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
(1) In the symptomatic treatment of constipation.
(2) In the treatment of hepatic encephalopathy.
The lactulose solution may be administered diluted or undiluted.
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids during the day.
Lactulose may be given as a single daily dose or in two divided doses.
After a few days, the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs.
Starting dose: 3 to 4 times daily 30-45 ml.
This dose may be adjusted to the maintenance dose to achieve 2 to 3 soft stools per day.
The safety and efficacy of Lactecon in children (newborn to 18 years of age) with hepatic encephalopathy have not been established. No data are available.
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
Oral use.
For Lactecon in bottles the measuring cup may be used to administer the appropriate dose.
If the dose is too high, the following may occur:
Symptom: diarrhoea, loss of electrolytes and abdominal pain.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Three years.
Do not store above 25°C. Do not refrigerate.
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.
No special requirements.
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