FLURBIPROFENE TE OS SPRAY 15ML

FLURBIPROFENE TEVA 0.25%

active ingredients

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

Excellent

Flurbiprofene Teva 0.25% collutory and Flurbiprofene Teva 0.25% oral mucosa spray: glycerol (98%), ethanol, non crystallizable liquid sorbitol, hydrogenated castor oil-40 polyxyethylene, sodium saccharin, metile parahydroxybenzoate, purified parahydroxybenzoate propile, mint aroma1), acid V (E13.

Therapeutic indications

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 the flurbiprofen active ingredient or any of the excipients listed in the paragraph 6.1. • In patients with known hypersensitivity (e.g. asthma, hives, allergy, rhinitis, angioedema, bronchospasm or other allergic manifestations) to ibuprofen, aspirin or other NSAIDs. • In patients with history of gastrointestinal hemorrhage or perforation related to previous treatments with NSAIDs. • In patients with active ulcerative colitis or anamnestic, Crohn's disease, recurrent peptic ulcer or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). • In patients with severe heart failure, severe liver failure and kidney failure (see paragraph 4.4).• Third quarter of pregnancy (see paragraph 4.6). Do not use the medicine in children under 12 years of age.

Population

Population 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 4.4). Collumination The recommended dose is 2 or 3 rinses or gargles per day with 10 ml of collutory (1 scourge). The collutory can be used pure or diluted in water. Method of administration For oropharyngeal use. Rinse or keep in the mouth during gargles up to 1 minute. Don't swallow. Oral Mucosa Spray The recommended dose is 2 sprays, 3 times a day directed directly to the affected part. Each spray dispenses 0.2 ml of solution, equivalent to 0.5 mg of active ingredient. Method of administration For oropharyngeal use. Address the dispenser to the back of the throat and spray on the affected part. Special popularity Pediatric population Children over 12 years: as for adults. Children under 12 years old: do not give children under 12 years old (see paragraph 4.3). Seniors: clinical data available at the moment are limited, so no recommendation on posology can be made. The elderly have a greater risk of serious consequences in case of adverse reactions (see paragraph 4.4). Patients with liver failure: a reduction in dose in patients with mild to moderate liver failure is not necessary. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3). Patients with kidney failure: a reduction in dose is not necessary in patients with mild to moderate kidney failure. Flurbiprofen is contraindicated in patients with severe kidney failure (see paragraph 4.3).

Conservation

This medicine does not require any special condition of conservation. For storage conditions after first opening, see paragraph 6.3.

Warnings

At the recommended doses, the possible swallowing of Flurbiprofene Teva 0.25% collutory and Flurbiprofene Teva 0.25% oral mucosa spray does not entail any harm to the patient as such doses are largely lower than those of the single posology of the product by systemic means. During the first and second quarter of pregnancy, flurbiprofen should not be administered unless strictly necessary (see paragraph 4.6). The administration of flurbiprofen is not recommended in nursing mothers with breast milk (see paragraph 4.6). The use of Flurbiprofene Teva 0.25% collutory and Flurbiprofene Teva 0.25% oral mucosa spray, especially if prolonged, can give rise to local sensitization or irritation phenomena; in such cases it is necessary to stop the treatment and consult the doctor to establish, if necessary, suitable therapy. Do not use for protracted treatments. After short periods of treatment without appreciable results it is necessary to check the patient. Other It is advisable not to associate the medicine with other NSAIDs (see paragraph 4.5). Heart, liver and kidney failure In patients with kidney, heart or liver failure, the product must be used with caution. In case of patients with severe heart failure, severe liver failure and severe kidney failure the use of the medicine is contraindicated (see paragraph 4.3). It has been reported that NSAIDs can cause various forms of nephrotoxicity, including interstitial nephritis, nephrosic syndrome and kidney failure. The administration of an NSAID can cause a dose-dependent reduction in prostaglandine formation and cause renal failure. Patients who present the highest risk of developing this reaction are those with impairment of kidney function, heart impairment, liver dysfunction, those in 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 erythematous lupus (LES) and mixed connective tissue disease Patients with systemic erythematosum Lupus and mixed connective tissue disease may present an increased risk of aseptic meningitis (see paragraph 4.8), however this effect is not usually observed with products intended for limited and short-term use as flurbiprofen. Respiratory diseases Cases of bronchospasm with flurbiprofen have been reported in patients with bronchial asthma anamnesi or allergies. Flurbiprofen should be used carefully in these patients. Cardiovascular and cerebrovascular effects Before starting treatment in patients with positive anamnesis for hypertension and/or heart failure and request caution (disputing with your physician or pharmacist), since in association with treatment with NSAIDs, fluid retention, hypertension and edema were found. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially high dosages 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). Effects on the central nervous system Kefalea induced by analgesics. In case of prolonged or irregular use of analgesics, cephalea can be manifested, which should not be treated by increasing the dose of the medicinal product. Gastrointestinal effects Flurbiprofen should be administered with caution to patients with peptic ulcer anamnesis and other gastrointestinal diseases since such conditions can be reascutized. 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. 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. 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. Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage 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 paragraph 4.2). Caution should be recommended in patients receiving concomitant medicines that can increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or pyastrinic anti-aggregants such as acetylsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients who are taking flurbiprofen, treatment must be stopped. Dermatory effects Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). Flurbiprofen should be suspended at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Infections Since isolated cases of exacerbation of inflammation related to infections (e.g. development of necrotizing fascites) have been described in temporal association with the systemic use of drugs belonging to the class of NSAIDs, it is recommended that patients immediately consult a doctor in case of the appearance or worsening of signs of a bacterial infection during flurbiprofen therapy. An indication should be taken at the beginning of antibiotic therapy. If the mouth irritation develops, the treatment should be stopped. Important information about some excipients The mouthwashing and oral mucosa spray contain para-hydroxybenzoates that can cause allergic reactions (also delayed). The blue coloring license V (E131) can cause allergic reactions. Hydrogenated castor oil-40 polyxyethylene can cause localized skin reactions. Both collutory and spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Interactions

Attention should be given to patients treated with any of the medicines listed below, since interactions have been reported in some patients. Flurbiprofen should be avoided in association with: Aspirin: As with other medicines containing NSAIDs, the concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential increase in unwanted effects (see paragraph 4.4), unless intake of aspirin at low doses (not more than 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by the doctor. Cox-2 inhibitors and other NSAIDs: the concomitant use of other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided due to potential additive effects and increased risk of adverse reactions (see paragraph 4.4). Flurbiprofen should be used with caution in association with: Antiagulants: NSAIDs can enhance the effects of anticoagulants such as warfarin (see paragraph 4.4). Anti-aggregation agents: increased risk of gastrointestinal hemorrhage. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage. Antihypertensives (diuretics, ACE inhibitors and antagonists of angiotensin II): NSAIDs can reduce the effect of diuretics. Other antihypertensive drugs can enhance nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with compromised kidney function (these patients must be properly hydrated). Heart glycosides: NSAIDs can exacerbate heart failure, reduce VGR (glomerular filtration) and increase plasma levels of glycosides. Ciclosporin: increased risk of nephrotoxicity. Courtesy: increased risk of gastrointestinal ulcer or hemorrhage with NSAID (see paragraph 4.4). Litio: there is evidence for a possible increase in plasma levels of lithium. Metotress: possible increase in plasma levels of methorate. Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone is administered, as NSAIDs can reduce the effect of mifepristone. Chinolonic Antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may have an increased risk of developing seizures. Tacrolimus: possible increase of the risk of nephrotoxicity when NSAIDs are administered along with tacrolimus. Zidovudina: increased risk of hematological toxicity when NSAIDs are administered with zidovudine. Alcohol: can increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract.

Effects

Hypersensitivity reactions to NSAIDs have been reported and these can consist of: (a) non-specific allergic reactions and anaphylaxis. (b) reactivity of the respiratory tract, for example asthma, aggravated asthma, bronchospasm, dispnea. (c) various skin disorders, including for example skin rashes of different types, itching, urticaria, porpora, angioedema and, more rarely, exfoliative and bollous dermatosis (including epidermal necrolysis and multiform erythema). The most commonly observed adverse reactions are gastrointestinal. The local use of the medicinal product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. The following undesirable effects were reported, particularly after the administration of formulations for systemic use. They refer to those detected with the use of short-term flurbiprofen and at doses compatible with the classification of automedication medicines. In case of treatment of chronic conditions and for long periods of time additional side effects may occur. The undesirable effects associated with the use of flurbiprofen are below divided according to the classification for systems and organs and frequency. The frequency is defined as: very common (≥ 1/10), common (≥1/100, Emolinfopoietic system pathologies. Notable: thrombocytopenia, anemia, aplastic anemia and agranulocytosis. Disorders of the immune system. Rare: anaphylactic reaction. Notable: angioedema, hypersensitivity. Psychiatric disorders. Not commonInsomnia. Notable: depression, hallucination. Nervous system pathologies. Town: dizziness, headache, paresthesia. Not commonDrowsiness. Notable: cerebrovascular accidents, optic neuritis, migraine, confusion, vertigo. Pathologies of the eye. Notable: visual disturbances. Ear and labyrinth pathologies. Notable: tinnitus. Heart disease. Notable: edema, heart failure. Vascular disease. Notable: hypertension. 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).Respiratory, chest and mediastinal pathologieswhat. Town: throat irritation. Not common: reactivity of the respiratory tract (asthma, bronchospasm and dispnea), bladders in oropharynx, oropharyngeal hypoesthesia. Gastrointestinal disease. The most commonly observed adverse events are gastrointestinal. Town: nausea, diarrhea, aftous ulcer, oral pain, oral paresthesia, oropharyngeal pain, oral discomfort (heat or burning sensation, mouth tingling). Not common: abdominal distension, vomiting, flatulence, constipation, dry mouth, dyspepsia, abdominal pain, glossodynia, dysgeusia, oral disestesia. Notable: melena, ematemesis, gastrointestinal hemorrhage and exacerbation of Crohn's colitis and disease (see paragraph 4.3), gastritis, peptic ulcer, perforation and hemorrhage from ulcer, pancreatis. Hepatobile pathologies. Notable: hepatitis. Kidney and urinary pathologies. Notable: nephrotoxicity in various forms, including interstitial nephritis, nephrosic syndrome and kidney failure (see paragraph 4.4). Pathologies of skin and subcutaneous tissue. Not common: skin disorders including rash, itching. Notable: hives, porpora, bollose dermatous angioedema (including Stevens- Johnson Syndrome, Epidermal Toxic Necrolysis and Multiform Erythema). During clinical studies carried out with flurbiprofene-based patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, eruptions, insensitivity and tingling); however, the incidence was low (4.6%). Systemic pathologies and conditions for administration. Not common: pyrexia, pain. Notable: discomfort, fatigue, malaise 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In view of the reduced content of active ingredient and its local and unlikely use that overdose situations may occur. Synonyms Most patients ingesting clinically important amounts of NSAIDs develop nausea, vomiting, gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious cases of intoxication by NSAIDs, toxicity is observed at the expense of the central nervous system, which is manifested with drowsiness, occasionally excitability, blurred vision and disorientation or coma. Occasionally patients develop seizures. In case of severe intoxication from NSAIDs, metabolic acidosis can occur and protrombine/INR time may be prolonged, probably due to interference with the action of the factors of the coagulation present in the circle. Acute kidney failure and liver damage can occur. Asthma exacerbation is possible in asthmatic subjects. Treatment The treatment must be symptomatic and supportive and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until stabilization. The oral administration of activated charcoal should be considered and, if necessary, the correction of the serum electrolytes if the patient occurs within an hour of the ingestion of a potentially toxic quantity. Convulsions must be treated with diazepam or lorazepam intravenously if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Pregnancy

Flurbiprofen should not be administered during the first and second trimester of pregnancy, if not in strictly necessary cases. The use of flurbiprofen during the third trimester of pregnancy is contraindicated (see paragraph 4.3). 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. 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 quarter 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.

Food

Flurbiprofen is excreted in breast milk. however the excreta quantity is only a small fraction of the maternal dose. Flurbiprofene administration is not recommended in nursing mothers with breast milk.

Fertility

Evidence indicates that the inhibitors of the cyclooxygenase/synthesis of prostaglandins can cause a compromise of female fertility through an effect on ovulation. This is reversible as a result of termination of treatment.

Source: Farmadati