FROBENGOLMED*SPRAY 15ML

FROBENGOLMED 8.75 mg/dose oromucosal spray, solution
Flurbiprofen

What it is and what it is used for
FROBENGOLMED contains the active ingredient flurbiprofen. Flurbiprofen belongs to a family of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that work by changing the body's response to pain, swelling, and fever.

FROBENGOLMED is indicated for the short-term symptomatic 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:
• you 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;
• you have had previous allergic reactions after taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid); e.g., asthma, wheezing, itching, runny nose, skin rashes or swelling;
• you have or have had one or more episodes of stomach ulcer or bleeding or intestinal ulcer;
• you have had severe colitis (inflammation of the intestine);
• you have had clotting or bleeding problems after taking NSAIDs;
• you are in the last three months of pregnancy;
• you 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:
• you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin;
• you suffer from tonsillitis (inflamed tonsils) or think you have a bacterial throat infection (as antibiotics may be needed);
• you have an infection - refer to the Infections section below;
• you are elderly (as you are more likely to experience side effects);
• you have or have had asthma or suffer from allergies;
• you suffer from a skin condition known as systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from hypertension (high blood pressure);
• you have a history of intestinal diseases (ulcerative colitis, Crohn's disease);
• you have heart, kidney or liver problems;
• you have had a stroke;
• you are in the first 6 months of pregnancy or are breastfeeding;

While using FROBENGOLMED
• At the first symptom of any skin reaction (rash, peeling, blistering) or other symptom of an allergic reaction, stop using the spray immediately and consult a doctor immediately;
• Tell your doctor about any unusual abdominal symptoms (especially bleeding);
• Consult your doctor if you do not notice improvements or if you notice a worsening or if you develop new symptoms;
• Medicines such as flurbiprofen may be associated with a modest 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
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infection such as fever and pain. This can delay the 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
This medicine should not be used in children and adolescents under 18 years of age.

Possible side effects
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 blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions due to severe adverse reactions to the medicine 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 characterized by swelling of the face, tongue or throat with consequent difficulty breathing, accelerated heart rate, drop in blood pressure and subsequent shock (these reactions can also occur with the first use of the medicine). 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 allergic reaction such as asthma, wheezing or unexplained shortness of breath, itching, runny nose or skin rashes. Frequency: uncommon (may affect up to 1 in 100 people);

If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist:

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

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

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

Reporting of side effects
If you get any side effects, including those 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.