ANGINOCOM 5 mg /5 mg Chewable Tablets, Lemon Flavor

chlorhexidine dihydrochloride/benzocaine

The active principles 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 ANGINOCOM:

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

Be especially careful with ANGINOCOM:

• 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.
• Do not take doses higher than recommended in section 3 (How to take ANGINOCOM).

It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and the possible discoloration of the teeth that chlorhexidine may cause.

Use of other medications:

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

Although not described in the recommended conditions of use, do not use with other medications applied to the mouth without consulting your doctor or pharmacist.

This is especially important in the case of:

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

Anionic 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.

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 ANGINOCOM unless your doctor has told you otherwise. Consult your doctor or pharmacist if you have any doubts.

If you think the action of ANGINOCOM is too strong or too 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 them, as their action is local and only manifests when the product is in direct contact with the affected area.

The normal 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.

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 you experience fever, headache, nausea, or vomiting, you must consult your doctor as soon as possible.

If you take more ANGINOCOM 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, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating. A decrease in blood pressure may also occur.

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

Discoloration of the teeth may appear. This staining or discoloration may be more pronounced in people with dental plaque. This alteration in tooth color is not permanent and can be removed through oral hygiene cleaning. 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, ANGINOCOM may produce temporary irritation in the mouth or irritation at the tip of the tongue, as well as allergic reactions to chlorhexidine or benzocaine.

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.

Keep out of reach and sight of children.

Do not store at a temperature above 86°F (30°C).

Do not use ANGINOCOM after the expiration date appearing on the packaging, following the abbreviation: CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of ANGINOCOM:

Each tablet contains:

• As active principles: Chlorhexidine dihydrochloride 5 mg, benzocaine 5 mg.
• The other components (excipients) are: Mannitol (E-421), microcrystalline cellulose, povidone, magnesium stearate, sodium cyclamate, sodium saccharin, peppermint aroma and lemon-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.

Other presentations:

ANGINOCOM 5 mg /5 mg Lozenges with orange flavor

This prospectus was approved in JULY 2008

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