Neo Borocillina sore throat pain: detailed information

PACKAGE LEAFLET

Package leaflet: Information for the patient

NEO BOROCILLINA THROAT PAIN 0.25% oral mucosa spray, mint, orange and honey flavor, lemon and honey flavor

flurbiprofen
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 you.

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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if symptoms worsen after a short period of treatment.

Contents of this leaflet:

What Neo Borocillina Gola Dolore oral mucosa spray is and what it is used for
What you need to know before using Neo Borocillina Gola Dolore oral mucosa spray
How to use Neo Borocillina Gola Dolore oral mucosa spray
Possible side effects
How to store Neo Borocillina Gola Dolore oral mucosa spray
Package contents and other information

1. What Neo Borocillina Gola Dolore oral mucosa spray is and what it is 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 oral mucosa spray is used to relieve symptoms of irritation and inflammation, even when associated with pain, in the oropharyngeal cavity (e.g. sore throat, gingivitis and stomatitis), including as a consequence of conservative or extractive dental treatments (dental care and tooth extraction).

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

DO NOT use Neo Borocillina Gola Dolore oral mucosa spray

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

Warnings and precautions
Accidental swallowing of the solution, at the recommended doses, does not cause any harm to the
patient, as such doses are considerably lower than those commonly used in systemic treatments
with flurbiprofen.
It is advisable not to use Neo Borocillina Gola Dolore oral mucosa spray together with other medicines
belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
The use, especially if prolonged, of topical products may lead to allergic reactions. In such cases,
discontinue treatment and consult your doctor.
Use Neo Borocillina Gola Dolore oral mucosa spray with caution:

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

Please 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 oral mucosa spray
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Flurbiprofen may occasionally affect the action of:

furosemide, a diuretic medicine
medicines used to thin the blood (anticoagulants)

No interaction has instead been demonstrated between flurbiprofen and medicines:

used to regulate heart rhythms (digoxin)
used in diabetes (tolbutamide)
used to counteract stomach acidity (antacids)

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, please consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use Neo Borocillina Gola Dolore oral mucosa spray only if strictly necessary and under direct medical supervision during the first and second trimesters of pregnancy.
Do not use Neo Borocillina Gola Dolore oral mucosa spray during the third trimester of pregnancy.
Use of this medicine during pregnancy may delay the onset of labour and prolong its duration.
Breastfeeding
Do not use Neo Borocillina Gola Dolore oral mucosa spray if you are breastfeeding.

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

Neo Borocillina Gola Dolore oral mucosa spray (all presentations) contains methyl
parahydroxybenzoate and propyl parahydroxybenzoate
Neo Borocillina Gola Dolore oral mucosa spray contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).

Neo Borocillina Gola Dolore oral mucosa spray (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 oral mucosa spray (all presentations) contains castor oil
This medicine contains hydrogenated polyoxyl castor oil, which may cause localized skin reactions.

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

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

Use this medicine exactly as described 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:
2 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 ingredient.
Do not exceed the recommended doses.
If you use more Neo Borocillina Gola Dolore oral mucosa spray than you should
Inform your doctor immediately or go to the nearest hospital if you accidentally ingest an amount exceeding the recommended daily dose of this medicine.
Symptoms that may occur in case of overdose include:

nausea
vomiting
gastrointestinal irritation

In case of overdose, appropriate treatments should be implemented; gastric lavage is indicated and, if necessary, correction of subsequent fluid and electrolyte losses.
Consult 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 reactions or local irritation. In such cases, stop treatment and consult your doctor to determine a more appropriate therapy.

Blood disorders

Altered results in certain blood tests (thrombocytopenia, aplastic anemia, agranulocytosis)

Immune system disorders

Allergic reactions, even 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 in limbs and other body parts (paresthesia)
Depression
Confusion
Hallucination
Vertigo
Feeling of discomfort
Fatigue and drowsiness

Ear disorders

Ringing in the ears (tinnitus)

Respiratory disorders

Constriction of the airways (bronchospasm)
Inflammation of the airways (asthma)
Difficulty breathing (dyspnea)

Gastrointestinal disorders
Most commonly observed:

Nausea
Vomiting
Diarrhea
Gas production (flatulence)
Lack of intestinal movement (constipation)
Digestive difficulties (dyspepsia)
Stomach ache or abdominal pain
Presence of blood in stools (black stools)
Presence of blood in vomit (hematemesis)
Mouth ulcerations (ulcerative stomatitis)
Internal gastrointestinal bleeding (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 (pruritus)
Hives (urticaria)
Dark red spots of varying size (purpura)
Very rarely, severe skin diseases such as Stevens-Johnson syndrome (skin rash and blisters, mouth and eye ulcers), Lyell's syndrome (peeling, painful, red skin), and erythema multiforme (skin lesions)

Kidney and urinary disorders

Kidney problems in various forms, including inflammation of the kidneys (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 experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 Sore Throat Oral Mucosa Spray

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.
After first opening, the spray remains valid for 1 year.
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 box and the leaflet.

6. Package contents and other information

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

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol, ethyl alcohol (ethanol 96%), sorbitol liquid (non-crystallizable), castor oil hydrogenated 40 polyoxyethylene, sodium hydroxide, sodium saccharin, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, triply rectified peppermint essential oil, patent blue V (E 131), citric acid, purified water. (See section 2)

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

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol, ethyl alcohol (ethanol 96%), sorbitol liquid (non-crystallizable), castor oil hydrogenated 40 polyoxyethylene, sodium hydroxide, sodium saccharin, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, honey flavour, orange flavour, mint flavour, sunset yellow (E110), citric acid, purified water. (See section 2)

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

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol, ethyl alcohol (ethanol 96%), sorbitol liquid (non-crystallizable), castor oil hydrogenated 40 polyoxyethylene, sodium hydroxide, sodium saccharin, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, honey flavour, lemon flavour, mint flavour, sunset yellow (E110), citric acid, purified water. (See section 2)

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

PACKAGE LEAFLET

Patient information leaflet

NEO BOROCILLINA THROAT PAIN 8.75 mg sugar-free tablets with mint, orange and honey, lemon and honey flavour

flurbiprofen
Please 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 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, 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.

Contents of this leaflet:

What Neo Borocillina Gola Dolore tablets are and what they are used for
What you need to know before taking Neo Borocillina Gola Dolore tablets
How to use Neo Borocillina Gola Dolore tablets
Possible side effects
How to store Neo Borocillina Gola Dolore tablets
Package contents and other information

1. What Neo Borocillina Gola Dolore tablets are and what they are 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 altering the body's response to pain and fever.
Neo Borocillina Gola Dolore sugar-free tablets are used to relieve symptoms of irritation and inflammation, even when associated with pain, in the oropharyngeal cavity (e.g. sore throat, gingivitis and stomatitis).

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

Do NOT use Neo Borocillina Gola Dolore pastilles

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

Warnings and precautions
Accidental swallowing of the pastilles, at the recommended doses, does not cause any harm to the
patient, as such doses are considerably lower than those commonly used in systemic treatments
with flurbiprofen.
It is advisable not to use Neo Borocillina Gola Dolore pastilles together with other medicines belonging
to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
The use, especially if prolonged, of locally acting products may lead to allergic reactions. In such cases,
discontinue treatment and consult your doctor.
Use Neo Borocillina Gola Dolore pastilles with caution:

if you suffer from reduced kidney function (renal insufficiency), reduced heart function (cardiac insufficiency), 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 pastilles in children and adolescents under 12 years of age.
Other medicines and Neo Borocillina Gola Dolore pastilles
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Flurbiprofen may occasionally affect the action of:

furosemide, a diuretic medicine
medicines used to thin the blood (anticoagulants)

No interaction of flurbiprofen has instead been demonstrated with medicines:

used to regulate heart rhythms (digoxin)
used in diabetes (tolbutamide)
that counteract stomach acidity (antacids)

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use Neo Borocillina Gola Dolore pastilles only if strictly necessary and under direct medical supervision during the first and second trimesters of pregnancy.
Do not use Neo Borocillina Gola Dolore pastilles during the third trimester of pregnancy.
The use of this medicine during pregnancy may delay the onset of labour and prolong its duration.
Breastfeeding
Do not use Neo Borocillina Gola Dolore pastilles if you are breastfeeding.
Driving and using machines
Neo Borocillina Gola Dolore pastilles do not affect the ability to drive or operate machinery.
Neo Borocillina Gola Dolore pastilles contain isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Neo Borocillina Sore Throat Lozenges

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and children over 12 years of age is:
one lozenge to be slowly dissolved in the mouth every 3–6 hours, as needed, up to a maximum of 8 lozenges per day.
Do not exceed the recommended doses.
If you take more Neo Borocillina Sore Throat Lozenges than you should
Immediately contact your doctor or go to the nearest hospital if you accidentally ingest a dose higher than the recommended daily amount of this medicine.
Symptoms that may occur in case of overdose include:

nausea
vomiting
gastrointestinal irritation

In case of overdose, appropriate treatment should be administered; gastric lavage is indicated and, if necessary, correction of resulting fluid and electrolyte losses should be carried out.
Consult your doctor or pharmacist if you have any questions about the use of Neo Borocillina Sore Throat Lozenges.

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 reactions or local irritation. In such cases, discontinue treatment and consult your doctor to receive a more appropriate therapy.

Blood disorders

Abnormal results in certain blood tests (thrombocytopenia, aplastic anemia, agranulocytosis)

Immune system disorders

Allergic reactions, even 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 in limbs and other body parts (paraesthesia)
Depression
Confusion
Hallucination
Vertigo
Feeling of discomfort
Fatigue and drowsiness

Ear disorders

Ringing in the ears (tinnitus)

Respiratory disorders

Constriction of the airways (bronchospasm)
Inflammation of the airways (asthma)
Difficulty breathing (dyspnea)

Gastrointestinal disorders
Most commonly observed:

Nausea
Vomiting
Diarrhea
Gas production (flatulence)
Lack of intestinal movement (constipation)
Digestive difficulties (dyspepsia)
Stomach ache (abdominal pain)
Presence of blood in stools (black stools)
Presence of blood in vomit (haematemesis)
Mouth ulcers (ulcerative stomatitis)
Internal bleeding of the digestive tract (gastrointestinal haemorrhage)
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 (pruritus)
Hives (urticaria)
Dark red spots of varying size (purpura)
Very rarely, severe skin diseases such as Stevens-Johnson syndrome (skin rash and blisters, mouth and eye ulcers), 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 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 Gola Dolore 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 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 Gola Dolore sugar-free peppermint-flavoured tablets contain

The active substance is flurbiprofen. Each tablet contains 8.75 mg of flurbiprofen.
The other ingredients are: glyceryl dibehenate, acesulfame potassium, balsamic peppermint flavour, isomalt , copovidone.

What Neo Borocillina Gola Dolore sugar-free orange and honey-flavoured tablets contain

The active substance is flurbiprofen. Each tablet contains 8.75 mg of flurbiprofen.
The other ingredients are: glyceryl dibehenate, acesulfame potassium, orange and honey flavour, isomalt , copovidone.

What Neo Borocillina Gola Dolore sugar-free lemon and honey-flavoured tablets contain

The active substance is flurbiprofen. Each tablet contains 8.75 mg of flurbiprofen.
The other ingredients are: glyceryl dibehenate, acesulfame potassium, lemon and honey flavour, isomalt , copovidone.

Description of the appearance of Neo Borocillina Gola Dolore tablets and package contents
Neo Borocillina Gola Dolore is presented as tablets and is available in packs of 16, 32,
48 tablets in peppermint, 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), Italy
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE), Italy

PACKAGE LEAFLET

Patient information leaflet: information for the patient

NEO BOROCILLINA GOLA DOLORE 0.25% mouthwash

flurbiprofen
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 you.

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.
Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What Neo Borocillina Gola Dolore mouthwash is and what it is used for
What you need to know before using Neo Borocillina Gola Dolore mouthwash
How to use Neo Borocillina Gola Dolore mouthwash
Possible side effects
How to store Neo Borocillina Gola Dolore mouthwash
Package contents and other information

1. What Neo Borocillina Gola Dolore mouthwash is and what it is 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 symptoms of irritation and inflammation, even when associated with pain, in the oropharyngeal cavity (e.g. sore throat, gingivitis and stomatitis), including cases following conservative or extractive dental treatments (dental care and tooth 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 to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to acetylsalicylic acid (e.g. aspirin) or to other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
if you have high respiratory sensitivity (asthma, bronchospasm)
if you are allergic and suffer from itching (urticaria)
if you have lesions of the stomach mucosa (peptic ulcer) or have previously suffered from this condition
during the third trimester of pregnancy or if you are breastfeeding (see section Pregnancy and breastfeeding)

Warnings and precautions
Accidental swallowing of the solution, at the recommended doses, does not cause any harm to the
patient, as these doses are considerably lower than those commonly used in systemic flurbiprofen
treatments.
It is advisable not to use Neo Borocillina Gola Dolore mouthwash together with other medicines belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
The use, especially if prolonged, of topical products may lead to allergic reactions. In such cases, discontinue treatment and consult your doctor.
Use Neo Borocillina Gola Dolore mouthwash with caution:

if you suffer from reduced kidney function (renal insufficiency), reduced heart function (cardiac insufficiency), or reduced liver function (hepatic insufficiency)

Please 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 mouthwash
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Flurbiprofen may occasionally affect the action of:

furosemide, a diuretic medicine
medicines used to thin the blood (anticoagulants)

No interaction of flurbiprofen has instead been demonstrated with medicines:

used to regulate heart rhythms (digoxin)
used in diabetes (tolbutamide)
that counteract stomach acidity (antacids)

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.
Pregnancy
Use Neo Borocillina Gola Dolore mouthwash only if strictly necessary and under direct medical supervision during the first and second trimesters of pregnancy.
Do not use Neo Borocillina Gola Dolore mouthwash during the third trimester of pregnancy.
The use of this medicine during pregnancy may delay the onset of labour and prolong its duration.
Breastfeeding
Do not use Neo Borocillina Gola Dolore mouthwash if you are breastfeeding.
Driving and using machines
Neo Borocillina Gola Dolore mouthwash does not impair the ability to drive or operate machinery.
Neo Borocillina Gola Dolore mouthwash contains methyl parahydroxybenzoate and propyl
parahydroxybenzoate
Neo Borocillina Gola Dolore mouthwash contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
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 polyoxyl castor oil, which may cause localized skin reactions.

3. How to use Neo Borocillina Gola Dolore mouthwash

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:
2–3 rinses or gargles per day with 10 ml of mouthwash (measured using the provided dosing cup), undiluted or diluted in half a glass of water.
Do not exceed the stated doses.
If you use more Neo Borocillina Gola Dolore mouthwash than you should
Immediately inform your doctor or contact the nearest hospital in case of accidental ingestion of a dose exceeding the recommended daily amount of this medicine.
Symptoms that may occur following an overdose include:

nausea
vomiting
gastrointestinal irritation

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 reactions or local irritation. In such cases, discontinue treatment and consult your doctor to receive a more appropriate therapy.

Blood disorders

Altered results in certain blood tests (thrombocytopenia, aplastic anemia, agranulocytosis)

Immune system disorders

Allergic reactions, even severe (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 in limbs and other body parts (paraesthesia)
Depression
Confusion
Hallucination
Vertigo
Feeling of discomfort
Fatigue and somnolence

Ear disorders

Ringing in the ears (tinnitus)

Respiratory disorders

Constriction of the airways (bronchospasm)
Inflammation of the airways (asthma)
Difficulty breathing (dyspnoea)

Gastrointestinal disorders
Most commonly observed:

Nausea
Vomiting
Diarrhoea
Gas production (flatulence)
Lack of intestinal movements (constipation)
Digestive difficulties (dyspepsia)
Stomach ache (abdominal pain)
Presence of blood in the stool (black stools)
Presence of blood in vomit (haematemesis)
Mouth ulcers (ulcerative stomatitis)
Internal bleeding of the digestive tract (gastrointestinal haemorrhage)
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

Rash
Itching (pruritus)
Urticaria
Dark red spots of varying size (purpura)
Very rarely, severe skin diseases such as Stevens-Johnson syndrome (skin rash and blisters, mouth and eye ulcers), Lyell's syndrome (painful, red, peeling skin), and erythema multiforme (skin lesions)

Renal and urinary disorders

Kidney problems in various forms, including inflammation of the kidneys (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 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 Gola Dolore mouthwash

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.
After first opening, the mouthwash is valid for 1 year.
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. Contents of the pack and other information

What Neo Borocillina Gola Dolore mouthwash contains

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol, ethanol 96 percent, sorbitol liquid non-crystallizable, castor oil hydrogenated-40 polyoxylated, sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, triply rectified 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 a solution supplied in a 160 ml bottle with an attached measuring device.

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)