FROBEN GOLA COLLUT 160ML 0.25%

FROBEN GOLA

active ingredients

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

Excellent

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

Therapeutic indications

Froben Gola is indicated for the symptomatic treatment of irritative-inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis), also as a result of conservative or extractive dentaria therapy.

Contraindications

Hypersensitivity to flurbiprofen or any of the excipients listed in the paragraph 6.1. Froben Gola is also contraindicated in: • patients who have previously manifested hypersensitivity reactions (e.g. asthma, hives) after taking aspirin or other fans. • patients with history of gastrointestinal hemorrhage or perforation related to previous treatments with fans. • patients with active ulcerative colitis or anamnestic, crohn disease, recurrent peptic ulcer or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). • patients with severe heart, kidney or liver failure (see paragraph 4.4). Froben Gola is contraindicated during the third trimester of pregnancy.

Population

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 that this medicinal product be used for a maximum of three days. Dosage: • COLOURS The recommended dose is two or three rinses or gargles per day with 10 ml of collutory. Can be diluted in water • SPRAY FOR ORAL MUCUS The recommended dose is 2 sprays 3 times a day directly addressed to the affected part. Pediatric population There are no adequate data on the pediatric population; therefore the use of the medicinal product is not recommended.

Conservation

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

Warnings

General precautions 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 paragraph 4.2 and below paragraphs on gastrointestinal and cardiovascular risks). Use in elderly patients Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal. Gastrointestinal effects Flurbiprofen should be administered with caution to patients with peptic ulcer anamnesis and other gastrointestinal diseases as such conditions can be re-acutized. Gastrointestinal bleeding, ulcer or drilling have been reported with all NSAIDs at any time of treatment. These adverse events may be fatal and may occur with or without warning symptoms or in case of previous history of serious gastrointestinal events. The risk of gastrointestinal hemorrhage, ulcer or perforation is higher when the dosage of flurbiprofen increases in patients with a history of ulcer, especially if complicated by hemorrhage and perforation and in the elderly. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must 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 below paragraph and paragraph 4.5). Patients with anamnesi of gastrointestinal diseases, especially if elderly, must report any unusual symptom of abdominal type (especially gastrointestinal hemorrhage) in the early stages of treatment. When bleeding or gastrointestinal ulceration occurs in patients taking Froben Gola treatment must be suspended. Respiratory disorders Cases of bronchospasm with flurbiprofen have been reported in patients with bronchial asthma anamnesi. Heart, kidney and liver failure Particular caution should be taken in the treatment of patients with severely compromised kidney, heart or liver function, as the use of NSAIDs can determine the deterioration of kidney function. In such patients the dosage must be kept as low as possible and the kidney function must be monitored. The administration of an NSAID can cause a reduced dose of prostaglandine formation, accelerating kidney failure. Patients at the highest risk of developing this reaction are those with compromised kidney function, heart failure and liver dysfunction, those taking diuretics and older people. In these patients the kidney function must be monitored (see also paragraph 4.3). Flurbiprofen should be given with caution in patients with heart failure anamnesis or hypertension since edema cases have been reported in association with flurbiprofene administration. Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure as, in association with the administration of flurbiprofen and treatment with NSAIDs, fluid and edema were found. In these patients Froben Gola must be taken with caution. Clinical studies and epidemiological data suggest that the use of some NSAIDs especially at high doses and long-term treatments may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There is no sufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with flurbiprofen only after careful evaluation. Analogue considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular disease (p.es. hypertension, hyperlipidemia, diabetes mellitus, smoking). Skin reactions Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Flurbiprofen should be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Renal effects Caution should be used when starting treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Ematologic effects Flurbiprofen, like other NSAIDs, can inhibit piastrinic aggregation and prolong bleeding time. Lupus Eritematoso Sistemico (LES) and connective system diseases In patients with Lupus Eritematoso Sistemico (LES) and connective system disorders, an increase in the risk of aseptic meningitis (see paragraph 4.8) may occur. The above effects were reported in particular after the administration of Flurbiprofene formulations for systemic use. At recommended doses, the possible swallowing of FROBEN GOLA does not involve any harm to the patient as such doses are largely lower than those of the single posology of the product by systemic means. The use of FROBEN GOLA, especially if prolonged, can give rise to phenomena of local sensitization or irritation; in such cases it is necessary to stop the treatment and consult the doctor to establish, if necessary, suitable therapy. Flurbiprofen should not be used for prolonged treatment. It is necessary to inform patients to request medical advice if after short periods of treatment without appreciable results. Comprogation of fertility The use of flurbiprofen can affect female fertility and is not recommended in women seeking to undertake pregnancy. In women who have difficulty in conceiving or who are subject to infertility investigations, the suspension of treatment with flurbiprofen should be taken into account. Important information about some excipients FROBEN GOLA 250mg/100ml Colluation contains: • Sorbitol (E420). Patients with hereditary fructose intolerance should not be given this medicine. • Ethanol. This medicine contains 12 vol% ethanol (alcohol), e.g. up to 1 g per dose, equivalent to 24 ml of beer, 10 ml of wine per dose. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. For those who carry out sports activities, the use of drugs containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations. • Blue Coloring License V(E131) which can cause allergic reactions. FROBEN GOLA 250mg/100ml Oral Mucosa Spray contains: • Sorbitol. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. • 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 carry out sports activities, the use of drugs containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations. • Blue Coloring License V(E131) which can cause allergic reactions.

Interactions

Attention should be provided in patients treated with any of the medicines listed below, as interactions have been reported in some patients. Diuretics, ACE inhibitors and antagonists of angiotensin II: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of NSAID nephrotoxicity. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Flurbiprofen in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently on a periodic basis. Salts of Litio: decrease in lithium elimination. Methodology: caution is recommended in case of concomitant administration of flurbiprofen and metotrexate as NSAIDs can increase metotrexate levels and therefore its toxic effects). Antiagulants, like warfarin: increase of the anticoagulant effect. Aggregating agents: increased risk of gastrointestinal hemorrhage Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage. Aspirin: as with other medicines containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended due to the potential increase in unwanted effects. Heart glycosides: NSAIDs can exacerbate heart failure, reduce the degree of glomerular filtration and increase the plasma levels of cardiac glycosides. Ciclosporine: increased risk of nephrotoxicity with NSAIDs. Corticosteroids: increased risk of gastrointestinal ulcer or hemorrhage with NSAIDs. Cox-2 inhibitors and other FANS: concurrent use of other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided due to potential additive effects. Mifepristone: NSAIDs should not be taken for 8-12 days after mifepristone is administered as NSAIDs can reduce the effects of mifepristone. Antibiotics Chinoloni: animal studies suggest that NSAIDs can increase the risk of convulsions associated with the use of chinolone antibiotics. Patients taking NSAIDs and Chinoloni may have an increased risk of developing seizures. Tacrolimus: 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 increase in the risk of hematoma and hematoma in hemophiliac patients with HIV in contemporary treatment with Zidovudine and other NSAIDs. The above interactions were reported in particular after the administration of Flurbiprofene formulations for systemic use. Recommended doses of FROBEN GOLA has not been reported interactions with other medicines or other types. In any case, please inform your doctor if you take other medications.

Effects

The following adverse reactions, reported in particular after the administration of formulations for systemic use, are reported according to the MedDRA classification. Frequency groupings are classified according to the following convention: very common (≥ 1/10), Common (≥1/100 to Classification for systems and organs according to MedDRA Frequency Reaction Emolinfopoietic system pathologies Not common Anemia Very rare Leucopenia, agranulocytosis, aplastic anemia, neutropenia, thrombocytopenia, hemolytic anemia. Immune system disorders Not common Hypersensitivity Rare Anaphylactic reaction Psychiatric disorders Rare Depression, confusion Very rare Hallucination Nervous System pathologies Town Migraine, dizziness Not common Opinion Rare Sleep, Insomnia Not known Optical neurosis, cerebrovascular accidents, headaches. Pathologies of the eye Not common View disturbances Ear and labyrinth pathologies Not common Tinnitus, vertigo Respiratory, chest and mediastinic pathologies Not common Asthma, dispnea Rare Broncospasmo Gastrointestinal diseases Town Dispepsia, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, melena, ematemesis, gastrointestinal hemorrhage Not common Gastrites, duodenal ulcer, gastric ulcer, mouth ulcer, gastrointestinal perforation Very rare Pancreatis Not known Crohn's Colite and Morbo Hepatobiliary diseases Very rare Ittero, ittero colestatico, abnormal liver function Not known Hepatitis Pathologies of skin and subcutaneous tissue Not common Rash, hive, itching, purple, angioedema, photosensitivity reactions Very rare Strict forms of boiling skin reactions (e.g.Eritema Multiforms, Stevens-Johnson Syndrome and Toxic Necrolysis Epidermal) Kidney and urinary pathologies Rare Nephrotoxicity in various forms i.e. interstitial nephritis, nephrotic syndrome, kidney failure and acute kidney failure. (see paragraph 4.4) Not known Glomerulonefried Systemic pathologies and conditions for administration Town Fatigue, malaise, edema Heart disease Not common Heart failure Vascular diseases Not common Hypertension Diagnostic examinations Town Abnormal liver function test, prolonged bleeding time Disorders of metabolism and nutrition Town Fluid detection Immune system disorders Following treatment with NSAIDs, hypersensitivity reactions were reported. These consist of: a) non-specific allergic reactions and anaphylaxis; b) reactions to the respiratory tract including asthma, also severe, bronchospasm or dispnea, or c) different skin disorders, such as rashes of various types, itching, hives, porporous, angioedema and, very rarely, exfoliative and bollose dermatitis (including Epidermal and multiform erythema necrolysis). Heart and vascular disease Cases of edema, hypertension and heart failure were reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that taking some NSAIDs (especially if high doses and long-term treatment) may be associated with increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4).Nervous System pathologies Aseptic meningitis (especially in patients with existing autoimmune disorders such as Lupus Eritematoso Sistemico and connective tissue disorders) with symptoms such as rigid neck, headache, nausea, vomiting, fever or disorientation (see paragraph 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Synonyms Overdose symptoms may include nausea, vomiting and gastrointestinal irritation. Treatment The treatment must include gastric lavender and, if necessary, correction of the sierial electrolytic framework. There is no specific antidote for flurbiprofen.

Fertility The use of FROBEN GOLA may adversely affect fertility and is not recommended in women who are trying to conceive. In women who have difficulty in conceiving or who are undergoing fertility surveys, it must be taken into account the interruption of intake FROBEN GOLA. Pregnancy The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, flurbiprofen should not be administered if not in strictly necessary cases. If flurbiprofen is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must 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 arterial duct and pulmonary hypertension); • kidney dysfunction, which can progress in kidney failure with oligo-idroamnios. The mother and the newborn, at the end of pregnancy, to: • Possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses; • Inhibition of uterine contractions resulting in delay or extension of labor. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy (see paragraph 4.3). Food In the few studies until now available, NSAIDs can appear in breast milk in very low concentrations. If possible, NSAIDs must be avoided during breastfeeding. See paragraph 4.4 Special warnings and precautions, as regards fertility in women.

Source: Farmadati