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  • Rogaron Orange & Honey Flavor
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    Active Ingredient

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Lozenges

    20

    not in the basket chart

    Dosage

    Adults and children over 6 years of age: one lozenge 3 times a day.
    The treatment must not exceed 7 days.
    Pediatric population children 6-11 years of age:
    The medicinal product should be administered under adult supervision.
    Children below 6 years of age: Due to the type of the pharmaceutical form, the administration should be restricted to children of more than 6 years of age.
    Method of administration for oropharyngeal use.
    Lozenge should be dissolved slowly in the mouth patients should not swallow or chew the lozenges.


    Indications

    Symptomatic local treatment of acute sore throat in adults and children above the age of 6 years.


    Contra-Indications

    Hypersensitivity to the active substance or to any of its excipients.
    Patients with phenylketonuria.
    Hypersensitivity to other NSAID’s (e.g.: ibuprofen) or salicylic acid.


    Special Precautions

    Benzydamine use is not advisable in patient with hypersensitivity to salicylic acid or other NSAIDs.  Notification Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients. In a minority of patients, buccal/pharyngeal ulceration may be caused by serious disease processes.
    Patients whose symptoms worsen or do not improve within 3 days, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate.
    – The medicinal product contains isomalt and patients with rare hereditary problems of fructose intolerance should not take this medicine.
    – This medicine contains 3.409 mg aspartame in each lozenge. Aspartame is a source of phenylalanine. It may be harmful for patient who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
    – Rogaron Orange-Honey contains Cochinille red colorant (E-124) which may cause allergic reactions.
    Please refer to the license holder for further details.


    Pregnancy and Lactation

    There are no data from the use of benzydamine in pregnant women.
    Breastfeeding
    There is insufficient information on the excretion of benzydamine in human milk.
    Please refer to the license holder for further details.

     


    Overdose

    Symptoms:  No overdose with the lozenge formulation has been reported. However, very rarely in children excitation, convulsions, sweating, ataxia, tremor and vomiting have been reported after the oral administration of benzydamine dosages about 100 times higher than those of the lozenge.
    Management in the event of acute overdose, only symptomatic treatment is possible; the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given supportive treatment. Adequate hydration must be maintained.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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