Anestefarin 5 mg/5 mg lozenges for sucking
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ANESTEFARIN 5 mg / 5 mg Sucking tablets
Chlorhexidine dihydrochloride / benzocaine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Always follow exactly the instructions for taking this medicine as described in this leaflet or as given 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 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 your condition worsens or does not improve after 2 days of starting treatment, or if you develop fever, headache, nausea, or vomiting.
Leaflet contents:
- What Anestefarin is and what it is used for
- What you need to know before using Anestefarin
- How to use Anestefarin
- Possible adverse effects
- How to store Anestefarin
- Contents of the pack and other information
1. What Anestefarin is and what it is used for
The active ingredients in this medicine combine the antiseptic and disinfectant action of chlorhexidine with the local anesthetic effect of benzocaine.
This medicine is used in adults and children over 6 years of age for the local and temporary symptomatic relief of mild infections of the mouth and throat associated with pain and without fever, such as: sore throat irritation, hoarseness, and minor 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 occur.
2. What you need to know before using Anestefarin
Do not use Anestefarin:
- if you are allergic to chlorhexidine, benzocaine, or any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using Anestefarin:
- 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 injury in the mouth.
- if you suffer from periodontitis (gum disease), as chlorhexidine may increase supragingival calculus formation.
A slight laxative effect may occur because it contains mannitol (542 mg).
This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; therefore, it is essentially "sodium-free".
Good oral hygiene is recommended to reduce tartar buildup and possible tooth staining that chlorhexidine may cause.
Children and adolescents
This medicine should not be given to children under 6 years of age without first consulting a doctor.
Use of Anestefarin with other medicines:
Tell 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, it should not be used with other medicines applied in the mouth without consulting your doctor or pharmacist.
This is especially important in the case of:
- Other mouth or throat antiseptics.
- 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 using toothpaste.
Interference with diagnostic tests
This medicine may interfere with the pancreatic function test using bentiromide. Do not use 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.
Driving and using machines:
No effects on the ability to drive or operate machinery have been reported.
3. How to use Anestefarin
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 6 years of age: 1 lozenge every 2 or 3 hours, slowly dissolving it in the mouth. Do not use more than 8 lozenges in 24 hours (1 day).
Use in children
This medicine is intended for children over 6 years of age.
Use in elderly patients
Elderly individuals and debilitated patients may be more sensitive to benzocaine.
This medicine is for oropharyngeal use; therefore, the lozenges must be slowly dissolved in the mouth without chewing or swallowing them, since its action is local and only becomes effective 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:
Symptoms of overdose may include: slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or convulsions, tinnitus, and increased sweating. A decrease in blood pressure may also occur.
In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare facility or call the Toxicology Information Service (Telephone 91 562 04 20), specifying the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, Anestefarin may produce adverse effects, although not everyone experiences them.
Discoloration of the teeth may occur. This staining or discoloration may be more pronounced in people who have dental tartar deposits. This change in tooth colour is not permanent and can be removed by dental cleaning. The colour of dental fillings may also be altered; in such cases, this staining may be permanent.
Altered taste perception may occur.
In some cases, Anestefarin may cause irritation in the mouth or irritation at the tip of the tongue, which are usually temporary, as well as allergic reactions to chlorhexidine or benzocaine.
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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Anestefarin
Do not store above 30 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of ANESTEFARIN:
Each lozenge contains:
- The active substances 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 contents of the package:
These are orange-flavored lozenges. This medicine is available in packs 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,
Alcalá de Henares. 28802. Spain
This leaflet was approved in September 2014.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/