Description
Benactivdolmed is indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.
Active Ingredients
One spray contains 2.92 mg Flurbiprofen, a dose equal to three sprays contains 8.75 mg Flurbiprofen, corresponding to 16.2 mg/ml Flurbiprofen. Excipients with known effect: Methyl parahydroxy benzoate (E218) 1.181 mg/dose Propyl parahydroxy benzoate (E216) 0.2362 mg/dose The flavours contain allergens (lemon flavour and honey flavour) For the full list of excipients, see section 6.1.
Excipients
Betadex, Disodium phosphate dodecahydrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium hydroxide, Honey flavour, Lemon flavour, N,2,3-Trimethyl-2-isopropylbutanamide, Sodium saccharin (E954), Hydroxypropylbetadex, Purified water. Qualitative composition of Honey flavour: Flavouring substance(s), Flavouring preparation(s), Propylene glycol (E1520). Qualitative composition of Lemon flavour: Flavouring substance(s), Flavouring preparation(s), Propylene glycol (E1520).
Dosage
Dosage : For short-term treatment only. Adults aged 18 years and over: one dose (3 sprays) administered into the back of the throat every 3-6 hours as needed, up to a maximum of 5 doses in a 24-hour period. Paediatric population : The safety and efficacy of Benactivdolmed in children or adolescents under 18 years of age have not been established. Elderly patients : A general dosage recommendation cannot be given, as clinical experience to date is limited. Elderly patients are at increased risk of serious consequences in the event of adverse reactions. The lowest effective dose for the shortest duration necessary to control symptoms should be administered (see section 4.4). Method of administration : For oromucosal administration. Do not inhale during spraying. This medicinal product should be used for a maximum of 3 days. Before first use, activate the pump by pointing the nozzle away from your body and spraying at least four times, until a fine, uniform mist is released. The pump is now activated and ready for use. Between uses, point the nozzle away from your body and spray a small amount of product, to ensure that the mist is fine and uniform. Always ensure that the mist is fine and uniform before using the product.
Warnings
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Infections : Since exacerbation of infectious inflammation (e.g. development of necrotising fasciitis) has been described in isolated cases in temporal association with systemic use of drugs belonging to the class of NSAIDs, the patient is advised to consult a doctor immediately if signs of a bacterial infection appear or worsen during therapy with flurbiprofen spray. Consideration should be given to whether initiation of antibiotic therapy is indicated. In case of purulent bacterial pharyngitis/tonsillitis, the patient is advised to consult a doctor for a reassessment of treatment. Treatment should be administered for a maximum of 3 days. If symptoms worsen or new symptoms appear, treatment should be reassessed. If mouth irritation occurs, treatment with flurbiprofen should be discontinued. Elderly population : The elderly show an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Respiratory effects : Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. Flurbiprofen spray should be used with caution in these patients. Other NSAIDs : The use of flurbiprofen spray should be avoided in conjunction with other NSAIDs, including cyclooxygenase-2 selective inhibitors (see section 4.5). Systemic lupus erythematosus (SLE) and mixed connective tissue disease : Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may be at increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen spray. Cardiovascular, renal and hepatic impairment : NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome and renal failure. Administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients most at risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those on diuretic therapy and the elderly; however, this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen spray. Hepatic effects : Mild to moderate hepatic dysfunction (see sections 4.3 and 4.8). Cardiovascular and cerebrovascular effects : Caution is advised before initiating treatment in patients with a history of hypertension and/or heart failure (consult your doctor or pharmacist) as fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Clinical trials and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk with flurbiprofen when administered at a daily dose not exceeding 5 doses (3 actuations for each dose). Effects on the nervous system : Analgesic-induced headache - Headache may occur in case of prolonged or inappropriate use of analgesics, which should not be treated by increasing the dose of the medicinal product. Gastrointestinal effects : NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Gastrointestinal bleeding, ulceration or perforation, which may be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly; however, this effect is not usually seen with products intended for limited short-term use such as flurbiprofen spray. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) to their doctor. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn. Haematological effects : Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with abnormal bleeding potential. Dermatological effects : Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs (see section 4.8). Flurbiprofen spray should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. This product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (sometimes delayed). This product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially “sodium-free”. Flavours containing allergens: This product contains flavours containing anisyl alcohol, citral, citronellol, d-Limonene, geraniol and linalool. Anisyl alcohol, citral, citronellol, d-Limonene, geraniol, linalool may cause allergic reactions.
Conservation
Do not refrigerate or freeze.
Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 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. • Active or previous recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration) and intestinal ulceration. • History of gastrointestinal bleeding or perforation, severe colitis, haemorrhagic or haematopoietic disorders related to previous NSAID therapy. • Last trimester of pregnancy (see section 4.6). • Severe cardiac insufficiency, severe renal insufficiency or severe hepatic insufficiency (see section 4.4). • Children and adolescents under 18 years of age.
Side effects
Hypersensitivity reactions to NSAIDs have been reported and may consist of: (a) non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea; (c) various skin reactions, e.g. pruritus, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Data are insufficient to exclude this risk with the use of flurbiprofen oromucosal spray, solution. The list of adverse effects reported below refers to those reported with flurbiprofen, used at doses consistent with the OTC classification and for a short period . (Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data)). Blood and lymphatic system disorders . Not known: anaemia, thrombocytopenia. Cardiovascular and cerebrovascular disorders . Not known: oedema, hypertension, cardiac failure. Nervous system disorders . Common: dizziness, headache, paraesthesia; Uncommon: somnolence. Respiratory, thoracic and mediastinal disorders . Common: throat irritation; Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal vesicular eruption, hypoaesthesia of the pharynx. Gastrointestinal disorders . Common: diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (sensation of heat or burning, tingling of the mouth); Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting. Skin and subcutaneous tissue disorders . Uncommon: rashes of various types, pruritus; Not known: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrosis. General disorders and administration site conditions . Uncommon: pyrexia, pain. Immune system disorders . Rare: anaphylactic reaction. Psychiatric disorders . Uncommon: insomnia. Hepatobiliary disorders . Not known: hepatitis. Reporting of suspected adverse reactions . Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Overdose
Symptoms The majority of patients who have ingested clinically important quantities of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In more severe NSAID intoxication, central nervous system toxicity is observed, manifested by drowsiness, occasionally excitation, blurred vision, and disorientation or coma. Occasionally, patients develop convulsions. In severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. Treatment Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stabilization. Oral administration of activated charcoal or gastric lavage and, if necessary, correction of serum electrolytes should be considered if the patient presents within 1 hour of ingestion of a potentially toxic amount. Seizures, if frequent or prolonged, should be treated with intravenous diazepam or lorazepam. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.
Pregnancy
Pregnancy : Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryonic/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis following use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given a prostaglandin synthesis inhibitor 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 may expose • the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; • the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy (see section 4.3). Breast-feeding : In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have any adverse effects on the breast-fed infant. However, due to the possible adverse effects of NSAIDs on breast-fed infants, the use of flurbiprofen spray by nursing mothers is not recommended. Fertility : There is some evidence to suggest that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.
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