ANGILEPTOL SUCKING TABLETS MINT-EUCALYPTUS FLAVOR

Introduction

Leaflet: Information for the user

Angileptol menthol-eucalyptus flavored lozenges

Chlorhexidine/Benzocaine/Enoxolone

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

This medication can be purchased without a prescription. However, to achieve the best results, it should be used properly.

Follow the administration instructions for the medication contained in this leaflet or as 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 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 your symptoms worsen or do not improve after 2 days.

Contents of the leaflet

1. What is Angileptol and what is it used for
2. What you need to know before taking Angileptol
3. How to take Angileptol
4. Possible side effects
5. Storage of Angileptol
6. Package contents and additional information

1. What is Angileptol and what is it used for

The active ingredients of Angileptol work by complementing the antiseptic action of chlorhexidine, with the anti-inflammatory action of enoxolone in the buccopharyngeal mucosa and the local anesthetic action of benzocaine, thus suppressing the typical discomfort caused by local irritation of the throat.

Angileptol is indicated for the symptomatic local and temporary relief of mild mouth and throat infections and inflammations that occur with pain and without fever in adults and children over 6 years old.

2. What you need to know before taking Angileptol

Do not take Angileptol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Angileptol:

• If you do not tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a hair dye component).
• If you have any severe or extensive oral lesions.
• If you have periodontitis (gum disease), as chlorhexidine may increase supragingival calculus.
• If you have hypertension or fluid retention, as enoxolone may worsen these symptoms.
• It is recommended to maintain good oral hygiene to reduce plaque accumulation and possible tooth discoloration that may be caused by chlorhexidine.
• Do not take doses higher than those recommended in section 3 (How to take Angileptol).

Children and adolescents

Do not use Angileptol in children under 6 years old without consulting a doctor first. Children may be more sensitive to benzocaine, as well as the elderly and debilitated patients.

Use in people over 65 years old

The use of this medication at high doses or in prolonged treatments may cause hypertension.

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

Other medications and Angileptol

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Although not described in the recommended conditions of use, do not use with other mouth or throat medications without consulting your 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, reduce the effectiveness of chlorhexidine, so the mouth should be rinsed well after using toothpaste.

Interference with diagnostic tests: Angileptol may interact with the pancreatic function test that uses bentiromide. Do not take this medication at least 3 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.

IMPORTANT FOR WOMEN:

Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

No effects on the ability to drive or use machines have been described due to the use of this medication.

Angileptol contains sorbitol

This medication contains 1194.25 mg of sorbitol in each lozenge.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

3. How to take Angileptol

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The normal dose is:

In adults and children over 12 years old:1 lozenge every 2-3 hours, dissolving slowly in the mouth, up to a maximum of 8 lozenges per day.

In children over 6 years old:1 lozenge every 4-5 hours, dissolving slowly in the mouth, up to a maximum of 6 lozenges per day.

Angileptol 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 becomes apparent if the product is in direct contact with the affected area.

Always use the lowest effective dose.

The normal treatment duration is 2 days.

If symptoms worsen or persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting appear, consult your doctor as soon as possible.

If you take more Angileptol than you should

If you have taken more Angileptol than you should, consult your doctor or pharmacist immediately.

The most common symptoms of overdose are: slurred speech, numbness, stumbling, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, increased sweating, and/or low blood pressure. Also, due to the fact that this medication contains enoxolone, symptoms such as hypertension (high blood pressure) and edema (swelling caused by fluid retention) may occur.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Exceptionally, generalized allergic reactions and digestive alterations. With high doses and prolonged treatments, edema (swelling caused by fluid retention) and hypertension may occur.

Tooth discoloration may appear, especially in people with plaque accumulation 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 occur.

In some cases, Angileptol may cause irritation in the mouth or irritation on the tip of the tongue, which are usually transient, as well as allergic reactions to chlorhexidine or benzocaine.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Angileptol

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Expiration date

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 medications you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Angileptol menthol flavor

Each lozenge contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and peppermint flavor

Appearance of the product and package contents

Angileptol are lozenges, white, round, and with the Greek letter σ on one side.

They are available in packages containing 15 and 30 lozenges.

Other presentations

Angileptol Menthol-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing authorization holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

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