Froben Throat 0.25% Flurbiprofen Mouthwash 160ml

Froben Throat 0.25% Flurbiprofen Mouthwash

Froben Gola what it is for

Composition by Froben Gola

Excipients contained in Froben Gola

Contraindications for Froben Gola

Dosage of Froben Gola

Warnings and precautions for Froben Gola

Interactions

Side effects of Froben Gola

Froben Throat in Pregnancy and Lactation

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Froben Gola what it is for

FROBEN is an anti-inflammatory drug belonging to the class of NSAIDs which exerts a marked anti-inflammatory, analgesic and antipyretic action. Due to its high antiprostaglandin activity, FROBEN is used in all those morbid conditions in which the inflammatory component is a predominant characteristic and electively in: phlebology, gynecology, pulmonology, rheumatology, traumatology, orthopedics, etc. FROBEN 0.25% Mouthwash and FROBEN 0.25% Solution to be nebulized are used in the symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative dental therapy or extractive.

Composition by Froben Gola

FROBEN 0.25% Mouthwash 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g

Excipients contained in Froben Gola

FROBEN 0.25% Mouthwash and FROBEN 0.25% Solution to nebulize Purified water, alcohol, patent blue VE 131, glycerol, mint essence, methyl para-hydroxybenzoate, hydrogenated castor oil 40-polyoxyethylenate, potassium bicarbonate, propyl para-hydroxybenzoate , sodium saccharinate, sorbitol

Contraindications for Froben Gola

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 haemorrhage (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 of Froben Gola

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). ORAL PHARMACEUTICAL FORMS: Adults The recommended dose is 150 to 200 mg per day in two, three or four divided doses or in one administration for prolonged-release capsules. In patients with severe symptoms or with recent illness or during exacerbations, the total daily dose can be increased up to 300 mg in divided doses. The prolonged-release capsules should be swallowed whole with some water, preferably in the evening after eating. In case of dysmenorrhea, a dosage of 100 mg at the onset of symptoms can be taken followed by 50 or 100 mg every 4-6 hours. The maximum total dose should not exceed 300 mg. Elderly The elderly are at increased risk of serious consequences from adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be taken with caution and the dosage should be determined individually. If the intake of an NSAID is considered necessary, the lowest dose should be taken and patients closely monitored. Mouthwash The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water. SOLUTION TO NEBULIZE The recommended dose is 2 sprays 3 times a day addressed directly to the affected area.

Warnings and precautions for Froben Gola

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 as 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. At the recommended doses, the possible swallowing of FROBEN 0.25% Mouthwash and FROBEN 0.25% Solution to be nebulised does not cause any harm to the patient as these doses are much lower than those of the single systemic dosage of the product. The use of FROBEN 0.25% Mouthwash and FROBEN 0.25% Solution to be nebulized, 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. After short periods of treatment without appreciable results, consult your doctor. Important information about some of the ingredients The tablets contain lactose and sucrose therefore patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. The syrup contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. The syrup, mouthwash and nebuliser solution contain para-hydroxybenzoates which can cause allergic reactions (including delayed ones).

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. 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. FROBEN 0.25% MOUTHWASH AND 0.25% SOLUTION TO NEBULIZE At the recommended doses, no interactions with other medicines or other types have been reported. However, inform your doctor if you are taking other medications.

Undesirable effects of Froben Gola

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 case of long-term treatment) may be associated with an increased risk arterial thrombotic events (e.g. 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.

Froben Throat in Pregnancy and Lactation

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 considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased 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 oligo-hydroamnios; 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.

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Froben Throat Flurbiprofen Mouthwash is sold in a 160ml bottle.

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