Angileptol lozenges with mint flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Angileptol lozenges with mint flavour
Chlorhexidine/Benzocaine/Enoxolone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
Follow exactly the instructions for taking this medicine as described in this leaflet or as advised 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you 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 side 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 complementing the antiseptic action of chlorhexidine with the anti-inflammatory effect 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 and temporary symptomatic relief of mild infections and inflammations of the mouth and throat accompanied by pain and without fever in adults and children aged 6 years and older.
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 ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Angileptol:
- If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
- If you have a severe or extensive lesion in the mouth.
- If you suffer from periodontitis (gum disease), as chlorhexidine may increase supragingival calculus formation.
- If you have hypertension or fluid retention, as enoxolone may worsen these symptoms.
- It is recommended to maintain proper oral hygiene to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.
- Do not exceed the recommended doses described in section 3 (How to take Angileptol).
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 or debilitated patients.
Use in people aged 65 years and older
Using this medicine at high doses or for prolonged periods 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, Angileptol should not be used together with other medicines for oral use without consulting your doctor or pharmacist.
This is especially important in the case of:
- Other antiseptics for the mouth or throat.
- Cholinesterase inhibitor medicines (used for Alzheimer's disease).
- Sulfonamides (used for infections).
Anionic compounds and suspending agents, common ingredients in toothpastes, reduce the effectiveness of chlorhexidine; therefore, the mouth should be thoroughly rinsed after toothpaste use.
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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
IMPORTANT FOR WOMEN:
Taking medicines during pregnancy may be harmful to 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 1,237.75 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 body 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 for use of this medicine given by your doctor or pharmacist. 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, 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause 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 occur.
Discoloration of the teeth may appear, especially in people who have accumulations of dental plaque. This change in tooth colour is not permanent and can be removed by professional 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 can 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 or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Angileptol mint flavour
Each tablet contains:
- Active substances:
Clorhexidina dihydrochloride, 5 mg
Benzocaine, 4 mg
Enoxolone, 3 mg
- Other components (excipients): sorbitol (E420), acesulfame potassium (E950), magnesium stearate and mint flavouring
Appearance of the product and contents of the pack
Angileptol are white, round, suckable tablets with the Greek letter σ on one side.
They are available in packs containing 15 and 30 suckable tablets.
Other presentations
Angileptol Mint-Eucalyptus flavour
Angileptol Honey-Lemon flavour
Marketing Authorisation Holder
Alfasigma España S.L.
C/ Aribau 195, 4º
08021 Barcelona. Spain
Manufacturer
Pharmaloop, S.L
Azque Industrial Estate, 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 most recent review of this leaflet: September 2021
Other sources of information
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es