Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
BETAHISTINE HYDROCHLORIDE
Abbott Healthcare Products Ltd
8 Milligram
Tablets
1979-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serc 8mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg betahistine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white to almost white, round, flat tablet, imprinted ‘256’ on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual daily dose is 8 to 16 mg, three times daily taken preferably with meals. 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 Serc and antihistamines could be expected on a theoretical basis, no such interactions have been reported. 4.6 FERTILITY, PREGNANCY AND LACTATION Betahistine should only be used in pregnancy if considered essential by the physician. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/10/2011_ _CRN 2107201_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES It has been shown that at over 4 times the recommended daily dose, betahistine does not affect driving or psychomotor ability. 4.8 UNDESIRABLE EFFECTS Gastrointestinal disorde Lugege kogu dokumenti