ASPIGOLADOLACT SPRAY 15ML

ASPIGOLADOLACT 8,75 MG/DOSE SPRAY FOR MUCOSA ORALE SOLUTION

active ingredients

A delivery contains 2.91 mg of flurbiprofene. 3 is equivalent to a dose, containing 8.75 mg of flurbiprofen, corresponding to 17.16 mg/ml of flurbiprofene. Excipients with known effect: ethanol: 0.22 mg/dose. For the full list of excipients, see paragraph 6.1.

Excellent

Betadex (E459), Hydroxypropylbetadex, Sodium bibasic phosphate dodecaidrate, Citric acid monohydrate, Sodium hydride, Aroma Cherry, Sodium saccharin (E954), Purified water. Qualitative composition of the cherry aroma: Flavoring substances, Flavoring preparation, Ethyl alcohol, Gliceril triacetate (E1518), Propilen glycol (E1520), Ascorbic acid (E300), Di-alpha tocopherol (E307), Water.

Therapeutic indications

Aspigoladolact is indicated for the symptomatic treatment of short duration of acute pain in the sore throat in adults.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the 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. - Patients with recurrent peptic ulcers/emorrhages in place or pregress (two or more distinct episodes of ulceration demonstrated) and intestinal ulcer. - Patients with history of bleeding or gastrointestinal perforation, severe colitis, hemorrhagic or hematopoietic disorders related to a previous therapy with NSAIDs. - Severe heart failure, kidney failure or liver failure (see paragraph 4.4). - Last trimester of pregnancy (see paragraph 4.6). - Children and teenagers under the age of 18.

Population

Population Adults aged 18 or older: A dose (3 dispenses) addressed to the affected part of the throat every 3-6 hours depending on the need, up to a maximum of 5 doses in a period of 24 hours. Do not reduce the number of dispenses per dose. This medicine should not be used for more than 3 days. Pediatric population The safety and effectiveness of Aspigoladolact were not established in children or adolescents under the age of 18. Senior Patients A general posological recommendation cannot be provided, since clinical experience is limited to this day. The elderly have an increased risk of serious consequences in case of adverse reactions. It must be given the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). Method of administration Do not inhale during delivery. For administration on oral mucosa and only for short-term treatments. Before first use, it is necessary to operate 4 times the pump, pointing the dispenser away from its body, until obtaining the release of a uniform and constant nebulization. The pump is therefore ready for use. Between use and other, provide a minimum amount of product, away from your body, in order to ensure that the nebulization is uniform and constant. Before using the product always make sure the nebulization is uniform and constant.

Conservation

Do not refrigerate or freeze.

Warnings

Undesirable effects can be minimized using the lowest effective dose for the shortest duration of treatment 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. An indication should be taken at the beginning of antibiotic therapy. In case of purulent bacterial faringitis/tonsillite, the patient should consult the doctor for a reassessment of treatment. Treatment should not be administered for more than 3 days. Respiratory diseases Bronchospasm can be precipitated into patients suffering 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 (LES) and mixed connective tissue disease Patients with systemic lupus erythematosis (LES) 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; this effect is usually not 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 anamnesi for hypertension and/or heart failure is required caution (disputing with your physician or pharmacist) since in association with the treatment with the 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 less than 5 doses (3 dispenses 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 of doses of NSAIDs, in patients with ulcer anamnesi, especially if complicated with presence of hemorrhage or perforation (see paragraph 4.3) and in the elderly; this effect is usually not 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. This medicine contains less than 1 mmol (23 mg) of sodium per dose (3 sprays), i.e. essentially ‘without sodium’. This medicine contains 0.22mg ethanol per dose (3 sprays), which is equivalent to 0.044% (w/v). The quantity in the dose of this medicine is equivalent to less than 0.9 ml of beer or 0.4 ml of wine. Treatment should be reassessed if symptoms worsen or new symptoms arise. 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.

Interactions

Flurbiprofen must be avoided in association with:
Other NSAIDs including selective cyclooxygenase-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).
Anticoagulants	NSAIDs can enhance the effects of anticoagulants such as warfarin (see paragraph 4.4).
Anti-platelet aggregates:	There is an increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4).
Antihypertensive drugs (Diuretics, ACE inhibitors, Angiotensine Antagonists II)	NSAIDs can reduce the effect of diuretics. Other antihypertensive drugs can enhance nephrotoxicity caused by inhibition of cycloxygenase, especially in patients with impaired kidney function.
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).
Lithium	There may be an increase in serum levels of lithium - adequate 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 to an increase in its toxic effects.
Mifepristone	NSAIDs should not be used for 8 to 12 days following mifepristone administration, as they can reduce the effect of mifepristone.
Oral antidiabetics	Alterations of blood glucose levels have been reported (it is recommended to increase the frequency of controls).
Fenitoin	Serum levels of phenytoin can increase, therefore a proper control is recommended and, if necessary, a dose adjustment.
Diuretic potassium savers	Concurrent use can cause hyperkaliemia.
Probenecid and Sulfinpirazone	Medicines containing probenecid and 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 increase in the risk of hematological toxicity when NSAIDs are administered with zidovudine.
Other	It can increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract.

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

Effects

Reactions of hypersensitivity to NSAIDs have been reported and these may 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 were 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 those indicated at the point 4.2. Very common (≥ 1/10); Common (from ≥ 1/100 to Emolinfopoietic system pathologies. Not known: anemia, thrombocytopenia. Cardiovascular and cerebrovascular pathologies. 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, formation of bladders at oropharyngeal level, pharyngeal hypoesthesia. Gastrointestinal disease. Common: diarrhea, mouth ulceration, nausea, oral pain, oral paresthesia, oropharyngeal pain, oral discomfort (heat or burning sensation, mouth tingling); Not common: abdominal distension, abdominal pain, constipation, mouth dryness, dyspepsia, flatulence, glossodinia, dysgeusia, oral disestesia, vomiting. Pathologies of skin and subcutaneous tissue. Not common: rashes of various types, itching; Not known: severe skin reactions such as boiling reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Systemic pathologies and conditions for administration. Not common: pyrexia, pain. Immune disorders. Rare: anaphylactic reaction. Psychiatric disorders. Not common: insomnia. Hepatobile pathologies. Not known: 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. 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 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: • the 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