Neo Borocillina

PACKAGE LEAFLET

Package leaflet: Information for the user

NEO BOROCILLINA 1.2 mg + 70 mg sugar-free vitamin C tablets

2.4-dichlorobenzyl alcohol, ascorbic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.
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 any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What Neo Borocillina sugar-free vitamin C tablets are and what they are used for
2. What you need to know before using Neo Borocillina sugar-free vitamin C tablets
3. How to use Neo Borocillina sugar-free vitamin C tablets
4. Possible side effects
5. How to store Neo Borocillina sugar-free vitamin C tablets
6. Package contents and other information

1. What Neo Borocillina Sugar-Free Vitamin C Tablets Are and What They Are Used For

Neo Borocillina sugar-free vitamin C tablets contain the active ingredients 2,4-dichlorobenzyl alcohol and ascorbic acid and belong to a class of medicines called antiseptics (antibacterials) for the oropharyngeal cavity (mouth and throat), used for the treatment of symptoms of inflammatory diseases of the mouth and throat.
2,4-dichlorobenzyl alcohol exerts a local antiseptic (antibacterial) action in the oral cavity. Furthermore, vitamin C (ascorbic acid) provides useful support in the treatment of cold-related illnesses.
Neo Borocillina sugar-free vitamin C tablets have a pleasant taste and are indicated as a disinfectant for the oropharyngeal cavity (mouth and throat), providing a pleasant feeling of freshness.
Neo Borocillina sugar-free vitamin C tablets:

• exert disinfectant and antibacterial action against numerous microorganisms that may cause diseases of the oral cavity
• have rapid bactericidal action (eliminate bacteria) and a prolonged effect

Neo Borocillina sugar-free vitamin C tablets can be used by individuals who need to avoid ingesting sucrose (sugar) and are therefore particularly suitable for patients who must control their sugar and calorie intake throughout the day.
Moreover, since they do not contain sugar, Neo Borocillina sugar-free vitamin C tablets do not promote the development of dental caries.

2. What you need to know before using Neo Borocillina vitamin C sugar-free tablets

DO NOT use Neo Borocillina vitamin C sugar-free tablets

• if you are allergic to 2,4-dichlorobenzyl alcohol, vitamin C, or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a rare disorder called phenylketonuria, as this product contains aspartame

Warnings and precautions
The use, especially if prolonged, of topical products may lead to allergic reactions. If this occurs, stop treatment immediately and consult your doctor.
Neo Borocillina vitamin C sugar-free tablets should be used with caution in patients:

• who currently have or have previously suffered from kidney stones (nephrolithiasis)
• affected by deficiency of the enzyme G6PD (glucose-6-phosphate dehydrogenase)
• affected by blood disorders involving red blood cells (hemochromatosis, thalassemia, or sideroblastic anemia)

Children
In children, this product should be used only when clearly necessary and under direct medical supervision.
Other medicines and Neo Borocillina vitamin C sugar-free tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking other antiseptic medicines for the mouth and throat together with Neo Borocillina vitamin C sugar-free tablets.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, Neo Borocillina vitamin C sugar-free tablets should be used only if clearly necessary and under direct medical supervision, as there are no reliable data on the use of 2,4-dichlorobenzyl alcohol and ascorbic acid during pregnancy and breastfeeding.
Driving and use of machinery
No studies have been conducted regarding the ability to drive vehicles or operate machinery.
Neo Borocillina vitamin C sugar-free tablets contain aspartame
This medicine contains 3 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly metabolize it.

3. How to use Neo Borocillina sugar-free vitamin C tablets

Use this medicine exactly as stated in this leaflet or as instructed 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 in order to keep the oropharyngeal 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 (not exceeding 7 days).
If you take more Neo Borocillina sugar-free vitamin C tablets than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion of a dose higher than the recommended daily dose of this medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very rare side effects:

• allergic reactions (hypersensitivity),
• dizziness,
• breathing difficulties (respiratory failure),
• swelling of the throat (glottal oedema),
• vomiting,
• malaise,
• sweating,
• swelling (oedema) of the arms,
• swelling of the mouth, eyelids or face,
• urticaria,
• damage to red blood cells leading to anaemia (haemolytic anaemia),
• yellowing of the skin and eyes (jaundice).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neo Borocillina vitamin C tablets without sugar

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.
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 you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the
package and the leaflet.

6. Package contents and other information

What Neo Borocillina sugar-free vitamin C tablets contain

• The active substances are 2,4-dichlorobenzyl alcohol and ascorbic acid. Each tablet contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 70 mg of ascorbic acid.
• The other components are: mannitol, polyvinylpyrrolidone K30, copovidone, orange flavour, glyceryl behenate, aspartame (see section 2 “Neo Borocillina sugar-free vitamin C tablets contain aspartame”).

Description of the appearance of Neo Borocillina sugar-free vitamin C tablets and pack contents
Neo Borocillina sugar-free vitamin C tablets are supplied as tablets.
Pack sizes contain 16, 18 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)
Alfasigma S.p.A. – Via Pontina km 30.400 – 00071 Pomezia (RM)

PACKAGE LEAFLET

Package leaflet: information for the user

NEO BOROCILLINA 1.2 mg + 20 mg sugar-free tablets

2.4-dichlorobenzyl alcohol, sodium benzoate
Please read this leaflet carefully before using this medicine because it contains important information for you.
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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What Neo Borocillina sugar-free tablets are and what they are used for
2. What you need to know before using Neo Borocillina sugar-free tablets
3. How to use Neo Borocillina sugar-free tablets
4. Possible side effects
5. How to store Neo Borocillina sugar-free tablets
6. Package contents and other information

1. What Neo Borocillina sugar-free tablets are and what they are used for

Neo Borocillina sugar-free tablets contain the active ingredients 2,4-dichlorobenzyl alcohol and sodium benzoate, and belong to a category of medicines known as oropharyngeal (mouth and throat) antiseptics (antibacterials), used for the treatment of symptoms of inflammatory diseases of the mouth and throat.
2,4-Dichlorobenzyl alcohol and sodium benzoate exert a local antiseptic (antibacterial) action in the oral cavity. Furthermore, sodium benzoate helps to liquefy respiratory secretions (phlegm).
Neo Borocillina sugar-free tablets have a pleasant taste and are indicated as a disinfectant for the oropharyngeal cavity (mouth and throat), providing a pleasant feeling of freshness.
Neo Borocillina sugar-free tablets:

• have disinfectant and antibacterial activity against numerous microorganisms that may cause diseases of the oral cavity
• have rapid bactericidal action (eliminate bacteria) and prolonged effect

Neo Borocillina sugar-free tablets can be used by individuals who need to avoid ingesting sucrose (sugar), making them particularly suitable for those who must control their sugar and calorie intake throughout the day.
Moreover, since they do not contain sugar, Neo Borocillina sugar-free tablets do not promote the development of dental caries.

2. What you need to know before using Neo Borocillina sugar-free tablets

Do NOT use Neo Borocillina sugar-free tablets

• if you are allergic to 2,4-dichlorobenzyl alcohol or sodium benzoate, or to any of the other ingredients of this medicine (listed in section 6)
• in children under two years of age with a predisposition to laryngospasm (contraction of the laryngeal muscles) and seizures
• if you have the rare inherited disease called phenylketonuria, because it contains aspartame

Warnings and precautions
The use, especially if prolonged, of locally applied products may lead to allergic reactions. If this occurs, discontinue treatment and consult your doctor.
Children
Neo Borocillina sugar-free tablets must not be used in children under two years of age with a predisposition to seizures and laryngospasm (contraction of the laryngeal muscles), because it contains levomenthol.
In children over two years of age, use this medicine with caution and under direct medical supervision.
Other medicines and Neo Borocillina sugar-free tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking other antiseptic medicines for the mouth and throat together with Neo Borocillina sugar-free tablets.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, Neo Borocillina sugar-free tablets should be used only if clearly needed and under direct medical supervision, as there are no reliable data on the use of 2,4-dichlorobenzyl alcohol and sodium benzoate during pregnancy and breastfeeding.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery.
Neo Borocillina sugar-free tablets contain aspartame
This medicine contains 10 mg of aspartame per tablet. Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
Neo Borocillina sugar-free tablets contain sodium
This medicine contains 3.2 mg of sodium as active ingredient (main component of table salt) per tablet and 25.5 mg of sodium per daily dose. This corresponds to 1.3% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Neo Borocillina sugar-free tablets

Use this medicine exactly as stated in this leaflet or as instructed 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 oropharyngeal mucosa under the effect of the medicine for as long as possible.
Consult your doctor if you do not observe any noticeable improvement after a short period of treatment (not exceeding 7 days).
If you take more Neo Borocillina sugar-free tablets than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion of a dose higher than the recommended daily dose of this medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects:

• allergic reactions (hypersensitivity),
• dizziness,
• breathing difficulties (respiratory failure),
• swelling of the throat (glottis edema),
• vomiting,
• malaise,
• sweating,
• swelling (edema) of the arms,
• swelling of the mouth, eyelids, or face,
• hives,
• damage to red blood cells leading to anaemia (haemolytic anaemia),
• yellowing of the skin and eyes (jaundice).

Sodium benzoate may have a mildly irritating effect on the skin and mucous membranes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neo Borocillina sugar-free 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.
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
packaging and the leaflet.

6. Package contents and other information

What Neo Borocillina sugar-free tablets contain

• The active substances are 2,4-dichlorobenzyl alcohol and sodium benzoate. Each tablet contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 20 mg of sodium benzoate (equivalent to 17 mg of benzoic acid).
• The other components are: magnesium stearate, hydrated colloidal silica, levomenthol, peppermint essence, eucalyptol, citral, peppermint, aspartame, granular mannitol (containing mannitol and polyvinylpyrrolidone), mannitol.

Description of the appearance of Neo Borocillina sugar-free tablets and pack contents
Neo Borocillina sugar-free tablets are presented as tablets.
Pack sizes: 16, 18 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturers:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)
Alfasigma S.p.A. – Via Pontina km 30.400 – 00071 Pomezia (RM)

PACKAGE LEAFLET

Package leaflet: information for the user

NEO BOROCILLINA 1.2 mg + 20 mg tablets

2,4 dichlorobenzyl 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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you would like 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 any improvement or if your symptoms worsen after 7 days.
  Contents of this leaflet:
  1. What Neo Borocillina tablets are and what they are used for
  2. What you need to know before using Neo Borocillina tablets
  3. How to use Neo Borocillina tablets
  4. Possible side effects
  5. How to store Neo Borocillina tablets
  6. Contents of the pack and other information

1. What Neo Borocillina tablets are and what they are used for

Neo Borocillina tablets contain the active substances 2,4-dichlorobenzyl alcohol and sodium benzoate and belong to a class of medicines known as antiseptics (antibacterials) for the oropharyngeal cavity (mouth and throat), used to treat symptoms of inflammatory diseases of the mouth and throat.
2,4-Dichlorobenzyl alcohol and sodium benzoate exert a local antiseptic (antibacterial) action in the oral cavity. In addition, sodium benzoate helps to fluidify respiratory secretions (catarrh).
Neo Borocillina tablets:

• have a disinfectant and antibacterial action against numerous germs that may cause diseases of the oral cavity
• have a rapid bactericidal effect (eliminates bacteria) and a prolonged action

2. What you need to know before using Neo Borocillina tablets

DO NOT use Neo Borocillina tablets

• if you are allergic to 2,4-dichlorobenzyl alcohol or sodium benzoate, or to any of the other ingredients of this medicine (listed in section 6)
• in children under two years of age with a predisposition to laryngospasm (contraction of the laryngeal muscles) and seizures

Warnings and precautions
The use, especially if prolonged, of topical products may lead to allergic reactions. If this occurs, stop treatment immediately and consult your doctor.
Children
Neo Borocillina tablets must not be used in children under two years of age who have a predisposition to seizures and laryngospasm (contraction of the laryngeal muscles), as it contains levomenthol.
In children over two years of age, use this medicine with caution and under direct medical supervision.
Other medicines and Neo Borocillina tablets
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Avoid taking other antiseptic medicines for the mouth and throat together with Neo Borocillina tablets.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, Neo Borocillina tablets should only be used if clearly needed and under direct medical supervision, as there are no reliable data on the use of 2,4-dichlorobenzyl alcohol and sodium benzoate during pregnancy and breastfeeding.
Driving and using machines
No studies have been conducted on the ability to drive or use machinery.
Neo Borocillina tablets contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine. This medicine contains 0.9 g of sucrose per tablet: this should be taken into account in patients with diabetes mellitus.
This medicine contains 3.2 mg of sodium as active ingredient (main component of table salt) per tablet and 25.5 mg of sodium per daily dose. This corresponds to 1.3% of the maximum recommended daily dietary intake for an adult.

3. How to use Neo Borocillina tablets

Use this medicine exactly as described in this leaflet or as instructed 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 longest possible exposure of the oropharyngeal mucosa to the medicine.
Consult your doctor if you do not observe noticeable improvement after a short period of treatment (no longer than 7 days).
If you use more Neo Borocillina 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very rare side effects:

• allergic reactions (hypersensitivity),
• dizziness,
• breathing difficulties (respiratory failure),
• throat swelling (glottis edema),
• vomiting,
• malaise,
• sweating,
• swelling (edema) of the arms,
• swelling of the mouth, eyelids, or face,
• hives,
• damage to red blood cells leading to anemia (hemolytic anemia),
• yellowing of the skin and eyes (jaundice).

Sodium benzoate may have a mildly irritating effect on the skin and mucous membranes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neo Borocillina 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.
Store below 30°C.
Do not dispose of medicines 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 keep the information about the medicine readily available; therefore, retain both
the packaging and the leaflet.

6. Package Contents and Other Information

What Neo Borocillina Tablets Contain

• The active substances are 2,4-dichlorobenzyl alcohol and sodium benzoate. Each tablet contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 20 mg of sodium benzoate (equivalent to 17 mg of benzoic acid).
• The other components are compressible sugar, copovidone, magnesium stearate, hydrated colloidal silica, levomenthol, sucrose, peppermint oil, eucalyptol, citral (see section 2 “Neo Borocillina tablets contain sucrose”).

Description of the Appearance of Neo Borocillina Tablets and Package Contents
Neo Borocillina tablets are presented as tablets.
Pack sizes: 16, 18 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)
Alfasigma S.p.A. – Via Pontina km 30,400 – 00071 Pomezia (RM)