Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
BETAHISTINE DIHYDROCHLORIDE
Ergha Healthcare Ltd
16 Milligram
Tablets
2001-01-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT By-Vertin 16 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg betahistine dihydrochloride. Each tablet contains 140 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 9 mm. Embossed 'B16' on one side, scored reverse. The tablet can be divided into equal halves. 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. IRISH MEDICINES BOARD _____________________________________________________________________ Olvassa el a teljes dokumentumot