Flurbiprofene PensA

Package leaflet: Information for the user

FLURBIPROFEN PENSA 2.5 mg/ml mouthwash

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 3 days of treatment.

Contents of this leaflet:

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

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

FLURBIPROFENE PENSA 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 PENSA 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 pain following conservative or extraction dental procedures (e.g. treatment of cavities or tooth extraction).
Consult your doctor if you do not feel better or feel worse after 3 days of treatment (see section 3).

2. What you need to know before using FLURBIPROFENE PENSA

Do not use FLURBIPROFENE PENSA

• 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 PENSA”);
• 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 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 PENSA to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FLURBIPROFENE PENSA.
In particular, inform your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may develop bronchospasm (narrowing of the airways causing severe breathing difficulty 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 have 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 recommended 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 is especially increased 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 such as FLURBIPROFENE PENSA 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 PENSA 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 (e.g. if you have high blood pressure, diabetes, high cholesterol, or smoke);
• you have an infection – refer to the section “Infections” below. 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 may increase the risk of complications. If you use this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

Inform your doctor of any unusual abdominal symptoms.
Use of this medicine, especially if prolonged, may cause allergic reactions or local irritation
(see section 4 “Possible side effects”); in such cases, stop treatment and
consult your doctor, who will initiate appropriate therapy if necessary.
If you experience mouth irritation, discontinue treatment.
Children and adolescents
Do not give FLURBIPROFENE PENSA to children under 12 years of age.
Other medicines and FLURBIPROFENE PENSA
Inform 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 (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), as their effect may be enhanced by NSAIDs;
• selective serotonin reuptake inhibitors (medicines used to treat 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 drugs 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 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 immunosuppressive medicine 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 and the risk of side effects may be increased.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, 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 newborn. It is not known
whether the same risk applies to FLURBIPROFENE PENSA. Do not use FLURBIPROFENE PENSA
during the last three months of pregnancy. Do not use FLURBIPROFENE PENSA during the first 6 months
of pregnancy unless strictly necessary and under medical advice. If treatment is necessary 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 the medicine 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 using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
FLURBIPROFENE PENSA contains parahydroxybenzoates, polyoxyl 40 hydrogenated castor oil, and ethanol
Parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
Polyoxyl 40 hydrogenated castor oil: 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 PENSA

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.

DOSE AND METHOD OF ADMINISTRATION
Use the lowest effective dose for the shortest duration necessary 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 2–3 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.
At the recommended doses, accidental ingestion is unlikely to cause harm, although it is advisable not to swallow the product.

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 a higher risk of developing stomach or intestinal ulcers, bleeding, or perforation (see section 4 “Possible side effects”).

Use in children and adolescents
Do not give FLURBIPROFENE PENSA to children under 12 years of age.

Duration of treatment
Use FLURBIPROFENE PENSA 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; therefore, 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 PENSA than you should
If you accidentally ingest/overdose on FLURBIPROFENE PENSA, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, you may experience symptoms such as nausea, vomiting, stomach or intestinal irritation, stomach ache, or rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will initiate appropriate treatment.

If you forget to use FLURBIPROFENE PENSA
Do not take a double dose to make up for the forgotten dose.

If you stop using FLURBIPROFENE PENSA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects while using FLURBIPROFENE PENSA, 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 effects: asthma, bronchospasm, breathlessness or shortness of breath
• Various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, or skin and mucous membrane ulceration.

If you experience any of the following side effects at the beginning of treatment with FLURBIPROFENE PENSA, contact your doctor immediately:

• abdominal pain
• peptic ulcer (stomach lesion)
• perforation and bleeding of the stomach or intestine.

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.

In addition, you may experience the following side effects:

Effects related to the blood

• anaemia (reduction in the number of red blood cells)
• thrombocytopenia (reduction in the number of platelets in the blood)
• aplastic anaemia (reduction in all types of blood cells: red blood cells, white blood cells, and platelets)
• agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood).

Effects related to the nervous system

• dizziness
• headache
• paresthesia (numbness of limbs or other body parts)
• drowsiness
• cerebrovascular events (diseases caused by lack of 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 bronchi causing severe breathing difficulty due to reduced airflow)
• dyspnea (shortness of breath)
• blisters in the mouth or throat
• numbness of the mouth or throat.

Effects related to the mouth, stomach, and intestine

• diarrhea
• mouth sores
• nausea
• pain in the mouth and throat
• abdominal bloating
• stomach pain
• constipation
• dry mouth
• indigestion
• flatulence (passing gas from the intestine)
• inflammation of the tongue
• altered taste
• vomiting
• blood in the stool
• blood in vomit
• bleeding from the stomach and intestine
• 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 tissue

• rash (skin eruption)
• itching
• urticaria (red, itchy skin patches)
• purpura (appearance of purple-colored skin spots 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 the kidney glomeruli leading to protein loss in the urine)
• renal failure (reduced kidney function).

General effects and effects at the site of administration

• fever
• pain
• discomfort
• fatigue.

Effects related to the liver

• hepatitis.

Effects related to psychiatric disorders

• insomnia
• depression
• hallucination.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 FLURBIPROFENE PENSA

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 after Exp.
The expiry date refers to the last day of that month.
After opening the bottle, 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 PENSA 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 4-hydroxybenzoate, propyl 4-hydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE PENSA and contents of the pack
Pack containing one bottle with measuring cup and child-resistant cap, 160 ml.
Marketing Authorization Holder
FG 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

Patient Information Leaflet: Information for the User

FLURBIPROFENE PENSA 2.5 mg/ml oral mucosa spray

Read this entire leaflet carefully before using this medicine, as 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 would like more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

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

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

FLURBIPROFENE PENSA 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 PENSA 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 pain following conservative or extraction 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 should know before using FLURBIPROFENE PENSA

Do not use FLURBIPROFENE PENSA

• 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 for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FLURBIPROFENE PENSA”);
• 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 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 PENSA to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FLURBIPROFENE PENSA.
In particular, inform your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may develop 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 and 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 such as FLURBIPROFENE PENSA 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 PENSA and do not use it for extended periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g. 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, consult 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 prescribe appropriate therapy if necessary.
If you experience mouth irritation, stop treatment.
Children and adolescents
Do not give FLURBIPROFENE PENSA to children under 12 years of age.
Other medicines and FLURBIPROFENE PENSA
Inform 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 (medicines 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), as NSAIDs may reduce the effect of diuretics or some antihypertensive drugs 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 their combined use may enhance their effects and increase the risk of side effects.

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 PENSA.
Do not use FLURBIPROFENE PENSA during the last three months of pregnancy. Do not use FLURBIPROFENE PENSA during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is needed 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 discontinued. Occasional use of this medicine is unlikely to affect the ability to become pregnant. However, consult your doctor if you have fertility concerns before using this medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
FLURBIPROFENE PENSA 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 PENSA

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

DOSE AND METHOD OF ADMINISTRATION
Use the lowest effective dose for the shortest duration necessary 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).
Warning: 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).
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 ulcers
If you are elderly or have previously had peptic ulcers (stomach lesions), it is advisable to use the lowest recommended dose, as the risk of serious consequences from adverse effects is higher. The risk of developing stomach or intestinal ulcers, bleeding, or perforation is also increased (see section 4 “Possible side effects”).

Use in children and adolescents
Do not give FLURBIPROFENE PENSA to children under 12 years of age.

Duration of treatment
Use FLURBIPROFENE PENSA only for short-term treatment, not exceeding 7 days.
If there is no noticeable improvement 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.

Method of administration
Rotate the nozzle to the right or left without touching the spray pump.
At first use, press the spray pump several times until a regular mist is produced.

If you use more FLURBIPROFENE PENSA than you should
If you accidentally ingest/absorb an excessive amount of FLURBIPROFENE PENSA, 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, stomach or intestinal irritation, stomach pain, or rarely diarrhea 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 PENSA
Do not use a double dose to make up for the missed dose.

If you stop using FLURBIPROFENE PENSA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following side effects during treatment with FLURBIPROFENE PENSA,
STOP treatment immediately and contact your doctor immediately:
Allergic reactions (sensitization phenomena):

• 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 PENSA, contact your doctor immediately:

• Abdominal pain
• Peptic ulcer (stomach lesion)
• 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.

In addition, you may experience the following side effects:
Effects related to the blood

• Anaemia (reduction in the number of red blood cells)
• Thrombocytopenia (reduction in the number of platelets in the blood)
• Aplastic anaemia (reduction in all types of blood cells: red blood cells, white blood cells, platelets)
• Agranulocytosis (reduction in the number of granulocytes, a type of white blood cells, in the blood)

Effects related to the nervous system

• Dizziness
• Headache
• Paresthesia (numbness or tingling in limbs or other body parts)
• Drowsiness
• Cerebrovascular accidents (diseases caused by lack of 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)
• Dyspnea (shortness of breath)
• Blisters in mouth or throat
• Numbness of mouth or throat

Effects related to the mouth, stomach and intestines

• Diarrhoea
• Mouth lesions
• Nausea
• Pain in mouth and throat
• Abdominal distension
• Abdominal pain
• Constipation
• Dry mouth
• Indigestion
• Flatulence (passing gas from the intestine)
• Tongue inflammation
• Taste disturbances
• Vomiting
• Blood in stools
• Blood in vomit
• Bleeding from stomach and intestines
• 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 tissue

• 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 effects and effects at the site of administration

• 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, 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 FLURBIPROFENE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
After opening the bottle, 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 PENSA 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, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE PENSA and contents of the pack
Pack containing one bottle with a dosing pump and dispenser, 15 ml.
Marketing Authorization Holder
FG 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