Froben Throat 0.25% mouthwash 160ml

Froben Gola 0.25% mouthwash 160ml is an effective treatment to relieve the symptoms of irritation-inflammatory conditions of the oropharyngeal cavity, such as gingivitis , stomatitis and pharyngitis . This mouthwash contains the active ingredient Flurbiprofen , known for its anti-inflammatory and analgesic properties. The formulation is designed to offer rapid and targeted relief, also ideal following conservative or extractive dental therapies. Froben Gola is available in a practical 160ml format, perfect for daily use. Its composition includes excipients such as ethanol and patent blue V (E131) , which contribute to the effectiveness of the product. Using Froben Gola, you can effectively manage pain and inflammation of the throat, ensuring long-lasting comfort.

ACTIVE INGREDIENTS

Active ingredients contained in Froben Gola 0.25% mouthwash 160ml - What is the active ingredient in Froben Gola 0.25% mouthwash 160ml?

• FROBEN GOLA 250mg/100ml Mouthwash 100 ml of solution contain: Active ingredient : Flurbiprofen 0.25 g Excipients with known effect : Ethanol, patent blue V(E131). • FROBEN GOLA 250mg/100ml Oral mucosa spray 100 ml of solution contain: Active ingredient : Flurbiprofen 0.25 g Excipients with known effect : Ethanol, patent blue V(E131). For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Froben Gola 0.25% mouthwash 160ml - What does Froben Gola 0.25% mouthwash 160ml contain?

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

DIRECTIONS

Therapeutic indications Froben Gola 0.25% mouthwash 160ml - Why is Froben Gola 0.25% mouthwash 160ml used? What is it for?

Froben Gola is indicated for the symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Froben Gola 0.25% mouthwash 160ml - When should Froben Gola 0.25% mouthwash 160ml not be used?

Hypersensitivity to flurbiprofen or to any of the excipients listed in section 6.1. Froben Gola is also contraindicated in: • patients who have previously shown 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 treatment. • patients with active or 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). • patients with severe cardiac, renal or hepatic insufficiency (see section 4.4). Froben Gola is contraindicated during the third trimester of pregnancy.

DOSAGE

Quantity and method of taking Froben Gola 0.25% mouthwash 160ml - How to take Froben Gola 0.25% mouthwash 160ml?

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). It is recommended to use this medicine for a maximum of three days. Dosage: • MOUTHWASH The recommended dose is two or three rinses or gargles per day with 10 ml of mouthwash. It can be diluted in water • ORAL MUCOSA SPRAY The recommended dose is 2 sprays 3 times a day directed directly at the affected area. Paediatric population There are no adequate data available in the paediatric population; therefore, the use of the medicine is not recommended.

CONSERVATION

Storage Froben Gola 0.25% mouthwash 160ml - How to store Froben Gola 0.25% mouthwash 160ml?

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

WARNINGS

Warnings Froben Gola 0.25% mouthwash 160ml - About Froben Gola 0.25% mouthwash 160ml it is important to know that:

General precautions Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and gastrointestinal and cardiovascular risks below). Use in elderly patients Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Gastrointestinal effects Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal disease as these conditions may be exacerbated. 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. 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 or perforation, and in the elderly. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs likely to increase gastrointestinal risk (see section below and section 4.5). Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. When gastrointestinal bleeding or ulceration occurs in patients receiving Froben Gola, the treatment should be withdrawn. 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 exercised when treating patients with severely impaired renal, cardiac or hepatic function, as the use of NSAIDs may result in deterioration of renal function. In such patients, dosage should be kept as low as possible and renal function should be monitored. Administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation, precipitating renal failure. Patients at highest risk of developing this reaction are those with impaired renal function, cardiac insufficiency and hepatic dysfunction, those taking diuretics and the elderly. 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 cardiac insufficiency or hypertension since cases of oedema have been reported in association with flurbiprofen administration. Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure since fluid retention and oedema have been reported in association with flurbiprofen administration and NSAID treatment. Froben Gola should be used with caution in these patients. 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, 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 ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar consideration 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. Patients appear to be at highest risk early in the course of therapy: 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. Renal effects Caution should be exercised when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Haematological effects Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Systemic Lupus Erythematosus (SLE) and connective tissue disorders In patients with Systemic Lupus Erythematosus (SLE) and connective tissue disorders, an increased risk of aseptic meningitis may occur (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, any swallowing of 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 use. The use of FROBEN GOLA, especially if prolonged, may give rise to phenomena of sensitization or local irritation; in such cases, treatment should be stopped and a doctor should be consulted to establish, if necessary, appropriate therapy. Flurbiprofen should not be used for prolonged treatments. Patients should be informed to seek medical advice if after short periods of treatment without appreciable results. Impairment of 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, withdrawal of flurbiprofen treatment should be considered. Important information about some of the excipients FROBEN GOLA 250mg/100ml Mouthwash contains: • Sorbitol (E420) . Patients with hereditary fructose intolerance should not be given this medicine. • Ethanol . This medicine contains 12 vol% ethanol (alcohol), i.e. up to 1 g per dose, equivalent to 24 ml of beer, 10 ml of wine per dose. May be harmful for alcoholics. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as people with liver disease or epilepsy. For those who play sports, the use of medicines containing ethyl alcohol may cause positive results in anti-doping tests in relation to the limits of alcohol concentration indicated by some sports federations. • Patent blue V (E131) colouring which may cause allergic reactions. FROBEN GOLA 250mg/100ml Spray for oral mucosa contains: • Sorbitol . The additive effect of co-administration of medicines containing sorbitol (or fructose) with the daily intake of sorbitol (or fructose) with the diet must be considered. The sorbitol content in medicines for oral use may modify the bioavailability of other co-administered medicines for oral use. • Ethanol . This medicine 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 practice sports, the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the limits of alcohol concentration indicated by some sports federations. • Patent blue V (E131) dye which may cause allergic reactions.

INTERACTIONS

Interactions Froben Gola 0.25% mouthwash 160ml - Which medicines or foods can modify the effect of Froben Gola 0.25% mouthwash 160ml?

Caution should be exercised in patients treated with any of the following medicinal products, 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 nephrotoxicity of NSAIDs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase 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. Lithium salts: decreased lithium elimination. Methotrexate: caution is advised when co-administering flurbiprofen and methotrexate as NSAIDs may increase methotrexate levels and thus its toxic effects). Anticoagulants, such as warfarin: increased anticoagulant effect. Anti-platelet agents: increased risk of gastrointestinal bleeding. Selective 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 adverse effects. Cardiac glycosides : NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Ciclosporins: increased risk of nephrotoxicity with NSAIDs. Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage with NSAIDs. Cox-2 inhibitors and other NSAIDs: concomitant use of other NSAIDs, including cyclooxygenase-2 selective 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 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. Tacrolimus : possible increased risk of nephrotoxicity in case of co-administration with NSAIDs. Zidovudine : increased risk of haematotoxicity in case of co-administration with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematoma in haemophiliac patients affected by HIV in concomitant treatment 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 no interactions with other medicinal products or other types have been reported. In any case, inform your doctor in case of taking other medicines.

SIDE EFFECTS

Like all medicines, Froben Gola 0.25% mouthwash 160ml can cause side effects - What are the side effects of Froben Gola 0.25% mouthwash 160ml?

The following adverse reactions, reported in particular after 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 <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥ 1/10,000 to <1/1000), Very rare (<1/10,000) and Not Known (frequency cannot be estimated).

Immune system disorders 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, including severe asthma, bronchospasm or dyspnoea, or c) 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 cardiac failure have been reported in association with treatment with NSAIDs. Clinical trial and epidemiological data suggest that the intake of some NSAIDs (particularly 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) (see section 4.4). 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 (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. 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/content/come-segnalare-una-sospetta-reazione-avversa.

OVERDOSE

Overdose Froben Gola 0.25% mouthwash 160ml - What are the risks of Froben Gola 0.25% mouthwash 160ml in case of overdose?

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 BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Froben Gola 0.25% mouthwash 160ml.

Fertility The use of FROBEN GOLA may adversely affect fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of fertility, discontinuation of FROBEN GOLA 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 use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformation increased from less than 1%, up 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-foetal 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 given unless clearly 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 may progress to renal failure with oligo-hydroamniosis. The mother and the neonate, at the end of pregnancy, to: • Possible prolongation of bleeding time, an anti-aggregating effect which 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 (see section 4.3). Breast-feeding In the few studies available to date, NSAIDs may appear in breast milk in very low concentrations. If possible, NSAIDs should be avoided during breast-feeding. See section 4.4 Special warnings and precautions for use , regarding fertility in women.

DRIVING AND USE OF MACHINERY

Taking Froben Gola 0.25% mouthwash 160ml before driving or using machines - Does Froben Gola 0.25% mouthwash 160ml affect driving or using machines?

Side effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If these effects occur, patients should not drive or operate machinery.