Leaflet: information for the user

ANESTEFARIN 5 mg /5 mg Lozenges

Chlorhexidine dihydrochloride/benzocaine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 2 days of starting treatment or if you develop fever, headache, nausea, or vomiting.

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 in adults and children over 6 years old for the symptomatic relief of mild, temporary infections of the mouth and throat accompanied by pain, but without fever, such as: sore throat, hoarseness, small mouth ulcers.

You should consult a doctor if it worsens or does not improve after 2 days of starting treatment or if fever, headache, nausea, or vomiting appears.

No use Anestefarin:

• if you are allergic to chlorhexidine, benzocaine, or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Anestefarin:

• if you cannot 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 injuries in the mouth.
• if you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus.

This medication may cause a mild laxative effect due to its mannitol content (542 mg).

This medication contains less than 23 mg of sodium (1mmol) per dose; it is essentially "sodium-free."

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

Children and Adolescents

This medication should not be administered to children under 6 years old without consulting a doctor first.

Use of Anestefarin with other Medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Although not described in the recommended conditions of use, it should not be used with other mouth or throat medications without consulting a 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).

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

Interference with Diagnostic Tests

This medication may interact with the pancreatic function test that uses bentiromide. Do not use this medication at least three days before the test and inform your doctor.

Pregnancy and Lactation:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines:

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years: 1 lozenge every 2 or 3 hours, dissolving it slowly in the mouth. Do not use more than 8 lozenges in 24 hours (1 day).

Use in children

This medication is indicated for children over 6 years.

Use in older adults

Older adults and those who are debilitated may be more sensitive to benzocaine.

This medication, 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.

Always use the smallest effective dose.

If you use more Anestefarin than you should:

The signs of overdose are manifested with: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement or convulsions, tinnitus, increased sweating. A decrease in blood pressure may also occur.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

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

Discoloration of the teeth may appear. This staining or discoloration may be more pronounced in people who have tartar buildup on their teeth. This alteration of tooth color is not permanent and can be removed through a dental 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 appear.

In some cases, Anestefarin may produce 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.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Keep this medication out of the reach and sight of children.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point (or any other medication waste collection system) 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 ANESTEFARIN:

Each lozenge contains:

• The active principles are: 5 mg of dihydrochloride of chlorhexidine, and 5 mg of benzocaine.
• The other components (excipients) are: mannitol (E-421), microcrystalline cellulose (E-460), povidone, magnesium stearate, sodium cyclamate, sodium saccharin (E-954), menthol aroma and orange aroma.

Appearance of the product and contents of the packaging:

They are lozenges with an orange flavor. This medication is presented in packs of 20 lozenges.

Marketing authorization holder:

Farline Comercializadora de Productos Farmacéuticos, S.A.

C/ Sta. Engracia, 31. 28010 MADRID

Responsible for manufacturing:

ALCALÁ FARMA, S.L.

Avenida de Madrid 82,

Alcala de Henares.28802. España

This leaflet was approved in September 2014

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/