Lactugal.

Active Ingredient:

Lactulose Solution BP 99.897 % v/v

(Equivalent to 62.0-74.0% w/v of Lactulose).

Oral solution. Banana Flavour

Constipation; Hepatic encephalopathy (Portal systemic encephalopathy).

For oral administration.

Adults:

Constipation: 15ml once or twice daily.

Hepatic Encephalopathy: Initially 30-50ml three times daily, adjust dose to produce 2 or 3 soft stools daily.

Children:

1-5 years: 5ml twice daily.

5-10 years: l0ml twice daily.

Elderly:

The normal adult dosage is appropriate.

Lactugal is contra-indicated where there is evidence of gastro-intestinal obstruction and to patients with galactosaemia.

There are no warnings or precautions for patients with any impaired organ function.

Lactulose should be used with caution in patients exhibiting lactose intolerance.

Due to the product's physiological mode of action it may take up to 48 hours before effects are obtained, however, the product does exhibit a 'carry over' effect which may enable the patient to reduce the dose gradually over a period of time.

Lactulose solution has a calorific value of approximately 19Kcals/5mI. As, however, only negligible amounts of lactulose are absorbed from the gastrointestinal tract the available calories will be much lower than this, and therefore, is unlikely to adversely affect diabetes.

There are no known interactions with lactulose.

Wide clinical experience in combination with data from animal production studies has not revealed any embryotoxic hazards to the foetus if used in the recommended dosage during pregnancy. If drug therapy is required during pregnancy or for lactating mothers, the use of this drug is acceptable.

There is no evidence to show that lactulose affects driving ability.

A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by administration with water, fruit juice or meals.

If clinically important electrolyte disturbances occur, suitable corrective measures should be taken.

Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut.

Its mode of action in constipation is as an osmotic agent producing soft stools.

A dual mode of action is proposed for the efficacy of lactulose in Portal System Encephalopathy, relating to the metabolism of ammonia and subsequent nitrogenous toxins. The reduction in gastro-intestinal pH results in a net entrapment of ammonia in the gut lumen. Lactulose has also been shown to alter ammonia metabolism by microbial flora.

Lactulose is absorbed from the gastro-intestinal tract to 0.4 - 2% and is excreted unchanged with the urine. There are no human lactulose disaccharide enzymes; metabolism of lactulose to lactic acid occurs via gastro-intestinal microbial flora only. Due to its poor bioavailability, plasma lactulose concentrations are negligible.

There are no known changes in kinetic properties in patients with organic diseases which may alter drug disposition.

None stated.

Banana Flavour Quinoline Yellow

(17.41.0042) (E 1 04)

There are no known incompatibilities.

36 months from the date of manufacture.

Store at a temperature not exceeding 20°C. Do not freeze

Amber glass winchesters with polypropylene caps as closures. Polyethylene containers with polypropylene caps as closures.

There are no special storage or handling instructions for this product.

Administrative Data

Intrapharm Laboratories Ltd

Maidstone

Kent

ME15 9QS

United Kingdom

PL 17509/0011

4 September 2003