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IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0030/043/001
Case No: 2061350
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS CONSUMER HEALTH UK LTD
WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LACTULOSE LIQUID PH. EUR. 67% W/V 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 12/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/06/2009_
_CRN 2061350_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Liquid Ph. Eur. 67% w/v Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of Lactulose Solution contains 3.35 g of Lactulose.
Excipients: also includes Lactose and Galactose <1.34g per 5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear to almost colourless to pale yellow syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chronic constipation.
Chronic portal systemic encephalopathy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHRONIC CONSTIPATION
Because lactulose acts naturally to encourage the normal activity of the b
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