DUPHALAC Oral solution

- if you are hypersensitive (allergic) to lactose or to any of the ingredients of Duphalac oral solution

- if you suffer from galactosaemia

- if you suffer from gastrointestinal obstruction, digestive perforation or risk of digestive perforation.

No interaction studies with other medications have been performed.

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

During pregnancy, no effects to the fetus are anticipated, since systemic exposure of lactulose to the pregnant woman is negligible.

Duphalac can be used during pregnancy.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of lactulose to the breast-feeding woman is negligible.

Duphalac oral solution can be used during breastfeeding.

Consultation of a physician is advised in case of:

- Painful abdominal symptoms of undetermined cause before the treatment is started.

- Insufficient therapeutic effect after several days.

If the desired results are not observed after several days of treatment, consult your doctor. Patients who are intolerant to lactose should take Duphalac oral solution with care (because it contains lactose).

The dose normally used in constipation should not pose a problem for diabetics. However, the dose used in the treatment of HE is usually much higher and should be taken into consideration for diabetics.

Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.

Paediatric population

See the package insert about the details.

This product contains lactose, galactose and small amounts of fructose. Therefore, patients with the rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pharmacotherapeutic group: Osmotically acting laxatives

In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lower the pH in the colonic lumen and increase the volume of the colonic contents via an osmotic effect. These effects stimulate peristalsis of the colon and return normal consistency of the stool. Constipation is corrected and the physiological rhythm of the colon is reinstated.

In hepatic encephalopathy (HE), the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect and alteration of bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis. Within this context, however, it should be realized that hyperammonemia alone cannot explain the neuropsychiatric manifestations of HE. The ammonia might, however, severe as a model compound for other nitrogenous substances.

Lactulose as a prebiotic substance strengthens the growth of health promoting bacteria, like Bifidobacterium and Lactobacillus, whereas potentially pathogenic bacteria, like Clostridium and Escherichia coli may be suppressed.

This may lead to a more favorable balance of the intestinal flora.