Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LACTULOSE
Intrapharm Laboratories Limited
3.4 g/5ml
Unknown
2004-10-08
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0997/008/001 Case No: 2036757 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to INTRAPHARM LABORATORIES LIMITED 60 BOUGHTON LANE, MAIDSTONE, KENT ME15 9QS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product LACTUGAL 3.4 G/5ML ORAL SOLUTION 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 08/06/2007 until 16/10/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/06/2007_ _CRN 2036757_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lactugal 3.4g/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of solution contains 3.4g lactulose. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution A yellow, banana-flavoured solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of hepatic encephalopathy and constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. HEPATIC ENCEPHALOPATHY ADULTS: Initially 30-50ml three to four times daily; dosage should be subsequently adjusted to produce 2-3 soft stools daily and an acidic faecal pH. CONSTIPATION ADULTS: Initially 15ml Read the complete document