LACTULOSE

Posology 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).

Constipation:

Starting dose Maintenance dose Adults 15-45 ml corresponding to 10-30 g lactulose 15-30 ml corresponding to 10-20 g lactulose Paediatric population Starting dose Maintenance dose Adolescents over 14 years 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 Babies up to 5 ml corresponding to up to 3 g lactulose If diarrhoea occurs, the dosing regimen should be reduced.

Treatment of portal systemic encephalopathy - for adults only:

Beginning with 30-50 ml 3 times daily (corresponding to 60-100 g Lactulose). 5. In elderly patients and patients with renal or hepatic insufficiency no special dosage recommendations exist. Paediatric population The safety and efficacy in children aged 0-18 years has not been established.

No data are available. Method of administration The lactulose solution may be administered diluted or undiluted. The dose should be titrated according to the clinical response. Lactulose may be given as a single daily dose or up to three divided daily doses, using the measuring cup.

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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.

Gastrointestinal disorders Very common (≥ 1/10): flatulence, abdominal pain. Common (≥ 1/100 < 1/10): nausea and vomiting; if dosed too high, diarrhoea. Investigations Electrolyte imbalance due to diarrhoea. Immune system disorders Not known (frequency cannot be estimated from the available data): hypersensitivity reactions Skin and subcutaneous tissue disorders Not known (frequency cannot be estimated from the available data): rash, pruritus, urticaria Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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In case of insufficient therapeutic effect after several days consultation of a physician is advised. From the route of synthesis Lactulose may contain traces of sugars (not more than 67 mg/ml lactose, 100 mg/ml galactose, 67 mg/ml epilactose, 27 mg/ml tagatose and 7 mg/ml fructose).

Lactulose should be administered with care to patients who are intolerant to lactose. The dose normally used in constipation should not pose a problem for diabetics. However, higher doses used for treatment of portal systemic encephalopathy may need to be taken into considerations for diabetics.

15 ml of Lactulose contain 42,7 KJ (10,2 kcals) = 0,21 bu. The defecation reflex may be altered during the treatment with lactulose. Patients with rare hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose mal-absorption should not take this medicine.

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.

Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance. For elderly patients or patients that are in bad general condition and who take lactulose for more than a 6 months period, periodic control of electrolytes is indicated.

In patients with portal systemic encephalopathy, concomitant administration of other laxatives should be avoided, because it hinders the individualization of drug dose. Furthermore, for the patients referred above, it should be taken into account the chance of causing electrolyte imbalance and, mainly, hypokalaemia that could aggravate encephalopathy.

5-2 l/day, equal to 6-8 glasses). Paediatric population Use of laxatives in children should be exceptional and under medical supervision. Lactulose should be administrated with caution in infants and small children with autosomal recessive hereditary fructose intolerance.

1. - Use in patients with 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.

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