DUPHALAC SYRUP 120ML
Each 5 mL of Duphalac contains lactulose 3.3 g.
Duphalac does not contain any excipients but may contain small amounts of related sugars (eg, lactose, galactose, epilactose, fructose) derived from the route of synthesis
Indications / Uses :
Constipation: Regulation of the physiological rhythm of the colon. It is where a soft stool is considered of medical benefit (hemorrhoids, post colonic/anal surgery).
Hepatic Encephalopathy: Treatment and prevention of hepatic coma or precoma.
May be taken with or without food: Swallow dose in one, do not keep in mouth for an extended period of time. For single daily dose, should be taken at the same time eg, during breakfast.
Hypersensitivity to lactulose or to any of the excipients of Duphalac.
Galactosemia and gastrointestinal obstruction, digestive perforation or risk of digestive perforation.
Special Precautions :
Consultation of a physician is advised in case of painful abdominal symptoms of undetermined cause before the treatment is started and insufficient therapeutic effect after several days.
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. The dose used in the treatment of HE is usually much higher and may need to be taken into consideration for diabetics.
Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance.
Duphalac contains lactose, galactose and small amounts of fructose. Therefore, patients with the rare heredity problem of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Duphalac.
Effects on the Ability to Drive or Operate Machinery: Lactulose has no or negligible influence on the ability to drive and use machines.
Impairment of Fertility: No effects are to be expected, since systemic exposure to lactulose is negligible.
Use in pregnancy: No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
Lactulose can be used during pregnancy.
Use in lactation: No effects on the breastfed newborn/infant are anticipated, since the systemic exposure of the breastfeeding woman to lactulose is negligible.
Lactulose can be used during breastfeeding.
Use in children: The safety and efficacy in children (newborn to 18 years) with HE have not been established.
No data are available.
Use of laxatives in children should be exceptional and under medical supervision.
It should be taken into account that the defecation reflex could be disturbed during treatment.