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  • Agiserc
    / Perrigo


    Active Ingredient
    Betahistine (dihydrochloride) 16 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30 X 16 mg

    not in the basket chart 8774 1042

    Dosage

    Adults: The usual optimal dose for adults (including the elderly) is 16 mg 3 times daily.
    An initial dose of 8 mg 3 times daily is possible if required.
    The daily dose varies from 24 to 48 mg, and it should be divided into three doses in order to achieve less variable plasma concentrations.
    It is recommended that the tablets/divided tablets are swallowed whole.
    The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease.
    Paediatric population: Agiserc is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
    Geriatric population: Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population.
    Renal insufficiency: There are no specific clinical trials available in this patient group. According to post marketing experience no dose adjustment appears to be necessary.
    Hepatic insufficiency: There are no specific clinical trials available in this patient group, but according to post marketing experience no dose adjustment appears to be necessary.


    Indications

    Meniere’s syndrome.
    Symptomatic treatment of peripheral vertigo.


    Contra-Indications

    Phaeochromocytoma.
    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Particular caution should be observed in the treatment of patients with bronchial asthma and those with a history of gastric or duodenal ulcer.


    Side Effects

    Headache, nausea and dyspepsia.
    See prescribing information for full details.


    Drug interactions

    No in vivo interaction studies have been performed.
    Based on data from in vitro studies, the product is not an inhibitor of CYP450 in vivo. In vitro data indicate an inhibition of betahistine metabolism by medicines that inhibit monoamino-oxidase (MAO), including MAO subtype B (e.g. selegiline).
    Caution is recommended in the concomitant use of betahistine and MAO inhibitors (including MAO-B selective).
    As betahistine is an analogue of histamine, interactions of betahistine with antihistamines may in theory affect the efficacy of one of these medicines.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of betahistine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown.
    Betahistine should not be used during pregnancy unless clearly necessary.
    Lactation: It is not known whether betahistine is excreted in human milk. Excretion has not been investigated in animal studies. The benefits of the product to the mother and the benefits of nursing should be weighed against the potential risks for the child.


    Overdose

    A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain).
    More serious complications- e.g. convulsions, pulmonary or cardiac complications – were observed in cases of intentional overdose particularly when betahistine was taken simultaneously with other medicines.
    Standard supportive therapy is recommended in overdose cases.


    Manufacturer
    Perrigo Israel
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