Flurbiprofen Teva oral spray 15ml 043509025

FLURBIPROFENE TE * OS SPRAY 15ML

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Dosage and method of use

DosageUndesirable 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).MouthwashThe recommended dose is 2 or 3 rinses or gargles per day with 10 ml of mouthwash (1 scoop). The mouthwash can be used pure or diluted in water.Method of administrationFor oropharyngeal use. Rinse or keep in mouth while gargling for up to 1 minute. Do not swallow.Oral mucosal sprayThe recommended dose is 2 sprays, 3 times a day addressed directly to the affected area. Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.Method of administrationFor oropharyngeal use. Point the nozzle towards the back of the throat and spray on the affected area.Special populations Pediatric populationChildren over 12 years old: Same as for adults. Children under 12 years of age: Do not administer to children under 12 years of age (see section 4.3).Elderly peopleClinical data currently available are limited, therefore no recommendation on a posology can be made. Elderly people have an increased risk of serious consequences in case of adverse reactions (see section 4.4).Patients with hepatic insufficiency: No dose reduction is required in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3).Patients with renal insufficiency: No dose reduction is required in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe renal insufficiency (see section 4.3).

Contraindications

• Hypersensitivity to the active substance flurbiprofen or to any of the excipients listed in section 6.1. • In patients with known hypersensitivity (eg asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm or other allergic manifestations) to ibuprofen, aspirin or other NSAIDs. • In patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. • In patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). • In patients with severe heart failure, severe hepatic insufficiency and renal insufficiency (see section 4.4) • Third trimester of pregnancy (see section 4.6). Do not use the medicine in children under 12 years of age.

Side effects

Hypersensitivity reactions to NSAIDs have been reported and these may consist of: (a) non-specific allergic reactions and anaphylaxis. (b) respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea. (c) various skin disorders, including for example skin rashes of different types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme). The most commonly observed adverse reactions are gastrointestinal in nature. Local use of the drug, especially if prolonged, can give rise to sensitization or local irritation. The following undesirable effects have been reported, particularly after administration of formulations for systemic use. They refer to those detected with the use of flurbiprofen used in the short term and at doses compatible with the classification of self-medication. Additional undesirable effects may occur when treating chronic conditions and for long periods of time. Undesirable effects associated with the use of flurbiprofen are categorized below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1 / 100, Blood and lymphatic system disorders.Not known: thrombocytopenia, anemia, aplastic anemia and agranulocytosis.Disorders of the immune system. Rare: anaphylactic reaction.Not known: angioedema, hypersensitivity.Psychiatric disorders. Uncommon: insomnia.Not known: depression, hallucination.Nervous system disorders. Common: dizziness, headache, paraesthesia.Uncommon: sleepiness.Not known: cerebrovascular accident, optic neuritis, migraine, confusional state, vertigo.Eye disorders. Not known: visual disturbances.Ear and labyrinth disorders. Not known: tinnitus.Cardiac pathologies. Not known: edema, heart failure.Vascular pathologies. Not known: hypertension. Clinical studies and epidemiological data suggest that the intake of some NSAIDs (especially at high doses and in the case of long-term treatment) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) ( see section 4.4).Respiratory, thoracic and mediastinal disordersthat.Common: throat irritation.Uncommon: reactivity of the respiratory tract (asthma, bronchospasm and dyspnoea), blisters in the oropharynx, oropharyngeal hypoesthesia.Gastrointestinal disorders.The most commonly observed adverse events are gastrointestinal in nature.Common: nausea, diarrhea, aphthous ulcer, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling of the mouth).Uncommon: abdominal distension, vomiting, flatulence, constipation, dry mouth, dyspepsia, abdominal pain, glossodynia, dysgeusia, oral dysesthesia.Not known: melaena, haematemesis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease (see section 4.3), gastritis, peptic ulcer, ulcer perforation and haemorrhage, pancreatitis.Hepatobiliary disorders. Not known:hepatitis.Renal and urinary disorders. Not known: nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure (see section 4.4).Skin and subcutaneous tissue disorders. Uncommon: skin disorders including rash, itching.Not known: urticaria, purpura, angioedema bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). During clinical trials with flurbiprofen patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, rash, numbness and tingling); however the incidence was low (4.6%).General disorders and administration site conditions. Uncommon: pyrexia, pain.Not known: discomfort, fatigue, malaiseReporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

At the recommended doses, the possible swallowing of Flurbiprofen Teva 0.25% mouthwash and Flurbiprofen Teva 0.25% spray for oral mucosa does not cause any harm to the patient as these doses are much lower than those of the single dosage of the product by route. systemic. During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases (see section 4.6). Administration of flurbiprofen is not recommended in nursing mothers (see section 4.6). The use of Flurbiprofen Teva 0.25% mouthwash and Flurbiprofen Teva 0.25% spray for oral mucosa, especially if prolonged, can give rise to sensitization or local irritation; 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 it is necessary to check the patient.Other NSAIDsIt is advisable not to combine the medicinal product with other NSAIDs (see section 4.5).Cardiac, hepatic and renal impairmentIn patients with renal, cardiac or hepatic insufficiency the product should be used with caution. In patients with severe heart failure, severe hepatic insufficiency and severe renal insufficiency the use of the medicinal product is contraindicated (see section 4.3). NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome and renal failure. Administration of an NSAID can cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at the highest risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those on diuretic therapy and the elderly; however, this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen.Systemic lupus erythematosus (SLE) and mixed connective tissue diseasePatients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen.Respiratory pathologiesCases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma or allergies. Flurbiprofen should be used with caution in these patients.Cardiovascular and cerebrovascular effectsBefore starting treatment in patients with a history of hypertension and / or heart failure and caution is required (discuss with your doctor or pharmacist), as fluid retention, hypertension 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).Effects on the central nervous systemAnalgesic-induced headache. Headache may occur in case of prolonged or unregulated use of analgesics, which should not be treated by increasing the dose of the medicine.Gastrointestinal EffectsFlurbiprofen 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, particularly 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 by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2). Caution should be advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be stopped.Dermatological effectsSerious 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 (see section 4.8). Flurbiprofen should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity.InfectionsSince isolated cases of infection-related exacerbation of inflammation (e.g. development of necrotizing fasciitis) have been reported in temporal association with systemic use of NSAID drugs, it is recommended that patients seek immediate medical attention if signs of a bacterial infection appearing or worsening during flurbiprofen therapy. A possible indication should be considered at the start of antibiotic therapy. If mouth irritation develops, treatment should be discontinued.Important information about some of the ingredientsMouthwash and oral mucosal spray contain para-hydroxybenzoates which can cause allergic reactions (including delayed ones). Patent V blue dye (E131) can cause allergic reactions. Polyoxyethylenated 40-hydrogenated castor oil can cause localized skin reactions. Both the mouthwash and the spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Pregnancy and breastfeeding

PregnancyFlurbiprofen should not be administered during the first and second trimester of pregnancy unless strictly necessary. The use of flurbiprofen during the third trimester of pregnancy is contraindicated (see section 4.3). Inhibition of prostaglandin synthesis can 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 an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. 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 thethird quarterduring 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 that can occur even at very low doses; • Inhibition of uterine contractions resulting in delayed or prolonged labor.Feeding timeFlurbiprofen 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 mothers who are breastfeeding breast milk.FertilityThere is evidence indicating that cyclooxygenase / prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.

Expiration and retention

This medicine does not require any special storage conditions. For storage conditions after first opening, see section 6.3.

Interactions with other drugs

Caution should be exercised in patients treated with any of the medicines listed below, as interactions have been reported in some patients. Flurbiprofen should be avoided in combination with: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 (see section 4.4), unless taking aspirin at low doses (not exceeding 100 mg / day or local prophylactic doses for cardiovascular protection) has been recommended by the physician. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects and an increased risk of adverse reactions (see section 4.4). Flurbiprofen should be used with caution in combination with:Anticoagulants: NSAIDs may potentiate the effects of anticoagulants such as warfarin (see section 4.4).Antiplatelet agents: increased risk of gastrointestinal bleeding.Selective Serotonin Reuptake Inhibitors (SSRIs): increased risk of gastrointestinal bleeding.Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): NSAIDs may reduce the effect of diuretics. Other antihypertensive drugs may potentiate nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with impaired renal function (these patients must be adequately hydrated).Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce GRV (glomerular filtration rate) and increase plasma glycoside levels.Cyclosporine: increased risk of nephrotoxicity.Corticosteroids: increased risk of gastrointestinal ulcer or haemorrhage with NSAIDs (see section 4.4).LithiumThere is evidence for a possible increase in plasma lithium levels.Methotrexate: possible increase in plasma levels of methotrexate.Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.Tacrolimus:Possible increased risk of nephrotoxicity when NSAIDs are co-administered with tacrolimus.Zidovudine: increased risk of haematological toxicity when NSAIDs are administered with zidovudine.Alcohol: may increase the risk of adverse reactions, especially of bleeding in the gastrointestinal tract.

Overdose

Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur.SymptomsThe majority of patients who ingest clinically significant amounts of NSAIDs develop nausea, vomiting, gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of NSAID intoxication, central nervous system toxicity is observed, manifesting as drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Occasionally patients develop seizures. In the event of severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time / INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage can occur. An exacerbation of asthma is possible in asthmatics.TreatmentTreatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stabilization. Oral administration of activated charcoal and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Active principles

100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g. Excipients with known effects: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, hydrogenated castor oil-40 polyoxyethylenate. For the full list of excipients, see section 6.1.

Excipients

Flurbiprofen Teva 0.25% mouthwash and Flurbiprofen Teva 0.25% oral mucosal spray: glycerol (98%), ethanol, non-crystallizable liquid sorbitol, hydrogenated castor oil-40 polyoxyethylenate, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, flavor mint, patent blue V (E131), citric acid, sodium hydroxide, purified water.