FROBEN GOLA*ORAL SPRAY 15ML 0.25%

FROBEN GOLA 250mg/100ml Mouthwash
FROBEN GOLA 250mg/100ml Oral mucosa spray
Flurbiprofen

What it is and what it is used for
FROBEN GOLA contains flurbiprofen and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain, redness, heat, and swelling due to inflammation.

FROBEN GOLA is used to reduce burning, redness, pain, and inflammation of the mouth and throat, due to, for example:
• gingivitis;
• stomatitis;
• pharyngitis;
• dental procedures (dental treatments).

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use FROBEN GOLA
• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have had asthma, hives, or any other allergic reaction after taking acetylsalicylic acid known as aspirin or other NSAIDs;
• if you have a peptic ulcer (stomach or duodenal ulcer) or Crohn's disease, suffer or have suffered from ulcerative colitis, have had two or more episodes of stomach or intestinal ulcers or bleeding, have had even a single episode of stomach and/or intestinal bleeding or perforation due to NSAIDs;
• if you have severe heart, kidney, or liver problems;
• in the last three months of pregnancy.

Warnings and precautions
Consult your doctor before taking FROBEN GOLA if:
• you are elderly, as you are more likely to develop adverse reactions to this medicine;
• you are pregnant or intend to become pregnant, or are breastfeeding;
• you have liver or kidney problems;
• you have heart or blood vessel problems, as medicines such as FROBEN GOLA may be associated with a modest 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 FROBEN GOLA 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, high cholesterol, or smoke);
• you have had a peptic ulcer (stomach or duodenal ulcer) or other stomach or intestinal diseases;
• you have asthma;
• you 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 in other organs;
• you are dehydrated as you are more likely to have kidney problems;
• you have an infection - refer to the Infections section below.

PAY ATTENTION, because during treatment with all pain and anti-inflammatory drugs (NSAIDs):
• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration, or perforation of the stomach or intestine have been reported, which can be fatal. The risk of ulceration or bleeding may increase if you are also taking medicines such as oral corticosteroids, anticoagulants, antiplatelets, and selective serotonin reuptake inhibitors (see Other medicines and FROBEN GOLA);
• although very rarely, severe skin reactions have been reported, some of which are fatal, manifesting as redness, blistering, and exfoliation (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). In the early stages of therapy, patients appear to be at higher risk: such reactions occur in most cases within the first month of treatment;
• a worsening of infections may occur, such as the appearance of necrotizing fasciitis, which manifests as fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruises in an area of the body due to tissue necrosis (death of tissue cells);
• headaches may occur if used for prolonged periods; in this case, do not increase the dose of FROBEN GOLA to relieve the pain;
• concomitant use of alcohol may increase the risk of side effects affecting the stomach and intestines or the nervous system.

STOP treatment and contact your doctor if:
• you notice any stomach or intestinal (gastrointestinal) symptoms, especially if it is bleeding;
• a skin rash, mucosal lesions, or any other sign of an allergic reaction (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure) appears.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections 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 infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

The effects reported above have been reported in particular after the administration of flurbiprofen-based formulations for systemic use.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In particular, some side effects that occur with other medicines containing flurbiprofen, taken orally or topically (for example, tablets or patches), or with other anti-inflammatory drugs (NSAIDs), may also occur during treatment with FROBEN GOLA.

Stop taking FROBEN GOLA immediately and consult your doctor if any of the following conditions occur:
• severe burning or abdominal pain, due to stomach or duodenal (peptic) ulcer. These side effects are uncommon;
• sudden and violent pain in the pit of the stomach (ulcer perforation). This side effect is uncommon;
• vomiting containing blood (hematemesis) or black stools (melena), associated with stomach or intestinal bleeding, unusual fatigue with reduced urine output (due to invisible bleeding). These side effects are common;
• allergic reactions, including severe ones, such as swelling (angioedema) of the face, eyes, lips, throat with breathing problems (these side effects are uncommon), with a sudden drop in blood pressure (anaphylactic reaction) (these side effects are rare);
• severe skin rashes with redness, exfoliation, and/or blistering (e.g., erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis). These side effects are very rare;
• respiratory problems, even severe ones such as asthma, and dyspnea (these side effects are uncommon) or bronchospasm (this side effect is uncommon);
• inflammation of the pancreas (pancreatitis). This side effect is very rare;
• swelling of the face, hands, legs (edema), decreased urine output or difficulty urinating (fluid retention). These side effects are common;
• fatigue, shortness of breath, and swelling of the legs, symptoms of heart failure; high blood pressure. These side effects are uncommon;
• blood clots in the arteries (which cause, for example, heart attack or stroke), cerebrovascular diseases. The frequency of these side effects is not known;
• inflammation of the meninges (aseptic meningitis) which manifests as: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness, and discomfort from light. The frequency of these side effects is not known.

Common side effects (may affect up to 1 in 10 people)
• nausea, vomiting, diarrhea, intestinal gas, difficulty evacuating (constipation), indigestion, abdominal pain;
• alterations in liver function tests, increased bleeding time;
• dizziness, migraine, fatigue, malaise.

Uncommon side effects (may affect up to 1 in 100 people)
• decreased red blood cells (anemia);
• gastritis, mouth ulcers;
• sudden appearance of skin lesions, for example, mottled or diffuse color changes (skin rash, purpura) even after sun exposure (photosensitivity reactions), hives, itching;
• ringing, whistling, buzzing, squealing, or other persistent sounds in the ears;
• visual disturbances, altered sensation, vertigo.

Rare side effects (may affect up to 1 in 1,000 people)
• depression, confusion, drowsiness, difficulty falling asleep (insomnia);
• kidney problems (nephrotoxicity) such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (kidney failure).

Very rare side effects (may affect up to 1 in 10,000 people)
• changes in blood parameters: decreased platelets (thrombocytopenia), decreased white blood cells (leukopenia) or neutrophils (neutropenia), severe decrease in granulocytes (agranulocytosis), decreased red blood cells due to bone marrow problems (aplastic anemia), destruction of red blood cells with consequent decrease in their number (hemolytic anemia);
• yellowish discoloration of the eyes or skin (jaundice, cholestatic jaundice), dark urine, pale stools, itching or abdominal pain, possible signs of liver problems;
• hallucinations.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• inflammation of the colon and Crohn's disease;
• vision problems due to inflammation of the optic nerve (optic neuritis), headache;
• kidney inflammation (glomerulonephritis);
• liver inflammation (hepatitis).

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.