Benactiv Throat Lozenges Lemon And Honey Flurbiprofen 16 Lozenges

RECKITT BENCKISER

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033262027

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BENACTIV THROAT

Active ingredients BENACTIV THROAT Mouthwash . 100 ml of mouthwash contain: active ingredient: flurbiprofen 250 mg. Excipients with known effects: hydrogenated castor oil-40-polyoxyethylenate, methyl parahydroxybenzoate, propyl parahydroxybenzoate BENACTIV THROAT Spray for oral mucosa . 100 ml of solution contain: active ingredient: flurbiprofen 250 mg. Excipients with known effects: hydrogenated castor oil-40-polyoxyethylenate, methyl parahydroxybenzoate, propyl parahydroxybenzoate BENACTIV THROAT Lemon and Honey flavored tablets . One tablet contains: active ingredient: flurbiprofen 8.75mg. Excipients with known effects: glucose, sucrose BENACTIV THROAT Sugar-free tablets Orange flavor . One tablet contains: active ingredient: flurbiprofen 8.75mg. Excipients with known effects: sunset yellow (E110), maltitol syrup, isomaltose For the full list of excipients, see section 6.1 .

Excipients BENACTIV THROAT Mouthwash . Glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E131), purified water. BENACTIV THROAT Spray for oral mucosa . Glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E131), purified water. BENACTIV THROAT Lemon and Honey flavored tablets . Sucrose, glucose, macrogol 300, potassium hydroxide, lemon flavor, menthol, honey. BENACTIV THROAT Sugar-free Orange flavored tablets . Macrogol 300, potassium hydroxide, orange flavor, levomenthol, acesulfame K, E110, maltitol syrup, isomaltose.

BENACTIV THROAT Mouthwash . BENACTIV THROAT Spray for oral mucosa . Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy. BENACTIV THROAT Lemon and Honey flavored tablets . BENACTIV THROAT Sugar-free Orange flavored tablets . Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis).

Contraindications Do not use the medicine in children under 12 years of age. Flurbiprofen is contraindicated in patients with known hypersensitivity to flurbiprofen or to any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm) to ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. Flurbiprofen should not be taken by patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe, severe heart failure hepatic insufficiency and renal insufficiency (see section 4.4). Third trimester of pregnancy.

Posology Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). BENACTIV THROAT Mouthwash . Dosage . Adults : 2-3 rinses or gargles per day with 10 ml (1 scoop) of mouthwash. Pediatric population . Children over 12 years of age: same 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 : Currently available clinical data are limited, therefore no recommendation on a posology can be made. The elderly have an increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic insufficiency : Dosage reduction is not necessary in patients with mild to moderate hepatic insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal insufficiency : Dosage reduction is not necessary in patients with mild to moderate renal insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration : For oropharyngeal use. Rinse or keep in mouth while gargling for up to 1 minute. Do not swallow. The mouthwash can be used pure or diluted in half a glass of water. BENACTIV THROAT Spray for oral mucosa . Dosage . Adults : apply one dose (2 sprays) 3 times a day, addressed directly to the affected part. Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient. Pediatric population . Children over 12 years of age: same 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 : Currently available clinical data are limited, therefore no recommendation on a posology can be made. The elderly have an increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic insufficiency : Dosage reduction is not necessary in patients with mild to moderate hepatic insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal insufficiency : Dosage reduction is not necessary in patients with mild to moderate renal insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration : For oropharyngeal use. Point the nozzle towards the back of the throat and spray on the affected area. BENACTIV THROAT Lemon and Honey flavored tablets . BENACTIV THROAT Sugar-free Orange flavored tablets . Dosage . Adults : 1 tablet every 3-6 hours, as needed. Do not exceed the dose of 8 tablets in 24 hours. Pediatric population . Children over 12 years of age: same 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 : Currently available clinical data are limited, therefore no recommendation on a posology can be made. The elderly have an increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic insufficiency : Dosage reduction is not necessary in patients with mild to moderate hepatic insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal insufficiency : Dosage reduction is not necessary in patients with mild to moderate renal insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration : For oropharyngeal use. Slowly dissolve in the mouth. As with all lozenges, in order to avoid local irritation, flurbiprofen lozenges should also be moved around the mouth during administration. If mouth irritation occurs, treatment should be discontinued.

Storage Benactiv Throat Tablets Sugar-Free Orange flavor and Benactiv Throat Tablets Lemon and Honey flavor: store at a temperature below 25 ° C.

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 haemorrhage and perforation, which can be fatal. Respiratory disorders : There have been reports of bronchospasm 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 have an increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with products intended for limited and short-lived use 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 can cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at the highest 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 observed with products intended for limited and short-term use such as flurbiprofen. Cardiovascular and cerebrovascular effects : Before starting treatment in patients with a history of hypertension and / or heart failure, caution is required (discuss with your doctor or pharmacist), as fluid retention, hypertension have been reported in association with treatment with NSAIDs. and edema. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking). Effects on the central nervous system : Analgesic induced headache. Headache may occur with prolonged or unregulated use of analgesics, which should not be treated by increasing the dose of the medicine. 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, ulcer 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 with the lowest available dose. Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse reactions can be fatal and can occur with or without warning symptoms or with a previous history of severe gastrointestinal reactions. Patients with a history of gastrointestinal disease, especially if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2). Caution should be advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be stopped. Dermatological effects : The use of the medicine, especially if prolonged, can give rise to sensitization or local irritation phenomena. In such cases it is necessary to stop the treatment and consult a doctor to establish, if necessary, a suitable therapy. 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 rash, mucosal lesions or any other signs of hypersensitivity. Infections : Since isolated cases of infection-related exacerbation of inflammation (e.g. development of necrotizing fasciitis) have been reported in temporal association with systemic use of NSAID drugs, it is recommended that patients seek immediate medical attention. if signs of a bacterial infection appear or worsen during flurbiprofen therapy. A possible indication should be considered at the start of antibiotic therapy. If mouth irritation develops, treatment should be discontinued. BENACTIV THROAT Mouthwash and BENACTIV THROAT Spray contain para-hydroxy-benzoates which can cause delayed allergic reactions, such as contact dermatitis; more rarely they can cause immediate reactions, with hives and bronchospasm. BENACTIV THROAT Lemon and Honey flavor tablets contain 1.069 g of glucose and 1.407 g of sucrose per tablet. Not recommended in hereditary fructose intolerances, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency. BENACTIV THROAT Sugar-free Orange flavored tablets is instead indicated for those patients who need to control the intake of sugars and calories. BENACTIV THROAT Sugar-free Orange flavored tablets contain the coloring agent E110 which can cause allergic reactions. Do not use for prolonged treatments beyond 7 days. If no appreciable results are seen after 3 days of treatment, the cause could be a different pathological condition. In these cases it is advisable to consult your doctor.

Effects Hypersensitivity reactions to NSAIDs have been reported and these may consist of: (a) non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea; (c) various skin disorders, including for example skin rashes of different types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme). The most commonly observed adverse reactions are gastrointestinal in nature. Local use of the drug, especially if prolonged, can give rise to sensitization or local irritation. The dissolution of the medicine in tablet form in the mouth may be accompanied by sensations of heat or tingling in the oropharynx. In such cases, treatment must be interrupted and appropriate therapy instituted if necessary. The following undesirable effects have been reported, particularly after administration of formulations for systemic use. They refer to those detected with the use of flurbiprofen used in the short term and at doses compatible with the classification of self-medication. When treating chronic conditions and over long periods of time, additional side effects may occur. Undesirable effects associated with the use of flurbiprofen are categorized below by system organ class and frequency. Frequencies are defined as: 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) and not known (cannot be estimated from the available data). Within each frequency group, undesirable effects are reported in order of decreasing severity.

System and organ classification	Frequency	Adverse reactions
Disorders of the blood and lymphatic system	Not known	Anemia, thrombocytopenia, aplastic anemia and agranulocytosis
Nervous system disorders	Common	Dizziness, headache, paraesthesia
	Uncommon	Drowsiness
	Not known	Cerebrovascular accidents, optic neuritis, migraine, confusional states, vertigo
Disorders of the immune system	Rare	Anaphylactic reactions
Disorders of the immune system	Not known	Angioedema, hypersensitivity
Eye disorders	Not known	Visual disturbances
Ear and labyrinth disorders	Not known	Tinnitus
Cardiac pathologies	Not known	Heart failure, edema
Vascular pathologies	Not known	Hypertension
Respiratory, thoracic and mediastinal disorders	Common	Throat irritation
Respiratory, thoracic and mediastinal disorders	Uncommon	Asthma, bronchospasm and dyspnoea, blisters in the oropharynx, oropharyngeal hypoesthesia
Gastrointestinal disorders	Common	Diarrhea, mouth ulcers, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling of the mouth)
	Uncommon	Abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysesthesia, vomiting
	Not known	Melena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage
Skin and subcutaneous tissue disorders	Uncommon	Rash, itching
Skin and subcutaneous tissue disorders	Not known	Urticaria, purpura, bullous dermatitis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme)
Renal and urinary disorders	Not known	Nephrotoxicity, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs)
General disorders and administration site conditions	Uncommon	Pyrexia, pain
General disorders and administration site conditions	Not known	Discomfort, fatigue
Hepatobiliary disorders	Not known	Hepatitis
Psychiatric disorders	Uncommon	Insomnia
Psychiatric disorders	Not known	Depression, hallucination

Reporting of suspected adverse reactions . Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdose Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur. Symptoms The majority of patients who ingest clinically significant amounts of NSAIDs develop nausea, vomiting, gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of NSAID intoxication, central nervous system toxicity is observed, manifesting as drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Occasionally patients develop seizures. In the event of severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time / INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage can occur. An exacerbation of asthma in asthmatics is possible. 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 and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Pregnancy Pregnancy: Flurbiprofen should not be administered during the first and second trimester of pregnancy unless strictly necessary. The use of flurbiprofen during the third trimester of pregnancy is contraindicated. Lactation: In a limited number of studies, flurbiprofen appears in breast milk in very low concentrations and is unlikely to have adverse effects on the breastfed infant. However, administration of flurbiprofen is not recommended in nursing mothers. Fertility : There is evidence indicating that cyclooxygenase / prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.

Package leaflet source: Farmadata

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