ANGINOCOM 5 MG/5 MG LOZENGES LEMON FLAVOUR

Patient Information Leaflet

Introduction

ANGINOCOM 5 mg / 5 mg Lozenge Tablets, lemon flavour

chlorhexidine dihydrochloride / benzocaine

Package leaflet:

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

1. What Anginocom 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, and small oral aphthae.

2. Before taking Anginocom

Do not take ANGINOCOM:

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

Take special care with ANGINOCOM:

• If you are intolerant to other local anaesthetics 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.
• Do not take doses higher than those recommended in section 3. (How to take ANGINOCOM).

It is recommended to maintain adequate oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.

Use with other medicines:

Inform your doctor or pharmacist if you are taking or have recently taken 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 for oral use 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 in Alzheimer's disease).
• Sulphonamides (used for infections).

Anionic compounds and suspending agents, commonly found 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.

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 doctor. Children may be more sensitive to benzocaine, just like the elderly and debilitated patients.

Driving and operating machinery:

There have been no reported cases of effects on the ability to drive or operate machinery.

3. How to take Anginocom

Follow exactly the administration instructions for ANGINOCOM unless your doctor has prescribed otherwise. Consult your doctor or pharmacist if you have any doubts.

If you feel that the effect of ANGINOCOM 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 them, as its action is local and only becomes evident when the product is in direct contact with the affected area.

The usual dose is:

Adults and children over 6 years of age:

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

Do not exceed 8 lozenges in 24 hours (1 day).

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

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 ANGINOCOM than you should:

If you have taken more than the recommended amount, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915 62 04 20, indicating the medicine and the quantity 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. A decrease in blood pressure may also occur.

4. Possible adverse effects

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

Discoloration of the teeth may occur. This staining or discoloration may be more pronounced in people who have dental tartar deposits. This change in tooth color 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 staining may be permanent.

A change in taste perception may occur.

In some cases, ANGINOCOM may cause irritation in the mouth or irritation of 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 effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Anginocom

Keep out of the reach and sight of children.

Do not store above 30 °C.

Do not use ANGINOCOM after the expiry date stated on the packaging, following the abbreviation: 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 empty containers and unused medicines at the SIGRE collection point at 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 ANGINOCOM:

Each tablet contains:

• Active substances: Chlorhexidine dihydrochloride 5 mg, benzocaine 5 mg.
• Other components (excipients): Mannitol (E-421), microcrystalline cellulose, povidone, magnesium stearate, sodium cyclamate, sodium saccharin, menthol flavor, and lime-lemon flavor.

Appearance of the product and contents of the package:

These are lemon-flavored lozenges. This medicine is available in packages containing 20 lozenges.

Other presentations:

ANGINOCOM 5 mg /5 mg Orange-flavored lozenges

This leaflet was approved in JULY 2008

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