FLURBIPROFEN PE*OS SPRAY 15ML

FLURBIPROFEN PENSA 0.25% oral mucosal spray

What it is and what it is used for
FLURBIPROFEN PENSA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine, which acts against inflammation and pain in the throat, mouth and gums.

FLURBIPROFEN PENSA is used in adults and adolescents over 12 years of age in the treatment of symptoms of pain and irritations of the gums, mouth and throat (e.g., gingivitis, stomatitis, pharyngitis), including as a result of conservative or extractive dental therapy (e.g., cavity treatment or tooth extraction).

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment (see paragraph 3).

What you need to know before taking the medicine
Do not use FLURBIPROFEN PENSA
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are allergic to acetylsalicylic acid (medicine for inflammation, pain, fever and heart conditions) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see paragraph Other medicines and FLURBIPROFEN PENSA);
- if you have a history of stomach or intestinal bleeding or perforation related to previous treatments 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 ulcers (stomach lesion) or stomach or intestinal bleeding (two or more distinct episodes of ulcer or bleeding);
- if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney failure (reduced kidney function);
- if you are in the last 3 months of pregnancy (see paragraph Pregnancy and breastfeeding).

Do not give FLURBIPROFEN PENSA to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using FLURBIPROFEN PENSA.
In particular, inform your doctor if:
- you have a history of bronchial asthma (a respiratory disease), as this increases the risk of bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow);
- you have a history of 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 respecting the dosage, as headaches may occur;
- you have a history of peptic ulcers (stomach lesion) and other stomach and intestinal diseases, as this increases the risk of these diseases recurring. This risk particularly increases with high doses of flurbiprofen, if you are elderly or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestines (see paragraph 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 FLURBIPROFEN 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 high doses and prolonged treatments; do not exceed the dose of FLURBIPROFEN 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 (for example, if you have high blood pressure, diabetes or high cholesterol or smoke);
- you have an infection - refer to the Infections paragraph below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain. This can delay appropriate treatment of the infection, which, in turn, can lead to an increased risk of complications. If you use this medicine during an infection and the infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, can cause allergic reactions or local irritation (see paragraph 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will provide appropriate therapy.
If you experience mouth irritation, stop treatment.

Children and adolescents
Do not give FLURBIPROFEN PENSA to children under 12 years of age.

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

If you experience the following side effects during treatment with FLURBIPROFEN PENSA, STOP treatment and contact your doctor immediately: allergic reactions (sensitisation phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes)
local irritation
- respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath
- various skin disorders: skin rashes of different types, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the start of treatment with FLURBIPROFEN 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 you may experience them with or without warning symptoms. These side effects are especially likely if you are elderly or have a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects concerning the blood
- anemia (reduction of the amount of red blood cells in the blood)
- thrombocytopenia (reduction of the number of platelets in the blood)
- aplastic anemia (reduction of the amount of all types of blood cells, red blood cells, white blood cells, platelets)
- agranulocytosis (reduction of the number of granulocytes, a type of white blood cell, in the blood).

Effects concerning the nervous system
- dizziness
- headache
- paraesthesia (numbness of the 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 can lead to vision reduction up to blindness)
- migraine (chronic disease characterized by recurrent headaches)
- confusion
- vertigo.

Effects concerning the immune system
- anaphylactic reactions (severe allergic reaction)
- angioedema (inflammatory skin reaction)
- hypersensitivity.

Effects concerning the eye
- visual disturbances.

Effects concerning the ear and labyrinth
- tinnitus (ringing in the ears).

Effects concerning the cardiovascular system
- heart failure
- swelling
- hypertension (high blood pressure)

Effects concerning the bronchi and lungs
- throat irritation
- asthma
- bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow)
- dyspnea (shortness of breath)
- blisters in the mouth or throat
- numbness of the mouth or throat.

Effects concerning the mouth, stomach and intestine
- diarrhea
- lesions inside the mouth
- nausea
- mouth and throat pain
- abdominal distension
- abdominal pain
- constipation
- dry mouth
- indigestion
- flatulence (emission of gas from the intestine)
- tongue inflammation
- altered taste
- vomiting
- blood in stools
- blood in vomit
- bleeding from the stomach and intestine
- colitis
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
- gastritis (stomach inflammation)
- peptic ulcer
- gastric perforation.

Effects concerning the skin and subcutaneous tissue
- rash
- itching
- urticaria (skin redness accompanied by itching) purpura (appearance of skin patches of various sizes with purple color)
- bullous dermatoses (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme

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

General effects and effects at the administration site
- fever
- pain
- discomfort
- fatigue

Effects concerning the liver
- hepatitis

Effects concerning the psychiatric sphere
- insomnia
- depression
- hallucination.

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.