FROBENPRET*16 LOZ LEMON HONEY

FROBENPRET 8.75 mg lozenges, lemon and honey flavour
flurbiprofen

What it is and what it is used for
FROBENPRET contains the active ingredient flurbiprofen, belonging to the class of medicines called non-steroidal 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).

Consult your doctor if you do not feel better or if you feel worse after 3 days (see paragraph 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 paragraph 6);
- if you are allergic to aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see paragraph Other medicines and FROBENPRET);
- if you have previously had allergic reactions such as asthma and/or skin rash, wheezing after taking this medicine or other medicines belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid);
- if you have suffered from bleeding due to lesions in the stomach, intestines 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), including 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 cardiac, renal or hepatic function);

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

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

Warnings and precautions
Consult your doctor or pharmacist before taking FROBENPRET.

In particular, inform your doctor if you:
- suffer from heart, kidney or liver problems (cardiac, renal or hepatic insufficiency);
- suffer from high blood pressure;
- have had asthma problems (bronchial asthma) as it increases the risk of bronchospasm (narrowing of the bronchi which causes severe breathing difficulties due to reduced air passage);
- have suffered from allergies;
- suffer from systemic lupus erythematosus (SLE, known as lupus) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs;
- have suffered from stomach or intestinal lesions (peptic ulcer) or other stomach and intestinal diseases 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 paragraph 4 Possible side effects);
- 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;
- are taking other analgesics for a long time or without respecting the dosage, as headaches may occur;
- are planning a pregnancy or are undergoing fertility investigations;
- you are elderly (as you are more likely to experience side effects, particularly bleeding and perforation of the digestive tract, which can be life-threatening);
- have heart or blood vessel problems, as medicines like FROBENPRET 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 FROBENPRET and do not take 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);
- have an infection - refer to the Infections paragraph below.

The 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 the appearance or worsening of signs of a bacterial infection to your doctor.

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

If you experience mouth irritation, stop treatment.

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 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 must 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, during treatment with FROBENPRET, you experience the following side effects, STOP treatment and contact your doctor immediately:
- allergic phenomena (sensitisation phenomena): allergic reaction, anaphylactic reactions (severe allergic reactions), sudden swelling of the mouth/throat and mucous membranes (angioedema)
- local irritation
- sensations of heat or tingling in the mouth and throat
- asthma, bronchospasm, shortness of breath or dyspnoea
- various skin disorders: skin rashes, itching, redness, swelling, skin shedding, blisters, peeling or tearing of the skin and mucous membranes.

If, at the beginning of treatment with FROBENPRET, you experience the following side effects, contact your doctor immediately:
- abdominal pain
- stomach lesion (peptic ulcer)
- perforation and bleeding of the stomach or intestine.

These side effects can be fatal and can occur with or without warning symptoms. These side effects occur especially if you are elderly or if you have previously suffered from stomach and intestinal diseases.

In addition, you may experience the following side effects:
Effects concerning the blood
- anaemia, haemolytic anaemia (reduction in the amount of red blood cells in the blood)
- neutropenia (reduction of certain white blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- leucopenia (reduction in the number of white blood cells in the blood)
- aplastic anaemia (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 concerning the immune system
- anaphylactic reactions (severe allergic reaction), hypersensitivity.
Effects concerning metabolism
- fluid retention.
Effects concerning the psychiatric sphere
- insomnia, depression, hallucination, confusion.
Effects concerning the nervous system
- dizziness, headache, migraine (chronic disease characterised by recurrent headaches)
- paraesthesia (numbness of the limbs or other parts of the body)
- somnolence
- cerebrovascular accidents (diseases caused by lack of blood flow to an area of the brain)
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision up to 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 concerning the eye: visual disturbances.
Effects concerning the ear and labyrinth: tinnitus (ringing in the ears), vertigo.
Effects concerning the cardiovascular system
- heart failure
- swelling
- hypertension (high blood pressure)
Effects concerning the bronchi and lungs
- throat irritation
- asthma, dyspnoea (shortness of breath)
- bronchospasm (narrowing of the bronchi which causes severe breathing difficulties due to reduced air passage)
Effects concerning the mouth, stomach and intestine
- diarrhoea, constipation, nausea, vomiting
- lesions inside the mouth, blisters in the mouth or throat, mouth and throat pain, numbness of the mouth or throat
- warm or burning sensation, tingling of the mouth, dry mouth
- abdominal distension, abdominal pain
- difficulty digesting
- flatulence (emission of gas from the intestine)
- inflammation of the tongue, altered taste
- blood in stools, 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 (blood loss from the stomach and intestine), gastrointestinal perforation
- pancreatitis (inflammation of the pancreas)
Effects concerning the liver: altered liver function, hepatitis (inflammation of the liver), jaundice, cholestatic jaundice.
Effects concerning the skin and underlying tissue
- skin rashes, itching, urticaria (skin redness accompanied by itching)
- purpura (appearance of purple skin patches of different sizes)
- angioedema (inflammatory reaction of the skin)
- severe skin lesions (bullous dermatoses characterised by erythema, bullous lesions with areas of skin detachment, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and erythema multiforme)
- excessive sensitivity to light (photosensitivity).
Effects concerning the kidneys and urinary tract
- kidney toxicity
- tubulo-interstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli leading to protein loss in the urine)
- renal failure, including acute (reduced kidney function)
- glomerulonephritis (inflammation of the kidney)
General effects and effects at the administration site
- fever, pain, discomfort, fatigue, malaise, oedema.
Effects on laboratory tests
- alterations in liver test results
- prolongation of bleeding time.

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

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.