FROBENPRET 8.75MG LEMON AND HONEY FLAVOURED TABLETS 16 TABLETS IN PVC/PVDC ALUMINIUM BLISTER

Name
FROBENPRET 8.75 mg lemon and honey flavoured lozenges
Flurbiprofen


What is it and what is it for?
FROBENPRET contains the active ingredient flurbiprofen, a member of 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) which may also be 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:
- have heart, kidney or liver problems (cardiac, renal or hepatic failure);
- suffers from high blood pressure;
- has had asthma problems (bronchial asthma) as this increases the risk of developing bronchospasm (narrowing of the bronchi which causes severe 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 connective tissue, causing joint or muscle pain, skin changes, and problems with other organs;
- have had lesions in the stomach or intestines (peptic ulcer) or other stomach and intestinal diseases, as this increases the risk of these diseases recurring. This risk is especially increased with high doses of flurbiprofen, if you are elderly, or if your peptic ulcer has been complicated by bleeding or perforation of the stomach and intestines (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 tests;
- you are elderly (as you are more likely to experience side effects especially bleeding and perforation of the digestive tract, which can be life-threatening);
- have heart or blood vessel problems, since medicines like 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 exceed the dose of 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 for 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 evaluate 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 the appearance or worsening of signs of a bacterial infection.

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

If you experience mouth irritation, discontinue treatment.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) can mask signs of infection, such as fever and pain. This can delay appropriate treatment of the infection, which, in turn, may increase the risk of complications. If you take this medicine during an infection and the symptoms 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 heat 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 start 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 are especially likely if you are elderly or have a history of stomach or intestinal diseases.

Additionally, you may experience the following side effects:
Effects affecting the blood
- anemia, hemolytic anemia (reduction in the number 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 number 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 affecting 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 which causes 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 in the mouth, dry mouth;
- abdominal distension, abdominal pain;
- difficulty digesting;
- flatulence (passing 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 varying 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 leads to 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 experience 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.