Bucomax lozenges for sucking, peppermint flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
bucomax sugar-free pastilles with mint flavour
amylmetacresol / 2,4-dichlorobenzyl alcohol
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use of 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 effects, consult your doctor, pharmacist or nurse, even if they are adverse effects 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 of treatment.
Contents of the leaflet
- What bucomax is and what it is used for.
- What you need to know before taking bucomax.
- How to take bucomax.
- Possible adverse effects.
- How to store bucomax.
- Contents of the pack and other information.
1. What bucomax is and what it is used for
bucomax belongs to a group of medicines called antiseptics.
It is used for the local symptomatic relief of mild infections of the mouth and throat without fever in adults and children aged 6 years and older.
You should consult a doctor if symptoms worsen or do not improve after 2 days.
2. What you need to know before taking bucomax
Do not take bucomax
- If you are allergic to amylmetacresol, 2,4-dichlorobenzyl alcohol, 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 bucomax.
If your symptoms do not improve, worsen after 2 days of treatment, or if you develop high fever, headache, nausea, or vomiting, you should consult your doctor.
Do not exceed the maximum recommended dose.
Children
This medicine must not be used in children under 6 years of age.
Taking bucomax with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
You should not take other oropharyngeal antiseptics (medicines for mild throat infections such as bucomax) while taking this medicine, although interactions are not expected.
Pregnancy, breastfeeding and fertility
If you are pregnant, 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 effect of this medicine on the ability to drive and operate machinery is none or negligible.
bucomax mint-flavored lozenges contain sodium. This medicine contains less than 23 mg of sodium (1 mmol) per lozenge, which means it is essentially “sodium-free”.
bucomax mint-flavored lozenges contain isomalt and maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains terpenes derived from levomenthol which, in excessive doses, may cause seizures in young children (under 6 years of age). However, at the doses and via the route of administration used in this medicine, absorption and activity of terpenes are very low.
3. How to take bucomax
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults: 1 tablet every 2 or 3 hours, as needed, up to a maximum of 8 tablets in 24 hours.
Children
Children from 6 years of age: 1 tablet every 2 or 3 hours, as needed, up to a maximum of 4 tablets in 24 hours.
Not recommended for children under 6 years of age.
How to take bucomax
Bucopharyngeal use, to be dissolved in the mouth.
Allow one lozenge to dissolve slowly in the mouth. Do not swallow, chew or bite.
If discomfort persists for more than 2 days, worsens, or is accompanied by high fever, headache, nausea or vomiting, consult your doctor as soon as possible.
If you take more bucomax than you should
In case of ingestion of large quantities, you may experience gastrointestinal discomfort.
In the event of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Very rare adverse effects (may affect up to 1 in 10,000 people): allergic reactions (hypersensitivity) such as redness, itching, or skin swelling (rash), or burning, stinging, or swelling of the mouth or throat.
Adverse effects with frequency not known (cannot be estimated from available data): abdominal pain, nausea, or oral discomfort.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of bucomax
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
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 must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to 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 bucomax menthol-flavoured lozenges
- The active substances are:
Amylmetacresol 0.60 mg
2,4-Dichlorobenzyl alcohol 1.20 mg
- The other components are: peppermint essential oil, levomenthol, indigo carmine colour (E-132), quinoline yellow (E-104), sodium saccharin (E-954), tartaric acid (E-334), isomalt (E-953) and maltitol (E-965).
Appearance of the product and contents of the pack
bucomax menthol-flavoured lozenges are green cylindrical lozenges with a menthol flavour.
Each pack contains 8 or 24 lozenges.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
LOZY’S PHARMACEUTICALS, S.L.
Campo Empresarial s/n
31795 Lekaroz (Navarra)
SPAIN
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent review of this leaflet: December 2019
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