Bucospray 15 mg/ml + 0.5 mg/ml solution for oral spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
BUCOSPRAY 15 mg/ml + 0.5 mg/ml solution for oral spray
Chlorhexidine gluconate / Benzocaine
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use 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 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 you worsen or do not improve after 2 days of treatment.
Leaflet contents:
- What BUCOSPRAY is and what it is used for
- What you need to know before using BUCOSPRAY
- How to use BUCOSPRAY
- Possible adverse effects
- How to store BUCOSPRAY
- Contents of the pack and other information
1. What Bucospray is and what it is used for
This medicinal product combines the antiseptic action of chlorhexidine with the local anesthetic effect of benzocaine. While the antiseptic provides disinfection in the oropharyngeal area, the local anesthetic relieves pain and soothes discomfort.
It is indicated in adults and children from 6 years of age for the symptomatic relief of mild infections of the mouth and throat that occur without fever and are accompanied by pain, such as: sore throat irritation, hoarseness, minor wounds, and aphthous ulcers.
You should consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
2. What you need to know before using BUCOSPRAY
Do not use BUCOSPRAY
- If you are allergic to chlorhexidine, benzocaine, or any of the other components of this medicine (listed in section 6).
- If you are intolerant to other local anesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
Warnings and precautions
Consult your doctor or pharmacist before starting to use BUCOSPRAY
- If you have any severe or extensive injury in the mouth.
- If you suffer from periodontitis (gum disease), as chlorhexidine may increase supragingival calculus formation.
- Do not exceed the recommended dose indicated in section 3 (How to use BUCOSPRAY).
- If you have asthma.
- Do not use before eating or drinking.
- If you have fillings on your incisor teeth, and if the filling surface or its margins are rough, they may become permanently stained by chlorhexidine.
- It is recommended to maintain proper oral hygiene to reduce tartar buildup and potential tooth staining that may be caused by chlorhexidine.
Interference with diagnostic tests
If you are scheduled to undergo any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter test results.
This medicine may interfere with pancreatic function tests that use bentiromide. Do not take this medicine at least 3 days before the test and inform your doctor.
Children
This medicine must not be used in children under 6 years of age.
Children between 6 and 12 years of age may only use it under adult supervision.
Use of BUCOSPRAY with other medicines
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 the 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 medicines (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.
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
The use of this medicine does not affect your ability to drive or operate machinery.
Use in people aged 65 years and older
Elderly or debilitated patients may be more sensitive to the adverse effects of benzocaine.
3. How to use Bucospray
Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age:
2 sprays every 2 or 3 hours, increasing the time between applications as discomfort decreases. Under no circumstances should more than 16 sprays per day be exceeded.
Children from 6 to 12 years of age:
1 spray every 2 or 3 hours. Under no circumstances should more than 8 sprays per day be exceeded.
How to use
This medicine is for oropharyngeal use.
The medicine has local action; therefore, swallowing or inhaling the medicine should be avoided.
Do not use this medicine before meals or before drinking.
Before using the bottle for the first time, it is advisable to administer 2 or 3 sprays into the air to prime the dosing valve.
Always use the lowest effective dose.
| For the correct application of BUCOSPRAY, follow the instructions shown in the illustration. Place the spray nozzle of the metering valve into the open mouth, gently pressing down on the tongue, then press down once or twice. |
You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.
If you notice that after 2 days of starting treatment you develop fever, headache, nausea, or vomiting, you should consult your doctor as soon as possible.
If you use more BUCOSPRAY than you should
If you use more BUCOSPRAY than recommended, you may experience slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement, or seizures, tinnitus, increased sweating. A decrease in blood pressure may also occur.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915 62 04 20, indicating the medication and the amount taken.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Discoloration of the teeth may occur, especially in individuals who have plaque or tartar build-up on their teeth. This change in tooth color is not permanent and can be removed by dental cleaning. The color of dental fillings may also be altered; in such cases, this discoloration may be permanent.
Altered taste perception may occur.
In some cases, BUCOSPRAY may cause irritation in the mouth or irritation at the tip of the tongue, which are usually temporary.
Reporting of adverse effects
If you experience any 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 via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bucospray
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of BUCOSPRAY
- The active substances are chlorhexidine gluconate and benzocaine. Each ml of solution contains 0.5 mg of chlorhexidine gluconate (each 0.05 ml spray contains 0.025 mg) and 15 mg of benzocaine (each 0.05 ml spray contains 0.75 mg).
- The other components (excipients) are: sodium saccharin, ethanol 96º, glycerol, ammonium glycyrrhizinate and strawberry flavour.
Appearance of the product and contents of the container
BUCOSPRAY is supplied as a spray bottle containing 25 ml of solution equipped with a metering valve.
Marketing Authorization Holder and Manufacturer
Teofarma S.r.l.
Via F.lli Cervi 8
27010 VALLE SALIMBENE (Pavia), ITALY
Date of the most recent revision of this leaflet: July 2014
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/