Angileptol honey-lemon flavored lozenges: detailed information

Brand name Angileptol honey-lemon flavored lozenges

Form lozenges, for sucking

Active substance / Dosage

ENOXOLONE · 3 mg

BENZOCAINE · 4 mg

CHLORHEXIDINE DIHYDROCHLORIDE · 5 mg

Prescription type Over The Counter

ATC code

R02A R02AA

Registration number 64119

Manufacturer Alfasigma Espana S.L.

Angileptol honey-lemon flavored lozenges lozenges, for sucking

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Angileptol is and what it is used for
2. What you need to know before starting to take Angileptol
3. How to take Angileptol
4. Possible adverse effects
5. Storage of Angileptol
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Angileptol lozenges with honey-lemon flavour

Chlorhexidine/Benzocaine/Enoxolone

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

This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.

Always follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
You should consult a doctor if you worsen or do not improve after 2 days.

Contents of the leaflet

What Angileptol is and what it is used for
What you need to know before taking Angileptol
How to take Angileptol
Possible adverse effects
How to store Angileptol
Contents of the pack and other information

1. What Angileptol is and what it is used for

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

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

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

Do not take Angileptol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Angileptol:

If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dye).
If you have a severe or extensive lesion in the mouth.
If you suffer from periodontitis (gum disease), because chlorhexidine may increase supragingival calculus formation.
If you have hypertension or fluid retention, because glycyrrhizic acid may worsen these symptoms.
It is recommended to maintain proper oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.
Doses higher than those recommended in section 3 (How to take Angileptol) must not be taken.

Children and adolescents

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

Use in people aged 65 years and older

The use of this medicine at high doses or for prolonged treatment may cause hypertension.

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

Other medicines and Angileptol

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

Although no interactions have been reported under recommended conditions of use, this medicine should not be used together with other oral or throat medications without consulting your doctor or pharmacist.

This is especially important in the case of:

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

Anionic compounds and suspending agents, commonly found in toothpastes, reduce the effectiveness of chlorhexidine; therefore, the mouth should be thoroughly rinsed after using toothpaste.

Interference with diagnostic tests: Angileptol may interfere with the pancreatic function test using bentiromide. Do not take this medicine 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

IMPORTANT FOR WOMEN:

Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported with this medicine.

Angileptol contains sorbitol

This medicine contains 1.238 mg of sorbitol per tablet.

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

3. How to take Angileptol

Follow exactly the instructions given by your doctor or pharmacist for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.

The usual dose is:

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

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

Angileptol is intended for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing them, as its action is local and only becomes evident when 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 occur, you should 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 include: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or convulsions, tinnitus (ringing in the ears), increased sweating and/or low blood pressure. Also, because this medicine contains enoxolone, symptoms such as hypertension (high blood pressure) and edema (swelling due to fluid retention) may occur.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Rarely, generalized allergic reactions and gastrointestinal disturbances may occur. With high doses and prolonged treatment, oedema (swelling due to fluid retention) and hypertension may develop.

Discoloration of the teeth may occur, especially in individuals who have accumulations of dental tartar. This tooth discoloration is not permanent and can be removed by dental cleaning. The colour of dental fillings may also be altered; in such cases, this discolouration may be permanent.

Altered taste perception may occur.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Angileptol

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

Do not store above 30 °C.

Expiry

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Angileptol honey-lemon flavour

Each tablet contains:

Active substances:

Clorhexidina dihidrocloruro, 5 mg

Benzocaína, 4 mg

Enoxolona, 3 mg

Other components (excipients): sorbitol (E420), acesulfame potassium (E950), magnesium stearate, honey flavour, and lemon flavour.

Appearance of the product and contents of the pack

Angileptol is a white, round, sucking tablet marked with the Greek letter σ on one side.

It is available in packs containing 15 or 30 sucking tablets.

Angileptol honey-lemon flavored lozenges