Benactiv Throat 16 Sugar-Free Orange Taste Tablets

€10.90
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Minsan
033262078
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WARNINGS
At the recommended doses, when using the product 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. The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation. In patients with renal, cardiac or hepatic insufficiency the product should be used with caution. It is advisable not to associate the product with other NSAIDs. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. Administer 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 events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms Mouthwash and spray contain para-hydroxy benzoates which may cause delayed-type allergic reactions , such as contact dermatitis; more rarely they can cause immediate reactions, with urticaria and bronchospasm. The lemon and honey flavored 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. Sugar-free tablets (including orange-flavored ones) are instead indicated for those patients who need to control the intake of sugars and calories. Orange flavored sugar-free tablets contain the color E110 which can cause allergic reactions.
PHARMACOTHERAPEUTIC CATEGORY
Dental.
STORAGE
Orange flavored sugar-free tablets: store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
>> Tablets: do not use in children under 12 years of age. Flurbiprofen is contraindicated in: patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs; patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment; patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding); patients with severe heart failure. Third trimester of pregnancy.
NAME
BENACTIV THROAT
EXCIPIENTS
>> Mouthwash and spray: glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E 131), purified water. >> Lemon and honey flavored tablets: sucrose, glucose, macrogol 300, potassium hydroxide, lemon flavor, menthol, honey. >> Sugar-free tablets: isomaltose, maltitol syrup, calcium carbonate, colloidal anhydrous silica, povidone, magnesium stearate, cherry essence. >> Orange flavored sugar-free tablets: macrogol 300, potassium hydroxide, orange flavor, levomenthol, acesulfame K, E110, maltitol syrup, isomaltose.
SIDE EFFECTS
Disorders of the blood and lymphatic system: thrombocytopenia, aplastic anemia and agranulocytosis. Immune system disorders: anaphylaxis, angioedema, allergic reaction. Nervous system disorders: dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, dizziness, discomfort, fatigue and somnolence. Acoustic and labyrinth disorders: tinnitus. Respiratory, thoracic and mediastinal disorders: reactivity of the respiratory tract (asthma, bronchospasm and dyspnoea). Disorders: gastrointestinal. The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported. Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Skin and subcutaneous tissue disorders: skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). Renal and urinary disorders: nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. Rare cases of renal failure have been reported. The topical use of the product, especially if prolonged, can give rise to sensitization or local irritation phenomena. The dissolution in the oral cavity of the product in the form of tablets can be accompanied by sensations of heat or tingling in the oropharynx. In such cases, treatment must be interrupted and appropriate therapy instituted if necessary.
PREGNANCY AND BREASTFEEDING
During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases. Administration of flurbiprofen is not recommended in nursing mothers.
INDICATIONS
>> Mouthwash and spray. 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. >> Pads. Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis).
INTERACTIONS
Attention should be paid in patients treated with any of the medicines listed below, as interactions have been reported in some patients. Concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects. Antiplatelet agents: increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Corticosteroids: increased risk of gastrointestinal ulcer or haemorrhage with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects.
DOSAGE
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. >> Mouthwash: 2-3 rinses or gargles a day with 10 ml (1 scoop) of mouthwash diluted in half a glass of water or pure. >> Spray: 2 sprays 3 times a day addressed directly to the affected area. Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient. >> Pads. Adults and children over 12 years: 1 tablet to be dissolved slowly in the mouth every 3-6 hours, depending on the need. Do not exceed the dose of 8 tablets in 24 hours. Do not administer to children under the age of 12. Dosage changes are not necessary for the elderly.
ACTIVE PRINCIPLES
Flurbiprofen.
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