Name
FROBENGOLMED 8.75 mg/dose oral spray, solution
Flurbiprofen


What is it and what is it for?
FROBENGOLMED contains the active substance flurbiprofen. Flurbiprofen belongs to a family of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and fever.

FROBENGOLMED is indicated for the short-term relief of sore throat symptoms such as throat inflammation, pain, difficulty swallowing, and swelling in adults aged 18 years and over.


What you need to know before taking the medicine
Do not take FROBENGOLMED if:
• are allergic to flurbiprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin (acetylsalicylic acid) or any of the other ingredients listed in section 6;
• have had previous allergic reactions following the use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid); e.g., asthma, wheezing, itching, runny nose, rash or swelling;
• have or have had one or more episodes of stomach ulcer or bleeding or intestinal ulcer;
• have had severe colitis (inflammation of the intestine);
• have had clotting or bleeding problems after taking NSAIDs;
• is in the last three months of pregnancy;
• suffer from severe heart failure, severe kidney failure or severe liver failure.


Warnings and precautions
Talk to your doctor or pharmacist before taking FROBENGOLMED if:
• are already taking other nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin.
• you have tonsillitis (inflamed tonsils) or think you have a bacterial inflammation of the throat (as you may need to take antibiotics):
• have an infection – see “Infections” below;
• are elderly (as they are more likely to experience side effects);
• have or have had asthma or suffer from allergies;
• have a skin condition known as systemic lupus erythematosus or mixed connective tissue disease;
• suffer from hypertension (high blood pressure);
• has a history of intestinal diseases (ulcerative colitis, Crohn's disease);
• have heart, kidney or liver problems;
• had a stroke;
• is in the first 6 months of pregnancy or is breastfeeding;

While using FROBENGOLMED
• At the first sign of any skin reaction (rash, peeling, vesicular eruption) or other sign of an allergic reaction, stop using the spray immediately and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• Talk to your doctor if you notice no improvement or if you notice worsening or if you develop new symptoms.
• Medicines such as flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

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
This medicine should not be used in children and adolescents under 18 years of age.


Possible side effects
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular:
• other nonsteroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors for pain or inflammation, as they may increase the risk of bleeding in the stomach or intestines
• warfarin, aspirin (acetylsalicylic acid) and other blood thinning or anticoagulant medicines
• ACE inhibitors, angiotensin II antagonists (antihypertensive medicines)
• diuretics (drugs that increase urine production) including potassium-sparing diuretics
• SSRIs (selective serotonin reuptake inhibitors) for depression
• cardiac glycosides such as digoxin (for heart problems)
• ciclosporin (to prevent rejection after an organ transplant)
• corticosteroids (to reduce inflammation)
• lithium (for behavioral disorders)
• methotrexate (for psoriasis, arthritis and cancer)
• mifepristone (used to terminate a pregnancy); NSAIDs should not be used for 8-12 days after taking mifepristone, as they reduce its effect
• oral antidiabetic drugs
• phenytoin (for epilepsy)
• probenecid, sulfinpyrazone (for gout and arthritis)
• quinolone antibiotics (for bacterial infections) such as ciprofloxacin,
levofloxacin
• tacrolimus (immunosuppressant used after an organ transplant)
Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking this medicine IMMEDIATELY and contact your doctor if you develop any of the following conditions:
• severe forms of skin reaction, such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions due to serious adverse drug reactions or an infection in which a severe reaction involving the skin and mucous membranes occurs).
Frequency: not known (frequency cannot be estimated from the available data);
• signs of anaphylactic shock characterised by swelling of the face, tongue or throat resulting in difficulty breathing, rapid heartbeat, drop in blood pressure and subsequent shock (these reactions may also occur when the medicine is used for the first time).
Frequency: rare (may affect up to 1 in 1,000 people);
• signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, flaking, or ulceration of the skin and mucous membranes. Frequency: uncommon (may affect up to 1 in 100 people);
• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or skin rash. Frequency: uncommon (may affect up to 1 in 100 people);

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

Common (may affect up to 1 in 10 people):
• dizziness, headache
• throat irritation
• mouth ulcers, pain or numbness in the mouth
• sore throat
• discomfort (sensation of heat or burning or tingling) in the mouth
• nausea and diarrhea
• tingling and itching sensation of the skin

Uncommon (may affect up to 1 in 100 people):
• drowsiness
• vesicular rash in the mouth or throat, numbness of the throat
• abdominal bloating, abdominal pain, flatulence, constipation, indigestion, feeling unwell
• dry mouth
• burning sensation in the mouth, altered sense of taste
• fever, pain
• drowsiness or difficulty falling asleep
• worsening of asthma, wheezing, shortness of breath
• reduced throat sensitivity

Not known (frequency cannot be estimated from the available data):
• anemia, thrombocytopenia (low platelet count which may lead to bruising and bleeding)
• swelling (edema), high blood pressure, heart failure or heart attack
• hepatitis (inflammation of the liver)

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.