Froben Throat 0.25% 15ml

Froben 0.25% Spray

Froben throat Mouthwash what good is it

It is a symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharyngeal cavity (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Composition:

FROBEN THROAT 0.25% Mouthwash 100 ml of solution contain: Active ingredient : flurbiprofen 0.25 g. • FROBEN THROAT 0.25% Spray for oral mucosa 100 ml of solution contain: Active ingredient : flurbiprofen 0.25 g. For the full list of excipients, see section 6.1.

Excipients

Purified water, alcohol, patent blue VE 131, glycerol, mint essence, methyl parahydroxybenzoate, 40-polyoxyethylenate hydrogenated castor oil, potassium bicarbonate, propyl para-hydroxybenzoate, sodium saccharinate, sorbitol.

Therapeutic 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.

Contraindications

Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs. Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. Flurbiprofen should not be taken by patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure. Third trimester of pregnancy

Posology or dosage

Mouthwash The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Warnings and Precautions

Gastrointestinal Effects Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases as these conditions may be exacerbated. 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. 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. 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. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks). Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Froben the treatment should be discontinued. Cardiovascular and cerebrovascular effects Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure since fluid retention and edema have been reported in association with NSAID treatment. 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 increased 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 (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking). Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Skin reactions 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 skin rash, mucosal lesions or any other signs of hypersensitivity. Other Reactions Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Particular caution should be adopted in the treatment of patients with severely reduced renal, cardiac or hepatic function, as the use of NSAIDs can lead to deterioration of renal function. In such patients the dosage should be kept as low as possible and renal function monitored. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. 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 FROBEN THROAT does not cause any harm to the patient as these doses are well below those of the single dosage of the product systemically. The use of FROBEN THROAT, especially if prolonged, can give rise to sensitization phenomena or local irritation; 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. After short periods of treatment without appreciable results, consult your doctor. Both the mouthwash and the oral mucosal spray contain para-hydroxybenzoates which can cause allergic reactions (including delayed ones). 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.

Interactions

Caution should be exercised 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. 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. Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the degree of glomerular filtration and increase plasma levels of cardiac glycosides. Anticoagulants, such as warfarin: increased anticoagulant effect. 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. Anti-aggregating agents: increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Lithium salts: lithium removal decrease. Methotrexate: Caution is advised in case of concomitant administration of flurbiprofen and methotrexate as NSAIDs may increase methotrexate levels. Ciclosporins: 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. 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. Mifepristone: NSAIDs should not be taken for 8-12 days after administration of mifepristone as NSAIDs may reduce the effects of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when co-administered with NSAIDs. Zidovudine: increased risk of haematic toxicity when co-administered 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 FROBEN THROAT no interactions with other medicinal products or other types have been reported. However, inform your doctor if you are taking other medications.

Side effects

The following undesirable effects have been reported, particularly after administration of formulations for systemic use: Blood and lymphatic system disorders Thrombocytopenia, aplastic anemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction. Psychiatric disorders Depression Nervous system disorders Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, dizziness, malaise, fatigue and somnolence. Acoustic and labyrinth disorders Tinnitus Cardiovascular disorders Edema, hypertension and heart failure Clinical studies and epidemiological data suggest that the intake of some NSAIDs (especially at high doses and in the case of long-term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Respiratory, thoracic and mediastinal disorders Respiratory tract reactivity (asthma, bronchospasm and dyspnoea) Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen (see Contraindications section). Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Local irritation can occur with suppositories. Cases of pancreatitis have been reported very rarely. Skin and subcutaneous tissue disorders Skin disorders including rash, pruritus, urticaria, purpura, angioedema and very rarely bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). During clinical trials with flurbiprofen patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, rash, numbness and tingling); however the incidence was low (4.6%). Renal and urinary tract disorders Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Fertility and pregnancy 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 absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors 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 can progress to renal failure with oligohydroamnios; the mother and the newborn, at the end of pregnancy, to: • Possible prolongation of the bleeding time, an antiplatelet effect which 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. Breastfeeding Flurbiprofen is excreted in breast milk; however the amount excreted is only a small fraction of the maternal dose. Administration of flurbiprofen is not recommended in nursing mothers.

Packaging

Froben Throat Mouthwash is sold in a 15ml bottle.