Froben Throat Oral Mucosa Spray 15 ml Flurbiprofen 0.25%

Froben Gola Spray is an over-the-counter drug based on Flurbiprofen indicated for the symptomatic treatment of irritative-inflammatory states associated with pain in the oropharynx.

Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain, redness, heat and swelling in the presence of inflammatory processes. For this Froben Gola Spray is used to reduce burning, redness, pain and inflammation of the mouth and throat , due to gingivitis, stomatitis, pharyngitis and as a consequence of conservative or extractive dental therapy .

Posology and method of use of Froben Throat Spray Oral Mucosa 15 ml Flurbiprofen 0.25%

How to take Froben Gola Oral Mucosa Spray 15 ml?

The recommended dose of Froben Gola Spray is 2 sprays 3 times a day directed directly to the affected part.

There are no adequate data on the pediatric population, therefore the use of the medicinal product is not recommended .

It is recommended to use Froben Gola Spray for up to three days.

Active Ingredients and Excipients Froben Throat Oral Mucosa Spray 15 ml Flurbiprofen 0.25%

Froben Throat Oral Mucosa Spray contains in 100ml of product:

Active ingredient : Flurbiprofen 0.25 g

Excipients: Purified water, alcohol, patent blue VE 131, glycerol, peppermint essence, 40-polyoxyethylene hydrogenated castor oil, potassium bicarbonate, sodium saccharinate, sorbitol.

Contraindications Froben Throat Spray Oral Mucosa 15 ml Flurbiprofen 0.25%

Froben Throat Oral Mucosa Spray 15 ml Flurbiprofen 0.25% is contraindicated in case of:

• Hypersensitivity to flurbiprofen or to any of the excipients. Froben Gola is also contraindicated in:
• Patients who have previously experienced hypersensitivity reactions (e.g. asthma, urticaria) after taking aspirin or other NSAIDs.
• Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatments.
• Patients with active or history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer disease, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding).
• Patients with severe cardiac, renal or hepatic insufficiency.
• During the third trimester of pregnancy.

Warnings Froben Throat Oral Mucosa Spray 15 ml Flurbiprofen 0.25%

The undesirable effects of Froben Gola Oral Mucosa Spray can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Use in elderly patients Elderly 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, ulceration or perforation has 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 GI bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with bleeding and perforation, and in the elderly. These patients should start treatment on 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 Froben Gola the treatment should be discontinued. Respiratory Disorders There have been reports of bronchospasm with flurbiprofen in patients with a history of bronchial asthma. Cardiac, renal and hepatic impairment Particular caution should be exercised in the treatment of patients with severely impaired renal, cardiac or hepatic function, since 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 can 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 liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Flurbiprofen should be administered with caution to patients with a history of cardiac failure or hypertension as cases of edema have been reported in association with flurbiprofen administration. Cardiovascular and cerebrovascular effects Appropriate monitoring and appropriate instructions are required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention has been reported in association with the administration of flurbiprofen and treatment with NSAIDs. and edema. 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 in long-term treatments, may be associated with a small increased risk of arterial thrombotic events such as 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 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 (e.g. 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 sign of hypersensitivity. Renal Effects Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Haematological effects Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Systemic lupus erythematosus (SLE) and connective system disorders Patients with systemic lupus erythematosus (SLE) and connective system disorders may experience an increased risk of aseptic meningitis. The above effects have been reported in particular after the administration of formulations based on Flurbiprofen for systemic use. At the recommended doses, any swallowing of Froben Gola Mucosa Oral Spray does not cause any harm to the patient as these doses are far lower than those of the single dosage of the product by systemic route. The use of Froben Gola Oral Mucosa Spray, 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 institute, if necessary, a suitable therapy. Flurbiprofen should not be used for prolonged treatments. It is necessary to inform patients to seek medical advice if after short periods of treatment without appreciable results. Impaired fertility The use of flurbiprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, discontinuation of flurbiprofen treatment should be considered.

Froben Throat Mucosa Oral Spray contains: sorbitol. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products on the daily dietary intake of sorbitol (or fructose) should be considered. The sorbitol content in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Ethanol. This medicinal product contains 12 vol% ethanol (alcohol), e.g. up to 40 mg per dose, equivalent to 1 ml of beer, 0.4 ml of wine per dose. For those who carry out sporting activities, the use of medicines containing ethyl alcohol can lead to positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations. patent blue dye V(E131) which may cause allergic reactions.

Side effects Froben Throat Oral Mucosa Spray 15 ml Flurbiprofen 0.25%

The following adverse reactions, reported in particular after the administration of formulations for systemic use:

• Blood and lymphatic system disorders: Uncommon Anaemia. Very rare Leucopenia, agranulocytosis, aplastic anaemia, neutropenia, thrombocytopenia, haemolytic anaemia.
• Immune system disorders: Uncommon Hypersensitivity. Rare Anaphylactic reaction
• Psychiatric disorders Rare Depression, Confusional state. Very rare Hallucination
• Nervous system disorders: Common Migraine, dizziness. Uncommon Paraesthesia. Rare Somnolence, Insomnia. Not known Optic neuritis, cerebrovascular accident, headache.
• Eye disorders Uncommon Visual disturbances
• Ear and labyrinth disorders Uncommon Tinnitus, vertigo
• Respiratory, thoracic and mediastinal disorders Uncommon Asthma, dyspnoea. Rare Bronchospasm
• Gastrointestinal disorders Common Dyspepsia, diarrhoea, 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, hepatic function abnormal. Not known Hepatitis
• Skin and subcutaneous tissue disorders Uncommon Rash, urticaria, pruritus, purpura, angioedema, photosensitivity reaction. Very rare Severe forms of bullous skin reactions (eg Erythema Multiforme, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis)
• Renal and urinary disorders Rare Nephrotoxicity in various forms ie interstitial nephritis, nephrotic syndrome, renal failure and acute renal failure. Not known Glomerulonephritis
• General disorders and administration site conditions Common Fatigue, malaise, oedema
• Cardiac disorders Uncommon Cardiac failure
• Vascular disorders Uncommon Hypertension
• Investigations Common Liver function test abnormal, bleeding time prolonged
• Metabolism and nutrition disorders Common Fluid retention
• Immune system disorders

Hypersensitivity reactions have been reported following treatment with NSAIDs such as Froben Throat Mucosa Oral Spray 15 ml Flurbiprofen 0.25%. These consist of:

• Nonspecific allergic reactions and anaphylaxis.
• Respiratory tract reactions including asthma, including severe, bronchospasm or dyspnoea.
• Various skin disorders, such as rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely, exfoliative and bullous dermatitis (including toxic epidermal necrolysis and erythema multiforme).

Cardiac and vascular disorders Cases of oedema, 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 if 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). Nervous system disorders Aseptic 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. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Interactions with other drugs
Caution should be exercised in patients receiving any of the medicinal products listed below, as interactions have been reported in some patients. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can 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 an angiotensin II antagonist and agents that inhibit 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 in elimination of lithium. Methotrexate: Caution is advised in case of concomitant administration of flurbiprofen and methotrexate since NSAIDs can increase methotrexate levels 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 medicines, the 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 glomerular filtration rate and increase plasma levels of cardiac glycosides. Cyclosporine: 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. Mifepristone: NSAIDs should not be taken for 8-12 days after mifepristone administration as NSAIDs can 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 in case of co-administration 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 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 Gola Mucosa Oral Spray, no interactions with other medicines or other kinds have been reported. However, inform your doctor if you are taking other medicines.

Overdose Froben Throat Oral Mucosa Spray 15 ml
Symptoms Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation. Treatment Treatment should include gastric lavage and, if necessary, correction of serum electrolytes. There is no specific antidote for flurbiprofen.

Pregnancy and lactation Froben Throat Oral Mucosa Spray 15 ml Flurbiprofen 0.25%

Can I take Froben Gola Mucosa Oral Spray 15 ml when pregnant or breastfeeding?

Fertility The use of Froben Gola Oral Mucosa Spray may adversely affect fertility and is not recommended in women attempting to conceive. In women who are having difficulty conceiving or who are undergoing fertility investigations, discontinuation of Froben Gola Spray Oral Mucosa should be considered. Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought 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-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have 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 unless strictly necessary. 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 may expose the fetus to: • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • Renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: • Possible prolongation of bleeding time, an antiplatelet effect which can occur even at very low doses; • Inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy. Breastfeeding In the few studies available up to now, NSAIDs can appear in breast milk in very low concentrations. If possible, NSAIDs should be avoided during breastfeeding. Special warnings and precautions for use, with regards to fertility in women

Expiration and conservation of Froben Throat Spray Oral Mucosa 15 ml Flurbiprofen 0.25%

How to store Froben Throat Oral Mucosa Spray 15 ml?

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