Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BETAHISTINE HYDROCHLORIDE
PCO Manufacturing
8 Milligram
Tablets
1987-08-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serc 8 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg of betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from France and Spain:_ White, round, flat tablets, imprinted ‘256’ on one face and ‘S’ on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of vertigo, tinnitus, and hearing loss associated with Meniere’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral _Adults only:_ The usual dose is 8 to 16mg, three times daily preferably with meals 4.3 CONTRAINDICATIONS o Hypersensitivity to any component of the product o Use concurrently with antihistamines. o Use in children. o Use in phaeochromocytoma. 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 administrating betahistine to patients with bronchial asthma. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions have been reported. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2009_ _CRN 2064908_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Betahistine should only be used in pregnancy if considered essential by the physician. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES It has been shown that at over 4 times the recommended dai Read the complete document