DUPHALAC Oral solution Ref.[50851] Active ingredients: Lactulose

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Duphalac 3.335 g/5 ml Oral Solution.

Pharmaceutical Form

Oral solution.

Clear, colourless to pale brownish-yellow viscous liquid.

Qualitative and quantitative composition

Lactulose 3.335 g per 5 ml oral solution (as Lactulose, liquid 667 g/l).

For a full list of excipients, see section 6.1.

Duphalac contains residues from the route of production with known effect, see section 4.4.

Active Ingredient Description
Lactulose

Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut. Its mode of action in constipation is as an osmotic agent producing soft stools.

List of Excipients

None.

Pack sizes and marketing

Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300 or 1000 ml, with a polypropylene measuring cup.

The graduations on the measuring cup are: 2.5ml, 5ml, 10ml, 15ml, 20ml, 25ml and 30ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/009/001

Date of first authorisation: 01 April 1983
Date of last renewal: 01 April 2008

Drugs

Drug Countries
DUPHALAC Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Malta, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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