DUPHALAC Oral solution Ref.[50851] Active ingredients: Lactulose

Painful abdominal symptoms of undetermined cause should be evaluated to exclude undiagnosed perforation or obstruction or undiagnosed disease/condition that predisposes to either before the treatment is started.

In case of insufficient therapeutic effect after several days the dose and/or additional measures should be re-considered.

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 diarrohea and disturbance of the electrolyte balance.

It should be taken into account that the defecation reflex could be disturbed during the treatment.

Information on residues from manufacturing with known effect

This product contains lactose, galactose and fructose from the route of production. Therefore, patients with the rare hereditary problem of galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Duphalac should be administered with care to patients who are intolerant to lactose.

This product contains sulphite from the route of production.

Paediatric population

Use of laxatives in children should be exceptional and under medical supervision.

Although lactulose could theoretically delay the intestinal release of mesalazine from modified-release preparations, a study found no evidence that lactulose influenced the release or disposition of mesalazine in healthy volunteers.

Fertility

No effects are to be expected, since systemic exposure to lactulose is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.

Duphalac can be used during pregnancy when considered necessary by the physician.

Lactation

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

Duphalac can be used during breastfeeding.

Duphalac has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than instructed are used, abdominal pain and diarrhea may occur. In such a case the dosage should be decreased.

If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.

Tabulated list of adverse reactions

The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients in placebo-controlled clinicial trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)]; Not known (cannot be estimated from the available data)

^* Post-marketing experience

Paediatric population

The safety profile in children is expected to be similar as in adults.

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 HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.