LACTULOSE

Posology The lactulose solution may be administered diluted or undiluted. , to increase palatability. 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.

The starting dose can be adjusted after adequate treatment effect individually (maintenance dose). Several days (2-3 days) of treatment may be needed in some patients before adequate treatment effect occurs. g. during breakfast. 5-2 L/day, equal to 6-8 glasses).

If diarrhoea occurs, the dosing regimen should be reduced. 5 ml twice daily Adults: Initially 15 ml twice daily. Dosage can often be gradually reduced to 10-20 ml a day or every other day.

Elderly:

Lactulose has been shown to be a suitable laxative for use in the elderly at the standard adult dose.

Hepatic encephalopathy Children:

Not recommended for treatment of children (newborn to 18 years of age).

Adults:

Initially 30 - 50 ml (6 – 10 x 5 ml spoonfuls) three times daily. Dosage should be adjusted to produce two or three soft stools daily and an acidic faecal pH.

Elderly:

The standard adult dose is recommended. Because of the physiological mode of action of lactulose it may take up to 48 hours before effects are obtained. However, clinical experience has shown that this medicament does exhibit a “carry-over” effect which may enable the patient to reduce the effective dose gradually over a period of time.

Method of administration For oral administration only.

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 the event of diarrhoea, adequate fluid intake should be maintained during treatment and the dosage reduced to prevent loss of fluid and potassium, and exacerbation of encephalopathy.

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.

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 residues from manufacturing with known effect:

This product contains lactose, galactose and fructose from the route of production. Therefore, Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Lactulose should be administered with care to patients who are intolerant to lactose. This product contains lactose, galactose and small amounts of fructose. (Not more than 67 mg/ml lactose, 100 mg/ml galactose, 67 mg/ml epilactose, 27 mg/ml tagatose and 7 mg/ml fructose).

Long term use of this product is inadvisable except under medical supervision. 3 g/5 ml), therefore it should be used with caution in patients who are lactose intolerant. For patients with gastro-cardiac syndrome (Roemheld syndrome) lactulose should only be taken after consultation of a physician.

If symptoms like meteorism or bloating occur in such patients after lactulose intake, the dose should be reduced or the treatment should be discontinued. Lactulose may contain more than 5 g lactose/galactose/epilactose depending upon the dose taken.

1. • Galactosaemia • Acute inflammatory bowel disease (ulcerative colitis, Crohn’s disease), Gastrointestinal obstruction, or subocclusive syndromes, digestive perforation or risk of digestive perforation, painful abdominal syndromes of undetermined cause.