Lactulose Solution BP /Duphalac®.

Lactulose 3.35 g/5 ml.

For excipients, see 6.1

A colourless to brownish yellow, clear or not more than slightly opalescent liquid.

1. For the treatment of constipation.

2. For the treatment of hepatic encephalopathy (portal systemic encephalopathy); hepatic coma.

Constipation:

Adults (including the elderly): initially 15 ml twice daily

Children 5 to 10 years: 10 ml twice daily

Children under 5 years:5 ml twice daily

Babies under 1 year: 2.5 ml twice daily

All dosages should subsequently be adjusted to the needs of the individual. Each dose may if necessary be taken with water or fruit juices, etc.

Hepatic encephalopathy:

Adults (including the elderly): Initially 30 - 50 ml (6-10 x 5 ml spoonfuls) three times a day. Subsequently adjust the dose to produce two or three soft stools each day.

Children: no dosage recommendations for this indication.

Contraindicated in patients with galactosaemia and in cases of gastro-intestinal obstruction.

The lactose content should be taken into account when treating patients with lactose intolerance.

None known.

Pregnancy: Wide clinical experience, together with data from animal reproduction studies has not revealed any increase in embryotoxic hazard to the foetus, if used in the recommended dosage during pregnancy. If drug therapy is needed during pregnancy, the use of this drug is acceptable.

Lactation: This product can be used by nursing mothers feeding their offspring.

Not known.

Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. See also overdose section 4.9.

If high doses (normally only associated with portosystemic encephalopathy, PSE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Dosage should then be adjusted to obtain two or three formed stools per day.

Gastrointestinal disorders

Flatulence, abdominal pain, nausea and vomiting. If dosed too high, diarrhoea.

Investigations

Electrolyte imbalance due to diarrhoea.

If the dose is too high, the following may occur:

Symptom: diarrhoea and abdominal pain.

Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

No specific antidote. Symptomatic treatment should be given.

The active ingredient, lactulose, is metabolised in the colon by the sacchrolytic bacteria, producing low molecular weight organic acids, mainly lactic acid, which lower the pH of the colon contents, promote the retention of water by an osmotic effect, thus increasing peristaltic activity.

Lactulose is minimally absorbed; therefore, the kinetics of the absorbed material are not relevant to the principal therapeutic action.

The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed appear to be more related to the effect of bulk in gastrointestinal tract than to a more specific toxic activity.

None.

None known.

HDPE: 2 years. Other containers: 3 years.

Do not store above 25°C. Do not refrigerate or freeze.

Brown glass and white HDPE bottles containing 200, 300, 500 and 1000 ml; polyethylene bottles containing 5 litres; 15 ml foil sachets.

None.

Solvay Healthcare Limited/Solvay Healthcare Ltd trading as Mansbridge Pharmaceuticals

Mansbridge Road

West End

Southampton

SO18 3JD

PL 00512/5001R

14.03.88 / 23.07.99

May 2009