BENACTIVDOL GOLLA SPRAY 15ML8.75 IS NOT INTENDED TO BE USED FOR THE TREATMENT OF:

BENACTIVDOL GOLA 8,75 MG/DOSE SPRAY FOR MUCOSA ORALE, SOLUTION

active ingredients

A delivery contains 2,92 mg of Flurbiprofene, three expenditure equal to a dose contain 8.75 mg, corresponding to 16.2 mg/ml of Flurbiprofene Eccipienti with known effects: Metil parahydroxybenzoate (E218) 1,18 mg/dose Propil parahydroxybenzoate (E216) 0.24 mg/dose Aromi containing allergens (mint aroma and cherry aroma) For the full list of excipients, see paragraph 6.1.

Excellent

Betadex Sodium phosphate bibasic dodecaidrate Citric Acid monohydrate Metil parahydroxybenzoate (E218) Propil parahydroxybenzoate (E216) Sodium Idroxide Aroma mint Aroma cherry N,2,3-Trimethyl-2-isopropylbutanamide Sodium (E954) Hydroxypropyl Flavoring substances Flavoring preparation Propilen glycol E1520 Gliceril triacetate (Triacetin) E1518 Qualitative composition of the aroma Cherry: Flavored substances Flavored preparation Propilen glycol E1520 Water

Therapeutic indications

Benactivdol Gola is indicated for symptomatic treatment of short duration of acute pain in the throatache in adults.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Patients who have previously manifested hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs. • Patients with recurring peptic ulcers/emorrhages in place or pregress (two or more separate episodes of demonstrated ulceration) and intestinal ulceration. • Patients with history 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, kidney failure or liver failure (see paragraph 4.4). • Children and teenagers under the age of 18.

Population

Posology Only for short-term treatments. Suitable for adults older than 18 years: 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. Pediatric population The safety and effectiveness of Benactivdol Gola in children or adolescents under the age of 18 have not been established. Senior population 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 to control symptoms (see paragraph 4.4). Method of administration For oromucosal administration Do not inhale during delivery. This medicine should not be used for more than 3 days. Before 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 consistent nebulization. The pump is therefore ready for use. Between use and other, provide a minimum quantity of product, away from your body, in order to ensure that the nebulization is uniform and consistent. Before using the product always make sure the nebulization is uniform and consistent.

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. Treatment should be reassessed if symptoms worsen or new symptoms arise. If you develop mouth irritation, treatment with flurbirprofen 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 suffering patients or with bronchial asthma or allergic pathology, Flurbiprofen spray should be used with caution in these patients. Other Using flurbiprofen spray should be avoided in conjunction with other NSAIDs, including selective cyclooxygenase-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 decrease 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 anamnesiums for hypertension and/or heart failure it is required caution (return to 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 or stroke infarction). There is no sufficient data to exclude this risk with flurbiprofen when administered to a daily dosage less than 5 times (3 issues 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 to patients with a history of gastrointestinal disease ( 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 product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate that can cause allergic reactions (sometimes also delayed). This medicine contains aromas containing citral, d-limonene, eugenol and linalol. Citral, d-limonene, eugenol and linalol can cause allergic reactions. This medicine contains less than 1 mmol (23mg) of sodium per dose, i.e. essentially ‘without sodium’.

Interactions

Paediatric population Additional information is not available.

Effects

Reactions of hypersensitivity to the 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, for example itching, hives, angioedema and, more rarely, exfoliative and bollous dermatderosis. 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 refers to the clinical evaluation carried out with flurbiprofen, used in the short term and at doses compatible with the OTC classification. (Very common (≥1/10), Common (from ≥1/100 to Emolinfopoietic System Pathologies Not known: Anemia, Trombocytopenia. Heart and vascular disease Not known: Edema, hypertension, heart failure. Diseases of the nervous system Municipality: Capogiri, Cefalea, Parestesia. Not common: Sleep. Respiratory, chest and mediastinic pathologies City: Irritation of the throat. Not common: exacerbation of Asthma and Broncospasmo, Dispnea, Sybilant Respiro, Formation of bladders at the oropharyngeal level, Pharyngeal hypoesthesia. Gastrointestinal diseases Common: Diarrhea, Oral Pain, Oral Pain, Oral Pain, Oral Pain, Oral Fastidium (sense of hot or burning, tingling of the mouth). Not common: Abdominal distension, Abdominal pain, Constipation, Mouth dryness, Despepsia, Flatulence, Glossodinia, Disgeusia, Oral Disesthesia, Vomito. Pathologies of skin and subcutaneous tissue Not common: Skin rashes of various kinds, Prurito. Not known: Severe skin reactions such as bollose reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrosis. Systemic pathologies and conditions for administration Not common: Pyrexia, Pain. Immune system disorders Rare: Anaphylactic reaction. Psychiatric disorders Not common: Insomnia. Hepatobiliary 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioniavverse

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 malformation 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 oligo-idramnios. • 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 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