Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BETAHISTINE DIHYDROCHLORIDE
Ergha Healthcare Ltd
8 Milligram
Tablets
2001-01-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT By-Vertin 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg betahistine dihydrochloride. Each tablet contains 70 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Cylindrical, biplane white tablet with bevel-edges on both sides, diameter 7 mm. Embossed 'B8' on one side, plain reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betahistine is indicated for the treatment of vertigo, tinnitus, hearing loss and nausea associated with Ménière´s syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dosage_ Adults (including the elderly): Initial oral treatment is 8 to 16 mg three times daily, taken with food. Maintenance doses are generally in the range 24 - 48 mg daily. Dosage can be adjusted to suit individual patient needs. Children: Betahistine tablets are not recommended for use in children. Betahistine efficacy and safety have not been studied in children and adolescents below the age of 18 years. 4.3 CONTRAINDICATIONS Betahistine is contraindicated in patients with phaeochromocytoma. As betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension. Also contraindicated are the following: o Known hypersensitivity to betahistine hydrochloride and/or any other excipient. o Concurrent use with antihistamines. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is advised in the treatment of patients with peptic ulcer or a history of peptic ulceration, because of the occasional dyspepsia encountered in patients on betahistine. Caution should be exercised in patients with bronchial asthma. IRISH MEDICINES BOARD _______________________________________________________ Read the complete document