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
Lactecon 3.335g/5ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. A clear, viscous liquid, colourless to brownish yellow. |
Lactulose 3.335g per 5 ml oral solution (as Lactulose, liquid 667 g/l).
For a full list of excipients, see section 6.1.
Lactecon 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. |
Bottles of HDPE with polypropylene closures, containing 200, 300, 500 or 1000 ml; with a polypropylene measuring cup. The graduations on the measuring cup are: 2.5 ml, 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and 30 ml.
Not all pack sizes may be marketed.
Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
PA2010/014/001
Date of first authorisation: 08 December 2000
Date of last renewal: 28 July 2010
| Drug | Countries | |
|---|---|---|
| LACTECON | Ireland, Romania |
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