Neo Borocillina oropharyngeal antiseptic
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: Information for the user
Neo Borocillina Oropharyngeal Antiseptic 6.4 mg + 52 mg Lozenges with Menthol Eucalyptus, Honey Lemon, Orange Flavour
Benzyl alcohol, sodium benzoate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment not exceeding 10 days.
Contents of this leaflet:
- What Neo Borocillina Oropharyngeal Antiseptic is and what it is used for
- What you need to know before using Neo Borocillina Oropharyngeal Antiseptic
- How to use Neo Borocillina Oropharyngeal Antiseptic
- Possible side effects
- How to store Neo Borocillina Oropharyngeal Antiseptic
- Package contents and other information
1. What Neo Borocillina Oropharyngeal Antiseptic is and what it is used for
Neo Borocillina Oropharyngeal Antiseptic contains the active ingredients benzyl alcohol and sodium benzoate and belongs to a category of medicines known as oropharyngeal (mouth and throat) antiseptics (antibacterials).
Benzyl alcohol soothes pain and burning sensations, while sodium benzoate acts as an antiseptic (antibacterial) and anticatarrhal agent (helps to fluidify respiratory secretions), thus facilitating swallowing of saliva and food.
Neo Borocillina Oropharyngeal Antiseptic lozenges are indicated to relieve burning and pain caused by inflammations of the mouth and throat, due to their disinfectant and antibacterial action against germs that may cause diseases of the oropharyngeal cavity (mouth and throat).
Consult your doctor if you do not feel better or if you feel worse after a treatment period not exceeding 10 days.
2. What you need to know before using Neo Borocillina Antisettico Orofaringeo
Do NOT use Neo Borocillina Antisettico Orofaringeo
- if you are allergic to benzyl alcohol or sodium benzoate or to any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Neo Borocillina Antisettico Orofaringeo
tablets.
The use, especially if prolonged, of topical products may lead to sensitization phenomena. In such cases, discontinue treatment and consult your doctor.
Children
Do not administer this medicine to children under 6 years of age, as the safety and efficacy of the medicine have not been established in this age group.
Other medicines and Neo Borocillina Antisettico Orofaringeo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, Neo Borocillina Antisettico Orofaringeo should only be used after consulting with your doctor.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or use machinery.
Neo Borocillina Antisettico Orofaringeo contains benzyl alcohol
This medicine contains 6.4 mg of benzyl alcohol per tablet as active ingredient.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
Neo Borocillina Antisettico Orofaringeo contains sodium benzoate
This medicine contains 52 mg of sodium benzoate per tablet as active ingredient, corresponding to 8.3 mg of sodium (the main component of table salt) per tablet and 66.4 mg of sodium per daily dose. This equals 3.3% of the maximum recommended daily dietary intake of sodium for an adult.
Neo Borocillina Antisettico Orofaringeo contains sugars
Menthol eucalyptol flavour: contains 1224 mg of glucose and 1494.02 mg of sucrose per tablet.
Honey lemon flavour: contains 1208.35 mg of glucose and 1475.88 mg of sucrose per tablet.
Orange flavour: contains 1205.11 mg of glucose and 1471.91 mg of sucrose per tablet.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This should be taken into account in patients with diabetes mellitus.
3. How to use Neo Borocillina Antisettico Orofaringeo
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
One tablet to be slowly dissolved in the mouth every 2 - 3 hours, up to a maximum of 8 tablets per day.
Do not exceed the recommended doses.
The tablets should be slowly dissolved in the mouth to maintain the mucosa under the effect of the medicine for as long as possible.
Consult your doctor if you do not notice any noticeable improvement after a short period of treatment (no longer than 10 days).
Use in children
In children aged 6 to 10 years: one tablet to be slowly dissolved in the mouth every 5 - 6 hours, up to a maximum of 4 tablets per day.
If you take more Neo Borocillina Antisettico Orofaringeo than you should
Immediately inform your doctor or go to the nearest hospital if you accidentally ingest a dose higher than the recommended daily dose of this medicine.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The components of this medicine are well-tolerated substances and therefore administration of Neo
Borocillina Antisettico Orofaringeo does not normally produce adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor or pharmacist. You may also report adverse
reactions directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to Store Neo Borocillina Oro-pharyngeal Antiseptic
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the packaging is open or damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the
carton and the package leaflet.
6. Package contents and other information
What Neo Borocillina Antisettico Orofaringeo contains
Menthol eucalyptol flavoured tablets
- The active substances are benzyl alcohol and sodium benzoate. One tablet contains 6.4 mg of benzyl alcohol and 52 mg of sodium benzoate (equivalent to 44.1 mg of benzoic acid).
- The other components are sucrose, glucose, peppermint flavour, levomenthol, cineole, indigotine (E132), curcumin extract (E100).
Honey lemon flavoured tablets
- The active substances are benzyl alcohol and sodium benzoate. One tablet contains 6.4 mg of benzyl alcohol and 52 mg of sodium benzoate (equivalent to 44.1 mg of benzoic acid).
- The other components are sucrose, glucose, lemon flavour, honey flavour, levomenthol, citrus flavour.
Orange flavoured tablets
- The active substances are benzyl alcohol and sodium benzoate. One tablet contains 6.4 mg of benzyl alcohol and 52 mg of sodium benzoate (equivalent to 44.1 mg of benzoic acid).
- The other components are sucrose, glucose, orange flavour, levomenthol, citrus flavour.
Description of the appearance of Neo Borocillina Antisettico Orofaringeo and the contents of the pack
Neo Borocillina Antisettico Orofaringeo is presented as tablets, available in the following flavours:
menthol eucalyptol, honey lemon, and orange.
Pack sizes: 10, 16, 18, 20, and 36 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. - Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO), Italy
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE), Italy
PACKAGE LEAFLET
Package leaflet: Information for the user
Neo Borocillina Oropharyngeal Antiseptic 6.4 mg + 52 mg Orodispersible Tablets
benzyl alcohol, sodium benzoate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, consult your pharmacist.
- If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment not exceeding 10 days.
Contents of this leaflet:
- What Neo Borocillina Oropharyngeal Antiseptic Orodispersible Tablets are and what they are used for
- What you need to know before using Neo Borocillina Oropharyngeal Antiseptic Orodispersible Tablets
- How to use Neo Borocillina Oropharyngeal Antiseptic Orodispersible Tablets
- Possible side effects
- How to store Neo Borocillina Oropharyngeal Antiseptic Orodispersible Tablets
- Contents of the pack and other information
1. What Neo Borocillina Antisettico Orofaringeo Orosoluble Tablets is and what it is used for
Neo Borocillina Antisettico Orofaringeo orosoluble tablets contain the active ingredients benzyl alcohol and sodium benzoate, and belong to a group of medicines called oropharyngeal antiseptics (antibacterials) (mouth and throat).
Benzyl alcohol relieves pain and burning sensations, while sodium benzoate acts as an antiseptic (antibacterial) and anticatarrhal (helps to liquefy respiratory secretions), making it easier to swallow saliva and food.
Neo Borocillina Antisettico Orofaringeo orosoluble tablets are indicated to soothe burning sensations and pain caused by inflammation of the mouth and throat, as they exert a disinfectant and antibacterial action against numerous germs that may cause diseases of the oropharyngeal cavity (mouth and throat).
Consult your doctor or pharmacist if you do not feel better or if you feel worse after a treatment period not exceeding 10 days.
2. What you should know before using Neo Borocillina Antisettico Orofaringeo orosoluble tablets
orosoluble
DO NOT use Neo Borocillina Antisettico Orofaringeo orosoluble tablets
- if you are allergic to benzyl alcohol or sodium benzoate or to any of the other ingredients of this medicine (listed in section 6)
- if you have a rare condition called phenylketonuria, as this product contains aspartame.
Warnings and precautions
Talk to your doctor or pharmacist before taking Neo Borocillina Antisettico Orofaringeo orosoluble tablets.
Neo Borocillina Antisettico Orofaringeo orosoluble tablets do not contain sugar and can be used by people who need to avoid sucrose (sugar) intake.
The use, especially if prolonged, of topical products may lead to sensitization reactions. If this occurs, stop treatment and consult your doctor.
Children
Do not give this medicine to children under 6 years of age, as the safety and efficacy of the medicine have not been established in this age group.
Other medicines and Neo Borocillina Antisettico Orofaringeo orosoluble tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using other medicines, consult your doctor or pharmacist for advice.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, Neo Borocillina Antisettico Orofaringeo orosoluble tablets should only be used after consulting your doctor.
Driving and operating machinery
No studies have been conducted on the ability to drive vehicles or operate machinery.
Neo Borocillina Antisettico Orofaringeo orosoluble tablets contain benzyl alcohol
This medicine contains 6.4 mg of benzyl alcohol per tablet as an active ingredient.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Neo Borocillina Antisettico Orofaringeo orosoluble tablets contain sodium benzoate
This medicine contains 52 mg of sodium benzoate per tablet as an active ingredient, corresponding to 8.3 mg of sodium (the main component of table salt) per tablet and 66.4 mg of sodium per daily dose.
This equals 3.3% of the maximum recommended daily dietary sodium intake for an adult.
Neo Borocillina Antisettico Orofaringeo orosoluble tablets contain aspartame
This medicine contains 5 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.
3. How to use Neo Borocillina Antiseptic Oropharyngeal Orodispersible Tablets
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
One tablet to be dissolved slowly in the mouth every 2–3 hours, up to a maximum of 8 tablets per day.
Do not exceed the recommended doses.
The tablets should be dissolved slowly in the mouth to maintain the mucosa under the effect of the medicine for as long as possible.
Consult your doctor if you do not notice appreciable results after a short period of treatment (not exceeding 10 days).
Use in children
In children aged 6 to 10 years: one tablet to be dissolved slowly in the mouth every 5–6 hours, up to a maximum of 4 tablets per day.
If you take more Neo Borocillina Antiseptic Oropharyngeal Orodispersible Tablets than you should
Immediately inform your doctor or go to the nearest hospital if you accidentally ingest a dose higher than the recommended daily dose of this medicine.
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
The components of this medicine are well-tolerated substances; therefore, administration of Neo Borocillina Antisettico Orofaringeo orosoluble tablets does not usually cause adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide further information on the safety of this medicine.
5. How to store Neo Borocillina Antisettico Orofaringeo orosoluble tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is open or damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the
carton and the package leaflet.
6. Package contents and other information
What Neo Borocillina Antisettico Orofaringeo Orodispersible Tablets contains
- The active substances are benzyl alcohol and sodium benzoate. One tablet contains 6.4 mg of benzyl alcohol and 52 mg of sodium benzoate.
- The other components are: mannitol, polyvinylpyrrolidone K30, powdered peppermint flavour, magnesium stearate, precipitated silica, powdered eucalyptus flavour, aspartame, powdered lemon flavour.
Description of the appearance of Neo Borocillina Antisettico Orofaringeo Orodispersible Tablets and
pack size
Neo Borocillina Antisettico Orofaringeo Orodispersible Tablets are presented as tablets to be dissolved in the mouth and are available in packs of 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. - Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO), Italy
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE), Italy