Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMISULPRIDE
Clonmel Healthcare Ltd
100 Milligram
Tablets
2007-03-02
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0126/155/002 Case No: 2036128 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CLONMEL HEALTHCARE LIMITED WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SULPROMEL 100 MG TABLET The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 12/06/2007 until 29/02/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/06/2007_ _CRN 2036128_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sulpromel 100 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of amisulpride. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White round flat tablet with a break line. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sulpromel is indicated in the treatment of schizophrenia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION As a general rule, amisulpride is administered once daily at doses up to 400 mg whereas doses above 400 mg are administered twice daily. _PREDOMINANT NEGATIVE EPISODES_ The recommended dosage is from 50 to 300 mg per day. Dosage Read the complete document