FROBENPRET 16PASTL LIM MIELE

FROBENPRET 8.75 MG PILLS TASTE OF LEMON AND HONEY

active ingredients

A pastel contains: active ingredient: flurbiprofen 8,75mg Eccipients with known effects: glucose, sucrose For the full list of excipients, see paragraph 6.1.

Excellent

Sucrose, glucose, macrogol, potassium hydroxide, lemon aroma, levomentol, honey.

Therapeutic indications

Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis).

Contraindications

Do not use in children under 12 years of age. Flurbiprofen is contraindicated in patients with known hypersensitivity towards flurbiprofen or any of the excipients listed in the paragraph 6.1. Patients who have previously shown hypersensitivity reactions (asthma, bronchospasm, hives, rhinitis, angioedema or allergic type) to ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAID). Flurbiprofen is also contraindicated in patients with gastrointestinal hemorrhage history or drilling related to previous treatments with NSAIDs. Flurbiprofen should not be taken by patients with active ulcerative or anamnestic colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure, kidney failure or liver failure (see paragraph 4.4). Last quarter of pregnancy.

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). This medicine is recommended for up to three days. Population Adults and children over 12 years: 1 tablet every 3-6 hours, as needed.Do not exceed 8 tablets in 24 hours. Pediatric population Children under 12 years old: do not give children under 12 years old (see paragraph 4.3). Special popularity 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 liver failure (see paragraph 4.3).Method of administration For oropharyngeal use. Dissolve slowly in your mouth. As with all pads, in order to avoid local irritations, also flurbiprofen tablets should be moved inside the mouth during administration. If mouth irritations occur, treatment should be stopped.

Conservation

This medicine does not require any special precaution for conservation.

Warnings

At recommended doses, swallowing does not involve any harm to the patient, as the dose of flurbiprofen is widely lower than that commonly used in systemic treatments. Seniors: Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal. 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. Other It is advisable not to associate the product with other NSAIDs (see paragraph 4.5). 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. Heart, kidney and liver failure In patients with kidney, heart or liver failure, the medicine must be used with caution. 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 failure, liver dysfunction, those in diuretic therapy and the elderly. The kidney function must be monitored in these patients (see also paragraph 4.3). Flurbiprofen should be given with caution to patients with positive anamnesis of heart failure or hypertension as edema was reported in association with the administration of flurbiprofen. Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are required in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure since in combination with flurbiprofen and treatment with NSAIDs, fluid and edema retention has been found. 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). Flurbiprofen, like other NSAIDs, can inhibit piastrinic aggregation and prolong bleeding time. 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, in particular 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. 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). 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 and paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients who are taking flurbiprofen, treatment must be stopped. Dermatory effects The use of the medicinal product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. In such cases it is necessary to stop treatment and consult a doctor to establish, if necessary, suitable therapy. 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. 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. Renal effects Caution is necessary when you start treatment with NSAIDs as flurbiprofen in patients with considerable dehydration. 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. Female altered fertility The use of flurbiprofen can alter female fertility and is not recommended in women who try to conceive. In women who have difficulty in conceiving or carrying out fertility surveys, it must be considered the interruption of flurbiprofen. If the mouth irritation develops, the treatment should be stopped. FROBENPRET Pastiglie gusto Limone e Miele contains: 1.095 g glucose and 1,375 g sucrose for pastilla. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. Do not use for extended treatments over 3 days. If you do not notice appreciable results after 3 days of treatment, the cause may be a different pathological condition. It is recommended in these cases to consult the doctor.

Interactions

It must be paid attention in patients treated with any of the medicines listed below, as interactions have been reported in some patients. In any case, please inform your doctor if you are taking other medicines. Flurbiprofen should be avoided in association with: - Aspirin: 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; as with other medicines containing NSAIDs, the concomitant administration of flurbiprofen and aspirin is not generally recommended due to the potential increase of unwanted effects (see paragraph 4.4) - 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 reactions. Flurbiprofen should be used with caution in association with: - Anti-agulants: NSAIDs can enhance the effects of anticoagulants such as warfarin (see paragraph 4.4) - Anti-aggregating agents: increased risk of gastrointestinal hemorrhage - selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrh 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. - Alcohol: can increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract - cardiac glycosides: NSAIDs can exacerbate heart failure, reduce VGR (glomerular filtration rate) and increase plasma levels of glycosides - Ciclosporin: increased risk of nephrotoxicity - Corticosteroids: increased risk of gastrointestinal ulcer or hemorrhage with NSAID (see paragraph 4.4) - Lithium: there is evidence for a possible increase in plasma levels of lithium - Metotressed: there may be an increase in plasma levels of metotressate - Mifepristone: NSAIDs should not be used for 8-12 days after the administration of mifepristone, since 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 Chinoloni may have an increased risk of developing seizures - Tacrolimus: possible increase in the risk of nephrotoxicity when NSAIDs are administered along with tacrolimus - Zidovudine: increased risk of hematological toxicity when NSAIDs are administered with zidovudine.

Effects

The local use of the medicinal product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. Dissolution in the oral cavity of the medicinal product in the form of tablets can be accompanied by sensations of heat or tingling charged with oropharynx. In such cases it is necessary to stop the treatment and to establish, if necessary, suitable therapy. 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,

Classification for systems and organsFrequencyAdverse reactionsEmolinfopoietic system pathologiesnot commonanemiavery rareagranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, leukopenia, neutropeniaImmune system disordersnot commonhypersensitivityrareanaphylactic reactionsDisorders of metabolism and nutritioncommonfluid retentionPsychiatric disordersnot commoninsomniararedepression, confusionvery rarehallucinationDiseases of the nervous systemcommonmatron, headache, paresthesianot commondrowsinessnot knowncerebrovascular accidents, optic neuritis, migraine, paresthesia, confusion, dizziness, drowsinessPathologies of the eyenot commonvisual disordersEar and labyrinth pathologiesnot commontinnitus, vertigoHeart diseasenot commonheart failureVascular diseasesnot commonhypertensionRespiratory, chest and mediastinic pathologiescommonthroat irritationnot commonasthma, bronchospasm and dispnea, bladders in oropharynx, oropharyngeal hypoesthesiaGastrointestinal diseasescommondiarrhea, ulcers of the mouth, nausea, oral pain, oral paresthesia, oropharyngeal pain, oral discomfort (warm or burning sensation, tingling of the mouth), abdominal pain, constipation, dyspepsia, flatulence, vomiting, melena, ematemesis, gastrointestinal hemorrhagenot commonabdominal distension, mouth dryness, glossodynia, dysgeusia, oral disestesia, gastritis, gastrointestinal perforation, gastric ulcer, duodenal ulcervery rarepancreatisnot knowncolitis, exacerbation of Crohn's diseaseHepatobiliary diseasesvery rarejaundice, cholestatic jaundice, abnormal liver functionnot knownhepatitisPathologies of skin and subcutaneous tissuenot commonrash, hive, itching, purple, angioedema, photosensitivity reactionsvery raresevere dermatological reactions (e.g. multiform erythema, bollose dermatosis including Stevens-Johnson syndrome, Toxic Necrolysis Epidermal)Kidney and urinary pathologiesrarenephrotoxicity in various forms (e.g. piping-interstitial nephritis, nephrotic syndrome, kidney failure and acute kidney failure)not knownglomerulonefriedSystemic pathologies and conditions for administrationcommonfatigue, discomfort, discomfort, edemanot commonpyrexia, painDiagnostic examinationscommonabnormality to liver function tests, prolongation of bleeding time

Immune system disorders: Following treatment with NSAIDs, hypersensitivity reactions were reported. These can consist of: (a) non-specific allergic reactions and anaphylaxis (b) reactivity of the respiratory tract, for example asthma, aggravated asthma, bronchospasm, dispnea or (c) various skin disorders, including for example skin rashes of different types, itching, hives, purple, angioedema and, more seldom, esfolitic and boditic dermatsis. 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). The most commonly observed adverse reactions are gastrointestinal. 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

In view of the reduced content of active ingredient and its local use it is unlikely 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

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. Therefore 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 on female fertility.

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