Prescribing information:

Product name: Duphalac®, Duphalac® Fruit, oral solution.

Active ingredient: Lactulose.

Therapeutic indications: Constipation: regulation of the physiological rhythm of the colon. Where a soft stool is considered of medical benefit. 

Dosing recommendations: Starting/maintenance dose oral solution: Infants < 1 yr: up to 5 ml. Children (1-6 yrs and 7-14 yrs): 5-10 ml, 15 ml respectively; maintenance dose: 5-10 ml, 10-15 ml respectively. Adults/adolescents: Starting dose 15-45 ml, maintenance dose 15-30 ml.

Contraindications: Hypersensitivity to the active substance/ingredients. Contra-indicated in patients with galactosaemia and in patients with gastrointestinal obstruction, digestive perforation or risk of digestive perforation.

Special warnings and precautions: Consult physician in case of painful abdominal symptoms of undetermined cause before treatment is started and in case of insufficient therapeutic effect after several days. Administer with care to lactose intolerant patients. Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance. Patients with the rare hereditary problem of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Trademark Fruit contains 0.4 vol % ethanol, i.e. up to 160 mg per dose.

Side effects: Flatulence may occur during first few days of treatment. Very common (may affect more than 1 in 10 people): diarrhea; Common (may affect up to 1 in 10 people): Flatulence, nausea, vomiting, abdominal pain; Uncommon (may affect up to 1 in 100 people): electrolyte imbalance due to diarrhea.

For further prescribing information, please consult your local prescribing information.