Package leaflet: information for the user

FLURBIPROFEN COOP 2.5 mg/ml mouthwash

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 need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

What FLURBIPROFEN COOP is and what it is used for
What you need to know before using FLURBIPROFEN COOP
How to use FLURBIPROFEN COOP
Possible side effects
How to store FLURBIPROFEN COOP
Contents of the pack and other information

1. What FLURBIPROFENE COOP is and what it is used for

FLURBIPROFENE COOP contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth, and gums.
FLURBIPROFENE COOP is used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation of the gums, mouth, and throat (e.g. gingivitis, stomatitis, pharyngitis), including cases following conservative or extraction dental procedures (e.g. dental caries treatment or tooth extraction).
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 3).

2. What you need to know before using FLURBIPROFENE COOP

Do not use FLURBIPROFENE COOP

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 (a medicine used for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FLURBIPROFENE COOP”);
if you have previously experienced gastrointestinal bleeding or perforation related to prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
if you frequently suffer from peptic ulcer (stomach ulcer) or gastrointestinal bleeding (two or more separate episodes of ulcer or bleeding);
if you have severe heart failure (reduced heart function), severe liver failure (reduced liver function), or severe kidney failure (reduced kidney function);
if you are in the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

Do not give Flurbiprofene Coop to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FLURBIPROFENE COOP
In particular, inform your doctor if:

you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
you have previously had allergic reactions;
you are taking other non-steroidal anti-inflammatory drugs (NSAIDs);
you suffer from systemic lupus erythematosus or mixed connective tissue disease;
you suffer from reduced kidney, heart, or liver function (renal, cardiac, or hepatic insufficiency);
you have hypertension (high blood pressure);
you have been taking other painkillers for a long time or without following the prescribed dosage, as this may lead to headache;
you have previously suffered from peptic ulcer (stomach ulcer) or other stomach or intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section 4 “Possible side effects”);
you are elderly (as you are more likely to experience side effects);
you have heart or blood vessel problems, since medicines such as Flurbiprofene COOP may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of Flurbiprofene COOP and do not use it for long periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke);
you have an infection – refer to the section “Infections” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain.
This may delay appropriate treatment of the infection, which in turn could increase the risk of complications.
If you take this medicine during an infection and symptoms of infection persist or worsen, contact your doctor or pharmacist immediately.
Inform your doctor of any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation (see section 4 “Possible side effects”); in such cases, discontinue treatment and consult your doctor, who will initiate appropriate therapy if necessary.
If you experience mouth irritation, stop treatment.
Children and adolescents
Do not give Flurbiprofene Coop to children under 12 years of age.
Other medicines and FLURBIPROFENE COOP
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:
medicines containing acetylsalicylic acid (a medicine used for inflammation, pain, fever, and heart conditions), as they may increase side effects;
antiplatelet agents (medicines that make the blood thinner, such as low-dose daily acetylsalicylic acid), as they increase the risk of gastrointestinal bleeding;
anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), since their effect may be enhanced by NSAIDs;
selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of gastrointestinal bleeding;
antihypertensive medicines (ACE inhibitors, angiotensin II antagonists, and diuretics), since NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
alcohol, as it may increase the risk of side effects, especially the risk of gastrointestinal bleeding;
cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase blood levels of cardiac glycosides;
cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of renal toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase the risk of gastrointestinal injury or bleeding;
lithium (a medicine used for behavioral disorders), as blood levels of lithium may increase;
methotrexate (a medicine used for psoriasis, arthritis, and tumors), as blood levels of methotrexate may increase;
mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of seizures;
tacrolimus (an immunosuppressant used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as their effects may be increased and the risk of side effects may rise.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the newborn.
It is not known whether the same risk applies to FLURBIPROFENE COOP.
Do not use FLURBIPROFENE COOP during the last three months of pregnancy. Do not use
FLURBIPROFENE COOP during the first 6 months of pregnancy unless absolutely necessary and on medical advice. If treatment is required during this period, use the lowest possible dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by a doctor.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility.
This effect is reversible when the drug is discontinued. Occasional use of this medicine is unlikely to affect the ability to become pregnant.
However, consult your doctor if you have fertility problems before taking this medicine.
Driving and use of machines
This medicine does not impair the ability to drive or operate machinery.
FLURBIPROFENE COOP contains parahydroxybenzoates, hydrogenated castor oil-40
polyoxylated and ethanol
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
Hydrogenated castor oil-40 polyoxylated may cause localized skin reactions.
This medicine contains 86.4 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

3. How to use FLURBIPROFENE COOP

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.
DOSE AND METHOD OF ADMINISTRATION
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Warning: Do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
The recommended dose is two or three mouth rinses or gargles per day (hold in the mouth for up to 1 minute).
You may use the mouthwash undiluted (without mixing with water), using 10 ml (1 measuring cup) of mouthwash, or diluted by pouring 10 ml (1 measuring cup) of mouthwash into half a glass of water.
When used at the recommended doses, accidental ingestion is unlikely to cause harm, although ingestion of the product should be avoided.
If you are elderly or have previously suffered from stomach ulcer
If you are elderly or have previously had a peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is an increased risk of serious consequences in case of adverse effects, and the risk of developing stomach or intestinal ulcers, bleeding or perforation is higher (see section 4 "Possible side effects").
Use in children and adolescents
Do not give FLURBIPROFENE COOP to children under 12 years of age.
Duration of treatment
Use FLURBIPROFENE COOP only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after 3 days of treatment, the cause may be a different medical condition; in this case, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
If you use more FLURBIPROFENE COOP than you should
If you accidentally ingest/absorb an excessive amount of FLURBIPROFENE COOP, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, symptoms such as nausea, vomiting, irritation of the stomach or intestine, stomach ache or rarely diarrhoea may occur. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to take FLURBIPROFENE COOP
Do not use a double dose to make up for a forgotten dose.
If you stop using FLURBIPROFENE COOP
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects during treatment with FLURBIPROFENE COOP,
STOP treatment immediately and contact your doctor immediately:

Allergic reactions (hypersensitivity reactions):
- allergic reaction
anaphylactic reactions (severe allergic reactions)
angioedema (sudden swelling of the mouth/throat and mucous membranes)
- Local irritation
- Respiratory events: asthma, bronchospasm, shortness of breath or difficulty breathing
- Various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following side effects at the beginning of treatment with FLURBIPROFENE COOP, contact your doctor immediately: abdominal pain
Peptic ulcer (stomach ulcer)
Perforation and bleeding of the stomach or intestines.
These side effects can be fatal and may occur with or without warning symptoms. These side effects are more likely if you are elderly or have previously suffered from stomach or intestinal diseases.

Additionally, you may experience the following side effects:

Effects related to the blood
anaemia (reduced number of red blood cells in the blood)
thrombocytopenia (reduced number of platelets in the blood)
aplastic anaemia (reduced number of all blood cell types: red blood cells, white blood cells, platelets)
agranulocytosis (reduced number of granulocytes, a type of white blood cells, in the blood).

Effects related to the nervous system
dizziness
headache
paraesthesia (numbness of limbs or other body parts)
drowsiness
cerebrovascular accidents (diseases caused by inadequate blood flow to an area of the brain)
visual disturbances
optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to blindness)
migraine (a chronic condition characterized by recurrent headaches)
confusion
vertigo.

Effects related to the immune system
anaphylactic reactions (severe allergic reactions)
angioedema (inflammatory reaction of the skin)
hypersensitivity.

Effects related to the eye
visual disturbances.

Effects related to the ear and labyrinth
tinnitus (ringing in the ears).

Effects related to the cardiovascular system
heart failure
swelling
hypertension (high blood pressure).

Effects related to the bronchi and lungs
throat irritation
asthma
bronchospasm (narrowing of the airways causing severe breathing difficulty due to reduced airflow)
dyspnoea (shortness of breath)
blisters in the mouth or throat
numbness of mouth or throat.

Effects related to the mouth, stomach and intestine
diarrhoea
mouth lesions
nausea
pain in mouth and throat
sensation of heat or burning, tingling in the mouth
abdominal distension
abdominal pain
constipation
dry mouth
dyspepsia (indigestion)
flatulence (passing gas from the intestine)
inflammation of the tongue
taste disturbances
vomiting
blood in stools
blood in vomit
gastrointestinal bleeding
colitis
worsening of inflammatory bowel diseases (Crohn's disease)
gastritis (inflammation of the stomach)
peptic ulcer
gastric perforation.

Effects related to the skin and underlying tissues
rash (skin eruption)
itching
urticaria (red, itchy skin patches)
purpura (appearance of purple-coloured skin patches of varying sizes)
bullous dermatoses (severe skin lesions characterized by erythema, blistering and skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema Multiforme.

Effects related to the kidneys and urinary tract
renal toxicity
tubulo-interstitial nephritis (inflammation of the kidneys)
nephrotic syndrome (alteration of kidney glomeruli leading to protein loss in urine)
renal failure (reduced kidney function).

General and administration site-related effects
fever
pain
discomfort
fatigue.

Effects related to the liver
hepatitis.

Effects related to psychiatric disorders
insomnia
depression
hallucinations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 FLURBIPROFENE COOP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
Once the bottle is opened, use within 9 weeks.
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.

6. Package contents and other information

What FLURBIPROFENE COOP contains

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavour, patent blue V (E131), citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE COOP and the contents of the pack
Pack containing one bottle with dosing dispenser and safety cap, 160 ml.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) – Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy

Package leaflet: Information for the user

FLURBIPROFENE COOP 2.5 mg/ml oral mucosa spray

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 would like 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 3 days of treatment.

Contents of this leaflet:

What FLURBIPROFENE COOP is and what it is used for
What you need to know before using FLURBIPROFENE COOP
How to use FLURBIPROFENE COOP
Possible side effects
How to store FLURBIPROFENE COOP
Contents of the pack and other information

2. What FLURBIPROFENE COOP is and what it is used for

FLURBIPROFENE COOP contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth and gums.
FLURBIPROFENE COOP is used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), including as a consequence of conservative or surgical dental procedures (e.g. treatment of cavities or tooth extraction).
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 3).

2. What you need to know before using FLURBIPROFENE COOP

Do not use FLURBIPROFENE COOP

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 (a medicine used for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FLURBIPROFENE COOP”);
if you have previously experienced stomach or intestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
if you frequently suffer from peptic ulcer (stomach lesion) or gastrointestinal bleeding (two or more separate episodes of ulcer or bleeding);
if you have severe heart failure (reduced heart function), severe liver failure (reduced liver function), or severe kidney failure (reduced kidney function);
if you are in the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

Do not give Flurbiprofene Coop to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FLURBIPROFENE COOP.
In particular, inform your doctor if:

you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
you have previously suffered from allergies;
you are taking other non-steroidal anti-inflammatory drugs (NSAIDs);
you suffer from systemic lupus erythematosus or mixed connective tissue disease;
you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
you suffer from hypertension (high blood pressure);
you have been taking other analgesics for a long time or without following the prescribed dosage, as this may lead to headache;
you have previously suffered from peptic ulcer (stomach lesion) or other stomach or intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section 4 “Possible side effects”);
you are elderly (as you are more likely to experience side effects);
you have heart or blood vessel problems, as medicines like Flurbiprofene COOP may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of Flurbiprofene COOP or use it for long periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or smoke);
you have an infection – refer to the section “Infections” below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain.
This could delay appropriate treatment of the infection, which in turn may increase the risk of
complications. If you use this medicine during an infection and infection symptoms persist or worsen,
seek immediate advice from your doctor or pharmacist.
Inform your doctor of any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation (see
section 4 “Possible side effects”); in such cases, discontinue treatment and consult your doctor, who
will initiate appropriate therapy if necessary.
If you experience mouth irritation, stop treatment.
Children and adolescents
Do not give Flurbiprofene Coop to children under 12 years of age.
Other medicines and FLURBIPROFENE COOP
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines:
medicines containing acetylsalicylic acid (medicines for inflammation, pain, fever and heart
conditions), as they may increase side effects;
antiplatelet agents (medicines that make the blood less sticky, such as low-dose daily
acetylsalicylic acid), as they increase the risk of gastrointestinal bleeding;
anticoagulants (medicines that slow or inhibit blood clotting, such as warfarin), as their effect
may be enhanced by NSAIDs;
selective serotonin reuptake inhibitors (medicines used for depression), as they increase the
risk of gastrointestinal bleeding;
antihypertensive medicines (ACE inhibitors, angiotensin II antagonists and diuretics), as
NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase
renal toxicity;
alcohol, as it may increase the risk of side effects, especially gastrointestinal bleeding;
cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure
and increase blood levels of cardiac glycosides;
cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk
of renal toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase the risk of
gastrointestinal lesions or bleeding;
lithium (a medicine used for behavioral disorders), as blood levels of lithium may increase;
methotrexate (a medicine used for psoriasis, arthritis and cancer), as blood levels of
methotrexate may increase;
mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12
days after taking mifepristone, as they reduce its effectiveness;
quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase
the risk of seizures;
tacrolimus (an immunosuppressant used after organ transplantation), as NSAIDs may
increase the risk of renal toxicity;
zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as this
could enhance the effect of these medicines and increase the risk of side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child.
It is not known whether the same risk applies to FLURBIPROFENE COOP. Do not use
FLURBIPROFENE COOP during the last three months of pregnancy. Do not use FLURBIPROFENE
COOP during the first 6 months of pregnancy unless absolutely necessary and on medical advice.
If treatment is required during this period, use the lowest effective dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and
advised by a doctor.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible
when treatment is stopped. Occasional use of this medicine is unlikely to affect your chances of
becoming pregnant. However, consult your doctor if you have fertility problems before using this
medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
FLURBIPROFENE COOP contains parahydroxybenzoates, hydrogenated castor oil-40
polyoxylated and ethanol

Parahydroxybenzoates may cause allergic reactions (including delayed-type reactions).
Hydrogenated castor oil-40 polyoxylated may cause localized skin reactions. This medicine contains 86.4 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

3. How to use FLURBIPROFENE COOP

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.
DOSE AND METHOD
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Caution: Do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
The recommended dose is 2 sprays, 3 times a day.
Spray the solution directly onto the affected area (mouth, throat).
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of flurbiprofen.
At the recommended doses, accidental ingestion is unlikely to cause harm, although ingestion of the product should be avoided.
If you are elderly or have previously suffered from stomach ulcer
If you are elderly or have previously had a peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is a higher risk of serious consequences from adverse effects, and an increased risk of developing ulcers, gastrointestinal bleeding or perforation (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give FLURBIPROFENE COOP to children under 12 years of age.
Duration of treatment
Use FLURBIPROFENE COOP only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after 3 days of treatment, the cause may be a different pathological condition; therefore, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
Method of administration
Direct the spray nozzle towards the back of the throat and spray onto the affected area.
If you use more FLURBIPROFENE COOP than you should
If you accidentally ingest/absorb an excessive dose of FLURBIPROFENE COOP, inform your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, symptoms such as nausea, vomiting, stomach or intestinal irritation, stomach ache, or rarely diarrhoea may occur. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.
If you forget to use FLURBIPROFENE COOP
Do not use a double dose to make up for the forgotten dose.
If you stop using FLURBIPROFENE COOP
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience any of the following adverse effects during treatment with FLURBIPROFENE COOP,
STOP treatment immediately and contact your doctor immediately:

Allergic phenomena (sensitization reactions):
- Allergic reaction
- Anaphylactic reactions (severe allergic reactions)
- Angioedema (sudden swelling of the mouth/throat and mucous membranes)
Local irritation
Respiratory effects: Asthma, bronchospasm, shortness of breath or difficulty breathing
Various skin disorders: Skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following adverse effects at the beginning of treatment with FLURBIPROFENE COOP, contact your doctor immediately: Abdominal pain
Peptic ulcer (lesion of the stomach)
Perforation and bleeding of the stomach or intestine.
These adverse effects can be fatal and may occur with or without warning symptoms. These adverse effects are especially likely if you are elderly or have previously suffered from stomach or intestinal diseases.

In addition, you may experience the following adverse effects:

Effects on the blood
Anaemia (reduced number of red blood cells in the blood)
Thrombocytopenia (reduced number of platelets in the blood)
Aplastic anaemia (reduced number of all types of blood cells: red blood cells, white blood cells, platelets)
Agranulocytosis (reduced number of granulocytes, a type of white blood cell, in the blood)

Effects on the nervous system
Dizziness
Headache
Paresthesia (numbness of limbs or other body parts)
Somnolence
Cerebrovascular accidents (diseases caused by inadequate blood flow to an area of the brain)
Visual disturbances
Optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to blindness)
Migraine (a chronic condition characterized by recurrent headaches)
Confusion
Vertigo

Effects on the immune system
Anaphylactic reactions (severe allergic reaction)
Angioedema (inflammatory reaction of the skin)
Hypersensitivity

Effects on the eye
Visual disturbances

Effects on the ear and labyrinth
Tinnitus (ringing in the ears)

Effects on the cardiovascular system
Heart failure
Swelling
Hypertension (high blood pressure)

Effects on the bronchi and lungs
Throat irritation
Asthma
Bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
Dyspnea (shortness of breath)
Blisters in mouth or throat
Numbness of mouth or throat

Effects on the mouth, stomach and intestine
Diarrhoea
Lesions inside the mouth
Nausea
Pain in mouth and throat
Sensation of heat or burning, tingling in the mouth
Abdominal distension
Abdominal pain
Constipation
Dry mouth
Indigestion
Flatulence (passing gas from the intestine)
Inflammation of the tongue
Taste disturbances
Vomiting
Blood in stools
Blood in vomit
Bleeding from stomach and intestine
Colitis
Worsening of inflammatory bowel diseases (Crohn's disease)
Gastritis (inflammation of the stomach)
Peptic ulcer
Gastric perforation

Effects on the skin and underlying tissues
Rash (skin eruption)
Itching
Urticaria (red, itchy skin patches)
Purpura (appearance of purple-coloured skin patches of varying sizes)
Bullous dermatoses (severe skin lesions characterized by erythema, blistering and skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema Multiforme

Effects on the kidneys and urinary tract
Renal toxicity
Tubulo-interstitial nephritis (inflammation of the kidneys)
Nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
Renal failure (reduced kidney function)

General and administration site effects
Fever
Pain
Discomfort
Fatigue

Effects on the liver
Hepatitis

Psychiatric effects
Insomnia
Depression
Hallucinations

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

5. How to store FLURBIPROFENE COOP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
Once the bottle is opened, use within 21 weeks.
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.

6. Package contents and other information

What FLURBIPROFENE COOP contains

The active substance is flurbiprofen. 100 ml of solution contain 250 mg of flurbiprofen.
The other components are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE COOP and package contents
Pack containing one bottle with dosing pump and dispenser, 15 ml.
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ) – Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy

Flurbiprofen Coop

Package leaflet: information for the user