FROBENGOLMED SPRAY 15 ML OF WHICH:

FROBENGOLMED 8.75 MG/DOSE SPRAY FOR MUCOSA ORALE SOLUTION

active ingredients

A dispensing contains 2,92 mg of flurbiprofen and three dispenses equal to a dose, which contains 8,75 mg and corresponds to 17,16 mg/ml of flurbiprofene. For a complete list of excipients, see the paragraph 6.1.

Excellent

Sodium saccharin, Citric acid, Sodium hydroxide, Dodecahydrate phosphate disodium, Betadex (E459), Idroxypropylbetadex, Purified water. Aroma cherry: Ethyl alcohol, triacetate Gliceril (E1518), Propilenglycol (E1520), Ascorbic Acid (E300), D-alpha tocopherol (E307).

Therapeutic indications

FROBENGOLMED is indicated for the short-term symptomatic treatment of acute throat pain in adults.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Patients who have previously shown hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs. • Recurrent peptic hemorrhage/ulcer in place or pregress (two or more distinct episodes of proven ulceration) and intestinal ulcer. • Anamnesis of bleeding or gastrointestinal perforation, severe colitis, hemorrhagic or hematopoietic disorders related to a previous therapy with NSAIDs. • Last trimester of pregnancy (see paragraph 4.6). • Severe heart failure, severe kidney failure or severe liver failure (see paragraph 4.4). • Children and teenagers under the age of 18.

Population

Population. . Adults aged 18 or older: A dose (3 dispenses) addressed to the back of the throat every 3-6 hours according to need, up to a maximum of 5 doses in a period of 24 hours. Do not inhale during delivery. It is recommended not to use this product for more than three days. Before first use, activate the pump by pointing the dispenser away from your body and spray at least four times until you get the release of a uniform and constant nebulization. The pump is then activated and ready for use. Between one dose and the other point the dispenser away from your body and spray at least once until you get the release of a uniform and constant nebulization. Before using the product always make sure the nebulization is uniform and constant. Pediatric population: The safety and effectiveness of FROBENGOLMED in children or adolescents under the age of 18 have not been established. Senior Patients: You cannot provide a general recommendation on the dose since the current clinical experience is limited. Older patients are exposed to a higher risk of severe adverse reactions. It must be given the lowest effective dose for the shortest duration necessary to control symptoms (see paragraph 4.4). Method of administration: Only for short duration administration on oral mucosa.

Conservation

This medicine does not require any special condition of conservation. Once opened, dispose after 1 month.

Warnings

Any side effects can be minimized with the lowest effective dose for the shortest duration needed to control symptoms. 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 the treatment based on flurbiprofen spray. This should be taken into account if the start of antibiotic therapy against infections is indicated. In case of purulent bacterial tonsillite/pharyngitis, the patient should consult a doctor for reassessment of treatment. Treatment should not be administered for more than three days. If the symptoms worsen or if new symptoms arise, the treatment must be reassessed. If you develop mouth irritation, treatment with flurbiprofen should be suspended. Senior population: The elderly manifest an increased frequency of adverse reactions to the NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal. Respiratory diseases: Bronchospasm may be precipitated into patients suffering from or with bronchial asthma or allergic pathology. Flurbiprofen spray should be used carefully in these patients. Other: Using flurbiprofen spray should be avoided in conjunction with other NSAIDs, including selective cycloxygenase-2 inhibitors (see paragraph 4.5). Systemic erythematous lupus and mixed connective tissue disease: Patients with systemic erythematosum Lupus and mixed connective tissue disease may have an increased risk of aseptic meningitis (see paragraph 4.8), but this effect is not usually observed with products intended for short-term use as flurbiprofen spray. Comprogation of cardiovascular, kidney and liver: 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 fall into kidney 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 short-term use such as flurbiprofene spray. Hepatitis effects: Hepatic mild to moderate dysfunction (see paragraph 4.3 and 4.8). Cardiovascular and cerebrovascular effects: Before starting treatment in patients with positive anamnesiums for hypertension and/or heart failure is required caution (disputing with your physician or pharmacist) since in association with treatment with NSAIDs fluid retention, hypertension and edema were found. Data from clinical and epidemiological studies suggest that the use of some NSAIDs (especially at high doses and long-term treatments) may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There is not enough data to exclude this risk with flurbiprofen when administered to a daily dosage not exceeding 5 doses (3 sprays per dose). Effects on the central nervous system: Cephalea induced by analgesics - In case of prolonged or uncontrolled use of analgesics, cephalea can be manifested, which should not be treated by increasing the dose of the medicinal product. Gastrointestinal diseases: NSAIDs should be administered with caution in patients with a history of gastrointestinal diseases ( ulcerative colitis, Crohn's disease) since these conditions can be exacerbated (see paragraph 4.8). Blood, ulceration or gastrointestinal perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, in the presence or absence of warning symptoms or an analogy of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with the increase in doses of NSAIDs, in patients with ulcer anamnesi, especially if complicated by presence of hemorrhage or perforation (see paragraph 4.3) and in the elderly; however, this effect is not usually observed with products intended for short-term use such as flurbiprofene spray. Patients with a gastrointestinal toxicity analogy, especially the elderly, must report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their attending physician. 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. Ematologic effects: Flurbiprofen, like other NSAIDs, can inhibit piastrinic aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with potential bleeding abnormalities. 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 spray must be suspended at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Excipients with known effects: This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’.

Interactions

Flurbiprofen should be avoided in association with:
Other NSAIDs included selective cycloxygenase-2 inhibitors	Avoid the concomitant use of two or more NSAIDs, as this can increase the risk of adverse effects (especially gastrointestinal adverse events such as ulcers and bleeding) (see paragraph 4.4).
Acetylsalicylic acid (low doses)	Unless intake of aspirin at low doses (not more than 75 mg/die) has been recommended by the doctor, since the potential risk of adverse events could increase (see paragraph 4.4).
Antiagulants	NSAIDs can enhance the effects of anticoagulants such as warfarin (see paragraph 4.4).
Flurbiprofen should be used with caution in association with:
Anti-platelet aggregates	There is an increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4).
Antihypertensive drugs (diuretics, ACE inhibitors, angiotensin antagonists II)	NSAIDs can reduce the effect of diuretics. Other antihypertensive drugs can enhance neurotoxicity caused by cycloxygenase inhibition, especially in patients with compromised kidney function.
Other	It can increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract.
Heart glycosides	NSAIDs can exacerbate heart failure, reduce VGR (glomerular filtration speed) and increase plasma levels of glycosides, therefore adequate control is recommended and, if necessary, a dose adjustment.
Ciclosporin	There is an increased risk of nephrotoxicity.
Courtesy	There is an increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4).
Litio	It can increase the serum levels of lithium, therefore a proper control is recommended and, if necessary, a dose adjustment.
Metotress	The administration of NSAIDs within 24 hours prior to or after the administration of metotressate may lead to high concentrations of metotressate and an increase in its toxic effects.
Mifepristone	NSAIDs should not be used for 8-12 days following mifepristone administration, as they can reduce their effect.
Oral antidiabetics	Alterations of blood glucose levels have been reported (it is recommended to increase the frequency of controls).
Fenitoin	It can increase the serum levels of phenytoin, therefore a proper control is recommended and, if necessary, a dose adjustment.
Diuretic potassium savers	Concurrent use can cause hyperkaliemia.
Probenecid and the Finpirazone	Medicines containing probenecid or sulfinpirazone may delay the excretion of flurbiprofene.
Chinolonic Antibiotics	Animal data indicates that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may experience an increased risk of developing seizures.
Selective serotonin reuptake inhibitors (SSRI)	There is an increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4).
Tacrolimus	An increased risk of nephrotoxicity is possible when NSAIDs are administered along with tacrolimus.
Zidovudina	There is an increased risk of hematological toxicity when NSAIDs are administered with zidovudine.

No study has yet detected any interaction between flurbiprofen and tolbutamide or antacids. Pediatric population: Additional information is not available.

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 reactions, such as itching, hives, angioedema and, more rarely, exfoliative and bollous dermatosis (including epidermal necrolysis and multiform erythema). Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. The data is insufficient to exclude this risk due to the use of flurbiprofen spray for oral mucosa, solution. The list of adverse effects reported below relates to what is experienced with flurbiprofen, used in the short term and at doses compatible with the OTC classification. (Very common (≥1/10), Common (≥1/100, Diseases of the emolinfopoietic system. Notable: anemia, thrombocytopenia. Cardiovascular and cerebrovascular disorders. Not known: edema, hypertension, heart failure. Nervous system pathologies. Municipality: capogiri, cephalea, parestesia; Not common: drowsiness. Respiratory, thoracic and mediastinic pathologies. Common: irritation of the throat; Not common: exacerbation of asthma and bronchospasm, dispnea, sibilant breathing, vesicular eruption oropharyngeal, hypoesthesia of pharynx. Gastrointestinal disease. Common: diarrhea, mouth ulceration, nausea, oral pain, oral paresthesia, oropharyngeal pain, oropharyngeal discomfort (sensation of heat or burning or tingling of the mouth); Not common: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodinia, dysgeusia, oral disestesia, vomiting. Pathologies of skin and subcutaneous tissue. Not common: rashes of various types, itching; Not known: severe forms of skin reaction such as bollose reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Systemic pathologies and conditions for administration. Not common: pyrexia, pain. Immune system pathologies. Rare: anaphylactic reaction. Psychiatric disorders. Not common: insomnia. Hepatobile pathologies. Notable: hepatitis. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms Most patients who have ingested clinically important quantities of NSAID will develop nausea, vomiting, 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. Management Management must be symptomatic and supportive and must include maintaining airway pervity and monitoring heart function and vital signs until stabilization. The oral administration of activated charcoal or gastric lavender should be taken into account and, if necessary, correction of serum electrolytes if the patient occurs within an hour of 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

: Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/fetal development. The data obtained from epidemiological studies suggest an increase in the risk of abortion, heart malformations and gastroschisis following the use of an inhibitor of the synthesis of prostaglandins at the beginning of pregnancy. The absolute risk of cardiovascular malformations was increased from less than 1% to approximately 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, it has been shown that the administration of an inhibitor of the synthesis of prostaglandins has shown to cause an increase of pre- and post-system losses and embryo-fetal lethal. In addition, an increased incidence of various malformations, including cardiovascular malformations, was reported in animals that had been given an inhibitor of prostaglandin synthesis during the organogenetic period. Flurbiprofen should not be administered during the first and second trimester of pregnancy. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose • fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction that can progress towards kidney failure with oligoidramnios. • 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. As a result, flurbiprofen is contraindicated during the third trimester of pregnancy (see paragraph 4.3).

Food

: In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have adverse effects on breast-feededed infant. However, due to the possible adverse effects of NSAIDs on breast-feeding infants, it is not recommended to use flurbiprofen spray by nursing mothers.

Fertility

: Evidence indicates that cycloxygenase/synthesis inhibitors of prostaglandins can cause female fertility to be compromised by ovulation. This is reversible as a result of termination of treatment.

Source: Farmadati