FARIGESIC 5 MG/5 MG LOZENGES LEMON FLAVOUR

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Faringesic 5 mg /5 mg Lozenges lemon flavour

Chlorhexidine dihydrochloride / Benzocaine

Read the entire leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• 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 your doctor.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Faringesic is and what it is used for
2. Before you take Faringesic
3. How to take Faringesic
4. Possible side effects
5. How to store Faringesic
6. Further information

1. What Faringesic is and what it is used for

The active substances in this medicine combine the antiseptic and disinfectant action of chlorhexidine with the local anesthetic action of benzocaine.

This medicine is used for the local and temporary symptomatic relief of mild infections of the mouth and throat associated with pain and without fever, such as: sore throat irritation, hoarseness, and small oral aphthae.

2. Before taking Faringesic

Do not take Faringesic

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

Take special care with Faringesic

• If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
• If you have a severe or extensive lesion in the mouth.
• If you suffer from periodontitis (gum disease), because chlorhexidine may increase supragingival calculus formation.
• It is recommended to maintain proper oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.
• Doses higher than those recommended in section 3 (How to take Faringesic) must not be taken.

Use with other medicines

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

Although no interactions have been reported under recommended conditions of use, this medicine should not be used together with other oral or throat medications without consulting your doctor or pharmacist.

This is especially important in the case of:

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

Anionic compounds and suspending agents, common ingredients in toothpastes, reduce the effectiveness of chlorhexidine; therefore, the mouth should be thoroughly rinsed after using toothpaste.

Interference with diagnostic tests

This medicine may interfere with the pancreatic function test using bentiromide. Do not take this medicine at least three days before the test and inform your doctor.

Pregnancy and Breast-feeding

Consult your doctor or pharmacist before using any medicine.

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

It is unknown whether benzocaine is excreted in breast milk; therefore, women who are breastfeeding should not use this medicine without consulting a physician.

Use in patients over 65 years of age

Elderly individuals and debilitated patients may be more sensitive to benzocaine.

Use in children

This medicine should not be administered to children under 6 years of age without first consulting a physician. Children may be more sensitive to benzocaine, similar to elderly individuals and debilitated patients.

Driving and operating machinery

There have been no reported cases affecting the ability to drive or operate machinery.

3. How to take Faringesic

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

The usual dose is:

Adults and children over 6 years of age:

1 lozenge to be sucked every 2 or 3 hours, slowly dissolving it in the mouth.

No more than 8 lozenges should be taken in 24 hours (1 day).

Slowly dissolve the lozenge in the mouth without chewing or swallowing it.

If you feel that the effect of Faringesic is too strong or too weak, inform your doctor or pharmacist.

This medicine is intended for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing, as its action is local and only becomes apparent when the product is in direct contact with the affected area.

Always use the lowest 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 occur, you should 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 or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 62 04 20, indicating the medicine and the amount taken.

Signs of overdose may include: 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 forget to take Faringesic

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

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

4. Possible adverse effects

Like all medicines, Faringesic may produce adverse effects, although not everyone will experience them.

The most characteristic adverse reactions due to benzocaine are:

Discoloration of the teeth may occur, especially in individuals who have plaque or tartar buildup on their teeth. This tooth discoloration is not permanent and can be removed by means of a dental cleaning. The color of dental fillings may also be altered; in such cases, this discoloration may be permanent.

A disturbance in taste perception may occur.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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 expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at a SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of FARINGESIC

Each tablet contains:

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

Presentation of the product and contents of the pack

These are effervescent tablets with lemon flavor. This medicine is available in packs containing 20 effervescent tablets.

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 most recent review of this leaflet: March 2007

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/