ANESTEFARIN 5 mg/5 mg LOZENGES

Introduction

Package Leaflet: Information for the User

ANESTEFARIN 5 mg/5 mg Lozenges

Chlorhexidine dihydrochloride/benzocaine

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet:

1. What Anestefarin is and what it is used for
2. What you need to know before taking Anestefarin
3. How to take Anestefarin
4. Possible side effects
5. Storage of Anestefarin
6. Package Contents and Additional Information

1. What Anestefarin is and what it is used for

The active ingredients of this medication work by combining the antiseptic 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 local and temporary relief of mild mouth and throat infections that occur with pain and without fever, such as throat irritation, hoarseness, and small mouth ulcers.

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

2. What you need to know before taking Anestefarin

Do not 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 do not tolerate other local anesthetics like para-aminobenzoic acid (PABA), parabens, or para-phenylenediamine (a component of hair dye).
• if you have any severe or extensive oral lesions.
• if you have periodontitis (gum disease), as chlorhexidine may cause an increase in supragingival calculus.

It may produce a mild laxative effect because it contains mannitol (542 mg).

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

It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and possible tooth discoloration that may be caused by chlorhexidine.

Children and Adolescents

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

Using Anestefarin with Other Medications:

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

Although not described in the recommended conditions of use, it should not be used with other medications for oral application without consulting a doctor or pharmacist.

This is especially important in the case of:

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

Anionic compounds and suspending agents, common components of toothpastes, decrease the effectiveness of chlorhexidine, so the mouth should be rinsed well after using toothpaste.

Interference with Diagnostic Tests

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

Pregnancy and Breastfeeding:

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

Driving and Using Machines:

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

3. How to Take Anestefarin

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years old: 1 lozenge every 2 or 3 hours, dissolving 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 old.

Use in Elderly

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

This medication is for buccopharyngeal use, so the lozenges should be dissolved slowly in the mouth without chewing or swallowing, as its action is local and only manifests when the product is in direct contact with the affected area.

Always use the lowest effective dose.

If you use more Anestefarin than you should:

Signs of overdose manifest as: slurred speech, numbness, staggering gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, 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 Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, Anestefarin can cause side effects, although not everyone will experience them.

Tooth discoloration may appear. This staining or discoloration may be more pronounced in people with plaque on their teeth. This alteration of tooth color is not permanent and can be removed by a dental cleaning. The color of fillings may also be altered, in which case this discoloration may be permanent.

Alteration in taste perception may appear.

In some cases, Anestefarin may cause 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 Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Anestefarin

Do not store above 30°C.

Keep this medication out of sight and reach 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 wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE Collection Point (or any other medication waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ANESTEFARIN:

Each lozenge contains:

• The active ingredients are: 5 mg of chlorhexidine dihydrochloride 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 flavor, and orange flavor.

Appearance of the Product and Package Contents:

They are orange-flavored lozenges. This medication is presented in packages of 20 lozenges.

Marketing Authorization Holder:

Farline Comercializadora de Productos Farmacéuticos, S.A.

C/ Sta. Engracia, 31. 28010 MADRID

Manufacturer:

ALCALÁ FARMA, S.L.

Avenida de Madrid 82,

Alcala de Henares. 28802. Spain

This package leaflet was approved in September 2014

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