Froben throat spray 0.25% - irritation and inflammation of the oropharyngeal cavity 15 ml

Product Description

Froben 0.25% Spray

Composition:

• FROBEN GOLA 0.25% Mouthwash 100 ml of solution contain:
-Active ingredient: flurbiprofen 0.25 g.
• FROBEN GOLA 0.25% Spray for oral mucosa 100 ml of solution contain:
-Active ingredient: flurbiprofen 0.25 g.

Excipients

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

Therapeutic indications

Symptomatic treatment of irritative–inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a result 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 a history of 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

Dosage

Undesirable effects may be minimized by using the lowest effective dose for the most effective dose. shortest possible duration of treatment as needed to control symptoms (see section 4.4).  ORAL MUCOSAL SPRAY The recommended dose is 2 sprays 3 times a day directed directly at the affected area.

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, ulceration 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 on the lowest available dose. Gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and may occur with or without warning symptoms or with a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in the course of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and the sections 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). If gastrointestinal bleeding or ulceration occurs in patients receiving Froben, the treatment should be discontinued.
Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are necessary for patients with a history of hypertension and/or mild to moderate congestive heart failure, since fluid retention and edema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs, particularly at high doses and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events, for example, myocardial infarction or stroke. There are insufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with flurbiprofen only after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g., hypertension, hyperlipidemia, 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. Patients appear to be at highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign 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 exercised when treating patients with severely reduced 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 should be monitored. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. The above-mentioned effects have been reported in particular after the administration of systemic formulations of Flurbiprofen. At the recommended doses, swallowing FROBEN GOLA does not cause any harm to the patient as these doses are much lower than those of the single dosage of the product for systemic administration. The use of FROBEN GOLA, especially if prolonged, may cause serious side effects. may cause sensitization or local irritation. In such cases, discontinue treatment and consult your doctor to initiate appropriate therapy, if necessary. Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor. Both the mouthwash and the oral mucosa spray contain parahydroxybenzoates, which may cause allergic reactions (even delayed). Both the mouthwash and the spray contain ethyl alcohol. For athletes, the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the blood 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 compromised renal function (e.g., dehydrated patients or elderly patients with compromised renal function), co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is 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 consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter. Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides. Anticoagulants, such as warfarin: increased anticoagulant effect. Aspirin: As with other NSAID-containing medicines, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased adverse effects. Antiplatelet agents: Increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding. Lithium salts: Decreased lithium elimination. Methotrexate: Caution is advised when administering flurbiprofen and methotrexate concomitantly, as NSAIDs may increase methotrexate levels. Cyclosporines: Increased risk of nephrotoxicity with NSAIDs. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding 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 convulsions associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Mifepristone: NSAIDs should not be taken for 8–12 days after mifepristone administration as NSAIDs may reduce the effects of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when coadministered with NSAIDs. Zidovudine: Increased risk of haematotoxicity when coadministered with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-infected haemophiliac patients receiving concomitant treatment with Zidovudine and other NSAIDs. The interactions reported above have been reported particularly after the administration of systemic formulations containing Flurbiprofen. At the recommended doses of FROBEN GOLA, no interactions with other medicinal products or other types of drugs have been reported. In any case, inform your doctor if you are taking other medications.

Side effects

The following side effects have been reported, particularly after the administration of systemic formulations: Blood and lymphatic system disorders Thrombocytopenia, aplastic anaemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction. Psychiatric disorders Depression Nervous system disorders Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue, and somnolence. Acoustic and labyrinth disorders Tinnitus Cardiovascular disorders Edema, hypertension, and cardiac failure Clinical studies and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in 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). Less frequently, gastritis, peptic ulcer, perforation, and ulcer haemorrhage have been observed. Local irritation may occur with suppositories. Pancreatitis has been reported very rarely. Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritus, urticaria, purpura, angioedema, and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme). In clinical trials with flurbiprofen patches, the most common adverse reactions were: Local skin reactions (including redness, rash, itching, eruptions, numbness, and tingling) were commonly reported, 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 suspected adverse reactions after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. 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/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage, 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 result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, flurbiprofen should not be administered unless clearly necessary. If flurbiprofen is used by a woman attempting to conceive or during the first and second trimesters 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 may expose the fetus to:
• Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension),
• Renal dysfunction, which may progress to renal failure with oligohydramnios, in the mother and the neonate, at the end of pregnancy.
• Possible prolongation of bleeding time, an antiplatelet effect that may 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 breastfeeding mothers.