NEO BOROKILLINA GOLA DOLORE 0.25% Mouthwash

Зміст інструкції

1. NEO BOROCILLINA GOLA DOLORE 0,25% spray per mucosa orale mint, orange and honey, lemon and honey flavour
   1. What is Neo Borocillina Gola Dolore oral mucosa spray and what is it for
   2. What you need to know before using Neo Borocillina Gola Dolore spray for oral mucosa
   3. How to use Neo Borocillina Gola Dolore spray for oral mucosa
   4. Possible side effects
   5. How to store Neo Borocillina Gola Dolore spray for oral mucosa
   6. Package Contents and Other Information
2. NEO BOROCILLINA GOLA DOLORE 8.75 mg sugar-free lozenges mint, orange and honey, lemon and honey flavour
   1. What is Neo Borocillina Gola Dolore lozenges and what are they for
   2. What you need to know before using Neo Borocillina Gola Dolore lozenges
   3. How to use Neo Borocillina Gola Dolore lozenges
   4. Possible side effects
   5. How to store Neo Borocillina Gola Dolore lozenges
   6. Contents of the pack and other information
3. NEO BOROCILLINA GOLA DOLORE 0,25% mouthwash
   1. What is Neo Borocillina Gola Dolore mouthwash and what is it used for
   2. What you need to know before using Neo Borocillina Gola Dolore mouthwash
   3. How to use Neo Borocillina Gola Dolore mouthwash
   4. Possible side effects
   5. How to store Neo Borocillina Gola Dolore mouthwash
   6. Contents of the pack and other information

NEO BOROCILLINA GOLA DOLORE 0,25% spray per mucosa orale mint, orange and honey, lemon and honey flavour

flurbiprofene

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What Neo Borocillina Gola Dolore spray per mucosa orale is and what it is used for
• 2. What you need to know before you use Neo Borocillina Gola Dolore spray per mucosa orale
• 3. How to use Neo Borocillina Gola Dolore spray per mucosa orale
• 4. Possible side effects
• 5. How to store Neo Borocillina Gola Dolore spray per mucosa orale
• 6. Contents of the pack and other information

1. What is Neo Borocillina Gola Dolore oral mucosa spray and what is it for

Neo Borocillina Gola Dolore contains flurbiprofen. Flurbiprofen belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines relieve
symptoms by modifying the body's response to pain and fever.
Neo Borocillina Gola Dolore oral mucosa spray is used to relieve symptoms of irritation and
inflammation, also associated with pain, of the oropharyngeal cavity (e.g. sore throat, gingivitis and
stomatitis), even as a result of conservative or extraction dental therapy (tooth care and extraction).

2. What you need to know before using Neo Borocillina Gola Dolore spray for oral mucosa

DO NOT use Neo Borocillina Gola Dolore spray for oral mucosa

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid (e.g. aspirin) or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• if you have a high sensitivity of the respiratory system (asthma, bronchospasm)
• if you are an allergic subject and suffer from itching (urticaria)
• if you suffer from lesions of the stomach mucosa (peptic ulcer) or if you have suffered from this disease in the past
• during the third trimester of pregnancy and if you are breastfeeding (see section Pregnancy and breastfeeding)

Warnings and precautions
The occasional swallowing of the solution, at the recommended doses, does not cause any harm to the
patient, as these doses are well below those commonly used in treatments
with flurbiprofen via systemic route.
It is advisable not to use Neo Borocillina Gola Dolore spray for oral mucosa with other medicines
that belong to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
The use, especially if prolonged, of products for local use can give rise to allergic reactions. In
this case, discontinue treatment and consult your doctor.
Use Neo Borocillina Gola Dolore spray for oral mucosa with caution:

• if you suffer from reduced kidney function (renal insufficiency) or reduced heart function (heart failure) or reduced liver function (hepatic insufficiency)

Remember:

• that this medicine should not be used for long-term treatments
• to consult your doctor after a short period of treatment if you do not notice any improvement

Other medicines and Neo Borocillina Gola Dolore spray for oral mucosa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Flurbiprofen may occasionally affect the action of:

• furosemide, a diuretic drug
• medicines to thin the blood (anticoagulants)

No interaction of flurbiprofen with medicines has been demonstrated:

• used in the regulation of heart rhythms (digoxin)
• used in diabetes (tolbutamide)
• that counteract stomach acidity (antacids)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use Neo Borocillina Gola Dolore spray for oral mucosa only if absolutely necessary and under
direct medical supervision during the first and second trimester of pregnancy.
Do not use Neo Borocillina Gola Dolore spray for oral mucosa during the third trimester of pregnancy.
The use of the medicine during pregnancy may delay the onset of labor and increase its duration.
Breastfeeding
Do not use Neo Borocillina Gola Dolore spray for oral mucosa if you are breastfeeding.

Driving and using machines
Neo Borocillina Gola Dolore spray for oral mucosa does not impair the ability to drive vehicles or
use machines.

Neo Borocillina Gola Dolore spray for oral mucosa (all presentations) contains methyl
parahydroxybenzoate and propyl parahydroxybenzoate
Neo Borocillina Gola Dolore spray for oral mucosa contains para-hydroxy benzoates, which may
cause allergic reactions (even delayed).

Neo Borocillina Gola Dolore spray for oral mucosa (all presentations) contains ethanol
This medicine contains 960 mg of ethanol per 10 ml of spray.
It may cause a burning sensation on damaged skin.

Neo Borocillina Gola Dolore spray for oral mucosa (all presentations) contains castor
oil
This medicine contains Hydrogenated polyoxidized castor oil which may cause localized skin reactions.

Neo Borocillina Gola Dolore spray for oral mucosa (only the orange and honey and lemon and honey
taste presentations) contains the sunset yellow (E110) coloring agent
Neo Borocillina Gola Dolore spray for oral mucosa orange and honey taste and Neo Borocillina Gola
Dolore spray for oral mucosa lemon and honey taste also contain the sunset yellow
(E110) coloring agent, which may cause allergic reactions.

3. How to use Neo Borocillina Gola Dolore spray for oral mucosa

Use this medicine following 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:
3 sprays 3 times a day directed directly onto the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active substance.
Do not exceed the indicated doses.

If you use more Neo Borocillina Gola Dolore spray for oral mucosa than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion
of a dose higher than that recommended for the daily intake of this medicine.
The symptoms that may occur in case of an overdose of the medicine are:

• nausea
• vomiting
• gastrointestinal irritation

In case of overdose, appropriate treatments should be adopted; gastric lavage is indicated
and, if necessary, correction of the resulting fluid and electrolyte losses.
Contact your doctor or pharmacist if you have any doubts about the use of Neo Borocillina Gola Dolore.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Prolonged use of Neo Borocillina Gola Dolore may cause allergic or local irritation reactions. In this case, discontinue treatment and consult your doctor to receive
more appropriate therapy.

Blood disorders

• Altered values in some blood tests (thrombocytopenia, aplastic anemia, agranulocytosis)

Immune system disorders

• Allergic reactions, including severe ones (anaphylaxis, swelling of the face, lips and/or tongue)

Nervous system disorders

• Dizziness
• Brain damage (stroke)
• Visual disturbances
• Inflammation of the optic nerve (optic neuritis)
• Headache (migraine)
• Sensory disturbances of the limbs and other parts of the body (paresthesia)
• Depression
• Confusion
• Hallucination
• Vertigo
• Feeling unwell
• Fatigue and drowsiness

Ear disorders

• Tinnitus (ringing in the ears)

Respiratory disorders

• Narrowing of the airways (bronchospasm)
• Inflammation of the airways (asthma)
• Difficulty breathing (dyspnea)

Gastrointestinal disorders
More commonly observed:

• Nausea
• Vomiting
• Diarrhea
• Gas production (flatulence)
• Lack of bowel movements (constipation)
• Digestive difficulties (dyspepsia)
• Abdominal or stomach pain (abdominal pain)
• Presence of blood in the stool (black stools)
• Presence of blood in vomit (hematemesis)
• Presence of ulcers in the mouth (ulcerative stomatitis)
• Internal bleeding of the digestive tract (gastrointestinal hemorrhage)
• Worsening of inflammatory bowel diseases (colitis, Crohn's disease)

Less frequently observed:

• Inflammation of the stomach (gastritis)
• Internal stomach lesions (peptic ulcer)
• Perforation and bleeding (from ulcer)

Skin disorders

• Rashes
• Itching
• Hives
• Dark red spots of varying sizes (purpura)
• Very rarely, severe skin diseases such as Stevens-Johnson syndrome (skin rash and blisters, ulcers of the mouth and eyes), Lyell's syndrome (peeling, painful, red skin) and erythema multiforme (skin lesions)

Kidney and urinary disorders

• Kidney problems in various forms, including kidney inflammation (interstitial nephritis)
• Impaired kidney function (nephrotic syndrome)

As with other NSAIDs, rare cases of reduced kidney function (renal
insufficiency) have been reported

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

5. How to store Neo Borocillina Gola Dolore spray for oral mucosa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the last day of that month.
After first opening, the spray is valid for 1 year.
Do not dispose of any medicine in 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 have the information about the medicine available, therefore keep both the

6. Package Contents and Other Information

What Neo Borocillina Gola Dolore spray for oral mucosa mint flavour contains

• The active ingredientis flurbiprofen. 100 ml of solution contains 250 mg of flurbiprofen.
• The other ingredientsare: glycerol,ethyl alcohol (ethanol96% ),sorbitolliquid (non-crystallizing), hydrogenated castor oil40 polyoxyethylene, sodiumhydroxide, saccharin sodium, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate,peppermint essential oil triple rectified, Patent Blue V (E 131), citric acid, purified water. (See paragraph 2)

What Neo Borocillina Gola Dolore spray for oral mucosa orange and honey flavour contains

• The active ingredientis flurbiprofen. 100 ml of solution contains 250 mg of flurbiprofen.
• The other ingredientsare: glycerol, ethyl alcohol (ethanol96% ),sorbitolliquid (non-crystallizing), hydrogenated castor oil40 polyoxyethylene, sodiumhydroxide, saccharin sodium, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, honey flavour, orange flavour, mint flavour, sunset yellow (E110), citric acid, purified water. (See paragraph 2)

What Neo Borocillina Gola Dolore spray for oral mucosa lemon and honey flavour contains

• The active ingredientis flurbiprofen. 100 ml of solution contains 250 mg of flurbiprofen.
• The other ingredientsare: glycerol,ethyl alcohol (ethanol96% ),sorbitolliquid (non-crystallizing), hydrogenated castor oil40 polyoxyethylene, sodiumhydroxide, saccharin sodium, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, honey flavour, lemon flavour, mint flavour, sunset yellow (E110), citric acid, purified water. (See paragraph 2)

Description of the appearance of Neo Borocillina Gola Dolore spray for oral mucosa and package contents
Neo Borocillina Gola Dolore spray for oral mucosa is available in mint,
orange and honey, lemon and honey flavours and is packaged in a 15 ml bottle. 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)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

NEO BOROCILLINA GOLA DOLORE 8.75 mg sugar-free lozenges mint, orange and honey, lemon and honey flavour

flurbiprofene

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after a short period of treatment.

Contents of this leaflet:

• 1. What Neo Borocillina Gola Dolore lozenges is and what it is used for
• 2. What you need to know before you use Neo Borocillina Gola Dolore lozenges
• 3. How to use Neo Borocillina Gola Dolore lozenges
• 4. Possible side effects
• 5. How to store Neo Borocillina Gola Dolore lozenges
• 6. Contents of the pack and other information

1. What is Neo Borocillina Gola Dolore lozenges and what are they for

Neo Borocillina Gola Dolore contains flurbiprofen. Flurbiprofen belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines relieve
symptoms by modifying the body's response to pain and fever.
Neo Borocillina Gola Dolore sugar-free lozenges are used to relieve symptoms of irritation
and inflammation, also associated with pain, of the oropharyngeal cavity (e.g. sore throat, gingivitis and
stomatitis).

2. What you need to know before using Neo Borocillina Gola Dolore lozenges

DO NOT use Neo Borocillina Gola Dolore lozenges

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid (e.g. aspirin) or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• if you have a high sensitivity of the respiratory system (asthma, bronchospasm)
• if you are an allergic subject and suffer from itching (urticaria)
• if you suffer from lesions of the stomach mucosa (peptic ulcer) or if you have suffered from this disease in the past
• during the third trimester of pregnancy and if you are breastfeeding (see section Pregnancy and breastfeeding)
• in children and adolescents under the age of 12

Warnings and precautions
The eventual swallowing of the lozenges, at the recommended doses, does not entail any harm to the
patient, as these doses are well below those commonly used in treatments
with flurbiprofen for systemic use.
It is advisable not to use Neo Borocillina Gola Dolore lozenges with other medicines that
belong to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
The use, especially if prolonged, of products for local use can give rise to allergic reactions. In
this case, discontinue treatment and consult your doctor.
Use Neo Borocillina Gola Dolore lozenges with caution:

• if you suffer from reduced kidney function (renal insufficiency) or reduced heart function (heart failure) or reduced liver function (hepatic insufficiency) Remember:
• that this medicine should not be used for long-term treatments
• to consult your doctor after a short period of treatment if you do not notice any improvement

Children and adolescents
Do not use Neo Borocillina Gola Dolore lozenges in children and adolescents under the age of
12 years.

Other medicines and Neo Borocillina Gola Dolore lozenges
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Flurbiprofen can occasionally affect the action of:

• furosemide, a diuretic drug
• medicines to thin the blood (anticoagulants)

No interaction of flurbiprofen with drugs has been demonstrated:

• used in the regulation of heart rhythms (digoxin)
• used in diabetes (tolbutamide)
• that counteract stomach acidity (antacids)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use Neo Borocillina Gola Dolore lozenges only if absolutely necessary and under direct
medical supervision during the first and second trimester of pregnancy.
Do not use Neo Borocillina Gola Dolore lozenges during the third trimester of pregnancy.
The use of the medicine during pregnancy may delay the onset of labor and increase its duration.
Breastfeeding
Do not use Neo Borocillina Gola Dolore lozenges if you are breastfeeding.

Driving and using machines
Neo Borocillina Gola Dolore lozenges does not impair the ability to drive vehicles or operate machinery.

Neo Borocillina Gola Dolore lozenges contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to use Neo Borocillina Gola Dolore lozenges

Use this medicine following exactly what is reported in this leaflet or the instructions
of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
The recommended dose for adults and children over 12 years of age is:
one lozenge, to be dissolved slowly in the mouth, every 3 - 6 hours, as needed, up to a
maximum daily dose of 8 lozenges.
Do not exceed the indicated doses.

If you use more Neo Borocillina Gola Dolore lozenges than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion
of a dose higher than that recommended for the daily intake of this medicine.
The symptoms that may occur in case of an overdose of the medicine are:

• nausea
• vomiting
• gastrointestinal irritation

In case of overdose, appropriate treatments should be adopted; gastric lavage is indicated
and, if necessary, correction of the resulting fluid and electrolyte losses.
Contact your doctor or pharmacist if you have any doubts about the use of Neo Borocillina Gola Dolore.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Prolonged use of Neo Borocillina Gola Dolore may cause allergic or local irritation reactions. In this case, stop treatment and consult your doctor to receive
more appropriate therapy.

Blood disorders

• Altered values in some blood tests (thrombocytopenia, aplastic anemia, agranulocytosis)

Immune system disorders

• Allergic reactions, including severe ones (anaphylaxis, swelling of the face, lips and/or tongue)

Nervous system disorders

• Dizziness
• Brain damage (stroke)
• Visual disturbances
• Inflammation of the optic nerve (optic neuritis)
• Headache (migraine)
• Sensory disturbances of the limbs and other parts of the body (paresthesia)
• Depression
• Confusion
• Hallucination
• Vertigo
• Feeling unwell
• Fatigue and drowsiness

Ear disorders

• Tinnitus (ringing in the ears)

Respiratory disorders

• Narrowing of the airways (bronchospasm)
• Inflammation of the airways (asthma)
• Difficulty breathing (dyspnea)

Gastrointestinal disorders
More commonly observed:

• Nausea
• Vomiting
• Diarrhea
• Gas production (flatulence)
• Lack of bowel movements (constipation)
• Digestive difficulties (dyspepsia)
• Stomach or abdominal pain (abdominal pain)
• Presence of blood in the stool (black stools)
• Presence of blood in vomit (hematemesis)
• Presence of ulcers in the mouth (ulcerative stomatitis)
• Internal bleeding of the digestive tract (gastrointestinal hemorrhage)
• Worsening of inflammatory bowel diseases (colitis, Crohn's disease)

Less frequently observed:

• Inflammation of the stomach (gastritis)
• Internal stomach lesions (peptic ulcer)
• Perforation and bleeding (from ulcer)

Skin disorders

• Rashes
• Itching
• Hives
• Dark red spots of varying size (purpura)
• Very rarely severe skin diseases such as Stevens-Johnson syndrome (skin rash and blisters, ulcers of the mouth and eyes), Lyell's syndrome (peeling, painful, red skin) and erythema multiforme (skin lesions)

Kidney and urinary tract disorders

• Kidney problems in various forms, including kidney inflammation (interstitial nephritis)
• Impaired kidney function (nephrotic syndrome) As with other NSAIDs, rare cases of reduced kidney function (renal failure) have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Gola Dolore lozenges

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Neo Borocillina Gola Dolore sugar-free lozenges mint flavour contains

• The active ingredient is flurbiprofen. Each lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: glyceroldibehenate, acesulfame potassium, balsamic mint flavour, isomalt, copovidone.

What Neo Borocillina Gola Dolore sugar-free lozenges orange and honey flavour contains

• The active ingredient is flurbiprofen. Each lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: glyceroldibehenate, acesulfame potassium, orange honey flavour, isomalt, copovidone.

What Neo Borocillina Gola Dolore sugar-free lozenges lemon and honey flavour contains

• The active ingredient is flurbiprofen. Each lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: glyceroldibehenate, acesulfame potassium, lemon honey flavour, isomalt, copovidone.

Description of the appearance of Neo Borocillina Gola Dolore lozenges and contents of the pack
Neo Borocillina Gola Dolore is available in lozenge form and in packs of 16, 32,
48 lozenges with mint, lemon and honey or orange and honey flavours.
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)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

NEO BOROCILLINA GOLA DOLORE 0,25% mouthwash

flurbiprofen

Read this leaflet carefully before using this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What Neo Borocillina Gola Dolore mouthwash is and what it is used for
• 2. What you need to know before using Neo Borocillina Gola Dolore mouthwash
• 3. How to use Neo Borocillina Gola Dolore mouthwash
• 4. Possible side effects
• 5. How to store Neo Borocillina Gola Dolore mouthwash
• 6. Contents of the pack and other information

1. What is Neo Borocillina Gola Dolore mouthwash and what is it used for

Neo Borocillina Gola Dolore contains flurbiprofen. Flurbiprofen belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines relieve
symptoms by modifying the body's response to pain and fever.
Neo Borocillina Gola Dolore mouthwash is used to relieve the symptoms of irritation and
inflammation, also associated with pain, of the oropharyngeal cavity (e.g. sore throat, gingivitis and
stomatitis), even as a result of conservative or extraction dental therapy (dental care and extraction).

2. What you need to know before using Neo Borocillina Gola Dolore mouthwash

DO NOT use Neo Borocillina Gola Dolore mouthwash

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid (e.g. aspirin) or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• if you have a high sensitivity of the respiratory system (asthma, bronchospasm)
• if you are an allergic subject and suffer from itching (urticaria)
• if you suffer from lesions of the stomach mucosa (peptic ulcer) or if you have suffered from this disease in the past
• during the third trimester of pregnancy and if you are breastfeeding (see section Pregnancy and breastfeeding)

Warnings and precautions
The possible swallowing of the solution, at the recommended doses, does not cause any harm to the
patient, as these doses are well below those commonly used in treatments
with flurbiprofen via systemic route.
It is advisable not to use Neo Borocillina Gola Dolore mouthwash with other medicines that
belong to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
The use, especially if prolonged, of products for local use can give rise to allergic reactions. In
this case, discontinue treatment and consult your doctor.
Use Neo Borocillina Gola Dolore mouthwash with caution:

• if you suffer from reduced kidney function (renal insufficiency) or reduced heart function (heart failure) or reduced liver function (hepatic insufficiency)

Keep in mind:

• that this medicine should not be used for long-term treatments
• to consult your doctor after a short period of treatment if you do not notice any improvement

Other medicines and Neo Borocillina Gola Dolore mouthwash
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Flurbiprofen may occasionally affect the action of:

• furosemide, a diuretic drug
• medicines to thin the blood (anticoagulants)

No interaction of flurbiprofen with drugs has been demonstrated:

• used in the regulation of heart rhythms (digoxin)
• used in diabetes (tolbutamide)
• that counteract stomach acidity (antacids)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use Neo Borocillina Gola Dolore mouthwash only if absolutely necessary and under direct
medical supervision during the first and second trimester of pregnancy.
Do not use Neo Borocillina Gola Dolore mouthwash during the third trimester of pregnancy.
The use of the medicine during pregnancy may delay the onset of labor and increase its duration.
Breastfeeding
Do not use Neo Borocillina Gola Dolore mouthwash if you are breastfeeding.

Driving and operating machinery
Neo Borocillina Gola Dolore mouthwash does not impair the ability to drive vehicles or operate machinery.

Neo Borocillina Gola Dolore mouthwash contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate
Neo Borocillina Gola Dolore mouthwash contains para-hydroxy benzoates, which may cause allergic reactions (even delayed).

Neo Borocillina Gola Dolore mouthwash contains ethanol
This medicine contains 960 mg of ethanol per 10 ml of mouthwash.
It may cause a burning sensation on damaged skin.

Neo Borocillina Gola Dolore mouthwash contains castor oil
This medicine contains hydrogenated polyoxidated castor oilwhich may cause localized skin reactions.
.

3. How to use Neo Borocillina Gola Dolore mouthwash

Use this medicine following 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:
2-3 rinses or gargles per day with 10 ml of mouthwash (measured using the provided measuring cup), as is or diluted in half a glass of water.
Do not exceed the indicated doses.

If you use more Neo Borocillina Gola Dolore mouthwash than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion of a dose higher than that recommended for the daily intake of this medicine.
The symptoms that may occur in case of an overdose of the medicine are:

• nausea
• vomiting
• gastrointestinal irritation

In case of overdose, appropriate treatments should be adopted; gastric lavage is indicated and, if necessary, correction of the resulting fluid and electrolyte losses.
Contact your doctor or pharmacist if you have any doubts about the use of Neo Borocillina Gola Dolore.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Prolonged use of Neo Borocillina Gola Dolore may cause allergic or local irritation reactions. In this case, stop treatment and consult your doctor to receive
more appropriate therapy.

Blood problems

• Altered values in some blood tests (thrombocytopenia, aplastic anemia, agranulocytosis)

Immune system problems

• Allergic reactions, including severe ones (anaphylaxis, swelling of the face, lips and/or tongue)

Nervous system problems

• Dizziness
• Brain damage (stroke)
• Visual disturbances
• Inflammation of the optic nerve (optic neuritis)
• Headache (migraine)
• Sensory disturbances of the limbs and other parts of the body (paresthesia)
• Depression
• Confusion
• Hallucination
• Vertigo
• Feeling unwell
• Fatigue and drowsiness

Ear problems

• Tinnitus (ringing in the ears)

Respiratory problems

• Narrowing of the airways (bronchospasm)
• Inflammation of the airways (asthma)
• Difficulty breathing (dyspnea)

Gastrointestinal problems
More commonly observed:

• Nausea
• Vomiting
• Diarrhea
• Gas production (flatulence)
• Lack of bowel movements (constipation)
• Indigestion (dyspepsia)
• Stomach or abdominal pain (abdominal pain)
• Presence of blood in the stool (black stools)
• Presence of blood in vomit (hematemesis)
• Presence of ulcers in the mouth (ulcerative stomatitis)
• Internal bleeding of the digestive tract (gastrointestinal hemorrhage)
• Worsening of inflammatory bowel diseases (colitis, Crohn's disease)

Less frequently observed:

• Inflammation of the stomach (gastritis)
• Internal stomach lesions (peptic ulcer)
• Perforation and bleeding (from ulcer)

Skin problems

• Rashes
• Itching
• Hives
• Dark red spots of varying sizes (purpura)
• Very rarely, severe skin diseases such as Stevens-Johnson syndrome (skin rash and blisters, ulcers of the mouth and eyes), Lyell's syndrome (peeling, painful, red skin) and erythema multiforme (skin lesions)

Kidney and urinary problems

• Kidney problems in various forms, including kidney inflammation (interstitial nephritis)
• Impaired kidney function (nephrotic syndrome) As with other NSAIDs, rare cases of reduced kidney function (renal failure) have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Gola Dolore mouthwash

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
After first opening, the mouthwash is valid for 1 year.
Do not dispose of any medicine in 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 have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Neo Borocillina Gola Dolore mouthwash contains

• The active ingredient is flurbiprofen. 100 ml of solution contains 250 mg of flurbiprofen.
• The other ingredients are: glycerol, ethanol96 percent, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodiumhydroxide, sodiumsaccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, triple-distilled peppermint essential oil, Patent Blue V (E131), anhydrous citric acid, purified water. (See section 2)

Description of the appearance of Neo Borocillina Gola Dolore mouthwash and contents of the pack
Neo Borocillina Gola Dolore mouthwash is in the form of a solution and is packaged in a
160 ml bottle with an attached special measuring cup.

Marketing authorisation holder and manufacturer
Marketing authorisation 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)