Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
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 encephalopythy 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 a more than 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.

During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 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.

Effects on Driving

4.7 Effects on ability to drive and use machines
Lactulose has no or negligible influence on the ability to drive and use machines.