Froben Throat Nebulizer Spray 0.25% 15 ml

WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. Flurbiprofen should be administered with caution to patients with peptic ulcer history and other gastrointestinal diseases as these conditions may be exacerbated. Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulcer or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal disease, especially if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. When gastrointestinal bleeding or ulceration occurs in patients taking the drug discontinue treatment.Cases of bronchospasm with flurbiprofen have been reported in patients with a history of bronchial asthma. Particular caution must be adopted in the treatment of patients with severely reduced renal, cardiac or hepatic function, as the use of NSAIDs can determine the deterioration of renal function. In such patients the dosage should be kept as low as possible and renal function monitored. Administration of an NSAID may cause a dose dependent reduction in prostaglandin formation, accelerating renal failure. Patients at highest risk of developing this reaction are those with impaired renal function, heart failure and hepatic dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Adequate monitoring and appropriate instructions are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. In these patients the medicinal product should be taken with caution. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors. for cardiovascular disease. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Flurbiprofen should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity '. Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. In patients with Systemic Lupus Erythematosus (SLE) and connective system disorders there may be an increased risk of aseptic meningitis. The effects reported above have been reported in particular after the administration of formulations based on Flurbiprofen for systemic use. At the recommended doses, the possible swallowing of the medicinal product does not cause any harm to the patient as these doses are well below those of the single dosage of the product per systemic route. The use of the drug, especially if prolonged, can give rise to sensitization or local irritation phenomena; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy. Do not use for prolonged treatments. Both the mouthwash and the spray contain ethyl alcohol. For those who carry out sports activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
PHARMACOTHERAPEUTIC CATEGORY
Dental.
STORAGE
Mouthwash: This medicine should not be stored above 25 degrees C. Oromucosal spray: this medicine should not be stored above 25 degrees C; keep the bottle in the outer carton to protect from light.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to flurbiprofen or to any of the excipients listed; patients who have previously experienced hypersensitivity reactions' (eg. asthma, urticaria) after taking aspirin or other NSAIDs; patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment; patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding); patients with severe cardiac, renal or hepatic insufficiency; third trimester of pregnancy.
NAME
FROBEN THROAT
EXCIPIENTS
Purified water, alcohol, patent blue VE 131, glycerol, mint essence, hydrogenated castor oil 40-polyoxyethylenate, potassium bicarbonate, sodium saccharinate, sorbitol.
SIDE EFFECTS
The following adverse reactions, particularly reported after administration of systemic formulations, are reported according to the MedDRA classification. Frequency groupings are classified according to the following convention: very common (> = 1/10), common (> = 1/100 to <1/10), uncommon (> = 1/1000 to <1/100) , rare (> = 1 / 10,000to <1/1000), very rare (<1 / 10,000) and not known. Disorders of the blood and lymphatic system. Uncommon: anemia; very rare: leukopenia, agranulocytosis, aplastic anemia, neutropenia, thrombocytopenia, haemolytic anemia. Disorders of the immune system. Uncommon: hypersensitivity '; rare: anaphylactic reaction. Psychiatric disorders. Rare: depression, confusional state; very rare: hallucination. Nervous System Pathologies. Common: headache, dizziness; uncommon: paraesthesia; rare: drowsiness, insomnia; not known: optic neuritis, cerebrovascular accident. Eye disorders. Uncommon: visual impairment. Ear and labyrinth disorders. Uncommon: tinnitus, vertigo. Respiratory, thoracic and mediastinal disorders. Uncommon: asthma, dyspnoea; rare: bronchospasm. Gastrointestinal disorders. Common: dyspepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage; uncommon: gastritis, duodenal ulcer, gastric ulcer, mouth ulcer, gastrointestinal perforation; very rare: pancreatitis; not known: colitis and crohn's disease. Hepatobiliary disorders. Very rare: jaundice, cholestatic jaundice, abnormal liver function. Skin and subcutaneous tissue disorders. Uncommon: rash, urticaria, pruritus, purpura, angioedema, photosensitivity reactions'; very rare: severe forms of bullous cutaneous reactions (eg Erythema Multiforme, Stevens-Johnsone Syndrome Toxic Epidermal Necrolysis). Renal and urinary disorders. Rare: nephrotoxicity in various forms ie tubulointerstitial nephritis, nephrotic syndrome, renal failure and acute renal failure; unknown: glomerulonephritis. General disorders and administration site conditions. Common: fatigue, malaise, edema. Cardiac pathologies. Uncommon: heart failure. Vascular pathologies. Uncommon: hypertension. Diagnostic tests. Common: liver function test abnormal, prolonged bleeding time. Metabolism and nutrition disorders. Common: fluid retention. Clinical studies and epidemiological data suggest that the intake of some NSAIDs (especially at high doses and in case of long-term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING
The use of the product may adversely affect fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing fertility investigations, discontinuation of the drug should be considered. Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk has been considered to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases. If flurbiprofen is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently flurbiprofen is contraindicated during the third trimester of pregnancy. In the few studies available to date, NSAIDs can appear in breast milk in very low concentrations. If possible, NSAIDs should be avoided during breastfeeding.
INDICATIONS
Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.
INTERACTIONS
Attention should be paid in patients treated with any of the medicines listed below, as interactions have been reported in some patients. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID nephrotoxicity. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking Flurbiprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and on a periodic basis thereafter. Lithium salts: lithium removal decrease. Methotrexate: caution is advised in case of concomitant administration of flurbiprofen and methotrexate since NSAIDs can increase the levels of methotrexate and therefore its toxic effects). Anticoagulants, such as warfarin: increased anticoagulant effect. Anti-aggregating agents: increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Aspirin: As with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects. Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the degree of glomerular filtration and increase plasma levels of cardiac glycosides. Ciclosporine: increased risk of nephrotoxicity with NSAIDs. Corticosteroids: increased risk of gastrointestinal ulcer or haemorrhage with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects. Mifepristone: NSAIDs should not be taken for 8-12 days after administration of lifepristone as NSAIDs may reduce the effects of mifepristone. Quinolone Antibiotics: Results from animal studies suggest that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Tacrolimus: Possible increased risk of nephrotoxicity when co-administered with NSAIDs. Zidovudine: increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-infected haemophiliac patients concomitantly treated with Zidovudine and other NSAIDs. The interactions reported above have been reported in particular after the administration of formulations based on Flurbiprofen for systemic use. At the recommended doses of medicine, no interactions with other medicines or other types have been reported. However, inform your doctor if you are taking other medicines.
DOSAGE
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Mouthwash: The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water. Children: no data are available on the use of the drug in the pediatric population is therefore not recommended. Oral mucosal spray: the recommended dose is 2 sprays 3 times a day addressed directly to the affected part. Children: no data are available on the use of the drug in the pediatric population is therefore not recommended.
ACTIVE PRINCIPLES
Flurbiprofen.