BENACTIV THROAT 2.5 mg/ml Mouthwash
BENACTIV THROAT 2.5 mg/ml Spray for oral mucosa
flurbiprofen
Directions
BENACTIV THROAT Mouthwash BENACTIV GOLA Spray for oral mucosa Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy. BENACTIV GOLA Lemon and Honey flavour lozenges BENACTIV THROAT Sugar-Free Lozenges Orange Flavor Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis).
Active Ingredients
BENACTIV GOLA Mouthwash 100 ml of mouthwash contain: active ingredient: flurbiprofen 250 mg Excipients with known effects: hydrogenated castor oil-40-polyoxyethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence (containing d-limonene). BENACTIV GOLA Oral mucosa spray 100 ml of solution contain: active ingredient: flurbiprofen 250 mg Excipients with known effects: hydrogenated castor oil-40-polyoxyethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence (containing d-limonene). BENACTIV THROAT Lemon and Honey Flavour Lozenges One lozenge contains: active ingredient: flurbiprofen 8.75 mg Excipients with known effects: liquid glucose (containing sulphites and wheat starch), liquid sucrose, honey, lemon flavouring and levomenthol (containing butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol, linalool). BENACTIV THROAT Sugar-Free Lozenges Orange Flavour One lozenge contains: active ingredient: flurbiprofen 8.75 mg Excipients with known effects: liquid maltitol (E965), isomalt (E953), orange flavouring and levomenthol (containing citral, citronellol, d-limonene, geraniol, linalool). For the full list of excipients, see section 6.1.
Excipients
BENACTIV THROAT Mouthwash Glycerol, ethanol (96 percent), sorbitol 70, polyoxyethylene-40 hydrogenated castor oil, sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence (containing d-limonene), patent blue V (E131), purified water. BENACTIV THROAT Oral mucosa spray Glycerol, ethanol (96 percent), sorbitol 70, polyoxyethylene-40 hydrogenated castor oil, sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence (containing d-limonene), patent blue V (E131), purified water. BENACTIV THROAT Lemon and Honey flavoured lozenges Liquid sucrose, liquid glucose (containing sulphites and wheat starch), macrogol 300, potassium hydroxide, lemon and levomenthol flavouring (containing butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol, linalool), honey. BENACTIV THROAT Sugar-free lozenges Orange flavoured Macrogol 300, potassium hydroxide, orange and levomenthol flavouring (containing citral, citronellol, d-limonene, geraniol, linalool), acesulfame potassium (E950), liquid maltitol (E965), isomalt (E953).
Dosage
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). BENACTIV THROAT Mouthwash Dosage Adults : 2-3 rinses or gargles per day with 10 ml (1 measuring spoon) of mouthwash. Paediatric population Children over 12 years of age: as for adults. Children under 12 years of age: do not administer to children under 12 years of age (see section 4.3). Special populations Elderly : The clinical data currently available are limited, therefore no recommendation on posology can be made. Elderly are at increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic impairment : no dosage reduction is necessary in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal impairment : no dosage reduction is necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration For oropharyngeal use. Rinse or keep in the mouth during gargling for up to 1 minute. Do not swallow. The mouthwash can be used pure or diluted in half a glass of water. BENACTIV GOLA Spray for oral mucosa Dosage Adults : apply one dose (2 sprays) 3 times a day, directed directly onto the affected area. Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient. Paediatric population Children over 12 years of age: as for adults. Children under 12 years of age: do not administer to children under 12 years of age (see section 4.3). Special populations Elderly : The clinical data currently available are limited, therefore no recommendation on posology can be made. Elderly are at increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic impairment : no dosage reduction is necessary in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal impairment : no dosage reduction is necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration For oropharyngeal use. Point the dispenser towards the back of the throat and spray on the affected area. BENACTIV GOLA Lemon and Honey flavour lozenges BENACTIV THROAT Sugar Free Lozenges Orange Flavor Dosage Adults : 1 lozenge every 3-6 hours, as needed. Do not exceed 8 lozenges in 24 hours. Paediatric population Children over 12 years of age: as for adults. Children under 12 years of age: do not administer to children under 12 years of age (see section 4.3). Special populations Elderly : Clinical data are currently limited, therefore no recommendation on posology can be made. Elderly are at increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic impairment : No dosage reduction is necessary in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal impairment : No dosage reduction is necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration For oropharyngeal use. Dissolve slowly in the mouth. As with all lozenges, flurbiprofen lozenges should be moved around the mouth during administration to avoid local irritation. If mouth irritation occurs, treatment should be discontinued.
Warnings
At the recommended doses, when using the medicine in its various pharmaceutical forms, any swallowing does not cause any harm to the patient, as the dose of flurbiprofen is much lower than that commonly used in systemic treatments. Elderly: elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Respiratory disorders Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma or allergies. Flurbiprofen should be used with caution in these patients. Other NSAIDs It is advisable not to combine the medicinal product with other NSAIDs (see section 4.5). Systemic lupus erythematosus (SLE) and mixed connective tissue disease Patients with systemic lupus erythematosus 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. Cardiac, hepatic and renal impairment The medicinal product should be used with caution in patients with cardiac, renal or hepatic insufficiency. 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 at greatest risk of developing this reaction are those with impaired renal function, cardiac insufficiency, 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. Cardiovascular and cerebrovascular effects Caution is advised before starting treatment in patients with a history of hypertension and/or heart failure (discuss with your doctor or pharmacist), as fluid retention, hypertension and oedema have been reported in association with NSAID treatment. Clinical trial 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 such as myocardial infarction or stroke. There are insufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Central nervous system effects Analgesic-induced headache. Headache may occur with prolonged or inappropriate use of analgesics and should not be treated by increasing the dose of the medicinal product. Gastrointestinal effects Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases as these conditions may be exacerbated. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment. These adverse reactions can be fatal and may occur with or without warning symptoms or in the presence of a previous history of serious gastrointestinal reactions. Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the early stages of treatment. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2). 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). When gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be discontinued. Dermatological effects Use of the medicinal product, especially if prolonged, may give rise to sensitisation or local irritation phenomena. In such cases, treatment should be discontinued and a doctor should be consulted to institute appropriate therapy if necessary. 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 should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Infections Since isolated cases of exacerbation of infection-related inflammation (e.g. development of necrotising fasciitis) have been described in temporal association with systemic use of NSAIDs, patients are advised to seek immediate medical attention if signs of bacterial infection appear or worsen during flurbiprofen therapy. The possibility of initiating antibiotic therapy should be considered. If mouth irritation develops, treatment should be discontinued. BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain para-hydroxy-benzoates which may cause allergic reactions (possibly delayed). BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain 40-polyoxyethylened hydrogenated castor oil which may cause localised skin reactions. BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain a flavouring which in turn contains d-limonene. D-limonene may cause allergic reactions. BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain less than 1 mmol (23 mg) sodium per 10 ml dose, i.e. essentially “sodium-free”. BENACTIV GOLA Lemon and Honey flavoured pastilles contain liquid glucose, liquid sucrose and honey (invert sugar). Patients with rare problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. To be taken into account in people with diabetes mellitus: this medicine contains 1.07 g glucose and 1.41 g sucrose per lozenge. BENACTIV GOLA Lemon and Honey flavour lozenges contain sulphites. It can rarely cause serious hypersensitivity reactions and bronchospasm. BENACTIV GOLA Lemon and Honey flavour lozenges contain only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and is very unlikely to cause problems for a patient with coeliac disease. One lozenge contains no more than 21.38 micrograms of gluten. If a patient is allergic to wheat (a condition other than coeliac disease) they should not take this medicine. BENACTIV GOLA Lemon and Honey flavour lozenges contain a flavouring which in turn contains citral, citronellol, d-limonene, farnesol, geraniol and linalool. Citral, citronellol, d-limonene, farnesol, geraniol and linalool can cause allergic reactions. BENACTIV THROAT Lemon and Honey flavoured lozenges contain a flavouring containing butylated hydroxyanisole which can cause localised skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. BENACTIV THROAT Sugar-Free Lozenges Orange flavoured are instead indicated for those patients who need to control their sugar and calorie intake. BENACTIV THROAT Sugar-Free Lozenges Orange flavoured contain a flavouring containing citral, citronellol, d-limonene, geraniol and linalool. Citral, citronellol, d-limonene, geraniol and linalool can cause allergic reactions. BENACTIV THROAT Sugar-Free Lozenges Orange flavoured contains liquid maltitol and isomalt. Patients with rare hereditary problems of fructose intolerance should not take this medicine. It may have a mild laxative effect. The caloric value of maltitol and isomalt is 2.3 kcal/g. Do not use for prolonged treatments beyond 7 days. If no appreciable results are noted after 3 days of treatment, the cause may be a different pathological condition. In these cases, it is advisable to consult your doctor.
