LACTULOSE BRISTOL LABORATORIES

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. For lactulose in bottles the measuring cup may be used. For lactulose in 15 ml single dose sachets the corner of the sachet should be torn off and contents taken immediately.

Dosing in constipation:

Lactulose may be given as a single daily dose or in two divided doses, for lactulose in bottles the measuring cup may be used. 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.

Lactulose oral solution in bottles:

Starting dose daily Maintenance dose daily Adults and adolescents 15-45 ml, corresponding to 10-30 g lactulose 15-30 ml, corresponding to 10-20 g lactulose Children (7-14 years) 15 ml, corresponding to 10 g lactulose 10-15 ml, corresponding to 7-10 g lactulose Children (1-6 years) 5-10 ml, corresponding to 3-7 g lactulose 5-10 ml, corresponding to 3-7 g lactulose Infants under 1 year up to 5 ml, corresponding to up to 3 g lactulose up to 5 ml, corresponding to up to 3 g lactulose * If the maintenance dose is below 15 ml, lactulose in bottles should be used.

For a precise dosing for infants and children up to 7 years lactulose in bottles should be used.

Dosing in hepatic encephalopathy (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. Paediatric population The safety and efficacy in children (newborn to 18 years of age) with HE have not been established.

No data are available. Elderly patients and patients with renal or hepatic impairment No special dosage recommendations exist, since systemic exposure to lactulose is negligible. Method of administration For administration by the oral route

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

Consultation of a physician is advised in case of: - 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 reconsidered. Long term use of this product is inadvisable except under medical supervision. 1). The dose normally used in constipation should not pose a problem for diabetics.

A dose of 30 ml provides 116 KJ (28 kcals) and is unlikely to adversely affect diabetics. The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics. Chronic use of unadjusted doses and misuse can lead to diarrohea and disturbance of the electrolyte balance.

g. patients with renal or hepatic impairment, patients receiving concomitant diuretics). Paediatric population Use of laxatives in children should be exceptional and under medical supervision. It should be taken into account that the defecation reflex could be disturbed during the treatment.

Important information regarding the ingredients of this medicine This medicine contains small amounts of lactose, galactose, fructose, tagatose and epilactose. Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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