Abbott Healthcare Products Limited

Duphalac 3.335 g / 5 ml Oral Solution

Lactulose solution containing 3.335 g of lactulose per 5 ml.

For a full list of excipients, see section 6.1

Oral solution.

Clear, colourless to pale brownish – yellow viscous liquid.

(1) In the treatment of constipation.

(2) In the treatment of hepatic encephalopathy.

Hepatic Encephalopathy

Initially 30 to 50 ml three times daily; dosage should be subsequently adjusted to produce 2 to 3 soft stools daily and an acidic faecal pH.

1. Use in patients who require a galactose-free diet.

2. Use in patients with evidence of gastrointestinal obstruction.

3. Hypersensitivity to any of the components of the product.

1. Long term use of this product is inadvisable except under medical supervision.

2. A dose of 30 ml provides 116 KJ (28 kcals) and is unlikely to adversely affect diabetics.

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

4. Use of laxatives in children should be under medical supervision.

The product should not be taken with enteric coated mesalazine (5-ASA) as the lower stool pH may prevent the release of mesalazine.

The product may be used during pregnancy when considered necessary by the physician.

None known.

Gastrointestinal disorders

1. 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, stomach ache and diarrhoea may occur. In such a case the dosage should be decreased.

2. 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.

No data on cases of overdosing are available. If dosed too high, stomach ache and diarrhoea can occur. In such instance, cessation of treatment will normally suffice.

In the colon, lactulose is broken down by colonic bacteria into low molecular weight organic acids. These acids lead to a lowering of pH in the colonic lumen and via an osmotic effect to an increase of the volume of the colonic contents. These effects stimulate the peristalsis of the colon and normalise the consistency of the stools. The constipation is cleared and the physiological rhythm of the colon is reinstated.

In hepatic encephalopathy (HE), the effect has been attributed to the suppression of proteolytic bacteria by an increase of acidophillic 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 the alteration of the bacterial nitrogen metabolism by stimulating the bacteria to utilise ammonia for bacterial protein synthesis. Within this context, however, it should be realised that hyperammonia alone cannot explain the neuropsychiatric manifestations of HE. The ammonia however might serve as a model compound for other nitrogenous substances.

Lactulose is largely unabsorbed and reaches the colon unchanged where it is metabolised by the bacterial flora. Metabolism is complete at doses up to 40 - 75 ml; at higher doses, some may be excreted unchanged.

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.

Purified Water

Not applicable

Three years.

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

Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300ml or 1 litre.

Not all pack sizes may be marketed

No special requirements

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

UK

PA 108/15/1

Date of first authorisation: 01 April 1983

Date of last renewal: 01 April 2008

1 April 2011