Name
FROBENPRET 8.75 mg lemon and honey flavoured tablets
Flurbiprofen


What it is and what it is used for
FROBENPRET contains the active substance flurbiprofen, which belongs to the class of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It acts against inflammation and pain in the throat, mouth and gums.
FROBENPRET is used in adults and adolescents over 12 years of age to relieve symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).

Talk to your doctor if you do not feel better or if you feel worse after 3 days (see section 3).


What you need to know before taking the medicine
Do not take FROBENPRET:
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section "Other medicines and FROBENPRET");
- if you have previously had allergic reactions such as asthma and/or skin rashes, wheezing after taking this medicine or other medicines belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid);
- if you have suffered from bleeding due to lesions in the stomach, intestine or perforations related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have or have had inflammation of the intestine characterised by lesions (ulcerative colitis) even chronic (Crohn's disease);
- if you have or have had two or more episodes of lesions or bleeding in the stomach or intestine (recurrent peptic ulcer or gastrointestinal bleeding);
- if you suffer from severe heart, kidney or liver problems (reduced heart, kidney or liver function);

Do not take FROBENPRET if you are in the last 3 months of pregnancy (see "Pregnancy and breast-feeding").

Do not give this medicine to children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking FROBENPRET.

In particular, tell your doctor if you:
- suffer from heart, kidney or liver problems (cardiac, renal or hepatic failure);
- suffers from high blood pressure;
- have had asthma problems (bronchial asthma) as it increases the risk that you may experience bronchospasm (narrowing of the bronchi which causes serious breathing difficulty due to reduced airflow);
- suffered from allergies;
- have systemic lupus erythematosus (SLE, commonly known as lupus) or mixed connective tissue disease, diseases that affect the connective tissue causing joint or muscle pain, skin changes, and problems with other organs;
- have suffered from lesions of the stomach or intestine (peptic ulcer) or other diseases of the stomach and intestine as it increases the risk that these diseases may recur. This risk increases especially 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 intestine (see section 4 "Possible side effects");
- you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see "other medicines and FROBENPRET") and other medicines that increase the risk of gastrointestinal bleeding;
- you are taking other painkillers for a long time or without respecting the dosage, as headache may occur;
- is planning a pregnancy or is undergoing fertility investigations;
- you are elderly (as you are more likely to experience side effects especially bleeding and perforation of the digestive tract, which may be life-threatening);
- have heart or blood vessel problems, as medicines such as FROBENPRET may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatment; do not take more FROBENPRET or take it for long periods.
Tell your doctor if you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or if you smoke);
- have an infection – see “Infections” below.

Your doctor will assess the need to prescribe protective agents such as misoprostol or proton pump inhibitors to reduce the risk of gastrointestinal effects.

While using FROBENPRET, report any unusual abdominal symptoms to your doctor.
Also report to your doctor if you develop or worsen signs of a bacterial infection.

The use of this medicine, especially if prolonged, may give rise to allergic or local irritation phenomena (see paragraph 4 "Possible side effects"); in such cases, stop the treatment and consult your doctor who will be able to define an appropriate therapy.

If you experience mouth irritation, stop treatment.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may hide signs of infection such as fever and pain. This may delay appropriate treatment of the infection, which may increase the risk of complications. If you take this medicine during an infection and the symptoms of the infection persist or worsen, contact your doctor or pharmacist immediately.

Children and adolescents
This medicine should not be given to children under 12 years of age (see "Do not take FROBENPRET").


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects while taking FROBENPRET, STOP treatment and contact your doctor immediately :
- allergic phenomena (sensitization phenomena): allergic reaction, anaphylactic reactions (severe allergic reactions), sudden swelling of the mouth/throat and mucous membranes (angioedema);
- local irritation;
- sensations of warmth or tingling in the mouth and throat;
- asthma, bronchospasm, wheezing or shortness of breath;
- various skin disorders: rash, itching, redness, swelling, skin loss, blisters, peeling or tearing of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with FROBENPRET, contact your doctor immediately:
- abdominal pain;
- stomach injury (peptic ulcer);
- 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 occur especially if you are elderly or if you have suffered from stomach and intestinal diseases in the past.

Additionally, you may experience the following side effects:
Effects affecting the blood
- anemia, hemolytic anemia (reduction in the amount of red blood cells in the blood);
- neutropenia (reduction of some white blood cells in the blood);
- thrombocytopenia (reduction in the number of platelets in the blood);
- leukopenia (reduction in the number of white blood cells in the blood);
- aplastic anemia (reduction in the amount of all types of blood cells, red blood cells, white blood cells, platelets);
- agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood).
Effects on the immune system
- anaphylactic reactions (severe allergic reaction), hypersensitivity.
Effects on metabolism
- fluid retention.
Effects on the psychiatric sphere
- insomnia, depression, hallucination, confusion.
Effects on the nervous system
- dizziness, headache, migraine (chronic disease characterized by recurrent headaches);
- paresthesia (numbness of the limbs or other parts of the body);
- drowsiness;
- cerebrovascular accidents (diseases caused by a lack of blood flow to an area of ​​the brain);
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision and even blindness);
- confusion, dizziness;
- aseptic meningitis (especially in patients with existing autoimmune disorders such as systemic lupus erythematosus and connective tissue disorders) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.
Effects affecting the eye
- visual disturbances.
Effects on the ear and labyrinth
- tinnitus (ringing in the ears), vertigo.
Effects on the cardiovascular system
- heart failure;
- swelling;
- hypertension (high blood pressure).
Effects affecting the bronchi and lungs
- throat irritation;
- asthma, dyspnea (shortness of breath);
- bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow).
Effects affecting the mouth, stomach and intestines
- diarrhea, constipation, nausea, vomiting;
- sores inside the mouth, blisters in the mouth or throat, pain in the mouth and throat, numbness in the mouth or throat;
- sensation of heat or burning, tingling of the mouth, dry mouth;
- abdominal distension, abdominal pain;
- difficulty digesting;
- flatulence (emission of gas from the intestine);
- inflammation of the tongue, alteration of taste;
- blood in stool, blood in vomit;
- colitis;
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease);
- gastritis (inflammation of the stomach);
- gastric ulcer, duodenal ulcer (loss of blood from the stomach and intestines), gastrointestinal perforation;
- pancreatitis (inflammation of the pancreas).
Effects affecting the liver
- impaired liver function, hepatitis (inflammation of the liver), jaundice, cholestatic jaundice.
Effects affecting the skin and underlying tissue
- skin rash, itching, hives (redness of the skin accompanied by itching);
- purpura (appearance of purple skin patches of various sizes);
- angioedema (inflammatory reaction of the skin);
- severe skin lesions (bullous dermatoses characterized by erythema, bullous lesions with areas of skin detachment, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and erythema multiforme);
- excessive sensitivity to light (photosensitization).
Effects on the kidneys and urinary tract
- kidney toxicity;
- tubulointerstitial nephritis (inflammation of the kidneys);
- nephrotic syndrome (alteration of the renal glomeruli which causes a loss of proteins in the urine);
- renal failure, even acute (reduction in kidney function);
- glomerulonephritis (inflammation of the kidney).
General and administration site effects
- fever, pain, discomfort, fatigue, malaise, edema.
Effects on laboratory tests
- changes in liver test results;
- prolongation of bleeding time.

The use of this medicine, especially if prolonged, may give rise to sensitization or local irritation phenomena including a sensation of heat or tingling in the oropharynx.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.