Leaflet: information for the user

Angileptol lozenges with peppermint-eucalyptus flavor

Chlorhexidine/Benzocaine/Enoxolone

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

This medicine can be purchased without a prescription. However, for the best results, it should be used properly.

Follow exactly the administration instructions 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 it worsens or does not improve after 2 days.

1. What is Angileptol and what it is used for

2. What you need to know before starting to take Angileptol

3. How to take Angileptol

4. Possible side effects

5. Storage of Angileptol

6. Contents of the pack and additional information

The active ingredients of Angileptol act by complementing the antisepsis action of chlorhexidine, with the anti-inflammatory action of enoxolone on the buccal and pharyngeal mucosa and the local anesthetic action of benzocaine, thereby suppressing the typical discomfort caused by local irritation of the throat.

Angileptol is indicated for the symptomatic relief of local and temporary infections and mild inflammation of the mouth and throat that are accompanied by pain and without fever in adults and children aged 6 years and above.

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 cannot tolerate other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or para-phenylenediamine (a hair dye component).
• 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.
• If you have hypertension or fluid retention, as enoxolone may worsen these symptoms.
• It is recommended to maintain good oral hygiene to reduce the accumulation of plaque and the possible discoloration of teeth that chlorhexidine may cause.
• 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 your doctor first. Children may be more sensitive to benzocaine, like the elderly and debilitated patients.

Use in people over 65 years old

The use of this medication at high doses or for prolonged periods may cause hypertension.

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

Other medications and Angileptol

Inform your doctor or pharmacist if you are using, have used recently, 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.
• Medications that inhibit cholinesterase (medications for Alzheimer's disease).
• Sulfonamides (used for infections).

Ionogenic 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:Angileptol 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

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

IMPORTANT FOR WOMEN:

The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

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

Angileptol contains sorbitol

This medication contains 1194.25 mg of sorbitol in each tablet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (HF), 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.

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

The usual dose is:

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

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

Angileptol is for buccal use, so the lozenges should be dissolved slowly in the mouth without chewing or swallowing them, as its action is local and only manifests if the product is in direct contact with the affected area.

Always use the lowest effective dose.

The usual duration of treatment is 2 days.

If symptoms worsen or persist for more than 2 days after starting treatment, or if fever, headache, nausea, or vomiting appear, you must 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 frequent symptoms of overdose are: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or convulsions, ringing in the ears, increased sweating, and/or low blood pressure. Also, due to the presence of enoxolona in this medication, symptoms such as 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 Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount ingested.

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

Exceptionally, generalized allergic reactions and gastrointestinal disturbances. With high doses and continuous treatment, it may produce edema (swelling caused by fluid retention) and hypertension.

It may appear tooth discoloration, especially in people who have accumulations of tartar on their teeth. This alteration of tooth color is not permanent and can be eliminated by means of a dental cleaning. It may also alter the color of fillings, in which case, this discoloration may be permanent.

It may appear alteration in the perception of taste.

In some cases, Angileptol may present irritation in the mouth or irritation at 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 adverse effects you experience are severe or if you appreciate any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Communication

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

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

No special storage conditions are required.

Expiration Date

Do not use this medication after the expiration date that appears on the packaging afterCAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Angileptol mint-eucalyptus flavor

Each tablet contains:

- The active principles:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

- The other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint-eucalyptus flavor.

Appearance of the product and content of the packaging

Angileptol are round, white, chewable tablets with the Greek letter σ on one face.

They are presented in packaging containing 15 and 30 chewable tablets.

Other presentations

Angileptol Mint Flavor

Angileptol Honey-Lemon Flavor

Marketing Authorization Holder

Alfasigma España S.L.

Av. Diagonal, 490

08006 Barcelona. SPAIN

Responsible for Manufacturing

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

Last review date of this leaflet: September 2021

Other sources of information

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