsible for Manufacturing

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat (Barcelona) Spain

Last review date of this leaflet: March 2007

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