FROBEN GOLA 0.25% MOUTHWASH 160 ML BOTTLE

Name
FROBEN THROAT 250mg/100ml Mouthwash
FROBEN THROAT 250mg/100ml Spray for oral mucosa
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 for example to:
• gingivitis;
• stomatitis;
• pharyngitis;
• dental procedures (dental therapies).

Talk to your doctor if you do not feel better or feel worse after a short time 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 to 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 ulcer or bleeding in the stomach or intestine, have had even one episode of bleeding or perforation of the stomach and/or intestine due to NSAIDs;
• if you have serious heart, kidney or liver problems;
• in the last three months of pregnancy.


Warnings and precautions
Talk to your doctor before taking FROBEN GOLA if:
• are elderly, as they are more likely to develop adverse reactions to this medicine;
• is pregnant or intends to become pregnant, or is breastfeeding;
• have liver or kidney problems;
• have heart or blood vessel problems, as medicines such as FROBEN GOLA 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 FROBEN GOLA and do not take it for long periods. Tell your doctor if you have heart problems, a history of stroke or think you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke);
• have had a peptic ulcer (ulcer in the stomach or duodenum) or other stomach or intestinal disease;
• has asthma;
• have systemic lupus erythematosus (SLE, known as lupus) or mixed connective tissue disease, diseases that affect the connective tissue causing joint or muscle pain, skin changes, and problems with other organs;
• is in a state of dehydration as he or she is more likely to have kidney problems;
• have an infection – see “Infections” below.

PLEASE NOTE , because during treatment with all pain and inflammation medicines (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, which can be fatal, has been reported. The risk of ulceration or bleeding may be increased if you take medicines such as oral corticosteroids, anticoagulants, antiplatelet agents and selective serotonin reuptake inhibitors at the same time (see "Other medicines and FROBEN GOLA");
• although very rarely, serious skin reactions, some of them fatal, manifesting as redness, blistering and peeling (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), have been reported. Patients appear to be at highest risk in the early stages of therapy: these reactions occur in the majority of cases within the first month of treatment;
• worsening of infections may occur, such as necrotizing fasciitis which manifests itself with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in an area of ​​the body due to tissue necrosis (death of tissue cells);
• headache 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:
• note any symptoms affecting your stomach and intestines (gastrointestinal), especially if they involve bleeding;
• a skin rash, mucosal lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may hide signs of infection such as fever and pain. This may delay appropriate treatment of the infection, which may increase the 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.

The above effects have been reported in particular after the administration of flurbiprofen 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 medicines (NSAIDs), may also occur during treatment with FROBEN GOLA.

Stop taking FROBEN GOLA immediately and contact your doctor if any of the following conditions occur:
• severe burning or abdominal pain, due to a stomach or duodenal (peptic) ulcer. These side effects are uncommon;
• sudden, severe pain in the pit of the stomach (perforation of the ulcer). This side effect is uncommon;
• vomiting containing blood (haematemesis) or black stools (melena), associated with bleeding from the stomach or intestine, abnormal tiredness with reduced urine output (due to invisible bleeding). These side effects are common;
• allergic reactions, even serious ones, such as swelling (angioedema) of the face, eyes, lips, throat with breathing problems (these side effects are uncommon), with sudden drop in blood pressure (anaphylactic reaction) (these side effects are rare);
• severe skin rashes with redness, peeling and/or blistering (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). These side effects are very rare;
• breathing problems, even serious ones such as asthma, and dyspnoea (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 amount of urine or difficulty urinating (fluid retention). These side effects are common;
• tiredness, 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 (e.g. causing heart attack or stroke), diseases of the vessels in the brain (cerebrovascular accidents). The frequency of these side effects is not known;
• inflammation of the meninges (aseptic meningitis) which manifests itself with: very high fever, sudden headache, inability to bend the head, nausea, vomiting, confusion, drowsiness and sensitivity to 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 in evacuating (constipation), indigestion, abdominal pain;
• changes in tests that evaluate liver function, increased bleeding time;
• dizziness, migraine, fatigue, malaise.

Uncommon side effects (may affect up to 1 in 100 people)
• decrease in red blood cells (anemia);
• gastritis, mouth ulcers;
• more or less sudden appearance of skin lesions, for example spotty or widespread changes in colour (rash, purpura) even following exposure to the sun (photosensitivity reactions), hives, itching;
• persistent ringing, buzzing, hissing, ringing, or whistling or other sounds in the ears;
• visual disturbances, altered sensation, dizziness.

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, inflammation of the kidney (tubulointerstitial nephritis), changes in function (renal failure).

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

Unknown side effects (frequency cannot be estimated from the available data)
• colon inflammation and Crohn's disease;
• vision problems due to inflammation of the nerve in the eye (optic neuritis), headache (cephalea);
• inflammation of the kidneys (glomerulonephritis);
• inflammation of the liver (hepatitis).

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