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
Duphalac 3.335 g/5 ml Oral Solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless to pale brownish-yellow viscous liquid. |
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. |
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.
Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
PA2010/009/001
Date of first authorisation: 01 April 1983
Date of last renewal: 01 April 2008
| Drug | Countries | |
|---|---|---|
| DUPHALAC | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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