Honey and lemon flavored sore throat lozenges.
Indications
Froben Activ are lozenges for the symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis).
Composition
Active ingredients per lozenge: flurbiprofen 8.75 mg.
Excipients: Sucrose, glucose, macrogol, potassium hydroxide, lemon flavoring, levomenthol, honey.
Directions for use and Dosage
Adults and children Over 12 years: 1 lozenge to dissolve slowly in the mouth every 3–6 hours, as needed.
Do not exceed a dose of 8 lozenges in 24 hours. Do not administer to children under 12 years of age. No dosage adjustments are necessary for elderly people.
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. Use of the product, especially if prolonged, may give rise to sensitization or local irritation; in such cases, treatment should be discontinued and a doctor should be consulted to institute appropriate therapy, if necessary. The product should be used with caution in patients with renal, cardiac, or hepatic insufficiency. It is advisable not to combine the product with other NSAIDs. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma.
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 events can be fatal and may occur with or without warning symptoms or in the presence of a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in the course of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Important information about some of the ingredients:The medicinal product contains 1.095 g glucose and 1.375 g sucrose per tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Do not use for long-term treatment. After short periods of treatment without appreciable results, consult your doctor. Keep this medicine out of the sight and reach of children.
For further information, read the package leaflet carefully.
Pregnancy and breastfeeding
During the first and second trimesters of pregnancy, flurbiprofen should not be administered unless strictly necessary. The medicine administered during pregnancy may delay the onset of labor and increase its duration. The administration of flurbiprofen is not recommended for breastfeeding mothers.
Format
16 Tablets.
Product Code:FRCM121283
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