FARINGESIC 5 MG/5 MG LOZENGES, PEPPERMINT FLAVOUR

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Faringesic 5 mg /5 mg Sucking tablets, peppermint flavour

Chlorhexidine dihydrochloride / Benzocaine

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

This medicine is available 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 further information, consult your pharmacist.
• If symptoms worsen or persist beyond 2 days, you must consult your doctor.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects 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 ingredients 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, minor oral 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.

Take special care with Faringesic

• If you do not tolerate 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), as 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 of 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 interactions have not been reported under recommended conditions of use, this medicine should not be used together with other medicines applied to the mouth without consulting your doctor or pharmacist.

This is especially important in the case of:

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

Anionic compounds and suspending agents, common components of 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 individuals 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

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

3. How to take Faringesic

Follow exactly the administration instructions for Faringesic indicated 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.

Do not take more than 8 lozenges 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 evident 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately 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, tinnitus, 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Faringesic may cause adverse effects, although not everyone experiences them.

The most characteristic adverse reactions due to benzocaine are:

Discoloration of teeth may occur, especially in individuals who have tartar build-up on their teeth. This tooth discoloration is not permanent and can be removed by means of a dental cleaning. Discoloration of dental fillings may also occur; in such cases, this staining may be permanent.

Altered 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 required.

Do not use Faringesic after the expiry date stated on the packaging, after EXP. The expiry date corresponds to the last day of the month indicated.

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

6. Additional Information

Composition of FARINGESIC

Each tablet contains:

• The active substances are clorhexidina dihidrocloruro, benzocaína.
• The other components are: sodium cyclamate, sodium saccharin, mannitol, microcrystalline cellulose, povidone, magnesium stearate, menthol, peppermint flavor.

Appearance of the medicinal product and contents of the container

These are sugar-free, mint-flavored lozenges. This medicine is available in packs of 20 lozenges.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of the most recent review of this leaflet: April 2012

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