LACTUGAL Unknown 3.4 g/5ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
LACTULOSE
Available from:
Intrapharm Laboratories Limited
Dosage:
3.4 g/5ml
Pharmaceutical form:
Unknown
Authorization date:
2004-10-08
Summary of Product characteristics
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
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