LACTULOSE

Posology The lactulose solution may be administered diluted or undiluted. Each dose may if necessary be taken with water or fruit juices, etc. Each 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. g. during breakfast. 5–2 litres, equal to 6-8 glasses) during the day.

Dosing in constipation:

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 daily Maintenance dose daily Adults and adolescents 15-45 ml 15-30 ml Children (7-14 years) 15 ml 10-15 ml Children (1-6 years) 5-10 ml 5-10 ml Infants under 1 year up to 5 ml up to 5 ml Dosing in HE (for adults only): Starting dose: 3 to 4 times daily 30-45 ml (6-9 x 5 ml spoonfuls).

This dose may be adjusted to the maintenance dose to achieve two or three soft stools each day.

Method of Administration Oral use Special populations Paediatric population:

The safety and efficacy in children (newborn to 18 years of age) with hepatic encephalopathy (HE) have not been established. No data are available.

Elderly patients and patients with renal or hepatic insufficiency:

No special dosage recommendations exist, since systemic exposure to lactulose is negligible.

Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.

See also overdose section

Painful abdominal symptoms of undetermined cause should be evaluated to exclude undiagnosed perforation or obstruction or undiagnosed disease/condition that predisposes to either before the treatment is started. In case of insufficient therapeutic effect after several days the dose and/or additional measures should be re-considered.

Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance. It should be taken into account that the defaecation reflex could be disturbed during the treatment. The dose normally used in constipation should not pose a problem for diabetics.

The dose used in the treatment of HE is usually much higher and may need to be taken into consideration for diabetics.

Information on related sugars from the route of synthesis with known effect:

This product may contain small amounts of lactose, galactose and fructose from the route of synthesis. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.

1 List of excipients). Paediatric population Use of laxatives in children should be exceptional and under medical supervision.

1. • Galactosaemia. • Gastro-intestinal obstruction, perforation or risk of perforation.