FROBEN THROAT * NEBUL 15ML 0.25%

FROBEN THROAT * NEBUL 15ML 0.25%

Therapeutic indications

Froben Gola is indicated for the 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.

Dosage and method of use

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). It is recommended to use this medicine for up to three days.Dosage:•MOUTHWASHThe recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water •SPRAY FOR ORAL MUCOSAThe recommended dose is 2 sprays 3 times a day addressed directly to the affected area.Pediatric populationThere are no adequate data on the pediatric population; therefore the use of the medicine is not recommended.

Contraindications

Hypersensitivity to flurbiprofen or to any of the excipients listed in section 6.1. Froben Throat is also contraindicated in: • patients who have previously experienced hypersensitivity reactions (eg asthma, hives) after taking aspirin or other NSAIDs. • patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatments. • 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). • patients with severe cardiac, renal or hepatic insufficiency (see section 4.4). Froben Gola is contraindicated during the third trimester of pregnancy.

Side effects

The following adverse reactions, particularly reported following 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

Disorders of the immune system

Hypersensitivity reactions have been reported following treatment with NSAIDs. These consist of: a) non-specific allergic reactions and anaphylaxis; b) respiratory tract reactions including asthma, even severe, bronchospasm or dyspnoea, or c) various skin disorders, such as various skin rashes, pruritus, urticaria, purpura, angioedema and, very rarely, exfoliative and bullous dermatitis (including necrolysis Toxic Epidermal and erythema multiforme).Cardiac and vascular disordersCases of edema, hypertension and heart failure have been reported in association with NSAID treatment. 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 (e.g. myocardial infarction or stroke) ( see section 4.4).Nervous System PathologiesAseptic meningitis (especially in patients with existing autoimmune disorders such as systemic lupus erythematosus and connective tissue disorders) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).Reporting of suspected adverse reactionsReporting 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/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

General precautionsUndesirable effects can be minimized by using 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).Use in elderly patientsElderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. 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. 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. The 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 (see section below and section 4.5). Patients with a history of gastrointestinal disease, particularly 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 Froben Throat the treatment should be discontinued. Respiratory Disorders Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. Cardiac, renal and hepatic impairment Particular caution should be taken in the treatment of patients with severely impaired renal, cardiac or hepatic function, as the use of NSAIDs may lead to 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 the highest risk of developing this reaction are those with impaired kidney function, heart failure and liver dysfunction, those taking diuretics, and older people. Renal function should be monitored in these patients (see also section 4.3). Flurbiprofen should be administered with caution in patients with a history of heart failure or hypertension as cases of edema have been reported in association with administration of flurbiprofen. 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 as fluid retention and edema have been reported in association with flurbiprofen administration and NSAID treatment. Froben Gola should be used with caution in these patients. 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). 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. Renal Effects Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Hematological effects Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Systemic Lupus Erythematosus (SLE) and diseases of the connective system An increased risk of aseptic meningitis may occur in patients with Systemic Lupus Erythematosus (SLE) and connective system disorders (see section 4.8). 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 involve 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. Flurbiprofen should not be used for prolonged treatments. Patients should be advised to seek medical advice if after short periods of treatment without appreciable results.Impaired fertilityThe use of flurbiprofen can impair female fertility and is not recommended in women trying to become pregnant. In women who have difficulty conceiving or who are undergoing infertility investigations, discontinuation of flurbiprofen treatment should be considered. Important information about some of the ingredients FROBEN THROAT 250mg / 100ml Mouthwashcontains: •Sorbitol (E420). Patients with hereditary fructose intolerance should not be given this medicine. •Ethanol. This medicine contains 12 vol% ethanol (alcohol), eg. up to 1 g per serving, equivalent to 24 ml of beer, 10 ml of wine per serving. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. For those who carry out sporting 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. •Patent V blue dye (E131)which can cause allergic reactions.FROBEN THROAT 250mg / 100ml Oral mucosal spraycontains: •Sorbitol. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products to the daily dietary intake of sorbitol (or fructose) should be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. •Ethanol. This medicine contains 12 vol% ethanol (alcohol), eg. up to 40 mg per serving, equivalent to 1 ml of beer, 0.4 ml of wine per serving. For those who carry out sporting 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. •Patent V blue dye (E131)which can cause allergic reactions.

Pregnancy and breastfeeding

FertilityThe use of FROBEN THROAT may adversely affect fertility and is not recommended in women who are trying to conceive. In women who have difficulty conceiving or who are undergoing fertility investigations, discontinuation of FROBEN THROAT should be considered.PregnancyInhibition of prostaglandin synthesis can 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 considered 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. In addition, 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 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 (see section 4.3). Feeding timeIn the few studies available to date, NSAIDs can appear in breast milk in very low concentrations. If possible, NSAIDs should be avoided during breastfeeding. See paragraph4.4 Special warnings and precautions for use, regarding fertility in women.

Expiration and retention

Mouthwash: This medicine should not be stored above 25C. Oromucosal spray: This medicine should not be stored above 25C; keep the bottle in the outer carton to protect from light.

Interactions with other drugs

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:decrease of removal of lithium.Methotrexate:caution is advised in case of concomitant administration of flurbiprofen and methotrexate as 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 bleedingSelective 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 glomerular filtration rate and increase plasma levels of cardiac glycosides.Cyclosporins: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 mifepristone administration as NSAIDs may reduce the effects of mifepristone.Quinolone Antibiotics:Results of 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 haematic toxicity in case of co-administration with NSAIDs. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-infected haemophilia 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.

Overdose

SymptomsSymptoms of overdose may include nausea, vomiting and gastrointestinal irritation.TreatmentTreatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.

Active principles

•FROBEN THROAT 250mg / 100ml Mouthwash100 ml of solution contain:Active principle: Flurbiprofen 0.25 gExcipients with known effect: Ethanol, patent blue V (E131). •FROBEN THROAT 250mg / 100ml Oral mucosal spray100 ml of solution contain:Active principle: Flurbiprofen 0.25 gExcipients with known effect: Ethanol, patent blue V (E131). For the full list of excipients, see section 6.1

Excipients

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