Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
BETAHISTINE DIHYDROCHLORIDE
PCO Manufacturing
BETAHISTINE DIHYDROCHLORIDE
16 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2010-12-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serc 16mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16mg betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Belgium and Spain:_ Circular, flat, white to almost white tablets imprinted with '267' on either side of a Breakline on one side and S on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Initially 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. 4.3 CONTRAINDICATIONS Hypersensitivity to any component of the product. Use in phaeochromocytoma. Use concurrently with antihistamines Use in children 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial asthma patients has been shown in a relatively few patients and therefore caution should be exercised when administering betahistine to patients with bronchial asthma. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Although an antagonism between betahistine and antihistamines could be expected on a theoretical basis, no such interactions have been reported. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/10/2010_ _CRN 2083852_ _page number: 1_ 4.6 PREGNANCY AND LACTATION There is insufficient data on the use of this drug during pregnancy to evaluate possible harmful effects. There are no indications of harmful effects in animal testing. Betahisti Soma hati kamili